Scientific Impact Paper No. 19
April 2010
The Use of Mesh in Gynaecological
Surgery
The Use of Mesh in Gynaecological Surgery
1.
Introduction
The use of mesh in gynaecological practice in the treatment of stress urinary incontinence and pelvicorgan prolapse is growing. There is anxiety and uncertainty about the long-term outcome of these
interventions. This paper highlights these controversies.
In 1996, Ulmsten described the transvaginal tape (TVT) procedure and the following year, with only
limited data, it was released to the market.1 This is a tape constructed of type-I polypropylene woven
mesh. It was aggressively promoted and rapidly adopted by many gynaecologists within Europe, even
though the UK and Ireland TVT Trial Group did not start recruiting patients until 1998.2 Fortunately,
long-term follow-up studies have confirmed not only the efficacy of this procedure but also its low
complication rate.3 Many would now consider a mid-urethral tape constructed of type-I polypro-pylene
mesh to be the surgical treatment of choice in primary urodynamic stress incontinence.
Pelvic-organ prolapse is a common condition affecting thousands of women worldwide and surgery rates
to correct prolapse are currently increasing. Up to 300 000 women undergo surgery for pelvic-organ
prolapse in the USA each year. Treatment for vaginal prolapse is associated with a high recurrence rate,
with the reoperation rate reported at 17% within 10 years, although even this was considered to
underestimate the true rate.4 The success obtained with the TVT operation and abdominal hernia surgery
using mesh and the high reoperation rate for prolapse, would therefore suggest the use of mesh for
prolapse surgery. However, concern exists that some of the currently available mesh materials and
techniques using mesh in gynaecological prolapse surgery could be associated with significant morbidity,
especially if the surgeon is not familiar with the principles and properties of the individual materials.
2.
Types of mesh
Two types of mesh are used in surgery: biological and synthetic. Synthetic meshes are further classified
into whether they are absorbable or non-absorbable.
Biological grafts have the theoretical advantage of reduced erosion rates but the disadvantages of
inconsistent tissue strength and potential transmission of infection. Chaliha et al.5 studied the use of
small intestine submucosa during anterior repair. At 6 months, SIS appeared to offer an advantage in
terms of quality of life and validated pelvic-organ prolapse quantification scores but the differences were
not present at 2 years. A recent report has demonstrated that xenogenic acellular collagen matrices used
for advanced prolapse repair failed to reduce graft-related complications and were associated with high
failure rates (data are available on the use of absorbable synthetic mesh in gynaecological prolapse
surgery).6 Animal experiments and in vitro human experience suggest that absorbable synthetic mesh is
an unsuitable prosthesis. It has been shown that adequate fibrous tissue incorporation does not occur
before the hydrolysis of implanted polyglactin mesh. An absorbable mesh that remains in place long
enough for significant three-dimensional fibrous in-growth remains an aspirational goal. With current
knowledge, the use of absorbable mesh cannot be recommended for reconstructive prolapse surgery.
A classification of synthetic meshes, based on their physical characteristics was proposed by Amid.7
Type-IV mesh is not suitable for use in soft tissue, being a relatively solid sheath which totally resists
incorporation. Type-II and type-III mesh materials are constructed using multifilamentous materials and
have small pore sizes. As a result of these characteristics, they can harbour bacteria and, by so doing,
promote bacterial growth. Type-I meshes are constructed using monofilament fibres and have a large
pore size (greater than 90 microns), as a result of which they have lower rates of infection and erosion.
The large pore size admits macrophages and allows rapid angiogenesis. The perimesh inflammatory
response soon settles and the mesh is incorporated by fibrous tissue ingrowth.8 The majority of meshes
Scientific Impact Paper No. 19
2 of 5
© Royal College of Obstetricians and Gynaecologists
currently available for incontinence and prolapse surgery are of Amid type-I. They are therefore similar
to the type of mesh used in the manufacturing of midurethral tapes but have a much larger surface area.
3.
Current clinical practice
Following the publication by Benson,9 which demonstrated that abdominal repair with mesh has a better
outcome than vaginal surgery with a sacrospinous fixation, there have been numerous publications
supporting the use of type-I mesh in abdominal surgery for apical vaginal prolapse. Reported erosion
rates were very low but most of these publications were case series.
Data related to the laying in of mesh to ‘reinforce’ an anterior or posterior repair are very limited and
consist mostly of case series. However, Higgs et al.10 reported a prospective randomised controlled trial
between anterior repair and repair with mesh. At 6 months, vaginal repair with mesh demonstrated
significantly higher success rates (75% compared with 57%) both objectively and subjectively. There
were three mesh erosions from 62 repairs. Although this study failed to identify differences in the rate
of dyspareunia, other case series data do suggest that this as a potential problem and appropriate
preoperative counselling is essential. A recent study demonstrated that anterior colporrhaphy reinforced
with mesh significantly reduced failure from 41% to 11% when compared with traditional surgery.11 The
guideline on surgical repair of vaginal wall prolapse using mesh from the National Institute for Health
and Clinical Excellence (NICE) suggests that mesh may have an advantage over traditional repair and
sets out guidance on the implementation of mesh repairs in practice.12
The newer operations for prolapse (apogee, perigee, prolift and so on) which attempt to provide level I
and level II (support to the upper and middle aspects of the vagina)13 support are transvaginal
procedures. Evidence for their use is based on case series with relatively short-term follow-up. A recent
retrospective multicentre study of these devices (289 women) demonstrated good short-term results in
terms of prolapse resolution but with significant complications: buttock pain (52%), vaginal erosion
(10%), one case of bladder erosion and two women with serious infection.14 Caution must be therefore
be employed before newer operations are introduced into clinical practice.
Each new procedure should declare the properties of the grafts and should supply data on erosion and
infection rates. Each operation should also supply data on bowel, bladder and sexual function.
4.
Opinion
The use of mesh in surgery for stress urinary incontinence (SUI) and pelvic-organ prolapse is growing
fast. There is evidence to support the use of type-I mesh materials in surgery for SUI. However, many
variants of the TVT procedure are being introduced with limited data and no long-term follow-up.
Further research and monitoring of these procedures is required before they are adopted widely.
A NICE interventional procedure guidance supports the use of mesh in abdominal surgery for apical
pelvic-organ prolapse, provided that the normal arrangements for consent, audit and clinical governance
are in place.15 The operation should only be carried out by surgeons specialising in the management of
pelvic-organ prolapse and female urinary incontinence.
Less evidence exists for the use of mesh materials transvaginally and stricter governance needs to be
employed in the introduction of techniques for mesh repair. With the current state of knowledge, the
transvaginal operations for prolapse should only be used under carefully controlled circumstances. Ideally,
they should be introduced under trial conditions but if this is not possible they should be introduced as
part of a registry. In any event, these procedures should only be carried out by gynaecologists with special
expertise in the surgical management of pelvic organ prolapse.12
Scientific Impact Paper No. 19
3 of 5
© Royal College of Obstetricians and Gynaecologists
The British Society of Urogynaecology has a web-based national database which offers the opportunity
for local and national audit of all incontinence and prolapse operations (http://bsug.net/index.php). This
offers a pragmatic approach to obtaining surgical outcome data in a rapidly changing environment.
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under
local anaesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor
Dysfunct 1996;7:81–6.
Ward KL, Hilton P, UK and Ireland TVT Trial Group. A prospective multicenter randomized
trial of tension-free vaginal tape and colposuspension for primary urodynamic stress
incontinence: two year follow-up. Am J Obstet Gynecol 2004;190:324–31.
Ward KL, Hilton P, UK and Ireland TVT Trial Group. Tension free vaginal tape versus
colposuspension for primary urodynamic stress incontinence: 5-year follow up. BJOG
2008;115:226–33.
Denman MA, Gregory WT, Boyles SH, Smith V, Edwards SR, Clark AL. Reoperation 10 years
after surgically managed pelvic organ prolapse and urinary incontinence. Am J Obstet
Gynecol 2008;198:555.e1–5.
Chaliha C, Khalid U, Campagna L, Digesu GA, Ajay B, Khullar V. SIS graft for anterior
vaginal wall prolapse repair: a case-controlled study. Int Urogynecol J Pelvic Floor Dysfunct
2006;17:492–7.
Deprest JA, Claerhout F, Lewi P, Coremans G, Werbrauk E, Van Beckevoort D, et al. Sacrocolpopexy using xenogenic acellular collagen matrices in patients at increased risk for graft
related complications. 34th Annual IUGA Meeting. Int Urogynecol J 2009;20 Suppl 2:S199.
Amid PK. Classification of biomaterials and their related complications in abdominal wall
hernia surgery. Hernia 1997;1:15–21.
Slack M, Sandhu JS, Staskin DR, Grant RC. In vivo comparison of suburethral sling materials.
Int Urogynecol J Pelvic Floor Dysfunct 2006;17:106–10.
Benson JT, Lucente V, McClellan E. Vaginal versus abdominal reconstructive surgery for the
treatment of pelvic support defects: a prospective randomized study with long-term outcome
evaluation. Am J Obstet Gynecol 1996;175:1418–22.
Higgs PJ, Carey MP, Goh JTW, Krause HG, Leong A, Cornish A. Randomised controlled trial
comparing vaginal prolapse repair with mesh augmentation to traditional repair; a six month
follow up. 31st Annual IUGA Meeting. Int Urogynecol J Pelvic Floor Dysfunct 2006;17 Suppl
2;64.
Nieminen K, Hiltunen R, Heiskaneu E, Takala T, Niemi K, Merikai M, et al. Symptom
resolution and sexual function after anterior vaginal wall repair with or without mesh. Int
Urogynecol J Pelvic Floor Dysfunct 2008;19:1611–16.
National Institute of for Health and Clinical Excellence. Surgical Repair of Vaginal Wall
Prolapse Using Mesh. Interventional Procedure Guidance No. 267. London: National Institute
for Health and Clinical Excellence; 2008.
DeLancey JO. Anatomical aspects of vaginal eversion after hysterectomy. Am J Obstet
Gynecol 1992;166:1717–28.
Abdel-Fattah M, Ramsay I, West of Scotland Study Group. Retrospective multicentre study of
the new minimally invasive mesh repair devices for pelvic organ prolapse. BJOG
2008;115:22–30.
National Institute of for Health and Clinical Excellence. Sacrocolpopexy using Mesh for
Vaginal Vault Prolapsed Repair. Interventional Procedure Guidance No. 283. London:
National Institute for Health and Clinical Excellence; 2009.
Scientific Impact Paper No. 19
4 of 5
© Royal College of Obstetricians and Gynaecologists
This Scientific Impact Paper was produced on behalf of the Royal College of Obstetricians and Gynaecologists by:
Mr MC Slack FRCOG, Cambridge, and Mr CJ Mayne FRCOG, Leicester.
and peer reviewed by: RCOG Consumers’ Forum; Mr P Hilton FRCOG, Newcastle; Mr RM Freeman FRCOG, Plymouth;
Professor L Cardozo FRCOG, London; Professor M Cervigni, Italy.
The Scientific Advisory Committee lead reviewer was: Mr AH Sultan FRCOG.
At the time of publication, the Chair of the Scientific Advisory Committee was Professor S Thornton FRCOG and the Vice Chair
was Professor R Anderson FRCOG.
The final version is the responsibility of the Scientific Advisory Committee of the RCOG.
The review process will commence in 2013 unless otherwise indicated.
Scientific Impact Paper No. 19
5 of 5
© Royal College of Obstetricians and Gynaecologists