SOGC CLINICAL PRACTICE GUIDELINE
No. 329, November 2015 (Replaces No. 143, February 2004; No. 174, April 2006;
No. 195, July 2007; No. 219, November 2008; & No. 280, September 2012)
Canadian Contraception Consensus
(Part 2 of 4)
This clinical practice guideline has been prepared by the
Contraception Consensus Working Group, reviewed by the
Family Physicians Advisory, Aboriginal Health Initiative,
Clinical Practice – Gynaecology, and Canadian Paediatric
and Adolescent Gynaecology and Obstetrics (CANPAGO)
Committees, and approved by the Executive and Board of
the Society of Obstetricians and Gynaecologists of Canada.
PRINCIPAL AUTHORS
Amanda Black, MD, Ottawa ON (Co-chair)
Edith Guilbert, MD, Quebec QC (Co-chair)
CO-AUTHORS
Dustin Costescu, MD, Hamilton ON
Sheila Dunn, MD, Toronto ON
William Fisher, PhD, London ON
Sari Kives, MD, Toronto ON
Melissa Mirosh, MD, Saskatoon SK
Wendy V. Norman, MD, Vancouver BC
Helen Pymar, MD, Winnipeg MB
Robert Reid, MD, Kingston ON
Geneviève Roy, MD, Montreal QC
Hannah Varto, NP(F), Vancouver BC
Ashley Waddington, MD, Kingston ON
Marie-Soleil Wagner, MD, Montreal QC
Anne Marie Whelan, PharmD, Halifax NS
Abstract
Objective: To provide guidelines for health care providers on the
use of contraceptive methods to prevent pregnancy and on the
promotion of healthy sexuality.
Outcomes: Guidance for Canadian practitioners on overall
effectiveness, mechanism of action, indications,
contraindications, non-contraceptive benefits, side effects
and risks, and initiation of cited contraceptive methods; family
planning in the context of sexual health and general wellbeing; contraceptive counselling methods; and access to, and
availability of, cited contraceptive methods in Canada.
Evidence: Published literature was retrieved through searches
of Medline and The Cochrane Database from January 1994
to January 2015 using appropriate controlled vocabulary
(e.g., contraception, sexuality, sexual health) and key words
(e.g., contraception, family planning, hormonal contraception,
emergency contraception). Results were restricted to
systematic reviews, randomized control trials/controlled
clinical trials, and observational studies published in English
from January 1994 to January 2015. Searches were updated
on a regular basis and incorporated in the guideline to June
2015. Grey (unpublished) literature was identified through
searching the websites of health technology assessment
and health technology-related agencies, clinical practice
guideline collections, clinical trial registries, and national and
international medical specialty societies.
Values: The quality of the evidence in this document was rated
using the criteria described in the Report of the Canadian Task
Force on Preventive Health Care (Table 1).
SPECIAL CONTRIBUTORS
Carrie Ferguson, MD, Kingston ON
Claude Fortin, MD, Montreal QC
Maria Kielly, MD, Ottawa ON
Shireen Mansouri, MD, Yellowknife NWT
Nicole Todd, MD, Vancouver BC
Disclosure statements have been received from all contributors.
The literature searches and bibliographic support for this
guideline were undertaken by Becky Skidmore, Medical
Research Analyst, Society of Obstetricians and Gynaecologists
of Canada.
Key Words: contraception, family planning, hormonal
contraception, emergency contraception, barrier contraceptive
methods, contraceptive sponge, spermicide, natural family
planning methods, tubal ligation, vasectomy, permanent
contraception, intrauterine contraception, counselling, statistics,
health policy, Canada, sexuality, sexual health, sexually transmitted
infection (STI)
J Obstet Gynaecol Can 2015;37(11):S1–S39
This document reflects emerging clinical and scientific advances on the date issued and is subject to change. The information
should not be construed as dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate
amendments to these opinions. They should be well documented if modified at the local level. None of these contents may be
reproduced in any form without prior written permission of the SOGC.
NOVEMBER JOGC NOVEMBRE 2015 l S1
SOGC clinical practice guideline
Table 1. Key to evidence statements and grading of recommendations, using the ranking of the Canadian Task Force
on Preventive Health Care
Quality of evidence assessment*
Classification of recommendations†
I:
A. There is good evidence to recommend the clinical preventive action
Evidence obtained from at least one properly randomized
controlled trial
II-1: Evidence from well-designed controlled trials without
randomization
B. There is fair evidence to recommend the clinical preventive action
II-2: Evidence from well-designed cohort (prospective or
retrospective) or case–control studies, preferably from
more than one centre or research group
C. The existing evidence is conflicting and does not allow to make a
recommendation for or against use of the clinical preventive action;
however, other factors may influence decision-making
II-3: Evidence obtained from comparisons between times or
places with or without the intervention. Dramatic results in
uncontrolled experiments (such as the results of treatment with
penicillin in the 1940s) could also be included in this category
D. There is fair evidence to recommend against the clinical preventive action
III:
Opinions of respected authorities, based on clinical experience,
descriptive studies, or reports of expert committees
E. There is good evidence to recommend against the clinical preventive
action
L. There is insufficient evidence (in quantity or quality) to make
a recommendation; however, other factors may influence
decision-making
*The quality of evidence reported in these guidelines has been adapted from The Evaluation of Evidence criteria described in the Canadian Task Force on
Preventive Health Care.
†Recommendations included in these guidelines have been adapted from the Classification of Recommendations criteria described in the Canadian Task Force
on Preventive Health Care.
Woolf SH, Battista RN, Angerson GM, Logan AG, Eel W. Canadian Task Force on Preventive Health Care. New grades for recommendations from the Canadian Task
Force on Preventive Health Care. CMAJ 2003;169:207–8.
Chapter 4.
Natural Family Planning
Summary Statements
21. Natural family planning methods may be appropriate methods
of contraception for couples who are willing to accept a higher
rate of contraceptive failure than with other more effective
contraceptive methods. (III)
22. The exact effectiveness of natural family planning (NFP) methods
is difficult to estimate. When NFP methods are not adhered to
and intercourse takes place during the fertile window, the risk of
conception from a single failure is high. (III)
23. Many women and couples have used natural family planning
methods, particularly withdrawal, at some point in their
reproductive lives. (III)
24. Coitus interruptus (“withdrawal”) as a risk-reduction strategy is
preferable to no contraception at all, but typical-use failure rates
are relatively high and it does not reliably protect against sexually
transmitted infections. (II-2)
25. Lactational amenorrhea is an effective method of birth control
when used by women who are less than 6 months postpartum,
fully or nearly fully breastfeeding, and have not resumed menses
postpartum. (II-2)
26. Abstinence is a contraceptive choice that requires supportive
counselling and information-sharing from health care providers. (III)
Recommendations
23. Health care providers should respect the choice of a natural
family planning (NFP) method, be aware of options for NFP,
and be able to provide appropriate resources/counselling on the
correct use of a woman or couple’s chosen method. (II-2B)
24. Natural family planning methods should not be proposed
to women solely based on contraindications to another
S2 l NOVEMBER JOGC NOVEMBRE 2015
contraceptive method without a thorough review of other
potentially safe and more effective methods. (II-2B)
25. Couples using natural family planning methods, including
withdrawal and abstinence, should be provided with information
about effective methods of emergency contraception and
screening for sexually transmitted diseases. (III-B)
26. All pregnant or postpartum women should receive clear
instructions on the lactational amenorrhea method of birth
control and the criteria that must be met to achieve reliable
contraception. (III-B)
Chapter 5.
Barrier Methods
Summary Statements
27. Latex condoms, used consistently and correctly, will provide
protection against pregnancy (II-2) and sexually transmitted
infections (STIs), including human immunodeficiency virus
infection (II-1). However, no barrier contraceptive method can
provide 100% protection from all STIs. (III)
28. Polyurethane and other non-latex male condoms have an increased
incidence of breakage and slippage than latex condoms; hence, the
protection they provide against sexually transmitted infections (STIs)
and human immunodeficiency virus (HIV) infection is inferior to
that of latex condoms (I). Polyurethane and polyisoprene condoms
remain important options for contraception and reduction of STIs in
the presence of latex allergies. Lambskin condoms do not protect
against HIV infection. (III)
29. The effectiveness of barrier methods can be complemented by
the use of emergency contraception. (III)
30. The contraceptive sponge and spermicides used alone are not
highly effective contraceptive methods; their effectiveness may be
enhanced when used in combination with another contraceptive
method. (II-2)
Canadian Contraception Consensus (Part 2 of 4)
31. Contraceptive products containing nonoxynol-9 may cause
vaginal epithelial damage and increase the risk of human
immunodeficiency virus infection. (I)
Recommendations
27. Health care providers should promote the consistent and correct
use of latex condoms to improve protection against pregnancy,
human immunodeficiency virus infection, and other sexually
transmitted infections. (II-2A)
28. Health care providers should educate women and men
about the correct use of barrier methods. They should
emphasize the need for dual protection against pregnancy and
infections. (II-2B)
29. Women who use barrier methods of contraception should be
counselled about emergency contraception. (III-B)
30. The use of spermicide-coated condoms should no longer be
promoted. (I-A)
31. Diaphragms and cervical caps should continue to be available in
Canada and appropriate training should be available for health
care providers to become proficient in fitting diaphragms. (III-C)
ABBREVIATIONS
BBT basal body temperature
CREST Collaborative Review of Sterilization
32. Nonoxynol-9 products should not be used to reduce the risk of
sexually transmitted infections and human immunodeficiency
virus infection (HIV) and should not be used by women at high
risk for HIV transmission. (I-A)
Chapter 6.
Permanent Contraception
Summary Statements
32. Women who do not desire a future pregnancy and who do not
wish to use a reversible method of contraception, particularly
long-acting reversible methods, may be candidates for a
permanent contraception procedure. (III)
33. Only individuals who have capacity to give informed consent
can agree to have a permanent contraceptive procedure. A
proxy decision-maker cannot consent to the non-therapeutic
sterilization of a mentally incompetent person. (III)
34. The 10-year cumulative failure rate of female permanent
contraceptive procedures is less than 2%. (II-2)
35. Although the risk of pregnancy after a permanent contraception
procedure is low, there is a substantial risk of an ectopic
pregnancy if a pregnancy occurs after tubal ligation. (II-2) The
absolute risk of ectopic pregnancy is lower than the risk among
women not using contraception. (III)
36. Tubal ligation is associated with a decreased risk of ovarian
cancer. (II-2)
37. Regret is one of the most common complications following a
permanent contraceptive procedure with young age being a
major risk factor. (II-2)
CV conventional vasectomy
EHFM electronic hormonal fertility monitors
FAB fertility awareness-based
FC female condom
GnRH gonadotropin releasing hormone
HIV human immunodeficiency virus
HPV human papillomavirus
HSG hysterosaplingogram
IVF in vitro fertilization
LAM lactational amenorrhea method
LARC long-acting reversible contraceptive
LH luteinizing hormone
MIV minimally invasive vasectomy
N–9 nonoxynol-9
NFP natural family planning
NIHB non-insured health benefits
NSV no-scalpel vas isolation
OPK ovulation predictor kits
43. Vasectomy does not increase the risk of prostate/testicular cancer,
coronary heart disease, stroke, hypertension, or dementia. (II-2)
PEP post-exposure prophylaxis
Recommendations
PVSA post-vasectomy semen analysis
RNMS rare non-motile sperm
SDM standard days method
STI sexually transmitted infection
33. Before providing permanent contraception, women should be
counselled on the risks of the procedure, the risk of regret,
and alternative contraceptive methods, including long-acting
reversible contraceptives and male vasectomy. Informed consent
must be obtained. (II-2A)
TSS toxic shock syndrome
UPI unprotected intercourse
UTI urinary tract infection
38. Tubal occlusion may not be complete for several months after the
hysteroscopic procedure. An additional method of contraception
is required for at least 3 months and until imaging confirms
bilateral tubal occlusion. (II-2)
39. Salpingenctomy may provide women, who are absolute in their
decision, the additional benefit of risk reduction against ovarian
cancer. (II-2)
40. Women and men who do not desire a future pregnancy and
who do not wish to use a reversible method of contraception,
particularly long-acting reversible methods, may be candidates
for permanent contraception. (III)
41. Compared to tubal ligation, vasectomy is generally safer,
more effective, less expensive, and is a less invasive surgical
procedure that can be performed under local anaesthetic. (II-2)
42. Vasectomy is not effective immediately. Once one fresh postvasectomy semen analysis shows azoospermia or ≤ 100 000 nonmotile sperm, the risk of contraceptive failure is 1 in 2000 (0.05%).
Repeat vasectomy is necessary in ≤ 1% of vasectomies. (II-2)
34. In a well-informed woman who understands her contraceptive
options and the permanency of the procedure and who is capable
of consent, age and parity should not be a barrier to permanent
contraception. (III-B)
NOVEMBER JOGC NOVEMBRE 2015 l S3
SOGC clinical practice guideline
35. Women should be advised to use an effective method of
contraception up until the day of their permanent contraception
procedure. A pregnancy test should be performed on the day of
the procedure. (III-A)
36. Women undergoing a laparoscopic procedure should continue to
use an effective method of contraception for one week following
the procedure. (III-B)
37. Women having a hysteroscopic tubal occlusion procedure should
use an effective method of contraception up until the day of
surgery and for at least 3 months afterward until imaging studies
have confirmed bilateral tubal occlusion. (II-2A)
38. Isolation of the vas deferens should be performed using a
minimally invasive vasectomy technique such as the no-scalpel
vas occlusion technique. Vas occlusion should be performed by
S4 l NOVEMBER JOGC NOVEMBRE 2015
any 1 of 4 techniques that are associated with occlusive failure
rates consistently below 1%. (III-B)
39. Patients who have had a vasectomy should be advised that they
may stop using a second method of contraception when one
uncentrifuged fresh semen specimen shows azoospermia or
≤ 100 000 non-motile sperm/mL. (III-B)
This document’s Abstract was
previously published in:
J Obstet Gynaecol Can 2014;35(11):1033–1035
CHAPTER 4
Natural Family Planning
N
FP refers to methods of contraception that do not
rely upon medical devices, compounds, or drugs.
There are a range of NFP contraceptive strategies including
FAB methods, lactational amenorrhea, withdrawal, and
abstinence from penile–vaginal intercourse.1 Health care
providers may underestimate the effectiveness of these
methods2 or may not be familiar with how to appropriately
counsel women or couples who wish to use NFP methods.
FERTILITY AWARENESS-BASED METHODS
FAB methods rely upon the knowledge that virtually all
conceptions arise from intercourse that occurs from 5 days
before to 1 day following ovulation.3 FAB methods of
contraception rely upon avoiding unprotected intercourse
during this “fertile window,” and can be used in combination
with abstinence or barrier methods during the fertile time.
The fertile window can be identified by one of 2 means:
by symptoms and signs of ovulation (the cervical mucus
method, the symptothermal method, and the two-day
method) or by calendar calculations of the fertile days (and
SDM).
Effectiveness
It is challenging to calculate an accurate estimate of
the effectiveness of FAB. With perfect use, the 1-year
pregnancy rates are 0.4% for the symptothermal method
and 4% and 5% for the standard days and two-day
methods, respectively. With typical use, however, the
1-year pregnancy rate for all FAB methods is estimated
to be 24%.4 When NFP methods are not adhered to and
intercourse takes place during the fertile window, the risk
of conception from a single contraceptive failure is high.
Failure rates are affected by several known and suspected
factors, including motivation on the part of both partners
to avoid pregnancy, belonging to a country of origin
where FAB methods are practised more widely, health care
provider knowledge, quality of teaching given to women,
coital frequency, and method of contraception used during
the fertile window (abstinence vs. withdrawal vs. barrier
method).5,6 One-year continuation rates are low4 and 5% to
62% of couples using FAB methods report difficulty with
mandated abstinence.7
Mechanism of Action
The mechanism of action of FAB methods is to avoid UPI
when there is a high probability of fertilization.
Initiation
For all FAB methods, women and their partners must
be educated about the fertile window and given specific
instructions on how to use the method.
Standard Days Method
This method requires avoiding unprotected sexual
intercourse on days 8 to 19 of the menstrual cycle in
women who have a menstrual cycle from 26 to 32 days
in length.8,9 Several aids exist to help couples track their
fertile window, including tracking on a calendar or use
of cycle-tracking beads, web-based trackers, or mobile
applications. Couples who use electronic applications to
time intercourse should be familiar with the algorithm
used by the program.
Calendar Days Method
Although this method has now largely been replaced by
SDM, it may be useful to women whose cycles are not in
the range of 26 to 32 days. A woman must track her natural
menstrual cycle length for 6 to 12 months prior to using
this method (during which time the risk of conception is
significant). To determine the start of the fertile window,
subtract 20 days from the length of her shortest cycle.
To determine the end of the fertile window, subtract
10 days from the length of the longest cycle. Unprotected
intercourse should be avoided during that time.
Symptothermal Method
The symptothermal method is a double-check method that
evaluates cervical mucus to determine the first fertile day
and then cervical mucus and temperature to determine the
last fertile day.
Cervical Mucus (Billing’s Method)
Women are taught to monitor the volume and changes
in cervical mucus throughout the cycle. As ovulation
approaches, mucus becomes abundant, clearer, and more
elastic. Fecundability is decreased 3 days after the clearest
and most elastic mucus is produced. If the follicular
response is very rapid, there may be mucus present during
NOVEMBER JOGC NOVEMBRE 2015 l S5
Canadian Contraception Consensus (Part 2 of 4)
menstruation. After ovulation, mucus first becomes thick,
opaque, and reduces in volume significantly.10 Some
practitioners advocate that couples using this method
should have a coital frequency less than once every 2
days to allow vaginal contents to clear and allow better
assessment of cervical mucus.11
Basal Body Temperature
Wake-up body temperature is measured every day, using a
special BBT thermometer, after at least 6 hours of sleep.
The BBT is then recorded on a chart (or entered into a
computer program) so that the woman can observe the
rise in her BBT following the post-ovulatory elevation
of progesterone. The BBT should rise by at least 0.5ºC.
To avoid pregnancy, there should be no unprotected
intercourse from the beginning of the cycle until after
3 consecutive days of temperature elevation.11 For this
reason, the BBT is usually used in combination with
another contraceptive method for pregnancy prevention.
Two-Day Method
The two-day method is based on evaluation of cervical
mucus and uses a simplified algorithm to identify a woman’s
fertile window. If cervical secretions were present “today”
and “yesterday” a woman is “very fertile.” If cervical
secretions were present either “today” or “yesterday” she
is “fertile.” If there was no cervical mucus “today” or
“yesterday” a woman’s fertility is low.12
USE OF FERTILITY MONITORS
FOR CONTRACEPTION
Ovulation Predictor Kits
OPKs use saliva patterns or urine LH measurements
to assess when ovulation may occur. They are primarily
indicated and marketed for those wishing to conceive, but
they can be used to assist those using NFP. Because most
conceptions occur from intercourse that precedes the LH
surge, OPKs are only useful to indicate that ovulation
has passed (once the LH reading returns to negative) and
fertility is low until menses.
Electronic Hormonal Fertility Monitors
EHFMs can be used to enhance NFP methods. A handheld
device will indicate when after menses testing should
commence. The device measures urinary LH and estrone3-glucuronide (an estrogen metabolite) to indicate periods
of high fertility. In one randomized trial comparing the
fertility monitor to cervical mucus self-screening (with
internet-based guidance for both groups), 12-month
unintended pregnancy rates were significantly lower in the
EHFM group (7% vs. 18.5%).13
S6 l NOVEMBER JOGC NOVEMBRE 2015
Indications
Fertility awareness-based methods may be a contraceptive
option for:
•• women and couples who wish to avoid contraceptive
devices or drugs,
•• women and couples wishing to augment the
effectiveness of another (non-hormonal) contraceptive
method by avoiding unprotected intercourse during the
fertile window,
•• women and couples for whom a relatively high risk of
contraceptive failure is acceptable, and
•• women and couples who wish to adhere to cultural or
religious norms about contraception.
Contraindications
In general, FAB methods can be used without concerns
for adverse health effects.1,9 However, some conditions
may make their use more complex and require special
counselling. FAB may not be suitable options when:
•• women or their partners are unwilling to comply with
abstaining from unprotected vaginal intercourse during
fertile periods;
•• women are unable to observe and chart the signs of
fertility;
•• women have conditions affecting body temperature
regulation (fever, insomnia, irregular sleeping habits,
shift workers);
•• women have unpredictable or irregular menstrual
cycles (e.g. polycystic ovarian syndrome, postpartum,
perimenopause);
•• women have difficulty assessing cervical mucus
because of vaginal infection or use of vaginal agents
(e.g., lubricants, spermicides);
•• women are at high risk of acquiring an STI or HIV; or
•• women have medical conditions for which pregnancy
poses an unacceptable health risk or for personal
reasons must avoid pregnancy, and thus a more
effective method would be advisable.
Non-contraceptive Benefits
The main non-contraceptive benefit of any FAB method is
that it provides a valid alternative for women and couples
who wish to avoid medical devices or drugs to prevent
pregnancy. NFP also helps women to learn about their
own bodies and menstrual cycle, and can help women
identify fertile days when conception is desired.
Risks and Side Effects
There is a relatively high probability of failure with all FAB
methods if they are not used consistently and correctly.
FAB methods do not provide protection against STIs.
CHAPTER 4: Natural Family Planning
Troubleshooting
Contraindications
LACTATIONAL AMENORRHEA METHOD
•• any of the 3 conditions for LAM are not met,
This is an inexpensive and effective method of
contraception used worldwide.
•• a woman has difficulties with breastfeeding that cannot
be overcome with regular pumping,
Couples who chose FAB methods should be counselled
about emergency contraception.
Effectiveness
LAM is only effective when all 3 following key criteria are
met:14–16
•• the woman is less than 6 months postpartum;
•• she is fully or nearly fully breastfeeding;
1,17,18
and
•• she has remained amenorrheic.
14,15
When used correctly, LAM is 98% effective.14 In a Cochrane
review on LAM, no differences in effectiveness were seen
in women who were taught and used LAM with the goal
of contraception and those women who simply were fully
breastfeeding for infant well-being (and by chance met the
additional criteria for LAM).19
Fully breastfeeding includes exclusive (infant receives no
other liquid or food, not even water) and almost-exclusive
(infant receives vitamins, water, juice, or other nutrients once
in a while) breastfeeding. Nearly fully breastfeeding means
that more than three quarter of all feeds are breast milk.20
Mechanism of Action
The primary mechanism of action of LAM is suppression
of the hypothalamic–pituitary–ovarian axis via disruption
of GnRH pulsatility, resulting in decreased LH production
and anovulation.21 Although ovulation may occur during
LAM in the first 6 months postpartum, ovulation and
the luteal phase rarely have normal characteristics. Only
60% of ovulations that precede the first menses have an
adequate luteal phase to support a pregnancy.22
Indications
The indications for LAM include:
•• women and couples who wish to avoid and/or cannot
afford contraceptive devices or drugs during the
postpartum period,
•• women and couples wishing a temporary method of
fertility regulation during the postpartum period,
•• women and couples for whom other family planning
methods are either not readily available or not desired,
and
•• women and couples who wish to adhere to cultural or
religious norms about contraception.
There are few medical conditions for which use of LAM
is absolutely contraindicated as a contraceptive method.
LAM is contraindicated when:
•• a woman has a medical condition for which another
pregnancy or a short interval between pregnancies
poses an unacceptable health risk, and thus a more
effective method would be advisable,
•• a woman has a contraindication to breastfeeding
including maternal HIV, untreated active tuberculosis,
use of drugs contraindicated with breastfeeding, and
maternal drug abuse, or1,16,23
•• the newborn has a condition that makes it difficult
to breastfeed (small-for-date or premature; needing
intensive neonatal care; unable to digest food normally;
or having deformities of the mouth, jaw, or palate) and
the mother is not able to pump her milk regularly.
Non-contraceptive Benefits
The Canadian Paediatric Society recommends exclusive
breastfeeding until the age of 6 months for healthy, term
infants due to the numerous benefits it has for infants.24
Breastfeeding is also much less expensive than formula
feeding, and is beneficial to maternal–child attachment.
LAM does not have an effect on breast milk production.
Risks and Side Effects
Failure to use LAM correctly results in a relatively higher
risk of failure from even one act of vaginal intercourse.
Ovulation occurs as early as 26 days postpartum in nonlactating women, and fertility can be restored quickly
when breastfeeding is reduced.22 Knowledge about LAM
is poor across most populations, due partly to inconsistent
information provided by health care practitioners. Evidencebased, factual instructions and information should be given
to all couples regarding postpartum contraception.25
LAM does not protect against STIs or HIV. In general,
the use of LAM and breastfeeding in HIV-positive
women should be discouraged. The Canadian Paediatric
Society considers HIV infection a contraindication to
breastfeeding23 and the Centers for Disease Control and
Prevention recommend against LAM in HIV-positive
women owing to the ease of access and safety of infant
formulas in the United States.16 Health care providers
should discuss possible contraindications to breastfeeding
with women prior to initiating LAM, making use of expert
consultation where appropriate.
NOVEMBER JOGC NOVEMBRE 2015 l S7
Canadian Contraception Consensus (Part 2 of 4)
WITHDRAWAL (COITUS INTERRUPTUS)
The prevalence of withdrawal (coitus interruptus) is
largely underestimated by clinicians, as it is often not seen
as a legitimate contraceptive method. However, it is widely
used, and in a 2006 survey 11.6% of Canadian women
reported using withdrawal as a contraceptive method.26
In one study from the United States, 58.8% reported ever
using withdrawal as a contraceptive method.27
Withdrawal has no direct associated health risks. It does
not affect breastfeeding, it is inexpensive, requires no
chemicals or devices, does not require consultation with a
health care provider, and is readily available for primary use
or as a backup method of contraception.1,9
Effectiveness
The effectiveness of withdrawal depends on the willingness
and ability of a couple to use withdrawal with every act
of intercourse.1,9 Estimates from large population based
studies estimate the typical-use failure rate of withdrawal
at 22%. With perfect use, 4% of couples will experience
pregnancy within 12 months.4
Pre-ejaculate fluid consists of secretions from the Cowpers’
glands and the glands of Littre. There is controversy over
whether or not there are sufficient quantities of motile
sperm in pre-ejaculate fluid to lead to fertilization. In a
study of 27 men and 40 samples of pre-ejaculate fluid
collected and analyzed within 2 minutes, 37% contained
a “reasonable number of motile sperm.”28 Theoretically,
there are enough motile sperm in the pre-ejaculate of
some men to fertilize an egg. Interestingly, among those
who provided more than one sample, spermatozoa were
either consistently present or consistently absent.28
Mechanism of Action
During coitus, the male withdraws his penis from the
vagina and away from the external genitalia of the female
partner prior to ejaculation. Sperm is not ejaculated into the
vagina or on the vulva, thereby avoiding contact between
spermatozoa and the ovum.
Indications
Withdrawal may be a useful contraceptive option when:
•• women and couples wish to augment the effectiveness
of other contraceptive methods,
•• women and couples wish to use NFP for
contraception,
•• a higher risk of contraceptive failure is acceptable to a
woman or couple, and
•• intercourse is infrequent.
S8 l NOVEMBER JOGC NOVEMBRE 2015
Withdrawal may be appropriate for couples who are highly
motivated, who for religious or philosophical reasons do not
wish to use other methods of contraception, who need a
temporary method while waiting to start another method or
waiting for another method to become effective, or who need
contraception immediately and have entered into a sexual act
without having another alternative method available.1,9
Contraindications
This method should be avoided in the following
circumstances:
•• The man is not sure that he can reliably withdraw prior
to ejaculation.
•• There is a high risk of STI or HIV transmission,
because withdrawal involves unprotected intercourse.
Condom use is recommended for STI and HIV
prevention.
•• Women and couples are not accepting of a method
with a relatively high typical-use failure rate.
•• A woman has a medical condition for which a
pregnancy poses an unacceptable health risk, and thus
a more effective method would be advisable.
Non-contraceptive Benefits
In one study of HIV sero-discordant couples (man is
HIV+ and woman is HIV−), users of withdrawal had
lower rates of seroconversion than those couples having
intercourse without withdrawal29; however, this potential
benefit must be weighed against an overall increased risk
of HIV acquisition if barriers are not used because HIVinfected cells have been isolated from pre-ejaculate.30
Risks and Side Effects
Use of withdrawal requires self-control. The man must
have the ability to recognize impending ejaculation and to
resist the urge to pursue coital orgasm. Withdrawal does
not reliably protect against STIs or HIV.30 Correct and
consistent use of condoms is recommended to decrease
the risk of STIs and HIV transmission.
Initiation
Health care providers should inquire about use of
withdrawal and provide information about its effectiveness.
It can be used to augment the effectiveness of other
contraceptive methods and for some couples may be a valid
contraceptive strategy. For couples using only withdrawal
and in need of very effective birth control, the reasons for
choosing this method should be explored, and acceptable
alternatives should be offered.
Troubleshooting
All couples using withdrawal should be counselled about
currently available options for emergency contraception.
CHAPTER 4: Natural Family Planning
Emergency contraception should be strongly considered
when there is any contact between ejaculatory fluid and
the vulva or vagina. In some circumstances, STI testing31
and post-exposure prophylaxis32,33 may also be considered.
ABSTINENCE
Abstinence refers to delaying or avoiding some or all
sexual behaviours. Abstinence may mean different things
to different people. From a family planning perspective,
it is only necessary for couples to avoid sexual acts that
involve the introduction of seminal contents into the
vagina; however, certain STIs may be transmitted from
skin-to-skin contact. Primary abstinence refers to delaying
some or all sexual behaviours by those who have never
been sexually active. Secondary abstinence refers to the
conscious decision to delay or avoid some or all sexual
behaviours among those who have been sexually active
in the past. Periodic abstinence refers to abstaining from
penile–vaginal intercourse during the fertile window of the
menstrual cycle.
Health care providers should support individuals who
choose abstinence and assist them with negotiation
and planning skills to use abstinence effectively. Health
care providers can also ensure that individuals who are
practising abstinence are aware of sexual health issues that
may become relevant to them currently or in the future.
Adopting an “abstinence-only” approach to counselling in
lieu of comprehensive sexual education may increase harm
and does not delay coital début.34
Effectiveness
Abstinence is 100% effective in terms of family planning,
provided that semen is not introduced onto the vulva
or into the vagina. Abstinence is not an effective STI
protection strategy if individuals are engaging in other
sexual activities.
Indications
Abstinence may be chosen by women or couples who
prefer to abstain from certain sexual behaviours for
personal reasons or whose cultural, moral, or religious
beliefs restrict the use of other methods of family planning.
Contraindications
It may be difficult to maintain a relationship where there
is strong discordance about the decision to abstain from
sex. Conversely, delaying sex may give a couple time to get
to know each other and may improve the quality of the
relationship.35 The decision to become sexually active must
be made individually and voluntarily without coercion by
others.
Non-contraceptive Benefits
Abstinence does not cost anything unless barrier methods
are used for other sexual acts. Individuals who practise
abstinence have a decreased risk of STIs and HIV
infection, and primary abstainers have a decreased risk of
cervical cancer.36
Risks and Side Effects
Abstinence may be too restrictive for some couples and
may leave women and couples unprepared if sexual activity
occurs they do not know how to reduce risks.
Initiation
What individuals define as abstinence is an important
question with clinical implications. Couples and individuals
practising abstinence deserve respect and non-judgemental
support. They should be offered education about other
methods of birth control and safer sex to help them if their
sexual agendas change. Assisting with communication skills
to transmit intentions to partners can be valuable, especially
for young people. Those who practise abstinence should be
informed about emergency contraception, STI screening,
and post-exposure prophylaxis in their community.
Some women may discontinue other contraceptive
methods when they are no longer in a relationship
(secondary abstinence). However, secondary abstinence
does not necessarily require that they take a “break” from
their other contraceptive method.
Troubleshooting
Health care providers should determine with those
choosing abstinence why they made this choice, what
sexual activities they will say “yes” to, and whether they
have discussed these with their partner. It is important to
help them avoid high-pressure sexual situations and teach
them techniques for saying “no.” It is also important to
suggest that condoms be readily available in case they
change their minds.
Summary Statements
21. Natural family planning methods may be
appropriate methods of contraception for
couples who are willing to accept a higher rate of
contraceptive failure than with other more effective
contraceptive methods. (III)
22. The exact effectiveness of natural family planning
(NFP) methods is difficult to estimate. When
NFP methods are not adhered to and intercourse
takes place during the fertile window, the risk of
conception from a single failure is high. (III)
23. Many women and couples have used natural family
planning methods, particularly withdrawal, at some
point in their reproductive lives. (III)
NOVEMBER JOGC NOVEMBRE 2015 l S9
Canadian Contraception Consensus (Part 2 of 4)
24. Coitus interruptus (“withdrawal”) as a riskreduction strategy is preferable to no contraception
at all, but typical-use failure rates are relatively high
and it does not reliably protect against sexually
transmitted infections. (II-2)
25. Lactational amenorrhea is an effective method
of birth control when used by women who are
less than 6 months postpartum, fully or nearly
fully breastfeeding, and have not resumed menses
postpartum. (II-2)
26. Abstinence is a contraceptive choice that requires
supportive counselling and information-sharing
from health care providers. (III)
Recommendations
23. Health care providers should respect the choice
of a natural family planning (NFP) method, be
aware of options for NFP, and be able to provide
appropriate resources/counselling on the correct
use of a woman or couple’s chosen method. (II-B)
24. Natural family planning methods should
not be proposed to women solely based on
contraindications to another contraceptive method
without a thorough review of other potentially safe
and more effective methods. (II-B)
25. Couples using natural family planning methods,
including withdrawal and abstinence, should be
provided with information about effective methods
of emergency contraception and screening for
sexually transmitted diseases. (III-B)
26. All pregnant or postpartum women should receive
clear instructions on the lactational amenorrhea
method of birth control and the criteria that must
be met to achieve reliable contraception. (III-B)
REFERENCES
1. World Health Organization. Improving access to quality care in family
planning: medical eligibility criteria for contraceptive use. 4th ed. Geneva
(CH): WHO; 2010.
2. Choi J, Chan S, Wiebe E. Natural family planning: physicians’ knowledge,
attitudes, and practice. J Obstet Gynaecol Can 2010;32:673–8.
3. Wilcox AJ, Weinberg CR, Baird DD. Timing of sexual intercourse
in relation to ovulation. Effects on the probability of conception,
survival of the pregnancy, and sex of the baby. N Engl J Med
1995;333:1517–21.
4. Trussell J. Contraceptive failure in the United States. Contraception
2011;83:397–404.
5. Fehring RJ, Schneider M, Barron ML, Pruszynski J. Influence of
motivation on the efficacy of natural family planning. MCN Am J Matern
Child Nurs 2013;38:352–8.
6. Freundl G, Sivin I, Batar I. State-of-the-art of non-hormonal methods
of contraception: IV. Natural family planning. Eur J Contracept Reprod
Health Care 2010;15:113–23.
S10 l NOVEMBER JOGC NOVEMBRE 2015
7. World Health Organization. A prospective multicenter trial of the
ovulation method of natural family planning. V. Psychosexual aspects.
World Health Organization. Fertil Steril 1987;47:765–72.
8. Arevalo M, Jennings V, Sinai I. Efficacy of a new method of family
planning: the standard days method. Contraception 2002;65:333–8.
9. Centers for Disease Control and Prevention. U.S. medical eligibility
criteria for contraceptive use, 2010. MMWR Recommend Rep
2010;59(RR-4):1–85.
10. Billings JJ. Ovulation method of family planning. Lancet 1972;2:1193–4.
11. Hatcher RA, Turussell J, Nelson A, Cates W, Kowal D, Policar M.
Contraceptive technology, 20th ed. New York (NY): Ardent Media; 2011.
12. Dunson DB, Sinai I, Colombo B. The relationship between cervical
secretions and the daily probabilities of pregnancy: effectiveness of the
TwoDay Algorithm. Hum Reprod. 2001;16:2278–82.
13. Fehring RJ, Schneider M, Raviele K, Rodriguez D, Pruszynski J.
Randomized comparison of two Internet-supported fertility-awarenessbased methods of family planning. Contraception 2013;88:24–30.
14. Kennedy KI, Rivera R, McNeilly AS. Consensus statement on the
use of breastfeeding as a family planning method. Contraception
1989;39:477–96.
15. Labbok M, Cooney K, Coly S. Guidelines: breastfeeeding, family
planning and the lactational amenorrhea method - LAM. Washington
(DC): Institute for Reproductive Health; 1994.
16. Centers for Disease Control and Prevention. U.S. medical eligibility
criteria for contraceptive use. mmWR. 2010;59(RR-4):73, Appendix I.
17. Diaz S, Aravena R, Cardenas H, Casado ME, Miranda P,
Schiappacasse V, et al. Contraceptive efficacy of lactational amenorrhea
in urban Chilean women. Contraception. 1991;43:335–52.
18. Short RV, Lewis PR, Renfree MB, Shaw G. Contraceptive effects of
extended lactational amenorrhoea: beyond the Bellagio Consensus.
Lancet 1991;337:715–7.
19. Van der Wijden C, Kleijnen J, Van den Berk T. Lactational amenorrhea
for family planning. Cochrane Database Syst Rev 2003(4):CD001329.
20. K4Health. Family planning: a global handbook for providers.
Chapter 19: lactational amenorrhea. Baltimore (MD): K4Health Orders
Team; 2015. Available at: https://www.fphandbook.org/chapter-19lactational-amenorrhea-method. Accessed on January 30, 2015.
21. McNeilly AS, Tay CCK, Glasier A. Physiological mechanisms
underlying lactational amenorrhea. In: Campbell KL, Wood JW, eds.
Human reproductive ecology: interactions of environment, fertility and
behaviour. New York (NY): Academy of Science; 1994: pp. 145–55.
22. Lewis PR, Brown JB, Renfree MB, Short RV. The resumption of
ovulation and menstruation in a well-nourished population of
women breastfeeding for an extended period of time. Fertil Steril
1991;55:529–36.
23. Canadian Paediatric Society. Maternal infectious diseases, antimicrobial
therapy or immunizations: very few contraindications to breastfeeding.
Paediatr Child Health 2006;11:489–91.
24. Boland M. Exclusive breastfeeding should continue to six months.
Paediatr Child Health 2005;10:148.
25. Speroff L, Mishell DR Jr. The postpartum visit: it’s time for a change in
order to optimally initiate contraception. Contraception 2008;78:90–8.
26. Black A, Yang Q, Wen SW, Lalonde A, Guilbert E, Fisher W.
Contraceptive use by Canadian women of reproductive age: results
of a national survey. J Obstet Gynaecol Can 2009;31:627–40.
27. Mosher WD, Jones J. Use of contraception in the United States:
1982-2008. Vital Health Stat 23 2010:1–44.
28. Killick SR, Leary C, Trussell J, Guthrie KA. Sperm content of
pre-ejaculatory fluid. Hum Fertil (Camb) 2011;14:48–52.
CHAPTER 4: Natural Family Planning
29. Pudney J, Oneta M, Mayer K, Seage G 3rd, Anderson D. Pre-ejaculatory
fluid as potential vector for sexual transmission of HIV-1. Lancet
1992;340:1470.
33. Wilton J. Post-exposure prophylaxis (PEP). Toronto (ON): CATIE; 2011.
Available at: http://www.catie.ca/fact-sheets/prevention/post-exposureprophylaxis-pep. Accessed on January 28, 2015.
30. Musicco M, Nicolosi A, Saracco A, Lazzarin A; for the Italian Study
Group on HIV Heterosexual Transmission. The role of contraceptive
practices in HIV sexual transmission from man to woman. In:
Nicolesi A, ed. HIV Epidemiology: Models and Methods. New York
(NY): Raven Press; 1994. pp. 121–35.
34. Chin HB, Sipe TA, Elder R, Mercer SL, Chattopadhyay SK, Jacob V,
et al. The effectiveness of group-based comprehensive risk-reduction
and abstinence education interventions to prevent or reduce the
risk of adolescent pregnancy, human immunodeficiency virus, and
sexually transmitted infections: two systematic reviews for the
Guide to Community Preventive Services. Am J Prev Med
2012;42:272–94.
31. Health Canada. Canadian guidelines on sexually transmitted infections.
Ottawa (ON): Health Canada; 2014. Available at: http://www.phac-aspc.
gc.ca/std-mts/sti-its/index-eng.php. Accessed on January 8, 2015.
32. Smith DK, Grohskopf LA, Black RJ, Auerbach JD, Veronese F,
Struble KA, et al. Antiretroviral postexposure prophylaxis after sexual,
injection-drug use, or other nonoccupational exposure to HIV in the
United States: recommendations from the U.S. Department of Health and
Human Services. MMWR Recomm Rep 2005;54(RR-2):1–20.
35. Sassier S, Addo F, Lichter DT. The tempo of sexual activity and later
relationship quality. J Marriage Fam 2012;74:708–25.
36. National Cancer Institute at the National Institutes of Health. Cervical
cancer prevention. Bethesda (MD): National Cancer Institute; 2015.
Available at: http://www.cancer.gov/cancertopics/pdq/prevention/
cervical/HealthProfessional/page1. Accessed on February 18. 2015.
NOVEMBER JOGC NOVEMBRE 2015 l S11
CHAPTER 5
Barrier Methods
B
arrier methods of contraception use a mechanical
or chemical barrier to prevent sperm from passing
through the woman’s cervix into the uterus and fallopian
tubes to fertilize an egg. Some barrier methods also protect
against STIs. Many barrier methods such as male and
female condoms, spermicides, sponges, certain cervical
caps (FemCap), and diaphragms (Caya diaphragm) can
be obtained without a prescription and do not require
consultation with a health care provider before use. The
silicone diaphragm (Milex wide-seal) requires an initial visit
to a health care provider for fitting. For maximum effect,
barrier contraceptive methods must be used correctly and
consistently.
MALE CONDOMS
A male condom is a sheath that covers the penis during
intercourse and acts as a physical barrier to prevent sperm
from entering the vagina. Male condoms may be made of
latex, polyurethane, polyisoprene, silicone, or lambskin.
Condoms are a safe, effective, and inexpensive usercontrolled method of contraception. In Canada, condoms
are the most common method of contraception used by
women of reproductive age.1
Latex condoms provide protection against many STIs,2–4
although they are less effective in preventing STIs that are
transmitted by skin-to-skin contact, such as herpes and
HPV, than those that are transmitted by body fluids because
they do not cover all of the infected skin area. The level of
protection against each specific STI has not been quantified.5
Latex condoms are offered in a variety of shapes, sizes,
textures, and colours. Novelty condoms, such as those
offered in sex toy supply stores or catalogues, cannot be sold
for the prevention of STIs or pregnancy and they should
not be used concurrently with a latex condom because they
are made of materials that may weaken the latex.6
Latex condoms may have disadvantages such as decreased
sensitivity during intercourse, difficulties putting on and
removing, potential deterioration during storage or when
exposed to oil-based lubricants,7,8 and risk of latex allergy.
Non-latex condoms (polyisoprene, polyurethane, silicone,
and lambskin) were developed as alternatives for people
S12 l NOVEMBER JOGC NOVEMBRE 2015
who had latex allergies, sensitivities, or preferences that
prevented the consistent use of latex condoms.9 Nonlatex condoms usually cost more than latex condoms.
Polyurethane condoms transmit more body heat, which
allows more sensitivity and a thinner feeling with a less
constricting fit. They are more resistant to deterioration
and can be used with oil-based lubricants. Lambskin
(“natural membrane”) condoms prevent pregnancy but are
not recommended for STI prevention.10 Laboratory tests
have shown that viruses such as hepatitis B, herpes simplex
virus (HSV), and HIV can pass through small pores on the
surface of lambskin condoms.11
In general, non-latex condoms do not perform as well
as latex condoms due mainly to significantly higher odds
of breakage or slippage.9 This may increase concerns
regarding their ability to prevent pregnancy and STIs;
however, the effect on contraceptive efficacy and STI
prevention has not been well studied.9 Despite this, they
may still be an acceptable alternative for those who cannot
or are unwilling to use latex condoms.
Efficacy and Effectiveness
Condoms are very effective when used consistently and
correctly. The estimated probability of failure with perfect
use is 2%, whereas typical-use failure rates are approximately
18%.12 Randomized controlled trials have found significantly
higher failure rates (breakage and slippage),13,14 typicaluse pregnancy probabilities,13 and perfect use pregnancy
probabilities14 with polyurethane condoms than with latex
condoms. A systematic review also found significantly
higher odds of breakage with non-latex condoms than with
latex condoms, but no difference in typical-use failure rates
between the Avanti polyurethane condom, the Standard
Tactylon, and latex condoms.9 Polyisoprene condoms are
made of synthetic latex, but do not have the allergenic
component of natural rubber latex. There are no published
data regarding their contraceptive effectiveness, but they
are considered to be comparable to latex condoms due to
similarity in manufacturing process and structural makeup.15
There is no evidence that condoms lubricated with N-9
are more effective in preventing pregnancy or sexually
transmitted infections than lubricated condoms that do
CHAPTER 5: Barrier Methods
not contain N-9. Due to the potential adverse effects of
N-9, including an increased risk of HIV transmission,16 the
use of condoms lubricated with N-9 is not recommended.
Mechanism of Action
The condom acts as a mechanical barrier to prevent exchange
of fluid and semen. Some condoms tend to fit better than
others; optimal fitting requires trying a variety of condoms.
Indications
Condoms are indicated for the prevention of pregnancy
and STIs. Ideally, condoms should be used in addition to
another primary contraceptive method (dual protection),
because condom use provides protection against STIs and
additional backup contraception.
Contraindications
The only relative contraindication to latex condom use is
an allergy or sensitivity to latex.17,18 Lanolin sensitivity is a
contraindication to the use of lambskin condoms.
Non-contraceptive Benefits
Condoms provide protection against STIs. A recent
review of the effectiveness of condoms against the
most common STIs emphasizes both the overall positive
level of protection provided by condoms as well as the
limitations in study design in trying to quantify this effect.3
Latex condoms decrease the risk of transmission of STIs
associated with cervical/vaginal discharge (chlamydia,
gonorrhea, trichomoniasis).4,19,20 A Cochrane Review
found consistent condom use can decrease AIDS/HIV
transmission by 80%.2
Regular and adequate use of condoms may also lower the
risk of cervical neoplasia although there is no consistent
evidence that it reduces the risk of HPV acquisition.21,22
Condoms can prolong ejaculatory latency in men who
have rapid/premature ejaculatory difficulties.
Side Effects
Condoms may cause irritation. Spermicides used with
condoms, including spermicide-coated condoms, increase the
risk of E. coli urinary tract infections due to alterations in the
normal vaginal flora.23–25 Alterations in vaginal flora, vaginal
irritation, and superficial abrasions may actually enhance the
risk of HIV transmission26 and hence spermicide-coated
condoms are no longer recommended. Some men may
complain of decreased sensation or loss of erection.27–31
Risks
Technical problems with condom use (unrecognized leakage,
slippage, breakage) are more common when men do not
take enough time or care to properly apply the condom.28
Common errors in condom use include not using condoms
throughout sex, applying the condom after penetration,
removing it before ejaculation, not leaving space at the
tip, not squeezing air from the tip, putting the condom on
upside down, not using water-based lubricants (with latex
and polyisoprene condoms), and incorrect withdrawal.31
Frequent problems with condom use included breakage,
slippage, leakage, condom-associated erection problems,
and concerns with fit and feel.29,31 Health care providers
should be aware of these potential errors and problems
when counselling patients on the use of condoms.
Myths and Misconceptions
“Everybody knows how to use a condom.”
Fact: Errors in condom use are common.31 Men and women
require counselling on how to correctly and consistently
use condoms in order to prevent condom “accidents” such
as breakage or spillage.
“I can’t get an STI if I always use a condom.”
Fact: Condom use is a risk-reduction strategy. Consistent
and correct use of latex condoms reduces the risk of
transmission of many STIs and HIV but it does not provide
absolute protection against any STI.4 Latex condoms
decrease the risk of transmission of STIs associated with
cervical/vaginal discharge such as chlamydia, gonorrhea,
and trichomoniasis, and decrease the risk of HIV
transmission.4 However, their protective effect against
HPV is uncertain. Although one study showed a decrease
in HSV-2 acquisition in consistent condom users whose
partners were serodiscordant,32 skin-to-skin contact with
an active lesion may still result in STI transmission. Novelty
condoms are not approved for STI prevention.6
Initiation
Condoms are available for purchase in pharmacies and in
many sexual health clinics. Innovative programs have been
developed to improve access to condoms for individuals
who find them difficult or embarrassing to purchase.33,34
Condoms provided through school-based clinics or
dispensing machines are innovative ways to improve
uptake and use in young people.35–37 Condoms are covered
under Health Canada’s NIHB program of.38
Proper Use and Precautions
Packaged condoms can be kept for up to 5 years if they are
stored in a dry place away from light and heat. Condoms
should not be used after their expiry date. Condoms
deteriorate more quickly when exposed to temperatures
over 37°C, high humidity, and air pollution.39 Some
condoms are pre-lubricated with silicone, jelly, or cream,
which may help to prevent condom breakage during
intercourse. Latex and polyisoprene condoms should only
be used with water-based lubricants because oil-based
NOVEMBER JOGC NOVEMBRE 2015 l S13
Canadian Contraception Consensus (Part 2 of 4)
Table 8. Lubricants and products that are safe or unsafe to use with latex condoms*
Safe
Unsafe
• Water and silicone-based lubricants
(check package insert for confirmation)
• Baby oil, mineral oil, suntan oil, fish oil, coconut oil/butter, palm oil
• Contraceptive foam and film
• Margarine, butter
• Glycerin USP
• Egg white
• Saliva
• Water
• Vaginal moisturizers
• Olive oil, peanut oil, or vegetable oil
• Hemorrhoid or burn ointments
• Petroleum jelly (e.g., Vaseline)
• Rubbing alcohol
• Vaginal creams (e.g., Monistat, Estrace, Femstat, Vagisil, Premarin)
• Some sexual lubricants (e.g., Elbow Grease, Hot Elbow Grease, Shaft)
*Check product insert and condom package for confirmation
USP: United States Pharmacopeial grade
Table 9. Using a condom
• Put a drop or two of water-based lubricant or saliva inside the condom.
• Place the rolled condom over the tip of the erect penis.
• Leave a half-inch space at the tip to collect semen.
• If not circumcised, pull back the foreskin before rolling on the condom.
• Pinch the air out of the tip with one hand (friction against air bubbles causes most condom breaks).
• Unroll the condom over the penis with the other hand.
• Roll it all the way down to the base of the penis.
• Smooth out any air bubbles.
• After ejaculation and while the penis is still erect, hold onto the rim of the condom at the base of the penis so that the
condom does not slip off.
• Do not spill the semen.
• Throw the condom away (do not flush down the toilet).
• Wash the penis with soap and water before any further contact.
lubricants can weaken condom integrity, reducing tensile
strength, elongation, burst pressure, and burst volume
(Table 8).7 Condoms should not be disposed of in toilets.
Ideally, women and their partners should be educated
on the correct use of condoms (Table 9), availability of
emergency contraception, and STI screening. A new
condom should be used with every act of intercourse.
Condoms should not be reused. The condom must be put
on after the penis is fully erect but before intimate contact.
In case of condom breakage or leakage, condom users
should be aware of and consider emergency contraception
as well as STI testing and PEP according to STI guidelines40
if necessary.
Troubleshooting
“I don’t have the same feeling with a condom.”
While condom use may reduce sensitivity, there is no
objective evidence for this. Reduced sensitivity may be
an advantage for some men by enhancing erection and
preventing premature ejaculation. To increase sensation,
S14 l NOVEMBER JOGC NOVEMBRE 2015
the male partner may use a textured, ultra-thin, or
polyisoprene condom, place a water-soluble lubricant
inside the reservoir of the condom, use the condom while
masturbating, or ask his partner to roll it up over his penis.
“I lose my erection when using a condom.”
Making the application of the condom by the partner a part
of sex play, for example during oral sex or masturbation,
or learning to use the condom while masturbating may
help overcome this obstacle.
“Using a condom interferes with the
spontaneity of sex.”
Condom use may interfere with, or interrupt, foreplay
and impair erection. Encouraging the partner to put the
condom on as a part of sex play, eroticizing condom use,
and using a condom during sex play before intercourse
may alleviate this problem.
“I am allergic to latex.”
Couples who have a latex allergy or sensitivity can consider
using polyurethane or polyisoprene condoms for both
contraception and STI prevention.
CHAPTER 5: Barrier Methods
“The condom breaks or slips during intercourse.”
Condom breakage may be due to rough handling, too much
friction during intercourse, use of oil-based lubricants,
incorrect storage (heat or light exposure), or usage after
the expiry date. Condoms rarely slip off completely during
intercourse, but they may slide down the shaft of the penis
without falling off. The condom must be held at the base of
the penis during withdrawal. Frequent slippage may indicate
that the condom is too large and use of a more “snug”
condom may be preferred. Emergency contraception
should be used as soon as possible after a condom accident
and STI testing/PEP should be considered according to
the Canadian Guidelines on STIs.40
Figure 3. Female condom
“My partner does not want to use condoms
during intercourse.”
Health care providers can rehearse specific scenarios with
their patients, walk through the process of when and how
to purchase condoms, where to carry them, and when and
how to bring up the subject of condom use. Negotiating
skills to address resistance to condom use may be helpful.
FEMALE CONDOMS
The female condom is a soft, loose-fitting, seamless nitrile
polymer sheath containing 2 flexible rings, one at each end.
It is sometimes called an “internal condom.” The external
ring at the open end of the condom sits outside the vagina
and provides some perineal protection. The internal ring
lies within the closed end of the pouch, allowing the
condom to be inserted into the vagina and kept in place
(Figure 3). The sheath is coated on the inside with a
silicone-based lubricant. It can be placed in the vagina up
to 8 hours before intercourse.41 The female condom does
not deteriorate with exposure to oil-based products and
withstands storage better than latex.
The FC2 female condom is the only female condom
available in Canada, replacing the FC1 polyurethane female
condom (Reality). The female condom can be purchased in
pharmacies without a prescription.
Efficacy and Effectiveness
The 12-month pregnancy rate for perfect (correct and
consistent) use of the female condom is 5%, while the
typical-use failure rate is 21%.12 One randomized trial
reported that the polyurethane female condom was as
effective as a synthetic latex condom (5.24% vs. 4.3%).42
Potential reasons for failure of the female condom include:
breakage (during intercourse or when withdrawing the
female condom from the vagina), slippage (the FC slips
completely out of the vagina during sexual intercourse),
misdirection (during vaginal penetration the penis is
inserted between the female condom and the vaginal wall),
and invagination (the external retention feature of the
condom is partially/fully pushed into the vagina during
sexual intercourse).43
Mechanism of Action
The female condom is an intravaginal barrier. It lines the
vagina completely, preventing contact. The female condom
is not intended for use with a male condom, because the 2
condoms may adhere to one another and slip or become
displaced.
Indications
The female condom is the only method of dual protection
(against both pregnancy and STIs) available specifically
for women. A woman who does not like the other vaginal
barrier methods may prefer to use the female condom.
The female condom has several advantages. A woman can
place it autonomously. It does not require an erect penis
for insertion. It is also safe to use for those with a latex
sensitivity and can be used with oil-based lubricants. Male
partners may find it more comfortable and less constricting
than male condoms. The internal and external rings may
make sex more enjoyable for the male or both partners by
increasing stimulation.44
NOVEMBER JOGC NOVEMBRE 2015 l S15
Canadian Contraception Consensus (Part 2 of 4)
Figure 4. Milex® Wide-Seal Silicone Omniflex
Diaphragm
Figure 5. Caya SILCS Diaphragm
Image provided by CooperSurgical, Inc.
Produced with permission from the Trimedic Supply Network Ltd.
Contraindications
•• The FC must be inserted before penile penetration
occurs. It can be inserted up to 8 hours prior to
intercourse.
There is no absolute contraindication to the female
condom.17 Relative contraindications include an allergy
to nitrile polymer, abnormal vaginal anatomy that may
interfere with a satisfactory fit or stable placement, and
inability to learn the correct insertion technique.
Non-contraceptive Benefits
The FC1 was made of polyurethane, which is impenetrable
in vitro to organisms the size of HIV.45 There are no data
available on efficacy and STI prevention for the synthetic
nitrile polymer FC2, although it was approved on the basis
that its properties were comparable to the polyurethane
female condom.43 There are no current data demonstrating
that female condoms are equivalent to male condoms
with respect to STI prevention.44 One study noted more
mechanical problems with the female polyurethane condom
than the male condom46 and thus semen exposure may
be significantly higher with the FC compared to the male
condom, particularly with the first few uses of the FC.46,47
Side Effects, Risks, and Challenges
Slippage, breakage, misdirection, and invagination are
possible challenges associated with use of the FC.43,44,48
FC users must practise inserting the device to become
confident. Although the rings may make sex more enjoyable
by providing greater stimulation, they may also cause
discomfort during coitus.49 Typically, female condoms cost
more than male condoms (approx. $3 each in Canada) and
are noisier during intercourse41; however, the new nitrile
polymer FC2 may be less expensive and less noisy than the
previous polyurethane versions.
Initiation
Female condoms do not need to be fitted. For correct use
the following instructions must be followed:
S16 l NOVEMBER JOGC NOVEMBRE 2015
•• Use a new FC for each act of intercourse.
•• Remove immediately after intercourse by squeezing
and twisting the outer ring before standing up to keep
semen inside the pouch.
•• Throw the FC away (do not flush).
Troubleshooting
If the female condom slips or breaks, emergency
contraception should be used as soon as possible if a
pregnancy is not desired. Testing for STIs or obtaining
PEP according to STI guidelines may also be appropriate.40
DIAPHRAGM AND CERVICAL CAP
Diaphragm
The diaphragm is an intravaginal barrier method of
contraception that is used in conjunction with a gel. It fits
into the vagina from the posterior vaginal fornix to behind
the upper part of the pubic bone to cover the cervix.
There are currently 3 types of diaphragm available
in Canada: the Milex Wide-Seal Silicone Omniflex
Diaphragm (Figure 4), the Milex Arcing Diaphragm
(not pictured; the arcing diaphram is very similar in
appearance to the wide-seal), and the Caya SILCS
Diaphragm (Figure 5). The Omniflex diaphragm has a
distortion-free spring that provides arc no matter where
the rim is compressed and the arcing diaphragm has a
tension-adjusted spring that curves in one place. The
arcing diaphragm is recommended for women who have
less pelvic support. The omniflex and arcing diaphragms
CHAPTER 5: Barrier Methods
(size 65 to 95 mm) are available by prescription in
pharmacies and must be fitted by a health care provider.
Yearly replacement is recommended.
Figure 6. Cervical cap
The SILCS diaphragm was approved by Health Canada in
December 201350 and is made of silicone and nylon. It is
available in one size and measures 67 mm in width and
75 mm in length. It fits most women (standard diaphragm
size 65 to 80 mm for traditional diaphragm fitting). It has
grip dimples at the side of the rim to provide a cue for
where to hold the diaphragm during insertion and a removal
dome to facilitate removal. It is available at pharmacies or
online without a prescription and can last up to 2 years.
Cervical Cap
The only cervical cap available in Canada is the silicone
FemCap which was approved by Health Canada in March
2009 (Figure 6).51 This can be purchased online or with
a prescription. Replacement is recommended every year.
The cap comes in 3 sizes based on pregnancy history.
Efficacy
Efficacy rates vary depending on the study and the
methodology used. With perfect use, 6% of diaphragm
users will experience an unintended pregnancy in the first
year of use compared to 12% with typical use.12 These
rates are based on diaphragm use in conjunction with a
spermicidal jelly or gel, which is no longer available in
Canada. These numbers are not based on use with the
lactic acid-based buffering gel (Caya gel, Contragel) that is
currently available in Canada for use with diaphragms. A
study in couples using the SILCS diaphragm with either a
nonoxynol-9 or an acid-buffering gel, reported a 6-month
perfect use pregnancy rate of 7.9% (95% CI 11.7% to
14.0%).52 With typical use, the 6-month pregnancy rate
was 10.4% (95% CI 6.9% to 14.0%) which extrapolated
to 12-month typical-use failure rate of 18.8% (95% CI
12.0% to 23.6%).52
There are no data on the efficacy/effectiveness of FemCap
with the currently available acid-buffering gel (Caya gel
or Contragel). In a randomized study comparing the first
model FemCap to the Ortho All-Flex diaphragm using
2% nonoxynol-9 gel, the 6-month pregnancy rates were
13.5% and 7.9%, respectively.53 Therefore, a woman’s
willingness to accept a higher risk of an unintended
pregnancy may be a determinant in her suitability for
these barrier methods.
Mechanism of Action for Diaphragm and
Cervical Cap
The diaphragm and cervical cap serve as a physical barrier
between sperm and the cervix and should always be used
Produced with permission from FemCap Inc.
in conjunction with a gel that immobilizes or kills sperm.
Currently, there is no nonoxynol-9 based jelly or cream
available in Canada. Diaphragm or cap users should use
an acid-buffering lubricant such as the SILCS diaphragm
gel or Contragel, which contain water, lactic acid, sodium
lactate, cellulose, and sorbic acid. The gel forms a physical
celluolose barrier in front of the cervix and lowers the pH
of the vaginal fluid, thereby inhibiting sperm motility.
A diaphragm or cervical cap can be inserted up to 2 hours
before intercourse. An additional application of an acidbuffering lubricant is required with each repeated act of
intercourse or if it has been more than 2 hours since the
device/gel was originally inserted and intercourse has not
yet occurred. An applicator is necessary for this repeat
insertion.
All devices should be left in place for at least 6 hours after
intercourse. Diaphragms should not be left in longer than 24
hours after insertion in order to decrease the risk of TSS. If
there has been sexual intercourse within the last 6 hours, the
diaphragm can be kept in situ more than 24 hours (until at
least 6 hours have passed since the last act of intercourse).
The cervical cap can be left in place for up to 48 hours.
Indications
Diaphragms and cervical caps may be suitable for women
who do not wish to use hormonal contraception or for whom
hormonal contraception is contraindicated. Diaphragms and
cervical caps can also be used by breastfeeding women, by
woman with a latex allergy or latex sensitivity, and those who
are willing to accept a higher risk of an unplanned pregnancy
taking into consideration the frequency of intercourse and the
decrease in fertility associated with increasing age. The patient
or her partner must be able to remove the diaphragm or cap.
NOVEMBER JOGC NOVEMBRE 2015 l S17
Canadian Contraception Consensus (Part 2 of 4)
Contraindications and Cautions
A history of HIV infection or being at high risk of HIV
were previously considered absolute contraindications to
use of the diaphragm or cervical cap because they were
used with nonoxynol-9 containing-spermicides which
themselves were associated with an increased risk of genital
lesions and potential HIV transmission to uninfected sex
partners.17 Nonoxynol-9 spermicidal gels are no longer
available in Canada, hence there are currently no absolute
contraindication to the cervical cap or the diaphragm.
Relative contraindications include latex allergy (does not
apply to silicone diaphragms or caps), silicone allergy (for
silicone diaphragms and caps), and history of TSS.17
the cervical cap provide limited HIV protection because
the vaginal mucosa is still exposed.
“Using a dia”phragm or cervical cap alone,
without a gel that immobilizes or kills sperm, is as
effective as using it with the gel.”
Fact: There are no conclusive studies indicating that a
diaphragm or cervical cap is equally effective at preventing
pregnancy if used with or without an acid-buffering gel or
spermicide. Manufacturers continue to recommend that a
gel that immobilizes or kills sperm be used with barrier
methods such as the diaphragm and cervical cap.63
Initiation
A large cystocele, rectocele, or marked uterine prolapse may
reduce the efficacy of the method.54 The SILCS diaphragm
is not recommended if a woman requires a diaphragm size
≥ 85 mm or < 60 mm. After delivery or second trimester
abortion, women should wait approximately 6 weeks
until uterine involution is complete, and be refitted for a
diaphragm or cap before re-using any of them. Refitting
of the omniflex or arcing silicone diaphragms is also
recommended after genital surgery or if the woman gains
or loses 10 or more pounds.
Omniflex or arcing silicone diaphragm
A pelvic examination by a qualified health care provider
is required for fitting the Omniflex or Arcing Silicone
diaphragms (See Table 10). Fitting ring sets are available
from the manufacturer. Fitting rings are produced in 5 mm
increments (65–85 mm in diameter), but Milex Wide-Seal
Silicone Omniflex diaphragms are available in sizes ranging
from 60 to 95 mm. The woman should be fitted with the
rim type (Omniflex or Arcing) type that she will ultimately
use and may practice with it under the supervision of her
health care provider.
Non-contraceptive Benefits
Cervical Cap
While some studies have suggested a decrease in risk for
developing some STIs and cervical intraepithelial neoplasia
in diaphragm users,55,56 others studies have not.57,58 This
has not been studied for the combination of diaphragm or
FemCap and Caya gel currently available in Canada.
Risks and Side Effects
Diaphragm use is associated with an increased risk of
persistent or recurrent UTIs, possibly because of pressure
from the diaphragm’s rim on the urethra and the concurrent
use of spermicides.59–-61 In a 6-month study comparing a 2%
nonoxynol-9 based gel with the Ortho All-Flex diaphragm
and the FemCap, there were significantly more UTIs in
diaphragm users (12.4% vs. 7.5%), but the percentages of
women who discontinued the study because they had 2 or
more infections were around 1% in both groups.53
The risk of TSS is increased slightly in women who use
vaginal barrier methods of contraception. The annual
incidence is 2 to 3 cases per 100 000 women. These TSS
cases would result in less than 1 death per year (0.18) for
every 100 000 vaginal barrier users.62
Myths and Misconceptions
“All barrier methods protect against HIV infection.”
Fact: While male latex condoms protect against HIV
infection, other barrier methods such as diaphragms and
S18 l NOVEMBER JOGC NOVEMBRE 2015
The cervical cap should fit comfortably over the cervix
with the brim adhering to the vaginal fornices. (See Figure 7
and Table 1164,65)
Before a woman can successfully use the diaphragm
or cervical cap, she will require detailed instructions for
insertion (Tables 12 and 13), the opportunity to practice,
and assistance/reassurance from her health care provider.
Online videos can help to demonstrate how to insert the
device. Providing information about the availability of, and
indications for, emergency contraception, STI screening,
and PEP is also important.
Troubleshooting
If a diaphragm user is experiencing recurrent UTIs, a refit
or change of rim type may help, or she may wish to try the
cervical cap which has been associated with lower odds of
UTIs than diaphragms66 Post-coital voiding or antibiotic
use may help.67
CONTRACEPTIVE SPONGE AND SPERMICIDES
Contraceptive Sponge
The sponge is a small, disposable, polyurethane foam device
that is used intravaginally. The Today sponge, a pillow-shaped
sponge containing nonoxynol-9, is the only contraceptive
sponge available in Canada. It comes in one size only and is
CHAPTER 5: Barrier Methods
Table 10. Fitting for an Omniflex or Arcing Silicone Diaphragm64,65
The correct diaphragm size can be estimated by the health care provider:
• inserting the index and middle fingers into the vagina until the posterior wall is reached (by middle
finger),
• marking the point at which the index finger touches the pubic bone with the tip of the thumb, and
• removing the fingers, then placing rim of diaphragm on tip of the middle finger. The opposite side
rim should be lying just in front of the thumb.
The health care provider then inserts a fitting diaphragm/ring into the correct position in the vagina.
The diaphragm should fit snugly with the posterior portion in contact with the posterior fornix, covering
the cervix, with the anterior portion sitting behind the pubic bone.
When the diaphragm is properly fitted, a woman should not be able to feel anything in her vagina.
Figure 7. Inserting the cervical cap
Table 11. Fitting for the FemCap cervical cap based
on a woman’s pregnancy history
Small
22 mm
Never been pregnant
Medium
26 mm
Previous pregnancy (ectopic, miscarriage,
Caesarean section)
Large
30 mm
Previous vaginal delivery
Spermicidal foam is effective immediately and for up to one
hour after insertion. This preparation contains 12.5%
nonoxynol-9 (Figure 10). It is inserted in the vagina using
a supplied applicator. A repeat application is required prior
to each additional act of intercourse.
Effectiveness
Produced with permission from FemCap Inc.
available in pharmacies without a prescription. The concave
dimple on one side fits over the cervix to provide a physical
barrier to sperm and a woven polyester loop on the other
side facilitates removal (Figure 8).
Spermicides
Spermicides are composed of a spermicidal agent in a
carrier that allows dispersion and retention of the agent
in the vagina. Nonoxynol-9 (N-9) is available in Canada as
a vaginal contraceptive film or as foam. Spermicides are
available without a prescription. The use of a spermicide
alone provides less effective contraception than using it in
combination with a barrier method.
Vaginal contraceptive film is a 2-by-2 in. sheet of film containing
28% nonoxynol-9 (Figure 9). It must be inserted at least 15
minutes before intercourse in order to melt and disperse.
If more than 3 hours have elapsed before intercourse,
another film must be inserted.
The Today sponge has a perfect use failure rate of 9%
in nulliparous women and 20% in parous women.12
Typical failure rates are 24% in parous users and 12% in
nulliparous women.68 Effectiveness can be increased by
using the sponge in combination with a male condom.68
A review of clinical trials found that the sponge was less
effective than the diaphragm in preventing pregnancy, and
discontinuation rates were higher.69
Vaginal spermicides are among the least effective of all
modern family planning methods.70 Studies are difficult
to compare and vary widely in size, focus, and quality.71 A
recent review concluded that the currently available studies
are of insufficient quality to predict pregnancy rates with
spermicide use.70 Failure rates in the first year of use vary
from 18% with perfect use to 28% with typical use.12
Mechanism of Action
The contraceptive action of the sponge is primarily provided
by the action of the impregnated spermicide, augmented
by its ability to absorb and trap sperm. The sponge acts as
a sustained release spermicidal reservoir for a period of 24
hours. Spermicides are composed of a spermicidal agent
in a carrier that allows dispersal and retention of the agent
in the vagina. Nonoxynol-9 is a surfactant that destroys the
NOVEMBER JOGC NOVEMBRE 2015 l S19
Canadian Contraception Consensus (Part 2 of 4)
Table 12. Instructions for diaphragm use65
PRIOR TO INSERTION
1. Wash hands. Check the diaphragm for holes, cracks, or tears by holding it up to the light
2. Check the expiration date of the Caya gel/Contragel
3. Insert the diaphragm no more than 2 hours before having sex
4. Prior to insertion of a diaphragm, put a teaspoon of acid-buffering gel into the bowl of the diaphragm and around the rim.
INSERTION
Press the rim together and push the diaphragm into the vagina as far as it will go. Feel the diaphragm to ensure that it covers
the cervix. If uncomfortable, take it out and insert again.
AFTER INTERCOURSE
Keep in place for at least 6 hours after sex. It should not be kept in longer than 24 hours.
For multiple acts of sex, ensure the diaphragm is in the correct position and insert additional gel into the vagina before each act
of sex.
REMOVAL
Wash hands. Insert a finger into the vagina, under the rim of the diaphragm, pull it down and out. The diaphragm should be
washed with mild soap and clean water and dried after each use.
Table 13. Instructions for cervical cap use
INSERTION
1. Place 1/2 teaspoon of Caya gel in the groove between the dome and brim of the cervical cap. Place 1/4 teaspoon in the
bowl of the device with a small amount over the brim.
2. Flatten the device by squeezing it. Place in the vagina with the bowl facing upward and the long brim directed toward the
woman’s back until it covers the cervix.
REMOVAL
1. Must be left in place for at least 6 hours after intercourse (no more than 48 h)
2. To remove the device, the woman should squat and bear down to bring the device closer to the fingers. The device
should be rotated and removed by breaking the suction using the finger strap.
sperm cell membrane.48 It is not a microbicide, and should
only be used for contraceptive purposes, not as a lubricant
or for STI prevention.
Indications
The sponge or the spermicide may be suitable for women
who wish to avoid pregnancy but who also wish to and/
or must avoid hormonal contraception, intrauterine
contraceptives, or other barrier methods. Women who
use the sponge or the spermicide alone should be aware
of its higher failure rate compared to other methods of
contraception. Some women choose the sponge because
of its prolonged 24 hours of protection. The sponge or
the spermicide may be used with other barrier methods to
increase its effectiveness.
Contraindications
The only absolute contraindication to the sponge or
the spermicide is being at high risk for HIV because
nonoxynol-9 increases the risk of vaginal and cervical
irritation or abrasions and thus, the transmission of HIV.17
S20 l NOVEMBER JOGC NOVEMBRE 2015
Relative contraindications include:
•• an allergy to nonoxynol-9,
•• being HIV-positive or having AIDS due to increased
risk of HIV transmission to uninfected sex partners,17
•• use of antiretroviral therapy,17 and
•• a history of TSS.
The following conditions may not be compatible with the
use of the sponge or spermicides:
•• abnormal vaginal anatomy that interferes with
satisfactory insertion of the spermicide or stable
placement of the sponge,
•• inability to use correct insertion technique,
•• repeated UTIs, or
•• full-term delivery within the past 6 weeks, a recent
spontaneous or induced abortion, or vaginal bleeding,
including menstrual flow (for sponges only)68
If there is a personal or medical need for highly effective
CHAPTER 5: Barrier Methods
contraception, the sponge or the spermicide should not be the
first contraceptive choice. The sponge and spermicides with
nonoxynol-9 should also not be recommended to sex workers
or to women with at increased risk of HIV infection.72
Figure 8. Contraceptive sponge
Non-contraceptive Benefits
There is currently no evidence that the sponge or
spermicides reduce the risk of acquiring STIs such as
gonorrhea, chlamydia, or trichomoniasis.72
Risks and Side Effects
The risk of TSS that is present with vaginal barrier use
also applies to sponge use.62 Sponge users must be aware
of the symptoms and signs of TSS and recommended
precautions.
Genital irritation associated with nonoxynol-9 can lead
to easier transmission of HIV.16,72 In a randomized study
of sex workers in HIV endemic countries, there was a
statistically increased risk of developing HIV in women
who used spermicide more than 3.5 times daily and no
reduction of HIV in those who used it less frequently.26
The use of spermicides has also been associated with an
increased risk of urinary tract infection.73,74
Produced with permission from FemCap Inc
Figure 9. Vaginal contraceptive film
Myths and Misconceptions
“Sponges and spermicides offer protection
against STIs.”
Fact: Sponges are not microbicides. Nonoxynol-9 is not an
effective microbicide; it may potentially damage vaginal
mucosa and thus may enhance HIV transmission.16,72,75,76
Spermicides have no protective effect against chlamydia,
gonorrhea, or trichomonas infections.73 Condoms should
always be used for STI prevention. Although nonoxynol-9
increases the risk of HIV infection when used frequently by
women at high risk of infection, it remains a contraceptive
option for women at low risk.
“Use of a spermicide alone provides contraception
that is as reliable as the use of a barrier method.”
Fact: Spermicides used alone have a substantially higher
failure rate than other contraceptive methods12 and quality
studies of efficacy are lacking.70
Illustration by Steve Cober
Figure 10. Spermicidal foam
“Nonoxynol-9 lubricated condoms are more
effective than regular condoms.”
Fact: Condoms lubricated with or without nonoxynol-9 are
similarly effective in preventing pregnancy.76 The use of
condoms lubricated with nonoxynol-9 is associated with
an increased risk of UTIs.24
Initiation of the Sponge
The contraceptive sponge (Today sponge) can be inserted
up to 24 hours before intercourse. Protection begins
immediately and lasts for 24 hours even with repeated acts
Illustration by Steve Cober
NOVEMBER JOGC NOVEMBRE 2015 l S21
Canadian Contraception Consensus (Part 2 of 4)
Table 14. How to use spermicides
• Read and follow the package instructions
• Insert spermicide high in the vagina to cover the cervix
• Use the appropriate amount of spermicide
• Wait the recommended time between insertion and intercourse
• Insert an additional application of spermicide with every act of
intercourse
• Do not douche for at least 6 hours after intercourse
• Always have additional supply of spermicides
of intercourse. It must be left in the vagina for at least
6 hours after the last act of intercourse but should not
remain in the vagina for more than 30 hours total.
Prior to using the sponge, women should wash their hands.
The sponge should be moistened with 2 tablespoons of
water and squeezed once in order to activate the spermicide.
With the dimpled side of the sponge facing the cervix, the
sponge is folded upward and inserted deep into the vagina.
The sponge must cover the cervix and the loop should be
on the bottom to facilitate removal. The sponge must be
inserted before the penis enters the vagina. The sponge
must be left in place for at least 6 hours after the last act of
intercourse, and then can be removed by pulling on the loop.
Initiation of Spermicides
It is important to read and follow the instructions
carefully, especially the length of time from insertion
of the spermicide to intercourse, and the duration of
effectiveness (See Table 14).
Spermicide users should be counselled about the use of
emergency contraception in the event that they fail to use
the spermicide or it was not used correctly.
Troubleshooting
Inserting a contraceptive sponge or a spermicide should
be practised before coitus takes place, in order to increase
comfort with use. If genital irritation or unpleasant odour
occurs, infections such as STIs, vaginal moniliasis, and
bacterial vaginosis should be ruled out.
Summary Statements
27. Latex condoms, used consistently and correctly,
will provide protection against pregnancy (II-2)
and sexually transmitted infection (STIs), including
human immunodeficiency virus infection (II-1).
However, no barrier contraceptive method can
provide 100% protection from all STIs. (III)
28. Polyurethane and other non-latex male condoms
have a higher incidence of breakage and slippage
than latex condoms; hence, the protection they
S22 l NOVEMBER JOGC NOVEMBRE 2015
provide against sexually transmitted infections (STIs)
and human immunodeficiency virus (HIV) infection
is inferior to that of latex condoms (I). Polyurethane
and polyisoprene condoms remain important
options for contraception and reduction of STIs in
the presence of latex allergies. Lambskin condoms
do not protect against HIV infection. (III)
29. The effectiveness of barrier methods can
be complemented by the use of emergency
contraception. (III)
30. The contraceptive sponge and spermicides used
alone are not highly effective contraceptive
methods; their effectiveness may be enhanced when
used in combination with another contraceptive
method. (II-2)
31. Contraceptive products containing nonoxynol-9 may
cause vaginal epithelial damage and increase the risk
of human immunodeficiency virus infection. (I)
Recommendations
27. Health care providers should promote the
consistent and correct use of latex condoms to
improve protection against pregnancy, human
immunodeficiency virus infection, and other
sexually transmitted infections. (II-2A)
28. Health care providers should educate women
and men about the correct use of barrier
methods. They should emphasize the need
for dual protection against pregnancy and
infections. (II-2B)
29. Women who use barrier methods of contraception
should be counselled about emergency
contraception. (III-B)
30. The use of spermicide-coated condoms should no
longer be promoted. (I-A)
31. Diaphragms and cervical caps should continue to
be available in Canada and appropriate training
should be available for health care providers to
become proficient in fitting diaphragms. (III-C)
32. Nonoxynol-9 products should not be used to
reduce the risk of sexually transmitted infections
and human immunodeficiency virus (HIV)
infection and should not be used by women at
high risk for HIV transmission. (I-A)
REFERENCES
1. Black A, Yang Q, Wen SW, Lalonde A, Guilbert E, Fisher W.
Contraceptive use by Canadian women of reproductive age: results of
a national survey. J Soc Obstet Gynecol Can 2009;31:627–40.
2. Weller S, Davis K. Condom effectiveness in reducing heterosexual
HIV transmission. Cochrane Database Syst Rev
2007(4):CD003255.
CHAPTER 5: Barrier Methods
3. Crosby R, Bounse S. Condom effectiveness: where are we now?
Sex Health 2012;9:10–7.
4. Crosby RA, Charnigo RA, Weathers C, Caliendo AM, Shrier LA.
Condom effectiveness against non-viral sexually transmitted infections:
a prospective study using electronic daily diaries. Sex Transm Infect
2012;88:484–9.
5. Food and Drug Administration HHS. Obstetrical and gynecological
devices; designation of special controls for male condoms made of
natural rubber latex. Fed Regist 2008;73:66522–39.
6. Government of Canada. Safer condom use. Ottawa (ON): Government
of Canada; 2014. Available at: http://www.healthycanadians.gc.ca/
healthy-living-vie-saine/sexual-sexuelle/condoms-eng.php.
Accessed on January 12, 2015.
22. Manhart LE, Koutsky LA. Do condoms prevent genital HPV infection,
external genital warts, or cervical neoplasia? A meta-analysis. Sex Transm
Dis 2002;29:725–35.
23. Fihn SD, Boyko EJ, Normand EH, Chen CL, Grafton JR, Hunt M,
et al. Association between use of spermicide-coated condoms and
Escherichia coli urinary tract infection in young women. Am J Epidemiol
1996;144:512–20.
24. Handley MA, Reingold AL, Shiboski S, Padian NS. Incidence of acute
urinary tract infection in young women and use of male condoms with
and without nonoxynol-9 spermicides. Epidemiology 2002;13:431–6.
25. Hooton TM, Hillier S, Johnson C, Roberts PL, Stamm WE. Escherichia
coli bacteriuria and contraceptive method. JAMA 1991;265:64–9.
7. Voeller B, Coulson AH, Bernstein GS, Nakamura RM. Mineral oil
lubricants cause rapid deterioration of latex condoms. Contraception
1989;39:95–102.
26. Van Damme L, Ramjee G, Alary M, Vuylsteke B, Chandeying V, Rees H,
et al. Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1
transmission in female sex workers: a randomised controlled trial. Lancet
2002;360:971–7.
8. Rosen AD, Rosen T. Study of condom integrity after brief exposure to
over-the-counter vaginal preparations. South Med J 1999;92:305–7.
27. Fennell J. “And isn’t that the point?”: pleasure and contraceptive decisions.
Contraception 2014;89:264–70.
9. Gallo MF, Grimes DA, Lopez LM, Schulz KF. Non-latex versus
latex male condoms for contraception. Cochrane Database Syst Rev
2006(1):CD003550.
28. Crosby RA, Graham CA, Yarber WL, Sanders SA. Problems with
condoms may be reduced for men taking ample time to apply them.
Sex Health 2010;7:66–70.
10. Cates W Jr., Stone KM. Family planning, sexually transmitted diseases
and contraceptive choice: a literature update—Part I. Fam Plann Perspect
1992;24:75–84.
11. d’Oro LC, Parazzini F, Naldi L, La Vecchia C. Barrier methods of
contraception, spermicides, and sexually transmitted diseases: a review.
Genitourin Med 1994;70:410–7.
12. Trussell J. Contraceptive failure in the United States. Contraception
2011;83:397–404.
13. Steiner MJ, Dominik R, Rountree RW, Nanda K, Dorflinger LJ.
Contraceptive effectiveness of a polyurethane condom and a latex
condom: a randomized controlled trial. Obstet Gynecol 2003;101:539–47.
14. Walsh TL, Frezieres RG, Peacock K, Nelson AL, Clark VA, Bernstein L.
Evaluation of the efficacy of a nonlatex condom: results from a
randomized, controlled clinical trial. Perspect Sex Reprod Health
2003;35:79–86.
15. Federal Drug Administration. Durex synthetic polyisoprene male
condom: pre-market notification 510(k) submission. Silver Spring (MD):
FDA; 2008. Available at: http://www.accessdata.fda.gov/cdrh_docs/
pdf7/K072169.pdf. Accessed on January 25, 2015.
29. Crosby RA, Yarber WL, Graham CA, Sanders SA. Does it fit okay?
Problems with condom use as a function of self-reported poor fit.
Sex Transm Infect 2010;86:36–8.
30. Crosby R, Shrier LA, Charnigo R, Sanders SA, Graham CA, Milhausen R,
et al. Negative perceptions about condom use in a clinic population:
comparisons by gender, race and age. Int J STD AIDS. 2013;24:100–5.
31. Sanders SA, Yarber WL, Kaufman EL, Crosby RA, Graham CA,
Milhausen RR. Condom use errors and problems: a global view. Sex
Health. 2012;9:81–95.
32. Wald A, Langenberg AG, Link K, Izu AE, Ashley R, Warren T, et al.
Effect of condoms on reducing the transmission of herpes simplex virus
type 2 from men to women. JAMA 2001;285:3100–6.
33. Denno DM, Chandra-Mouli V, Osman M. Reaching youth with out-offacility HIV and reproductive health services: a systematic review.
J Adolesc Health 2012;51:106–21.
34. Kennedy CE, Spaulding AB, Brickley DB, Almers L, Mirjahangir J,
Packel L, et al. Linking sexual and reproductive health and HIV
interventions: a systematic review. J Int AIDS Soc 2010;13:26.
16. Obiero J, Mwethera PG, Hussey GD, Wiysonge CS. Vaginal microbicides
for reducing the risk of sexual acquisition of HIV infection in women:
systematic review and meta-analysis. BMC Infect Dis 2012;12:289.
35. Tomnay JE, Hatch B. Council-supported condom vending machines:
are they acceptable to rural communities? Sex Health.
2013;10:465–6.
17. Centers for Disease Control and Prevention. U.S. medical eligibility criteria
for contraceptive use. MMWR Recommend Rep 2010;59(RR-4):1–85.
36. Brown NL, Pennylegion MT, Hillard P. A process evaluation of condom
availability in the Seattle, Washington public schools. J Sch Health
1997;67:336–40.
18. The World Health Organization. Improving access to quality care in
family planning: medical eligibility criteria for contraceptive use. 4th ed.
Geneva (CH): WHO; 2010.
19. Gallo MF, Steiner MJ, Warner L, Hylton-Kong T, Figueroa JP,
Hobbs MM, et al. Self-reported condom use is associated with reduced
risk of chlamydia, gonorrhea, and trichomoniasis. Sex Transm Dis
2007;34:829–33.
20. Warner L, Newman DR, Kamb ML, Fishbein M, Douglas JM Jr.,
Zenilman J, et al. Problems with condom use among patients attending
sexually transmitted disease clinics: prevalence, predictors, and relation to
incident gonorrhea and chlamydia. Am J Epidemiol. 2008;167:341–9.
21. Lam JU, Rebolj M, Dugue PA, Bonde J, von Euler-Chelpin M, Lynge E.
Condom use in prevention of human papillomavirus infections and
cervical neoplasia: systematic review of longitudinal studies. J Med Screen
2014;21:38–50.
37. Baraitser P, Brown KC, Gleisner Z, Pearce V, Kumar U, Brady M. ‘Do it
yourself ’ sexual health care: the user experience. Sex Health 2011;8:23–9.
38. Health Canada. Non-insured health benefits: First Nations and health
benefits. Drug benefit list. Ottawa (ON): Health Canada; 2014.
Available at: http://www.hc-sc.gc.ca/fniah-spnia/alt_formats/pdf/
nihb-ssna/provide-fournir/pharma-prod/med-list/list_drug_med_
2014-eng.pdf. Accessed on April 29, 2015.
39. Food and Drug Administration. Condoms and sexually transmitted
infections. Silver Spring (MD): FDA; 2015. Available at:
http://www.fda.gov/ForPatients/Illness/HIVAIDS/ucm126372.htm.
Accessed on February 4, 2015.
40. Health Canada. Canadian guidelines on sexually transmitted infections.
Ottawa (ON): Health Canada; 2014. Available at: http://www.phac-aspc.
gc.ca/std-mts/sti-its/index-eng.php. Accessed on January 8, 2015.
NOVEMBER JOGC NOVEMBRE 2015 l S23
Chapter 5
41. Batar I, Sivin I. State-of-the-art of non-hormonal methods of
contraception: I. Mechanical barrier contraception. Eur J Contracept
Reprod Health Care 2010;15:67–88.
42. Beksinska M, Smit J, Mabude Z, Vijayakumar G, Joanis C. Performance of
the Reality polyurethane female condom and a synthetic latex prototype:
a randomized crossover trial among South African women. Contraception
2006;73:386–93.
58. Padian NS, van der Straten A, Ramjee G, Chipato T, de Bruyn G,
Blanchard K, et al. Diaphragm and lubricant gel for prevention of HIV
acquisition in southern African women: a randomised controlled trial.
Lancet 2007;370:251–61.
59. Hooton TM, Fihn SD, Johnson C, Roberts PL, Stamm WE. Association
between bacterial vaginosis and acute cystitis in women using diaphragms.
Arch Intern Med 1989;149:1932–6.
43. Beksinska M, Smit J, Joanis C, Usher-Patel M, Potter W. Female
condom technology: new products and regulatory issues. Contraception
2011;83:316–21.
60. Fihn SD, Latham RH, Roberts P, Running K, Stamm WE.
Association between diaphragm use and urinary tract infection. JAMA
1985;254:240–5.
44. Gallo MF, Kilbourne-Brook M, Coffey PS. A review of the effectiveness
and acceptability of the female condom for dual protection. Sex Health
2012;9:18–26.
61. Vessey MP, Metcalfe MA, McPherson K, Yeates D. Urinary tract
infection in relation to diaphragm use and obesity. Int J Epidemiol
1987;16:441–4.
45. Drew WL, Blair M, Miner RC, Conant M. Evaluation of the
virus permeability of a new condom for women. Sex Transm Dis
1990;17:110–2.
46. Macaluso M, Blackwell R, Jamieson DJ, Kulczycki A, Chen MP, Akers R,
et al. Efficacy of the male latex condom and of the female polyurethane
condom as barriers to semen during intercourse: a randomized clinical
trial. Am J Epidemiol 2007;166:88–96.
47. Galvao LW, Oliveira LC, Diaz J, Kim DJ, Marchi N, van Dam J, et al.
Effectiveness of female and male condoms in preventing exposure to
semen during vaginal intercourse: a randomized trial. Contraception
2005;71:130–6.
48. Trussell J, Guthrie KA. Choosing a contraceptive: safety, efficacy, and
personal considerations. In: Hatcher RA, Trussell J, Nelson AL, Cates W,
Kowal D, Policar M, eds. Contraceptive technology, 20th ed. rev.
New York (NY): Ardent Media; 2011.
49. Smit J, Beksinska M, Vijayakumar G, Mabude Z. Short-term acceptability
of the Reality polyurethane female condom and a synthetic latex
prototype: a randomized crossover trial among South African women.
Contraception 2006;73:394–8.
50. Health Canada. Caya contoured diaphragm. Licence No. 92539.
Ottawa (ON): Health Canada; 2013. Available at:
http://we bprod5.hc-sc.gc.ca/mdll-limh/information.do?deviceId_
idInstrument=597122&deviceName_nomInstrument=
CAYA+CONTOURED+DIAPHRAGM&licenceId=92539&lang=eng.
Accessed on February 5, 2015.
51. Health Canada. FemCap (contraceptive cervical cap). Licence
no. 79318. Ottawa (ON): Health Canada; 2009. Available at:
http://webprod5.hc-sc.gc.ca/mdll-limh/information.do?companyId_
idCompanie=129287&lang=eng. Accessed on February 5, 2015.
52. Schwartz JL, Weiner DH, Lai JJ, Frezieres RG, Creinin MD, Archer DF,
et al. Contraceptive efficacy, safety, fit, and acceptability of a singlesize diaphragm developed with end-user input. Obstet Gynecol
2015;125:895–903.
53. Mauck C, Callahan M, Weiner DH, Dominik R. A comparative study of
the safety and efficacy of FemCap, a new vaginal barrier contraceptive,
and the Ortho All-Flex diaphragm. The FemCap Investigators’ Group.
Contraception 1999;60:71–80.
54. Kost K, Forrest JD, Harlap S. Comparing the health risks and benefits of
contraceptive choices. Fam Plann Perspect 1991;23:54–61.
55. Minnis AM, Padian NS. Effectiveness of female controlled barrier
methods in preventing sexually transmitted infections and HIV:
current evidence and future research directions. Sex Transm Infect
2005;81:193–200.
56. Ramjee G, van der Straten A, Chipato T, de Bruyn G, Blanchard K,
Shiboski S, et al. The diaphragm and lubricant gel for prevention of
cervical sexually transmitted infections: results of a randomized controlled
trial. PLoS One 2008;3:e3488.
57. de Bruyn G, Shiboski S, van der Straten A, Blanchard K, Chipato T,
Ramjee G, et al. The effect of the vaginal diaphragm and lubricant gel on
acquisition of HSV-2. Sex Transm Infect 2011;87:301–5.
S24 l NOVEMBER JOGC NOVEMBRE 2015
62. Schwartz B, Gaventa S, Broome CV, Reingold AL, Hightower AW,
Perlman JA, et al. Nonmenstrual toxic shock syndrome associated with
barrier contraceptives: report of a case-control study. Rev Infect Dis
1989;11(Suppl 1):S43–8; discussion S48–S49.
63. Cook L, Nanda K, Grimes D. Diaphragm versus diaphragm with
spermicides for contraception. Cochrane Database Syst Rev
2003(1):CD002031.
64. Allen RE. Diaphragm fitting. Am Fam Physician 2004;69:97–100.
65. K4Health. Family planning: a global handbook for providers. Chapter 15:
spermicides and diaphragms. Baltimore (MD): K4Health Orders Team;
2015. Available at: https://www.fphandbook.org/sites/default/files/
chap_15_eng.pdf. Accessed on February 5, 2015.
66. Gallo MF, Grimes DA, Schulz KF. Cervical cap versus diaphragm for
contraception. Cochrane Database Syst Rev 2002(4):CD003551.
67. Albert X, Huertas I, Pereiro, II, Sanfelix J, Gosalbes V, Perrota C.
Antibiotics for preventing recurrent urinary tract infection in
non-pregnant women. Cochrane Database Syst Rev
2004(3):CD001209.
68. Hatcher RA, Trussell J, Nelson A, Cates W, Kowal D, Policar M.
Contraceptive technology. 20th ed. New York (NY):
Ardent Media; 2011.
69. Kuyoh MA, Toroitich-Ruto C, Grimes DA, Schulz KF, Gallo MF. Sponge
versus diaphragm for contraception: a Cochrane review. Contraception
2003;67:15–8.
70. Raymond EG, Trussell J, Weaver MA, Reeves MF. Estimating
contraceptive efficacy: the case of spermicides. Contraception
2013;87:134–7.
71. Grimes DA, Lopez LM, Raymond EG, Halpern V, Nanda K, Schulz KF.
Spermicide used alone for contraception. Cochrane Database Syst Rev
2013;12:CD005218.
73. Wilkinson D, Tholandi M, Ramjee G, Rutherford GW. Nonoxynol-9
spermicide for prevention of vaginally acquired HIV and other sexually
transmitted infections: systematic review and meta-analysis of randomised
controlled trials including more than 5000 women. Lancet Infect Dis
2002;2:613–7.
74. Hooton TM, Scholes D, Hughes JP, Winter C, Roberts PL, Stapleton AE,
et al. A prospective study of risk factors for symptomatic urinary tract
infection in young women. N Engl J Med 1996;335:468–74.
75. Scholes D, Hooton TM, Roberts PL, Stapleton AE, Gupta K, Stamm WE.
Risk factors for recurrent urinary tract infection in young women. J Infect
Dis 2000;182:1177–82.
76. Daly CC, Helling-Giese GE, Mati JK, Hunter DJ. Contraceptive methods
and the transmission of HIV: implications for family planning. Genitourin
Med 1994;70:110–7.
77. World Health Organization, Department of Reproductive Health and
Research. WHO/CONRAD Technical Consultation on Nonoxynol-9:
Geneva, 9-10 October, 2001. Geneva (CH): WHO; 2003.
CHAPTER 6
Permanent Contraception
FEMALE CONTRACEPTION
F
emale permanent contraception methods are the most
popular contraceptive methods worldwide,1 and are
the fourth most commonly used method of contraception
in Canada.2 They are intended to be irreversible, and
women should be counselled about the importance of
being certain that they do not desire a pregnancy in the
future. They should also be counselled on the availability of
reversible contraceptive methods, including LARCs, which
may confer additional non-contraceptive benefits. The
decision to have a procedure for permanent contraception
should be made without pressure or coercion.
Female permanent contraception methods may be
performed laparoscopically, abdominally, or hysteroscopically.
They include tubal interruption, salpingectomy (total or
fimbriectomy), and transcervical tubal occlusion (Microinserts;
Figure 11).
Procedures for female permanent contraception may be
performed remote from a pregnancy (also called interval
sterilization), post-abortion, or postpartum. Postpartum
permanent contraceptive procedures are usually performed
at the time of Caesarean section or after a vaginal delivery
and should not extend a patient’s hospital stay.3,4 Postabortion permanent contraceptive procedures, either
by laparoscopy or mini-laparotomy, can be performed
immediately after an uncomplicated induced abortion with
no increased risk compared to an interval procedure.5 A
single anaesthetic can be used for both the abortion and
the permanent contraceptive procedures.3
Efficacy
Although tubal ligation is highly effective, failures do occur
and can occur many years after the surgery. The U.S. CREST
study found a 5-year cumulative failure rate of 1.3% and a 10year cumulative failure rate of 1.85%.6 (Table 15) A Canadian
study found a 20-year cumulative failure rate of 0.9%.7 The
risk of pregnancy varies by the occlusion technique used and
by the age of the woman at the time of the procedure.6–8
In the CREST study, the most effective methods of
tubal permanent contraception were postpartum partial
salpingectomy and laparoscopic unipolar coagulation,
while the least effective was laparoscopic spring (Hulka)
clip application.6 After adjusting for age, race/ethnicity,
and study site, postpartum partial salpingectomy was
significantly less likely to have a failure compared to interval
partial salpingectomy, spring clip application, and bipolar
coagulation. Women who had a permanent contraceptive
procedure at 34 years and older were at significantly less
risk of failure than women who were less than 33 years
of age at the time of the procedure.6 Similarly, a Canadian
study showed higher rates of sterilization failure in
younger women compared to women over the age of 35
(1.5% versus 0.4%).7 The titanium Filshie clip was not
included in the CREST study; subsequent large studies
have documented a 0.2% failure rate 5 years or more after
Filshie clip application.9,10
The timing of permanent contraception failure may also
vary by method. A high proportion of pregnancies after
clip application occur in the first 3 years after the procedure,
whereas pregnancies after bipolar coagulation occur at about
the same rate year after year.6,11 Failure following a permanent
contraceptive procedure may result from incomplete
occlusion at the time of the procedure, application of the clip/
coagulation on the wrong structure, or incorrect placement
of the clip. Failures after partial salpingectomy, coagulation,
and clip or band application may be due to tuboperitoneal
fistula formation.11 In a clinical trial of the transcervical tubal
occlusion device, no pregnancies were reported among the
643 women who had tubal occlusion confirmed by HSG
after the occlusion procedure.12 In another study, out of
50 000 women who had the transcervical tubal occlusion
procedure, 64 pregnancies were reported to the manufacturer
between 1997 and 2005 (failure rate of 0.13%).13 Similarly,
a large 10-year retrospective study reported a failure rate of
0.15%.14 Most failures occurred in women that did not have
appropriate follow-up, while other causes included misread
HSGs, undetected pre-procedure pregnancies, and failure to
follow the product labeling guidelines.13–15 A systematic review
concluded that among women who were followed beyond 3
months after hysteroscopic sterilization, pregnancies were rare
and generally occurred among women who had no imaging
follow-up or had inadequate confirmation of placement or
NOVEMBER JOGC NOVEMBRE 2015 l S25
Canadian Contraception Consensus (Part 2 of 4)
Figure 11A. A flexible insert is inserted under
hysteroscopic visualization into each of the tubal ostia.
A
Figure 11B. A tissue barrier forms over the next 3
months.
B
Image provided with permission from Bayer, Inc.
Image provided with permission from Bayer, Inc.
occlusion.16 A French cohort study found that women who
underwent transcervical tubal occlusion had significantly lower
pregnancy rates compared to laparoscopic procedures (0.36%
vs. 0.46%, hazard ratio 0.62, 95% CI 0.40 to 0.96).17 However,
an evidence-based Markov model to estimate probability of
pregnancy over 10 years after 3 different female permanent
contraception procedures (hysteroscopic, silicone bands, and
bipolar coagulation) estimated the expected pregnancy rates
at 1-year were 5.7%, 0.7%, and 0.3%, respectively, and 10-year
cumulative pregnancy rates were 9.6%, 2.4%, and 3.0%.18
Mechanism of Action
There is potential for luteal phase pregnancies with
interval procedures, even if there is a negative pregnancy
test on the day of the procedure. Women should thus be
counselled to consistently use a highly effective method of
contraception up until the procedure and for the first week
after the permanent contraceptive procedure is performed
(laparoscopy or laparotomy).19 A pregnancy test should
be done on the day of the procedure.3 If a woman has
an intrauterine device in situ prior to a laparoscopic/
laparotomy procedure, it should be left in place and not
removed for at least one week after the tubal occlusion
procedure.19 Women who are having a transcervical tubal
occlusion procedure must continue to use an effective
method of contraception for the first 3 months after
successful coil placement and until an imaging study has
confirmed bilateral tubal occlusion.
Postpartum permanent contraceptive procedures usually
use a tubal excision method rather than an occlusion
method and postpartum salpingectomy has one of the
lowest failure rates of all the permanent contraception
techniques.6 The titanium Filshie clip is significantly less
effective than partial salpingectomy when used in the
postpartum period4,20 and is not recommended immediately
postpartum or at the time of Caesarean section.4
S26 l NOVEMBER JOGC NOVEMBRE 2015
Tubal ligation techniques result in the occlusion of the
fallopian tubes, preventing the ovum and spermatozoa
from meeting. The Filshie titanium clip works by exerting
continuous pressure on the fallopian tube, which causes
avascularization of the area it encompasses, a decrease
in fallopian tube size, and fibrosis with subsequent
peritonealization of the clip. The choice and timing of
permanent contraceptive methods depends upon patient
preference, medical and risk profile, health care provider’s
training, and access to services and technical facilities.
Timing of the procedure (interval, post-abortion, or
postpartum) influences the surgical approach and method
of permanent contraception.
Hysteroscopic tubal occlusion techniques involve inserting
a 4-cm coil containing occlusive material into the intramural
portion of each fallopian tube under direct hysteroscopic
guidance. The coil fibres elicit an inflammatory reaction
and tissue in-growth occurs, creating tubal occlusion. An
alternative method of birth control must be continued
until tubal occlusion is verified by imaging studies.
Interval and post-abortal permanent contraceptive
procedures are most commonly performed via laparoscopy
using electrocoagulation, mechanical devices, or tubal
excision. Bipolar electrocoagulation involves completely
coagulating a 3 cm isthmic portion of the fallopian tube.
Unipolar electrocoagulation is rarely used now due to
past associations with thermal bowel injury.21 Mechanical
occlusion devices such as silicone rings, spring-loaded
clips (Hulka), or titanium clips lined with silicone rubber
(Filshie) require a special applicator. The clips are applied
to the mid-isthmic portion of the tube at right angles
to the full axis of the tube so that they fully enclose the
tube and the lower jaw of the clip is visible through the
CHAPTER 6: Permanent Contraception
Table 15. Pregnancy rates by sterilization method6
Method
Bipolar tubal coagulation
Unipolar tubal coagulation
5-year rate
%
10-year rate
% (95% CI)
1.65
2.48 (1.63–3.33)
—
0.75 (0.11–1.39)
Silicone ring
1.00
1.77 (1.01–2.53)
Spring clip (Hulka)
3.17
3.65 (2.53–4.77)
—
2.01 (0.47–3.56)
0.63
0.75 (0.27–1.23)
1.3
1.85 (1.51–2.18)
Interval partial salpingectomy
Postpartum partial salpingectomy
All methods
Titanuim clip (Filshie)
0.210
Hysteroscopy (Essure)
0.13
mesosalpinx. Mechanical devices are most effective when
used to occlude a normal fallopian tube; the presence of
tubal adhesions or dilated/thickened tubes may increase
the likelihood of poor application and failure. In the
presence of abnormal fallopian tubes, complete or partial
salpingectomy is preferable.3 Although interval permanent
contraceptive procedures may also be performed via a small
(“mini”) laparotomy incision, mini-laparotomy procedures
are generally reserved for postpartum procedures. Minilaparotomy after a vaginal delivery is performed through a
small infra-umbilical incision before the onset of significant
uterine involution. The most common techniques used by
mini-laparotomy, such as the Pomeroy, modified Pomeroy,
and Parkland methods, involve a complete transection of
the tubal lumen and excision of a sufficient section of the
fallopian tube. Tubal segments should be sent to pathology
to confirm complete transection.
Indications
Women who do not desire a future pregnancy and who
do not wish to use a reversible method of contraception,
particularly LARCs, may be candidates for a permanent
contraceptive procedure. These procedures are intended
to be irreversible, particularly transcervical tubal occlusion.
In the case of regret, reversal procedures may be difficult
to obtain, may be prohibitively expensive, may not be
successful in restoring fertility, and may have associated
procedural risks.7,22,23
Only individuals who have capacity to give informed
consent can agree to a permanent contraceptive procedure.
While Canadian courts have the power to act on behalf of
those who cannot care for themselves, that power can’t be
used to order sterilization for non-medical reasons without
a person’s consent. According to a 1986 Supreme Court
ruling, a proxy decision-maker cannot consent to the
12
—
0.15% –9.6%14 (—)
13
non-therapeutic sterilization of a mentally incompetent
person.24
The choice for permanent contraception has personal,
social, and medical implications. It is important to provide
adequate counselling and ensure informed consent.25
Women should be aware of risk factors for regret,
efficacy, safety, reversible contraceptive alternatives, and
available sterilization techniques. In one British study, only
41% of women who had appointments for permanent
contraception counselling had the procedure;26 many
women were unaware of highly effective LARCs and
decided against permanent contraception after counselling.
If a woman is well informed about alternative contraceptive
methods, as well as the permanency and risks of permanent
contraceptive procedures, and she is making the decision
free of coercion, then age, parity, and other practical
concerns should not be a barrier to obtaining permanent
contraception.3
In the case of hysteroscopic tubal occlusion procedures,
only women who are willing to use an effective method
of contraception for at least 3 months after the procedure
and have a confirmatory test to confirm tubal occlusion
should be considered. Because it can be performed in an
outpatient clinic, transcervical tubal occlusion is associated
with significant cost savings compared with tubal ligation
procedures; however, this cost savings may not be as great
when both procedures are performed in the operating room
setting.27–29 At this time, access to transcervical permanent
contraceptive procedures may be limited by a lack of trained
providers and by the cost of the device; in some cases the
cost is borne by the hospital, which may limit numbers,
while in other cases it is borne by the individual, who may
find it too costly as a contraceptive option.
NOVEMBER JOGC NOVEMBRE 2015 l S27
Canadian Contraception Consensus (Part 2 of 4)
Contraindications
There is no medical condition that would absolutely
restrict a women’s eligibility for permanent contraception,30
although there are some conditions in which the procedure
should be delayed until the condition is evaluated and/or
corrected.31 These include:
•• Systemic health problems, especially cardiopulmonary
conditions that may be aggravated by general
anaesthesia (laparoscopic methods only).
•• Pregnancy (unless a laparoscopic or mini-laparotomy
procedure is done at the time of abortion or
immediately postpartum). Hysteroscopic tubal
occlusion is contraindicated in the first 6 weeks
postpartum or post-abortion.
•• Current or recent (within last 3 months) pelvic
inflammatory disease or current sexually transmitted
infection.
•• Cervical, ovarian, or endometrial cancer (awaiting
treatment) or malignant trophoblastic disease.
•• Known allergy to contrast media (hysteroscopic tubal
occlusion only).
•• Uncertainty about whether permanent contraception is
desired.
Women who have risks for, or contraindication to,
laparoscopic procedures and who do not have a uterine
or tubal anomaly may be candidates for transcervical
tubal occlusion procedures. Women with uterine or tubal
anomalies that may make insert placement difficult, may
not be good candidates for a transcervical tubal occlusion
procedure. Patients with a nickel allergy may have an
allergic reaction to the inserts. Although there are reports
in the literature,32 the manufacturer does not recommend
performing a transcervical tubal occlusion and endometrial
ablation at the same time because intrauterine adhesions
may limit the ability to assess tubal patency. If both
procedures are desired, an ablation may be performed after
tubal occlusion has been documented.3,33
Non-contraceptive Benefits
Tubal ligation, although initially invasive, provides women
with an ongoing private, cost effective, coitally-independent
method of contraception that does not rely on ongoing
user adherence.
Multiple studies have shown an approximately 40%
decreased risk of ovarian cancer after tubal sterilization.34–37
The degree of protection appears to be subtypespecific with a greater magnitude of risk reduction
seen for endometrioid and clear cell cancers than for
serous cancer.34,35,37 The protective effect provided by
S28 l NOVEMBER JOGC NOVEMBRE 2015
tubal occlusion persists for over 30 years following the
procedure and was not associated with age at the time of
the procedure,37 BRCA status, use of oral contraceptives,
and parity.38 This protective effect is likely attained by
altering ovarian function, or by providing a barrier to
ascending cancer cells or carcinogens.39 Differences in
subtype-specific protective effects of tubal ligation may be
explained by their different cells of origin and the extent
to which tubal ligation ablates or obstructs these cells from
seeding the ovaries.37 Most serous ovarian cancers appear
to originate from precursor lesions at the fimbriated end
of the fallopian tube,40–42 whereas most endometrioid
and clear cell cancers seem to originate from exfoliated
endometrial cells and are associated with endometriosis.43
Excisional methods may confer greater risk reduction
than other tubal ligation methods;36 however, studies are
needed to determine if tubal ligation procedures, such as
salpingectomy, that ablate/remove a greater portion of the
fallopian tube would result in greater reductions in the risk
of ovarian cancer.37
Permanent contraceptive methods do not protect against
STIs/HIV and ongoing correct and consistent use of
condoms is recommended if there is a risk of STI/HIV.30,31
However, permanent contraceptive procedures have been
associated with a decreased risk of hospitalization for
pelvic inflammatory disease presumably by preventing
organisms from ascending into the upper genital tract and
causing a bacterial peritonitis.44
Side Effects
Following laparoscopic permanent contraception
procedures, women may experience shoulder tip pain
secondary to intraperitoneal CO2, bruising or bleeding
from incision sites, and lower abdominal pain or cramping.
Prospective studies that have adjusted for possible
confounders, such as previous use of oral contraceptives,
have demonstrated that tubal ligation has little or no effect
on menstrual bleeding patterns.45–48 Data from the CREST
study found no difference in menstrual cycle length or
intermenstrual bleeding but did find decreased amounts
of bleeding and number of bleeding days compared to
controls.49 Current data on the effect of hysteroscopic
transcervical tubal occlusion on menstrual patterns are
conflicting.50,51
Risks
Procedure-related Risks
The incidence of complications depends on the procedure
performed (laparoscopy, laparotomy, hysteroscopy;
mechanical, thermal, excisional, microinserts), the anaesthesia
used (local or general), and the experience of the surgeon.
Major complications from laparoscopic tubal ligation are
CHAPTER 6: Permanent Contraception
uncommon and overall complication rates are estimated
to be 0.9% to 1.6%.52 Intraoperative complications include
anaesthesia-related risks, uterine perforation with uterine
manipulator, mesosalpingeal tears and trans-section of the
tube from ring or clip application, injury to blood vessels,
intestines or other organs (0.6 per 1000 cases), and unintended
conversion to laparotomy (1.4 to 3.1/1000 cases).19 Thermal
bowel injuries during tubal electrocoagulation may result in
delayed bowel perforation and peritonitis.53–55 Independent
risk factors for complications include diabetes, general
anaesthesia, previous abdominal or pelvic surgery, and
obesity.52 Postoperative complications include fever, wound
infection, and bruising.
The overall complication rate with hysteroscopic transcervical
tubal occlusion is approximately 2.7%.56 In a review of
over 4300 women who had office-based transcervical tubal
occlusion procedures, none had a complication requiring
more than 2 hours of observation.56 Potential complications
of hysteroscopic tubal occlusion include50,56–58
•• tubal perforation (1–5%),58
•• uterine perforation,
•• hypervolemia from uterine distension medium,57
•• intraperitoneal (0.5–3.0%) or improper (0.5%)
placement of the coil,
•• coil expulsion (0.4–2.2%), and
•• vasovagal syncope (0.9–5.0%).50,56,57
Rates of unsuccessful bilateral coil placement at one session
vary from 1.5% to 11.6%,51,56,59 and a follow-up procedure may
be required. Subsequent procedures such as electrocautery,
endometrial biopsy, dilatation and curettage, or endometrial
ablation could potentially dislodge a microinsert or interrupt
its ability to prevent pregnancy.
Post-Procedure Risks
Regret is one of the most common complications following
a permanent contraceptive procedure. In a large American
cohort study, the 5-year cumulative probability of regret
among women after tubal sterilization was 7%.60 Other
recent studies among various countries have shown
probabilities of regret varying from 2% to 5.5% in the
years following permanent contraceptive procedures.10,61–63
In Western countries, the cumulative likelihood of
expressing regret, requesting information about reversal
of a permanent contraceptive procedure, and obtaining
reversal, generally increases over the years following
sterilization7,64,65
Younger age is a major risk factor for regret.22,62,64,66–68 During
a follow-up interview within 14 years of tubal ligation,
20.3% of women who have had the procedure before age 30
expressed regret about undergoing the procedure, compared
to 5.9% of those who had it after age 30.64 A Canadian
study showed that the cumulative probability of obtaining
a reversal within 20 years of a tubal ligation was 4.2% in
women who had the procedure before 31 years compared
to 0.4% and 0.2% in women who had the procedure at age
31–35 years and 36–49 years, respectively.7
Other known risk factors for regret and reversal are the
subsequent death of a child; having had fewer children
than desired; having a current partner with no children
prior to the current union or a change of partner after
the tubal ligation; experiencing couple disharmony;
pressure of the partner; and having less information
about permanent contraceptive procedures and other
contraceptive methods.7,64,65,67,68
Ectopic pregnancy should be ruled out whenever a woman
has signs of pregnancy following tubal occlusion. Of the
pregnancies that occurred in the CREST study, 32.9% were
ectopic; however, the overall rate of ectopic pregnancy
was decreased compared to the general population with
a 10-year probability of only 0.73%.6 The proportion of
pregnancies that were ectopic varied by method, with
the highest proportion occurring in women undergoing
bipolar coagulation and the lowest proportion occurring
in the spring clip group.69 A more recent study found a
10-year and 15-year probability of ectopic pregnancy of
0.24% and 0.29%; the 10-year cumulative probability was
3.5 times higher for women who had the procedure before
aged 28 compared to those who had it after age 33.70
Myths and Misconceptions
“There is a risk of menstrual disturbance after
tubal ligation.”
Fact: Prospective studies that have adjusted for possible
confounders, such as previous use of oral contraceptives,
have demonstrated that tubal ligation has little or no effect
on menstrual bleeding patterns.45–48 Data from the CREST
study found no difference in menstrual cycle length or
intermenstrual bleeding but did have decreased amount of
bleeding and number of bleeding days.49
“A woman cannot have an MRI after a
hysteroscopic transcervical tubal occlusion
procedure or mechanical tubal occlusion.”
Fact: Women who have Essure inserts or who have had
a tubal ligation using Filshie or Hulka clips may have an
MRI. The Essure inserts are MR-conditional meaning that
they do not pose any known hazards in a specified MRI
environment with specified conditions of use.
NOVEMBER JOGC NOVEMBRE 2015 l S29
Canadian Contraception Consensus (Part 2 of 4)
“Patients with a nickel allergy cannot use Essure.”
Fact: Nickel sensitivity is not a contraindication to hysteroscopic
tubal occlusion. However, patients with nickel sensitivity
should be counselled that the microinserts do contain trace
amount of nickel and that an adverse event secondary
to nickel hypersensitivity is possible but very unlikely
(< 0.01%).3
Initiation
Women who request permanent contraception should be
carefully and comprehensively counselled. They should
understand that the procedure is not intended to be
reversible and that some factors, such as young age and
other factors may increase the risk of regret. Alternate
effective methods of contraception, particularly longacting reversible contraceptives and vasectomy, should
be discussed. Counselling should include the risk of
failure (including the risk of ectopic pregnancy), the risk
of regret, and the need for an effective contraceptive
method to be used up until the day of the procedure;
contraception should be continued for an additional week
after laparoscopic procedures and an additional 3 months
after hysteroscopic procedures (until tubal occlusion is
verified).30,57 If compliance with abstinence or another
method of contraception for 3 months will be problematic,
health care providers may consider an injection of depot
medroxyprogesterone acetate at the time of hysteroscopic
sterilization to ensure adequate contraception for 3 months.
The choice of permanent contraceptive procedure should
involve consideration of the woman’s medical health, ability
to tolerate office procedures, ability to comply with followup testing, the safety of abdominal surgery and general
anaesthesia, insurance coverage, health care provider
expertise and training, ovarian cancer risk reduction,
and patient preference. Hysteroscopic tubal occlusion
procedures may offer advantages over other permanent
contraception procedures: no incision is required; it
is performed under local anaesthesia and/or minimal
sedation, in an office setting with a rapid recovery; and it
has been shown to be highly effective and cost effective. It
may thus be a better permanent contraceptive choice for
women who are obese, have significant coexisting medical
conditions, or who have intra-abdominal adhesive disease.
Women who consent to a hysteroscopic procedure should
be aware of the possibility that bilateral coil placement may
not be possible in every patient.
Some experts are of the opinion that given the equivalent
complication rates seen with tubal interruption and
salpingectomy71 (even at Caesarean section), that
salpingectomy does not leave women at risk of an
intrauterine or ectopic pregnancy, and that salpingectomy
S30 l NOVEMBER JOGC NOVEMBRE 2015
decreases the risk of ovarian cancer, bilateral salpingectomy
should be routinely offered to women who are certain
about their request for permanent contraception.72
A medical and contraceptive history is essential. Key
elements in the medical history are the woman’s age,
marital status, type of relationship, number and age of
children, contraceptive experience, reasons for permanent
contraception, and systemic health problems. The medical
history should inquire about history of pelvic disease,
previous abdominal or pelvic surgery, heart or lung disease,
bleeding problems, allergies, medication, and previous
problems with general anaesthesia.
Information about the type of operation—including risks
and benefits, contraceptive alternatives, the possibility
of failure, and the possibility of reversal—must all be
discussed so that the individual can provide informed
consent for surgical sterilization.
If a laparoscopic approach is chosen and a clip is used
for the procedure, the clip should be applied after the
fallopian tube has been identified out to its fimbriated end
and placed on stretch. The clip should be placed on the
isthmic portion of the tube, approximately 3 cm distal
to the uterotubal junction, at a 90-degree angle relative
to the long axis of the fallopian tube. The clips should
be advanced over the tube until the tube reaches the
hinge of the clip. When closed, the clip should include a
small portion of mesosalpinx. When bipolar coagulation
techniques are used, the surgeon should use a cutting wave
form at 25 to 35 watts and coagulate 3 contiguous areas
of the isthmic portion of the tube (approximately 3 cm),
taking care to avoid transecting the tube.
With hysteroscopic procedures, a confirmatory test for
tubal occlusion such as transvaginal ultrasound (TVUS),73
pelvic X-ray, or HSG should be performed 3 months
after insertion of intra-fallopian microinserts.19,74 This
confirmatory test must be performed by a gynaecologist or
radiologist who is trained in the assessment of microinsert
position.74 Although pelvic ultrasound59,75–79 or HSG
can be used as a confirmatory test in Canada,74 HSG is
recommended in the following circumstances:74
•• suspicion of possible perforation during the
procedure;
•• difficulty identifying the tubal ostia due to anatomical
variation or technical factors;
•• uncertainty regarding placement at time of insertion;
•• procedure time > 15 minutes;
•• microinsert placement with zero (0) or > 8 trailing
coils (i.e. coils protruding into the uterine cavity);
CHAPTER 6: Permanent Contraception
•• transient or persistent post-procedure pain without any
identifiable cause; or
•• if X-ray or TVUS is equivocal or unsatisfactory.
Troubleshooting
Reversal
Couples who desire a pregnancy after a permanent
contraception procedure have the option of tubal surgery/
re-anastomosis or IVF.80,81 Both are expensive, carry health
risks, and do not guarantee success. Pre-reversal assessment
includes exclusion of possible male infertility factors, female
ovulation disorders, and laparoscopic assessment of the tubal
segments if the patient had a laparoscopic tubal ligation.
IVF may be an option for women who are poor candidates
for reversal surgery or who are older.81 The probability
of reversal in one Canadian province, over 20 years, was
respectively 4.2% and 3.9% for women and men who had a
permanent contraceptive procedure performed before age
30, and 0.2% and 1.0% for those who had the procedure
in their late 30s.7 Among women who had a reversal
procedure performed, 73% of women who were sterilized
before age 30 and 46% of those who were sterilized in their
late 30s achieved a pregnancy after sterilization reversal.7
When using microsurgical tubal re-anastomosis, one study
showed that intrauterine pregnancies occurred in 72% after
ring procedures, 78% after clip procedures and 67% after
Pomeroy procedures.82 Another study showed that women
less than age 37 were significantly more likely to have a
successful delivery after surgical reversal compared to IVF
(72.2 % vs. 52.4%), whereas women ≥ 37 years of age had
higher success rates with IVF compared to reversal (51.4%
vs. 36.6%).81 After hysteroscopic tubal occlusion procedure,
one small study showed implantation and successful
pregnancy outcomes after IVF in 2 patients.83 Another small
study reported on successful hysteroscopic sterilization
reversal; 19 of 70 patients (27%) who had a tubo-uterine
implantation subsequently reported a live birth.84
Bilateral tubal occlusion not confirmed on
HSG at 3 months
Women must have follow-up imaging at 3 months
to confirm tubal occlusion. This may include pelvic
X-ray, TVUS, or HSG. According to the manufacturer’s
recommendations,85 if occlusion at 3-month HSG is
not confirmed, the patient should remain on alternative
contraception for 3 more months and have a repeat
HSG. If occlusion is again rated as unsatisfactory, then
she should be advised not to rely on the microinserts for
contraception. In a cohort of 203 patients who underwent
hysteroscopic tubal occlusion,86 the tubal patency rates at
the 90-day and 180-day HSG were 16.1% (95% CI 7.4%
to 31.7%) and 5.8% (95% CI 1.2% to 24.4%); the 90-day
patency rate was significantly higher than the 90-day rate
of 8% reported in the 2003 multicenter phase III pivotal
trial.87
The risk of non-compliance with post-procedure imaging
is increased with age less than 35 years, having 3 or more
children, and the absence of an institutional protocol to
keep track of patients after their hysteroscopic procedure.86
Summary Statements
32. Women who do not desire a future pregnancy and
who do not wish to use a reversible method of
contraception, particularly long-acting reversible
methods, may be candidates for a permanent
contraception procedure. (III)
33. Only individuals who have capacity to give
informed consent can agree to have a permanent
contraceptive procedure. A proxy decision-maker
cannot consent to the non-therapeutic sterilization
of a mentally incompetent person. (III)
34. The 10-year cumulative failure rate of female
permanent contraceptive procedures is less than
2%. (II-2)
35. Although the risk of pregnancy after a permanent
contraception procedure is low, there is a
substantial risk of an ectopic pregnancy if a
pregnancy occurs after tubal ligation. (II-2) The
absolute risk of ectopic pregnancy is lower than the
risk among women not using contraception. (III)
36. Tubal ligation is associated with a decreased risk of
ovarian cancer. (II-2)
37. Regret is one of the most common complications
following a permanent contraceptive procedure
with young age being a major risk factor. (II-2)
38. Tubal occlusion may not be complete for several
months after the hysteroscopic procedure. An
additional method of contraception is required
for at least 3 months and until imaging confirms
bilateral tubal occlusion. (II-2)
39. Salpingenctomy may provide women, who are
absolute in their decision, the additional benefit of
risk reduction against ovarian cancer. (II-2)
Recommendations
33. Before providing permanent contraception, women
should be counselled on the risks of the procedure,
the risk of regret, and alternative contraceptive
methods, including long-acting reversible
contraceptives and male vasectomy. Informed
consent must be obtained. (II-2A)
34. In a well-informed woman who understands her
contraceptive options and the permanency of the
procedure and who is capable of consent, age
NOVEMBER JOGC NOVEMBRE 2015 l S31
Canadian Contraception Consensus (Part 2 of 4)
and parity should not be a barrier to permanent
contraception. (III-B)
35. Women should be advised to use an effective
method of contraception up until the day of their
permanent contraception procedure. A pregnancy
test should be performed on the day of the
procedure. (III-A)
36. Women undergoing a laparoscopic procedure
should continue to use an effective method
of contraception for one week following the
procedure. (III-B)
37. Women having a hysteroscopic tubal occlusion
procedure should use an effective method of
contraception up until the day of surgery and for at
least 3 months afterward until imaging studies have
confirmed bilateral tubal occlusion. (II-A)
MALE VASECTOMY
National survey data indicate that 7.4% of sexually
active women use male vasectomy as their method of
contraception.2 Compared to tubal ligation, vasectomy is
safer, more effective, less expensive, and less invasive. It
can be performed under local anaesthetic.3,19,88,89 Canada is
one of only 8 countries in which vasectomy use is equal
to or more frequent than tubal ligation for contraception.1
Efficacy
Although vasectomy is highly effective, failures do occur
and can occur many years after the procedure. The failure
rate of male vasectomy in the first year is 0.15%90 and the
risk of pregnancy once post-vasectomy azoospermia or
rare non-motile sperm has been confirmed is 1 in 2000.91,92
The main cause of post-vasectomy conception is the failure
of couples to use backup contraception immediately after
the procedure.93 Vasectomy is not effective immediately and
couples must continue to use another effective method of
contraception until one fresh PVSA shows azoospermia
or ≤ 100 000 RNMS.19,92 The time from vasectomy to
azoospermia or RNMS varies and may take weeks to
months to occur,92,94 although most men are azoospermic
by 3 months post-vasectomy and 98–99% are azoospermic
by 6 months.95 Spermatozoa persist in the seminal vesicles,
and thus in the ejaculate, for 2 to 3 months or between
10 and 30 ejaculations after vasectomy;96 recanalization
cannot be assessed before such time or number of
ejaculations have passed.97 Recanalization is diagnosed
when there is persistence of motile sperm or rising sperm
concentrations on repeated semen analysis. Vasectomy is
considered a failure if there are still motile sperm seen on
PVSA at 6 months; at this time, a repeat procedure should
S32 l NOVEMBER JOGC NOVEMBRE 2015
be considered.92 When vas occlusion techniques associated
with low occlusive failure rates have been used, repeat
vasectomy is necessary in ≤ 1% of vasectomies.92
Methods of vas occlusion are CV and MIV, which includes
the NSV technique. Efficacy varies slightly with the type
of vas occlusion technique used, surgeon experience,92
and the use of electrocautery and fascial interposition.98–101
In a large multi-centre randomized controlled trial, fascial
interposition significantly decreased time to azoospermia,
severe oligospermia, and failures based on semen analysis
in men who underwent NSV compared with those who
did not have fascial interposition.98 Reported failure rates
with intraluminal cautery and/or fascial interposition are
less than 1%.91,92 Suture ligation of the vas without fascial
interposition is not recommended because of higher
failure rates (up to 11.5%).92,99
Mechanism of Action
In a vasectomy procedure, the vas deferens is isolated first and
then occluded, thus preventing motile sperm from being in
the ejaculate (must be confirmed on PVSA 8 to 16 weeks after
the procedure). The methods of vas isolation include MIV,
which includes the NSV, and CV, which uses a larger incision.
MIV techniques use a small scrotal incision (< 10 mm) and
minimal dissection of the vas deferens and perivasal tissues
with special instruments.92 Due to shorter operating times and
decreased rates of hematomas, infections, and intraoperative
pain,102,103 MIV techniques should be performed to isolate the
vas deferens.19,92 The ends of the vas should be occluded by
any one of 4 techniques that are associated with occlusive
failure rates consistently below 1%.92 These include the
following 3 divisional techniques:
•• mucosal cautery with fascial interposition (no clips or
sutures applied to vas);
•• mucosal cautery without fascial interposition (no clips or
sutures applied to vas);
•• open-ended vasectomy that uses mucosal cautery and
fascial interposition on the abdominal end of the vas
and leaves the testicular end of the vas unoccluded.92
Alternatively, non-divisional extended electrocautery can
be used.92
The goal of mucosal cautery is to destroy only the mucosal
layer, which then scars to create a plug in the lumen, while
avoiding thermal injury to the muscular layer so that the
segment doesn’t completely slough off and potentially
result in recanalization.91 The goal of facial interposition
is to separate the 2 newly divided ends of the vas, thereby
reducing the chance of recanalization. It is not necessary
to remove any length of vas.92
CHAPTER 6: Permanent Contraception
Table 16. Vas occlusion studies and failure rates
Number of
study arms
Number of
patients
Range of
occlusive
failure rates, %
Mucosal cautery and fascial interposition
13
18 456
0.0–0.55
Mucosal cautery of both ends
6
13 851
0.0–1.00
Open testicular end, mucosal cautery of abdominal
end, and fascial interposition
4
4600
0.0–0.50
Non-divisional extended electrocautery
(Marie Stopes Technique)
1
41 814
0.64
Occlusion method
When compared to other vas occlusion techniques,
cauterization followed by division of the vas deferens
(with or without excision), is associated with the lowest
likelihood of early recanalization (failure). Vas occlusion
should be followed by diathermy or ligation and fascial
interposition due to high failure rates with division alone.19
Indications
Men who do not wish to have children in the future and
would like a permanent method of contraception may
be candidates for a vasectomy. Vasectomy procedures are
intended to be irreversible. In the case of regret after the
procedure, options for fertility include reversal procedures
and sperm retrieval with IVF; however, these procedures
may be difficult to obtain, may be prohibitively expensive,
and may not be successful in restoring fertility.92 If the
man is uncertain about his desire for future fertility, other
reversible methods of contraception should be encouraged.
Only individuals who have capacity to give informed consent
can agree to have a permanent contraceptive procedure.
According to a 1986 Supreme Court ruling, a proxy decisionmaker cannot consent to the non-therapeutic sterilization of
a mentally incompetent person.24
Contraindications
There are no medical conditions that would absolutely
restrict a man’s eligibility for permanent contraception,31,104
although there are some conditions in which the procedure
should be delayed (Category D) until the condition is
evaluated and/or corrected (Table 16).31 These include
•• local infection including scrotal infection, active
sexually transmitted infection, balanitis, orchitis, or
epididymitis;
•• scrotal mass;
•• gastroenteritis and systemic infection including
currently ill with AIDS-related illness, and
a previous scrotal injury, a large varicocele or hydrocele
(might impair adequate localization of vas deferens),
and unilateral undescended testis. Special arrangements
(Category S) that include having an experienced surgeon
and staff performing the procedure in a setting with
equipment to provide general anaesthetic and other
medical backup support should be made for men with an
inguinal hernia (hernia should be repaired first or at the
same time as vasectomy), bilateral undescended testes,
AIDS on anti-retroviral therapy, coagulations disorders,
and severe thrombocytopenia.31
Non-contraceptive Benefits
Vasectomy provides a man with a private and cost-effective
method of contraception, with no significant longterm side effects, no adherence issues (other than using
contraception until a PVSA demonstrates azoospermia
and/or ≤ 100 000 non-motile sperm), and no interference
with intercourse. At 5 years post-procedure, it is the most
cost-effective method of contraception.105,106
Vasectomy does not protect against STIs/HIV and ongoing
correct and consistent use of condoms is recommended if
there is a risk of STI/HIV.30,31
Side Effects and Risks
The rate of complications has decreased with minimally
invasive techniques, with an overall complication rate of
1% to 2%.92 Possible complications include:
•• infection or hematoma (1–3%),91,107
•• epididymitis (1–3%),92
•• sperm granuloma (< 5%, rarely symptomatic),92
•• vasovagal reaction (up to 30%),
•• early recanalization with persistent motile sperm on
PVSA requiring reoperation (0.2-5.3%),104 and
•• filariasis or elephantiasis.
•• late recanalization after previous clearance on PVSA
(0.03–1.2%).104–108
Caution (Category C) should be used with men who are
young, who have a depressive disorder, who have diabetes,
The risks of intraoperative and early postoperative pain,
bleeding, and infection are related mainly to the method of
NOVEMBER JOGC NOVEMBRE 2015 l S33
Canadian Contraception Consensus (Part 2 of 4)
vas isolation as opposed to the method of vas occlusion.92
The risk of complications is also affected by surgeon
experience.107 Rare complications include Fournier’s
gangrene, vasocutaneous and vaso-urinary fistula, and
trauma to neighbouring structures (i.e. perforated small
hydrocele).98,107
Post-Procedure Risks
The risk of chronic severe postoperative scrotal or testicular pain
that interferes with quality of life is 1% to 2%.91,92 Nonsteroidal anti-inflammatory medications may be used
for symptom relief.19 Few of these patients will require
additional surgery (i.e. vasectomy reversal).19,92
Rates of regret following a vasectomy procedure range from
2 to 6%,7,109,110 although a large American cohort found
that 19.6% of men who had undergone vasectomy desired
more children in the future.109 One American study found
that 2% of men who had a vasectomy had a subsequent
reversal procedure,109 while a Canadian study found a
20-year cumulative probability of obtaining a vasectomy
reversal of 2.6% (3.9% in men < 33 years of age, 1.0%
in men > 37 years of age).7 Risk factors for regret include
younger age,7,108,110 belonging to a religious group,109 and
having no children.108 Six percent of women expressed
regret within 5 years of their partner’s vasectomy; the
probability of requesting a reversal was significantly higher
in women who reported substantial conflict with their male
partner prior to the vasectomy procedure (RR 25.3, 95%
CI 2.9 to 217.2).60 The likelihood of obtaining a reversal
generally increases over the years following sterilization.7
Immunological consequences for up to two thirds of vasectomized
men include the development of anti-sperm antibodies
that may persist for as long as 10 years after surgery.107,111
However, vasectomy does not appear to be associated with
an increased long-term risk of autoimmune disease such
as ankylosing spondylitis, asthma, diabetes, inflammatory
bowel disease, multiple sclerosis, myasthenia graves,
rheumatoid arthritis, testicular atrophy, or thyrotoxicosis.112
Myths and Misconceptions
“Vasectomy increases the risk of prostate cancer.”
Fact: Based on the best available evidence to date, there
does not appear to be an association between vasectomy
and prostate cancer. One recent meta-analysis found no
increased risk of prostate cancer in men with a history of
vasectomy (RR 1.08, 95% CI 0.88 to 1.32).92 There does
not appear to be an association between prostate cancer
and age at vasectomy, time from vasectomy, or calendar
year of vasectomy.113 A 2014 cohort study with 24 years
of follow-up found that vasectomy was associated with a
small increased risk of prostate cancer overall (RR 1.10,
S34 l NOVEMBER JOGC NOVEMBRE 2015
95% CI 1.04 to 1.17).114 However, a subsequent metaanalysis performed by the American Urology Association
included the results of the 2014 study and again found no
significant increase in the risk of prostate cancer in men
who had undergone vasectomy (RR 1.05, 95% CI 0.95 to
1.17).115 There is no evidence of an association between
vasectomy and testicular cancer.19,116
“Men who have a vasectomy are at an increased
risk of cardiovascular disease and atherosclerosis.”
Fact: There does not appear to be an association between
vasectomy and cardiovascular disease, atherosclerosis,
thrombotic disease, or stroke.19,92,116,117
“Vasectomy affects sexual function.”
Fact: Vasectomy does not affect sexual function.118 It does
not affect the ability to obtain an erection, the duration of
erection, or ejaculatory function.
Initiation
Men who request permanent contraception should be
carefully and comprehensively counselled and written
informed consent should be obtained prior to performing a
vasectomy procedure.19,91,92,100 They should understand that
vasectomy is intended to be permanent and that reversal
procedures and other fertility options post-vasectomy are
costly, may not be readily available, and may be unsuccessful.
A medical, surgical, medication, and social history should
be taken and known predictors of regret should be
assessed. Failure rates (early and late), possible risks and
complications, alternative family planning methods, and
common myths and misconceptions should be discussed.
Men should also be informed that vasectomy is generally
safer, quicker to perform, and is associated with lower failure
rates and less morbidity than female tubal ligation.19 Men
who have a vasectomy procedure must be aware that it does
not produce immediate sterility and another method of
contraception must be used until vas occlusion is confirmed
by PVSA.19,92,100 The American Urology Association advises
that the issues of prostate/testicular cancer, coronary heart
disease, stroke, hypertension, and dementia are not required
routinely in pre-vasectomy counselling because vasectomy
does not increase the risk of these conditions.92
A physical examination of the scrotum should be performed
to assess for scrotal abnormalities such as an undescended
testis, testicular tumour, hydrocele or varicocele, to
manually isolate the vas deferens, and to determine if the
patient is a candidate for local anaesthesia. Men who are
not able to tolerate manual isolation of the vas or whose
vas are difficult to locate or isolate may require sedation
or even general anaesthesia for their vasectomy procedure.
Preoperative bloodwork is usually not required unless
CHAPTER 6: Permanent Contraception
Table 17. Category of recommendations for permanent contraception procedures
Category A
Accept
No medical reason exists to deny permanent contraception to a person with this condition.
Category C
Caution
The procedure is normally conducted in a routine setting but with extra preparation and
precautions.
Category D
Delay
The procedure is delayed until the condition is evaluated and/or corrected. Alternative
temporary methods should be provided.
Category S
Special
The procedure should be undertaken in a setting with an experienced surgeon and staff,
equipment needed to provide general anaesthesia, and other backup medical support.
Alternative temporary methods of contraception should be provided, if referral is required
or there is otherwise any delay.
there is a suspicion of a coagulopathy.91,92 Prophylactic
antibiotics are not indicated unless the individual is at an
increased risk of infection.19,91,92
Vasectomy should be offered with local anaesthesia with
or without oral sedation.19,92 If it cannot be tolerated with
local anaesthetic with/without oral sedation, it can be
performed with IV sedation or under regional or general
anaesthetic.92
A minimally invasive approach should be used for vas
isolation because it is associated with less pain and fewer
early complications than CV.19,92,101,103 A technique for vas
occlusion with a failure rate of ≤ 1% should be used.92
Cauterization followed by division of the vas deferens
(± excision) is associated with the lowest likelihood of
early recanalization when compared with other methods.
The use of clips has shown inconsistent results and is not
generally recommended because failure rates are higher
than those of other methods (Table 17).19,91,92 Routine
histological examination of the excised parts of the vas
deferens is not required.19,91,92
Following the procedure, patients should be advised to
use analgesics (non-steroidal anti-inflammatory and/or
acetaminophen) and an ice pack as required. They should
refrain from ejaculation and strenuous physical activity for one
week after vasectomy to allow luminal occlusion to mature.91,92
The use of an athletic support/tight underpants may help to
relieve symptoms, particularly in the first 48 hours after the
procedure.19 Men should contact their health care provider if
there is persistent bleeding, pain, possible infection, fever, or
a rapidly enlarging scrotal hematoma.19 Men who have had
a vasectomy procedure must be aware of the need to use
additional contraception until sterility is confirmed and be
provided with instructions on how and when to perform a
PVSA. Up to 30% of men fail to submit a single PVSA hence
it is important to reinforce the need for this test.100
Although most studies advocate performing the first PVSA
at 12 weeks post-vasectomy,19,91,92 PVSA can be performed
anytime between 8 and 16 weeks post-vasectomy.92 Earlier
testing increases the probability of requiring additional
tests.19 The number of post-vasectomy ejaculation should
not be used as a guide for timing of the first PVSA because
it is not reliably related to rates of azoospermia and
RNMS.92,99,119 The PVSA should be performed on a fresh
uncentrifuged specimen120 within 2 hours of ejaculation
and the report should indicate both the presence or
absence of sperm and the presence or absence of sperm
motility (non-motile sperm/mL).92 Patients can stop
using a second method of contraception when the PVSA
demonstrates azoospermia or rare non-motile sperm
(≤ 100 000 non-motile sperm/mL).19,92 A routine second
PVSA is not required.19
Troubleshooting
“Motile sperm are seen on PVSA 12 weeks
after the vasectomy procedure.”
Motile sperm should disappear within a few weeks after
vasectomy if the vas has been successfully occluded.121
If motile sperm are seen on PVSA at 6 to 12 weeks,
this indicates either recanalization or a technical failure.92
Repeat testing should be performed every 4 to 6 weeks
until azoospermia or RNMS is seen.91 Delayed vasectomy
success has been shown to occur in more than 50% of
men with a first PVSA showing motile sperm.94 However,
motile sperm at 6 months indicates a vasectomy failure and
a repeat vasectomy should be considered.19,92
“More than 100 000 non-motile sperm/mL are seen
on PVSA 6 months after vasectomy.”
Non-motile sperm concentrations ≤ 100 000/mL on
PVSA have a risk of pregnancy similar to a PVSA
with azoospermia.122 Patients can discontinue other
contraception after one PVSA shows either azoospermia
or rare non-motile sperm (≤ 100 000/mL). If more than
100 000 non-motile sperm/mL are present on PVSA after
6 months, the decision to repeat the vasectomy is based
on clinical judgement that includes trends in sperm count,
patient preference, and the patient’s tolerance for risk of
NOVEMBER JOGC NOVEMBRE 2015 l S35
Canadian Contraception Consensus (Part 2 of 4)
Table 18. Probability of pregnancy following
vasectomy reversal125,127
Sperm in the
semen, %
Pregnancy, %
Less than 5 years
91.0–98.6
63.3–88.0
5 to 10 years
88.0–97.6
68.8–82.0
10 to 15 years
91.0–95.3
55.1–86.0
More than 15 years
89.0–97.1
56.5–44.0
Time since vasectomy
pregnancy.19,91,92
“An individual who has had a vasectomy wishes to
discuss options for future fertility.”
Options for fertility post-vasectomy include reversal
(vasovasostomy or vasoepididymostomy) and assisted
reproductive technology involving sperm aspiration and
IVF. These options may be expensive and success cannot
be guaranteed.92 The likelihood of success varies with
surgical experience, past surgical history, pre-vasectomy
fertility, testicular volume, and female partner age and
fertility.123–125 The effect of the duration of the obstructive
interval (time from vasectomy to reversal) on fertility
outcomes is controversial. Some have shown that success
rates are lower with a longer obstructive interval,126 while
other studies have not demonstrated any association
between the obstructive interval and postoperative
outcomes of vas patency and rates of spontaneous
pregnancy (Table 18).125,127 The sperm count rises slowly
after vasectomy reversal, and usually reaches a plateau by
6 months after surgery. However, recovery of physiologic
fertility may take up to 2 years after vasectomy reversal.124
In instances of older female partners, vasectomy reversal
may have comparable success rates to assisted reproductive
technology.124 Counselling regarding vasectomy reversal
should address fertility potential of the partner, potential
complications, probability of success, and cost-effectiveness.
Due to lower morbidity and costs, vasectomy reversal is the
gold standard for fertility options post-vasectomy; however,
in some clinical situations, such as advanced maternal
age or decreased ovarian reserve in the partner, assisted
reproductive technology may be a better option.128
Summary Statements
40. Women and men who do not desire a future
pregnancy and who do not wish to use a reversible
method of contraception, particularly longacting reversible methods, may be candidates for
permanent contraception (III).
S36 l NOVEMBER JOGC NOVEMBRE 2015
41. Compared to tubal ligation, vasectomy is generally
safer, more effective, less expensive, and is a less
invasive surgical procedure that can be performed
under local anaesthetic. (II-2)
42. Vasectomy is not effective immediately. Once
one fresh post-vasectomy semen analysis shows
azoospermia or ≤ 100 000 non-motile sperm,
the risk of contraceptive failure is 1 in 2000
(0.05%). Repeat vasectomy is necessary in ≤ 1% of
vasectomies. (II-2)
43. Vasectomy does not increase the risk of prostate/
testicular cancer, coronary heart disease, stroke,
hypertension, or dementia. (II-2)
Recommendations
38. Isolation of the vas deferens should be performed
using a minimally invasive vasectomy technique
such as the no-scalpel vas occlusion technique.
Vas occlusion should be performed by any 1 of 4
techniques that are associated with occlusive failure
rates consistently below 1%. (III-B)
39. Patients who have had a vasectomy should be
advised that they may stop using a second method
of contraception when one uncentrifuged fresh
semen specimen shows azoospermia or ≤ 100 000
non-motile sperm/mL. (III-B)
REFERENCES
1. United Nations Department of Economic and Social Affairs, Population
Division. World contraceptive use. New York (NY): United Nations;
2014. Available at: http://www.un.org/en/development/desa/
population/publications/dataset/contraception/wcu2014.shtml.
Accessed on January 30, 2015.
2. Black A, Yang Q, Wen SW, Lalonde A, Guilbert E, Fisher W.
Contraceptive use by Canadian women of reproductive age:
results of a national survey. J Soc Obstet Gynecol Can
2009;31:627–40.
3. American College of Obstetricians and Gynecologists. ACOG practice
bulletin no. 133: benefits and risks of sterilization. Obstet Gynecol
2013;121(2 Pt 1):392–404.
4. Rodriguez MI, Edelman AB, Kapp N. Postpartum sterilization with the
titanium clip: a systematic review. Obstet Gynecol 2011;118:143–7.
5. Akhter HH, Flock ML, Rubin GL. Safety of abortion and tubal
sterilization performed separately versus concurrently. Am J Obstet
Gynecol 1985;152(6 Pt 1):619–23.
6. Peterson HB, Xia Z, Highes JM, Wilcox LS, Tylor LR, Trussell J.
The risk of pregnancy after tubal sterilization: findings from the
US Collaborative Review of Sterilization. Am J Obstet Gynecol
1996;174:1611–70.
7. Trussell J, Guilbert E, Hedley A. Sterilization failure, sterilization reversal,
and pregnancy after sterilization reversal in Quebec. Obstet Gynecol.
2003;101:677–84.
8. Lawrie TA, Nardin JM, Kulier R, Boulvain M. Techniques for the
interruption of tubal patency for female sterilisation. Cochrane Database
Syst Rev 2011(2):CD003034.
CHAPTER 6: Permanent Contraception
9. Kovacs GT, Krins AJ. Female sterilisations with Filshie clips: what is the
risk failure? A retrospective survey of 30,000 applications. J Fam Plann
Reprod Health Care 2002;28:34–5.
29. Franchini M, Cianferoni L, Lippi G, Calonaci F, Calzolari S, Mazzini M,
et al. Tubal sterilization by laparoscopy or hysteroscopy: which is the most
cost-effective procedure? Fertil Steril 2009;91(4 Suppl):1499–502.
10. MacKenzie IZ, Thompson W, Roseman F, Turner E, Guillebaud J.
Failure and regret after laparoscopic Filshie clip sterilization under local
anesthetic. Obstet Gynecol 2009;113(2 Pt 1):270-5.
30. Centers for Disease Control and Prevention. U.S. medical eligibility
criteria for contraceptive use, 2010. MMWR Recommend Rep.
2010;59(RR-4):1–85.
11. Peterson HB. Sterilization. Obstet Gynecol 2008;111:189–203.
31. The World Health Organization. Improving access to quality care in
family planning: medical eligibility criteria for contraceptive use, 4th ed.
Geneva (CH): WHO; 2010.
12. Levy B, Levie MD, Childers ME. A summary of reported pregnancies
after hysteroscopic sterilization. J Minim Invasive Gynecol 2007;14:271–4.
13. Munro MG, Nichols JE, Levy B, Vleugels MP, Veersema S. Hysteroscopic
sterilization: 10-year retrospective analysis of worldwide pregnancy
reports. J Minim Invasive Gynecol 2014;21:245–51.
14. Gariepy AM, Creinin MD, Smith KJ, Xu X. Probability of pregnancy
after sterilization: a comparison of hysteroscopic versus laparoscopic
sterilization. Contraception 2014;90:174–81.
15. Basinski CM. A review of clinical data for currently approved
hysteroscopic sterilization procedures. Rev Obstet Gynecol.
2010;3:101–10.
16. Veersema S, Vleugels MP, Moolenaar LM, Janssen CA, Brolmann HA.
Unintended pregnancies after Essure sterilization in the Netherlands.
Fertil Steril 2010;93:35–8.
17. Cleary TP, Tepper NK, Cwiak C, Whiteman MK, Jamieson DJ,
Marchbanks PA, et al. Pregnancies after hysteroscopic sterilization:
a systematic review. Contraception 2013;87:539–48.
18. Fernandez H, Legendre G, Blein C, Lamarsalle L, Panel P. Tubal
sterilization: pregnancy rates after hysteroscopic versus laparoscopic
sterilization in France, 2006-2010. Eur J Obstet Gynecol Reprod Biol
2014;180:133–7.
19. Roayl College of Obstetricians and Gynaecologists. Faculty of
Family Planning and Reproductive Health Care Clinical Effectiveness
Unit. Male and female sterilisation: summary of recommendations.
London (GB) RCOG; 2014. Available at: http://www.fsrh.org/pdfs/
MaleFemaleSterilisationSummary.pdf. Accessed on October 6, 2015.
20.Rodriguez MI, Seuc A, Sokal DC. Comparative efficacy of postpartum
sterilisation with the titanium clip versus partial salpingectomy:
a randomised controlled trial. BJOG 2013;120:108–12.
21. Peterson HB, Ory HW, Greenspan JR, Tyler CW, Jr. Deaths associated
with laparoscopic sterilization by unipolar electrocoagulating devices, 1978
and 1979. Am J Obstet Gynecol 1981;139:141–3.
22. Curtis KM, Mohllajee AP, Peterson HB. Regret following female
sterilization at a young age: a systematic review. Contraception
2006;73:205–10.
23. Kariminia A, Saunders DM, Chamberlain M. Risk factors for strong regret
and subsequent IVF request after having tubal ligation. Aust N Z J Obstet
Gynaecol. 2002;42:526–9.
24. Eve vs Mrs. Eve. Supreme Court of Canada; 1986. p. 438.
25. Akkad A, Jackson C, Kenyon S, Dixon-Woods M, Taub N, Habiba M.
Informed consent for elective and emergency surgery: questionnaire study.
BJOG 2004;111:1133–8.
26. Mattinson A, Mansour D. Female sterilisation: is it what women really
want? J Fam Plann Reprod Health Care 2003;29:136–9.
27. Hopkins MR, Creedon DJ, Wagie AE, Williams AR, Famuyide AO.
Retrospective cost analysis comparing Essure hysteroscopic sterilization
and laparoscopic bilateral tubal coagulation. J Minim Invasive Gynecol
2007;14:97–102.
28. Thiel JA, Carson GD. Cost-effectiveness analysis comparing the essure
tubal sterilization procedure and laparoscopic tubal sterilization. J Obstet
Gynaecol Can 2008;30:581–5.
32. Mircea CN, Goojha C, Thiel JA. Concomitant NovaSure endometrial
ablation and Essure tubal sterilization: a review of 100 cases. J Obstet
Gynaecol Can 2011;33:361–6.
33. Hopkins MR, Creedon DJ, El-Nashar SA, Brown DL, Good AE,
Famuyide AO. Radiofrequency global endometrial ablation followed by
hysteroscopic sterilization. J Minim Invasive Gynecol 2007;14:494–501.
34. Cibula D, Widschwendter M, Majek O, Dusek L. Tubal ligation and the
risk of ovarian cancer: review and meta-analysis. Hum Reprod Update
2011;17:55–67.
35. Rice MS, Murphy MA, Tworoger SS. Tubal ligation, hysterectomy and
ovarian cancer: a meta-analysis. J Ovarian Res 2012;5:13.
36. Lessard-Anderson CR, Handlogten KS, Molitor RJ, Dowdy SC, Cliby WA,
Weaver AL, et al. Effect of tubal sterilization technique on risk of serous
epithelial ovarian and primary peritoneal carcinoma. Gynecol Oncol
2014;135:423–7.
37. Sieh W, Salvador S, McGuire V, Weber RP, Terry KL, Rossing MA, et al.
Tubal ligation and risk of ovarian cancer subtypes: a pooled analysis of
case-control studies. Int J Epidemiol 2013;42:579–89.
38.Narod SA, Sun P, Ghadirian P, Lynch H, Isaacs C, Garber J, et al. Tubal
ligation and risk of ovarian cancer in carriers of BRCA1 or BRCA2
mutations: a case-control study. Lancet 2001;357:1467–70.
39. Cibula D, Widschwendter M, Zikan M, Dusek L. Underlying mechanisms
of ovarian cancer risk reduction after tubal ligation. Acta Obstet Gynecol
Scand 2011;90:559–63.
40. Crum CP, Drapkin R, Miron A, Ince TA, Muto M, Kindelberger DW,
et al. The distal fallopian tube: a new model for pelvic serous
carcinogenesis. Curr Opin Obstet Gynecol 2007;19:3–9.
41. Folkins AK, Jarboe EA, Roh MH, Crum CP. Precursors to pelvic serous
carcinoma and their clinical implications. Gynecol Oncol 2009;113:391–6.
42.Salvador S, Gilks B, Kobel M, Huntsman D, Rosen B, Miller D. The
fallopian tube: primary site of most pelvic high-grade serous carcinomas.
Int J Gynecol Cancer 2009;19:58–64.
43. Kurman RJ, Shih Ie M. The origin and pathogenesis of epithelial ovarian
cancer: a proposed unifying theory. Am J Surg Pathol 2010;34:433–43.
44. Levgur M, Duvivier R. Pelvic inflammatory disease after tubal sterilization:
a review. Obstet Gynecol Surv 2000;55:41–50.
45. Bhiwandiwala PP, Mumford SD, Feldblum PJ. Menstrual pattern changes
following laparoscopic sterilization with different occlusion techniques:
a review of 10,004 cases. Am J Obstet Gynecol 1983;145:684–94.
46. Sahwi S, Toppozada M, Kamel M, Anwar MY, Ismail AA. Changes in
menstrual blood loss after four methods of female tubal sterilization.
Contraception 1989;40:387–98.
47. Thranov I, Hertz JB, Kjer JJ, Andresen A, Micic S, Nielsen J, et al.
Hormonal and menstrual changes after laparoscopic sterilization by
Falope-rings or Filshie-clips. Fertil Steril 1992;57:751–5.
48. Gentile GP, Kaufman SC, Helbig DW. Is there any evidence for a
post-tubal sterilization syndrome? Fertil Steril 1998;69:179–86.
49.Peterson HB, Jeng G, Folger SG, Hillis SA, Marchbanks PA,
Wilcox LS. The risk of menstrual abnormalities after tubal sterilization.
U.S. Collaborative Review of Sterilization Working Group. N Engl J Med
2000;343:1681–7.
NOVEMBER JOGC NOVEMBRE 2015 l S37
Canadian Contraception Consensus (Part 2 of 4)
50. Sinha D, Kalathy V, Gupta JK, Clark TJ. The feasibility, success and
patient satisfaction associated with outpatient hysteroscopic sterilisation.
BJOG 2007;114:676–83.
69. Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR, Trussell J. The risk
of ectopic pregnancy after tubal sterilization. U.S. Collaborative Review of
Sterilization Working Group. N Engl J Med 1997;336:762–7.
51. Mino M, Arjona JE, Cordon J, Pelegrin B, Povedano B, Chacon E. Success
rate and patient satisfaction with the Essure sterilisation in an outpatient
setting: a prospective study of 857 women. BJOG 2007;114:763–6.
70. Malacova E, Kemp A, Hart R, Jama-Alol K, Preen DB. Long-term
risk of ectopic pregnancy varies by method of tubal sterilization:
a whole-population study. Fertil Steril 2014;101:728–34.
52. Jamieson DJ, Hillis SD, Duerr A, Marchbanks PA, Costello C,
Peterson HB. Complications of interval laparoscopic tubal sterilization:
findings from the United States Collaborative Review of Sterilization.
Obstet Gynecol 2000;96:997–1002.
71. McAlpine JN, Hanley GE, Woo MM, Tone AA, Rozenberg N,
Swenerton KD, et al. Opportunistic salpingectomy: uptake, risks, and
complications of a regional initiative for ovarian cancer prevention.
Am J Obstet Gynecol 2014;210:471.e1–11.
53. Abu-Rafea B, Vilos GA, Al-Obeed O, AlSheikh A, Vilos AG,
Al-Mandeel H. Monopolar electrosurgery through single-port
laparoscopy: a potential hidden hazard for bowel burns. J Minim Invasive
Gynecol. 2011;18:734–40.
54. Moore LJ, Patel S, Kowal-Vern A, Latenser BA. Cecal perforation in
thermal injury: case report and review of the literature. J Burn Care
Rehabil 2002;23:371–4.
55. Kowal-Vern A, McGill V, Gamelli RL. Ischemic necrotic bowel disease in
thermal injury. Arch Surg 1997;132:440–3.
56. Povedano B, Arjona JE, Velasco E, Monserrat JA, Lorente J,
Castelo-Branco C. Complications of hysteroscopic Essure((R))
sterilisation: report on 4306 procedures performed in a single centre.
BJOG 2012;119:795–9.
57. Food and Drug Administration. Essure system: summary of safety and
effectiveness data. Silver Spring (MD): FDA; 2002. Available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020014b.pdf.
Accessed on January 30, 2015.
58.Langenveld J, Veersema S, Bongers MY, Koks CA. Tubal perforation
by Essure: three different clinical presentations. Fertil Steril
2008;90:2011.e5–10.
59. Veersema S, Vleugels M, Koks C, Thurkow A, van der Vaart H,
Brolmann H. Confirmation of Essure placement using transvaginal
ultrasound. J Minim Invasive Gynecol 2011;18:164–8.
60. Jamieson DJ, Kaufman SC, Costello C, Hillis SD, Marchbanks PA,
Peterson HB. A comparison of women’s regret after vasectomy versus
tubal sterilization. Obstet Gynecol 2002;99:1073–9.
61. Verkuyl DA. Sterilisation during unplanned caesarean sections for women
likely to have a completed family—should they be offered? Experience in
a country with limited health resources. BJOG 2002;109:900–4.
62. Singh A, Ogollah R, Ram F, Pallikadavath S. Sterilization regret among
married women in India: implications for the Indian national family
planning program. Int Perspect Sex Reprod Health. 2012;38:187–95.
63. Legendre G, Varoux M, Nazac A, Fernandez H. [Regret following
hysteroscopic tubal sterilization]. J Gynecol Obstet Biol Reprod (Paris).
2014;43:387–92.
64. Hillis SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret:
findings from the United States Collaborative Review of Sterilization.
Obstet Gynecol 1999;93:889–95.
65. Schmidt JE, Hillis SD, Marchbanks PA, Jeng G, Peterson HB. Requesting
information about and obtaining reversal after tubal sterilization:
findings from the U.S. Collaborative Review of Sterilization. Fertil Steril
2000;74:892–8.
72. Creinin MD, Zite N. Female tubal sterilization: the time has come to
routinely consider removal. Obstet Gynecol 2014;124:596–9.
73. Thiel J, Suchet I, Tyson N, Price P. Outcomes in the ultrasound follow-up
of the Essure micro-insert: complications and proper placement. J Obstet
Gynaecol Can 2011;33:134–8.
74. Bayer Inc. Essure permanent birth control. ESS305 Purple Handle:27–30.
75. Paladini D, Di Spiezio Sardo A, Coppola C, Zizolfi B, Pastore G,
Nappi C. Ultrasound assessment of the Essure contraceptive devices:
is three-dimensional ultrasound really needed? J Minim Invasive Gynecol
2015;22:115–21.
76. Thiel JA, Suchet IB, Lortie K. Confirmation of Essure microinsert tubal
coil placement with conventional and volume-contrast imaging threedimensional ultrasound. Fertil Steril 2005;84:504–8.
77. Weston G, Bowditch J. Office ultrasound should be the first-line
investigation for confirmation of correct ESSURE placement.
Aust N Z J Obstet Gynaecol. 2005;45:312–5.
78. Veersema S, Vleugels MP, Timmermans A, Brolmann HA. Follow-up of
successful bilateral placement of Essure microinserts with ultrasound.
Fertil Steril. 2005;84:1733–6.
79. Garcia-Lavandeira S, Vazquez-Rodriguez M, Blanco-Perez S,
Pato-Mosquera M, Janeiro-Freire MJ, Araujo-Fernandez JE.
[Ultrasonography as a method to determine the correct implantation of
intratubaric devices]. Ginecol Obstet Mex 2014;82:523–9.
80. Dubuisson JB, Chapron C, Nos C, Morice P, Aubriot FX, Garnier P.
Sterilization reversal: fertility results. Hum Reprod 1995;10:1145–51.
81. Boeckxstaens A, Devroey P, Collins J, Tournaye H. Getting pregnant
after tubal sterilization: surgical reversal or IVF? Hum Reprod
2007;22:2660–4.
82. Gordts S, Campo R, Puttemans P. Clinical factors determining
pregnancy outcome after microsurgical tubal reanastomosis. Fertil Steril
2009;92:1198–202.
83. Kerin JF, Cattanach S. Successful pregnancy outcome with the use of
in vitro fertilization after Essure hysteroscopic sterilization. Fertil Steril
2007;87:1212.e1–4.
84. Monteith CW, Berger GS, Zerden ML. Pregnancy success after
hysteroscopic sterilization reversal. Obstet Gynecol 2014;124:1183–9.
85. Food and Drug Administration. Essure product monograph.
Silver Spring (MD): FDA; 2015. Available at: http://www.accessdata.fda.
gov/cdrh_docs/pdf2/P020014c.pdf. Accessed on February 9, 2015.
66. Hardy E, Bahamondes L, Osis MJ, Costa RG, Faundes A. Risk factors
for tubal sterilization regret, detectable before surgery. Contraception
1996;54:159–62.
86. Rodriguez AM, Kilic GS, Vu TP, Kuo YF, Breitkopf D, Snyder RR.
Analysis of tubal patency after essure placement. J Minim Invasive
Gynecol. 2013;20:468–72.
67. Moseman CP, Robinson RD, Bates GW Jr., Propst AM. Identifying
women who will request sterilization reversal in a military population.
Contraception 2006;73:512–5.
87. Howard DL, Wall J, Strickland JL. What are the factors predictive of
hysterosalpingogram compliance after female sterilization by the Essure
procedure in a publicly insured population? Matern Child Health J
2013;17:1760–7.
68. Ludermir AB, Machado KM, Costa AM, Alves SV, Araujo TV. Tubal
ligation regret and related risk factors: findings from a case-control study
in Pernambuco State, Brazil. Cad Saude Publica 2009;25:1361–8.
S38 l NOVEMBER JOGC NOVEMBRE 2015
88. Bartz D, Greenberg JA. Sterilization in the United States. Rev Obstet
Gynecol. 2008;1:23–32.
CHAPTER 6: Permanent Contraception
89. Shih G, Turok DK, Parker WJ. Vasectomy: the other (better) form of
sterilization. Contraception 2011;83:310–5.
90. Trussell J. Contraceptive failure in the United States. Contraception.
2011;83:397–404.
91. Rogers MD, Kolettis PN. Vasectomy. Urol Clin North Am
2013;40:559–68.
92. Sharlip ID, Belker AM, Honig S, Labrecque M, Marmar JL, Ross LS, et al.
Vasectomy: AUA guideline. J Urol. 2012;188(6 Suppl):2482–91.
93. Schwingl PJ, Guess HA. Safety and effectiveness of vasectomy. Fertil
Steril 2000;73(5):923–36.
94.Labrecque M, St-Hilaire K, Turcot L. Delayed vasectomy success in men
with a first postvasectomy semen analysis showing motile sperm. Fertil
Steril. 2005;83(5):1435–41.
95. Badrakumar C, Gogoi NK, Sundaram SK. Semen analysis after
vasectomy: when and how many? BJU Int. 2000;86:479–81.
109. Sharma V, Le BV, Sheth KR, Zargaroff S, Dupree JM, Cashy J, et al.
Vasectomy demographics and postvasectomy desire for future children:
results from a contemporary national survey. Fertil Steril 2013;99:1880–5.
110. Potts JM, Pasqualotto FF, Nelson D, Thomas AJ Jr., Agarwal A. Patient
characteristics associated with vasectomy reversal. J Urol 1999;161:1835–9.
111. Ansbacher R. Humoral sperm antibodies: a 10-year follow-up of
vas-ligated men. Fertil Steril 1981;36:222–4.
112. Goldacre MJ, Wotton CJ, Seagroatt V, Yeates D. Immune-related disease
before and after vasectomy: an epidemiological database study. Hum
Reprod 2007;22:1273–8.
113. Holt SK, Salinas CA, Stanford JL. Vasectomy and the risk of prostate
cancer. J Urol 2008;180:2565–7; discussion 67–8.
114. Siddiqui MM, Wilson KM, Epstein MM, Rider JR, Martin NE,
Stampfer MJ, et al. Vasectomy and risk of aggressive prostate cancer:
a 24-year follow-up study. J Clin Oncol. 2014;32:3033–8.
96. Schiff J, Chan P, Li PS, Finkelberg S, Goldstein M. Outcome and late
failures compared in 4 techniques of microsurgical vasoepididymostomy
in 153 consecutive men. J Urol 2005;174:651–5; quiz 801.
115. American Urological Association. AUA responds to study linking
vasectomy with prostate cancer. Linthicum (MD): AUA; 2014.
Available at: http://www.auanet.org/press-media/vasectomy-withprostate-cancer.cfm. Accessed on Feb 20, 2015.
97.Richardson DW, Aitken RJ, Loudon NB. The functional competence
of human spermatozoa recovered after vasectomy. J Reprod Fertil
1984;70:575–-9.
116. Kohler TS, Fazili AA, Brannigan RE. Putative health risks associated with
vasectomy. Urol Clin North Am 2009;36:337–45.
98. Sokal D, Irsula B, Hays M, Chen-Mok M, Barone MA. Vasectomy by
ligation and excision, with or without fascial interposition: a randomized
controlled trial [ISRCTN77781689]. BMC Med 2004;2:6.
99. Barone MA, Nazerali H, Cortes M, Chen-Mok M, Pollack AE,
Sokal D. A prospective study of time and number of ejaculations
to azoospermia after vasectomy by ligation and excision. J Urol
2003;170:892–6.
117. Goldacre MJ, Wotton CJ, Seagroatt V, Yeates D. Cancer and cardiovascular
disease after vasectomy: an epidemiological database study. Fertil Steril
2005;84:1438–43.
118. Smith A, Lyons A, Ferris J, Richters J, Pitts M, Shelley J. Are sexual
problems more common in men who have had a vasectomy?
A population-based study of Australian men. J Sex Med
2010;7(2 Pt 1):736–42.
100. Zini A. Vasectomy update 2010. Can Urol Assoc J 2010;4:306–9.
119. Barone MA, Irsula B, Chen-Mok M, Sokal DC. Effectiveness of
vasectomy using cautery. BMC Urol 2004;4:10.
101. Labrecque M, Dufresne C, Barone MA, St-Hilaire K. Vasectomy surgical
techniques: a systematic review. BMC Med 2004;2:21.
120. World Health Organization. WHO laboratory manual for the examination
and processing of human semen, 5th ed. Geneva (CH): WHO; 2010.
102. Sokal D, McMullen S, Gates D, Dominik R. A comparative study
of the no scalpel and standard incision approaches to vasectomy
in 5 countries. The Male Sterilization Investigator Team. J Urol
1999;162:1621–-5.
121. Labrecque M, Hays M, Chen-Mok M, Barone MA, Sokal D. Frequency
and patterns of early recanalization after vasectomy. BMC Urol 2006;6:25.
103. Cook LA, Pun A, Gallo MF, Lopez LM, Van Vliet HA. Scalpel versus
no-scalpel incision for vasectomy. Cochrane Database Syst Rev
2014;3:CD004112.
104. Dohle GR, Diemer T, Kopa Z, Krausz C, Giwercman A, Jungwirth A.
European Association of Urology guidelines on vasectomy. Eur Urol
2012;61:159–63.
105. Trussell J, Lalla AM, Doan QV, Reyes E, Pinto L, Gricar J. Cost
effectiveness of contraceptives in the United States. Contraception
2009;79:5–14.
106. Trussell J. Update on and correction to the cost-effectiveness of
contraceptives in the United States. Contraception 2012;85:611.
107. Awsare NS, Krishnan J, Boustead GB, Hanbury DC, McNicholas TA.
Complications of vasectomy. Ann R Coll Surg Engl 2005;87:406–10.
108. Holman CD, Wisniewski ZS, Semmens JB, Rouse IL, Bass AJ. Populationbased outcomes after 28,246 in-hospital vasectomies and 1,902
vasovasostomies in Western Australia. BJU Int 2000;86:1043–9.
122. Korthorst RA, Consten D, van Roijen JH. Clearance after vasectomy with
a single semen sample containing < than 100 000 immotile sperm/mL:
analysis of 1073 patients. BJU Int 2010;105:1572–5.
123. Nagler HM, Jung H. Factors predicting successful microsurgical
vasectomy reversal. Urol Clin North Am 2009;36:383–90.
124. Schwarzer JU, Steinfatt H. Current status of vasectomy reversal. Nat Rev
Urol 2013;10:195–205.
125. Magheli A, Rais-Bahrami S, Kempkensteffen C, Weiske WH, Miller K,
Hinz S. Impact of obstructive interval and sperm granuloma on patency
and pregnancy after vasectomy reversal. Int J Androl. 2010;33:730–5.
126. Bolduc S, Fischer MA, Deceuninck G, Thabet M. Factors predicting
overall success: a review of 747 microsurgical vasovasostomies. Can Urol
Assoc J 2007;1:388–94.
127. Boorjian S, Lipkin M, Goldstein M. The impact of obstructive interval
and sperm granuloma on outcome of vasectomy reversal. J Urol
2004;171:304–6.
128. Robb P, Sandlow JI. Cost-effectiveness of vasectomy reversal. Urol Clin
North Am 2009;36:391–6.
NOVEMBER JOGC NOVEMBRE 2015 l S39