Parietex™ Composite (PCO) Mesh
Value Analysis Committee
Product Information Kit
IMPORTANT
Please refer to the package insert for
COVIDIEN, COVIDIEN with logo, Covidien logo and positive
results for life are U.S. and/or internationally registered
trademarks of Covidien AG. Other brands are trademarks of a
Covidien company. © 2010 Covidien.
complete instructions, contraindications,
warnings and precautions.
11.10 P100195
TM*
For more information or to set up a
product demonstration, contact your local
Covidien Surgical Device Representative or
call Customer Service at 1-800-722-8772.
555 Long Wharf Drive
New Haven, CT
06511
800-722-8772
Trademark of its respective owner.
www.covidien.com/hernia
Parietex™ Mesh
innovation in Your hands
Parietex™ polyester mesh, with its unique balance
of properties, is designed to provide fast and true
tissue ingrowth with a reduced foreign material
reaction.1 Parietex™ mesh is a macroporous mesh
that is more hydrophilic than polypropylene,1
providing improved biocompatibility and superior
cellular proliferation in vitro.2
The proprietary weave of Parietex™ mesh is
designed to support patient comfort and mobility.
The Parietex™ family of synthetic mesh features
a comprehensive line of products designed to
combine superior economic efficiency with positive
clinical outcomes for your patients, putting
innovation in your hands.
Parietex™ Composite (PCO) Mesh: AHeAD oF iTS Time. AND STiLL AHeAD oF THe CuRve.
Our complete line of synthetic mesh supports
surgeon-preferred techniques for both inguinal
and ventral hernia repairs.
Magenta shows area
covered by pocket
Table of Contents
1 Product Introduction
Product Overview
Product Diagram
Specialty Configurations
510(k) Clearance
Instructions for Use
11 Technical Data
Clinical Literature
Product Claims Data
15Reimbursement
16 Competitive Information
Competitive Products Overview
25Materials Management Information
Packaging Overview
Ordering Information
Product Order Codes
Product Introduction
Product Introduction
Product Overview
Product Diagram
Parietex™ Composite (PCO) Mesh:
Ahead of its time. And still ahead of the curve.
Parietex™ Composite (PCO) Mesh
Introduced in 1999, Parietex™ composite (PCO) mesh is proven effective in advanced treatment for complex ventral hernias.
It was the first mesh to offer a resorbable collagen barrier on one side to limit visceral attachments, and a three-dimensional
polyester knit structure on the other to promote differentiated tissue ingrowth. Its unique polyester material works with
the body’s natural systems for true tissue integration,3 and it is optimized to minimize shrinkage.3,4 Parietex™ PCO mesh
was ahead of its time and remains the standard that others strive to reach.
3-D portion fully coated
to protect the viscera
Optimal memory to
facilitate placement
Why should a hospital purchase Parietex™ Composite (PCO) Mesh?
Optimal Patient Outcomes
Operational Efficiencies
At 12 months, the recurrence rate with
Parietex™ PCO mesh is only 2.5%; Only
1.8% at 4 years; no other long-term
complications observed.5
A comprehensive portfolio of
mesh products offers opportunity
for standardization and hospital
efficiencies.
In outpatient procedures, transactional
data shows Parietex™ PCO mesh had
the lowest recurrence rate (1%) at 12
months when compared to Composix™*
(4%) and Sepramesh™* (5%).6
Covidien partners with customers to
offer versatile contracting options.
Resorbable collagen
barrier/hydrophilic
film designed to limit
attachments
3-D polyester knit
promotes fast
tissue ingrowth
What are the competitive advantages of Parietex Composite (PCO) Mesh?
™
Clinically Proven Protection
• Parietex™ PCO mesh is proven effective,
with more than 10 years of documented
success.
• Parietex™ PCO mesh is proven safe,
based on a mean clinical follow-up
of four years in a prospective, multicenter
human trial. 86% of studied PCO
patients were attachment-free at 12
months post-surgery.5
• Parietex™ PCO mesh features a resorbable
hydrophilic film that minimizes visceral
attachments.7
1
Clinically Proven Integration
• Parietex™ PCO mesh provides strong
incorporation into the abdominal wall
in prospective and comparative animal
studies.3,8
• Incites true tissue integration rather
than inflammatory encapsulation9 and is
optimized to minimize shrinkage.3,4
Parietex™ Composite
(PCO) Mesh
Parietex™ Composite
Parietex™ Composite
Parietex™ Composite
Open Skirt (PCO OS) Mesh Parastomal (PCO PM) Mesh Hiatal (PCO 2H) Mesh
Ease of Use
• Larger sizes can be rolled up and are easily
inserted through a standard trocar.
• Polyester mesh is easy to place and
manipulate.
• It is proven to develop a stronger
attachment to the anterior abdominal wall
than polypropylene mesh.4
• It provides superior cell proliferation
when compared to polypropylene mesh
in vitro.2
2
Product Introduction
Product Introduction—510(k)
specialty Configurations
Procedure-specific options for hernia repair
The Parietex™ family of synthetic mesh products supports surgeon-preferred techniques, allowing surgeons to provide
patient-specific repairs.
LAPArOsCOPIC VenTrAL
OPen VenTrAL
Parietex™ Composite (PCO) Mesh†
• Proven effective, with more than 10 years of
documented success
Parietex™ Composite Open Skirt (PCO OS) Mesh
• Based on PCO mesh, which is proven effective, with more
than 10 years of documented success
• Stronger incorporation into the abdominal wall
in prospective and comparative animal studies3,8
• Stronger incorporation into the abdominal wall in
prospective and comparative animal studies3,8
• Larger sizes can be rolled up and inserted through
a standard trocar
• Skirt on the parietal side allows for mechanical fixation,
which can reduce procedure time
HIATAL
Parietex™ Composite Hiatal (PCO 2H) Mesh
• Allows for easy placement and manipulation around
the esophagus
• resorbable barrier with more than 10 years of
documented success for clinically proven protection
• Stronger incorporation into the abdominal wall in
prospective and comparative animal studies3,8
†
3
Parietex™ Composite (PCO) mesh is also indicated for use in open ventral repairs.
PArAsTOmAL
Parietex™ Composite Parastomal (PCO PM) Mesh
• Designed for direct and modified Sugarbaker techniques
• resorbable barrier with more than 10 years of documented
success for clinically proven protection
• Stronger incorporation into the abdominal wall in
prospective and comparative animal studies3,8
Additional 510(k)s available upon request.
4
Product Introduction—510(k)
Additional 510(k)s available upon request.
5
Product Introduction—510(k)
Additional 510(k)s available upon request.
6
Product Introduction—510(k)
Additional 510(k)s available upon request.
7
Product Introduction—510(k)
Additional 510(k)s available upon request.
8
indicated for the treatment of incisional hernias, abdominal wall repair, parietal (i.e. pertaining to the
walls) reinforcement of tissues. The non-absorbable three-dimensional polyester mesh provides long
term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue
attachment to the mesh in case of direct contact with the viscera.
CONTRAINDICATIONS
All the usual contraindications for the use of wall reinforcements apply to the use of PARIETEX™ Composite.
This includes, but may not be limited to: patient in a period of growth : the limited extensibility may be
insufficient for the growth of a child / surgery in an infected or contaminated place.
POSSIBLE COMPLICATIONS
The complications arising from wall reconstruction with reinforcements can also be seen after PARIETEX™
Composite has been used. These complications include, but may not be limited to : seroma, hematoma,
recurrence, infection, visceral adherence, allergic reactions to the components of the product.
WARNINGS AND PRECAUTIONS
1. PARIETEX™ Composite is provided in a sterile packaging. The packaging is to be checked for any damage
before use. Do not use the mesh if the packaging is open or damaged.
2. Carefully examine the blister to check that it has not been damaged during transportation.
3. It is recommended that the reinforcement be used in the form in which it is provided without being cut.
This will ensure that the film protecting the edge is left intact.
der Platzierung und4. der
Befestigung
des Maschengewebes
helfen.
In order
to maintain
the elasticity and the
porosity of the reinforcement, it is recommended that the
• Die Kante des Maschengewebes
mindestens
5 cm
überitdie
Kanten
mesh should notmuss
be overly
stretched
when
is being
putderin Gewebedefektöffnung(en)
place. A moderate and equalhinaus
tension in all
ragen. Die für die Befestigung
des Maschengewebes
directions, should
be applied. verwendete Technik (Nahtmaterial oder Klammern) bleibt dem
Arzt überlassen. Die5. Fixierungen
müssen an der Textilgrundlage
befestigtpowder,
werdenit und
nicht nur am that
resorbierbaren
Due to the pro-inflammatory
properties of talcum
is recommended
gloves without
Film.
talcum powder or which have been thoroughly rinsed are used to handle the reinforcement.
STERILISATIONSTECHNIK
6. The mesh is provided in a double sterile packaging. It is recommended to open the last packaging only
PARIETEX™ Composite
ist placement
als Einmalprodukt
konzipiert.
Durch Gammabestrahlung
for the
of the mesh
and to handle
the latter using cleansterilisiert.
gloves and instruments.
LAGERUNG 7. This mesh should only be used by experienced practitioners who do so under their own responsibility.
Empfohlene Lagerbedingungen für das Produkt: trocken, bei +2 bis +25 °C. Das Produkt bleibt jedoch bei + 40 °C
OPERATING STEPS  POSITIONING
2 Monate lang stabil.
• PARIETEX™ Composite must be hydrated in its original blister before being handled. This is carried
Die Produkt nicht über
letzten Tagit des
in der Kennzeichnung
ausgewiesenen
Verfallsmonats
hinausforverwenden.
out bydenimmersing
completely
in a sterile saline
serum for several
seconds in order
it to recover its
Nach Eingang der conformability
Lieferung sicherstellen,
dass die Packung ungeöffnet und unbeschädigt ist und ihre Dichtigkeit/
and flexibility.
Unversehrtheit gewahrt
Dieses
verwenden,
wenn pinpoint
die Packung
unversehrt
erscheint.
• Whenblieb.
putting
it inProdukt
place, itnicht
is essential
to perfectly
the nicht
smooth
and continuous
side from the
GARANTIE
porous and rehabitable side in order to situate it correctly :
SOFRADIM PRODUCTION
bescheinigt,
dass die
deranMaterialien
und der
Herstellungsmethoden für dieses Produkt
• the porous
side against
theWahl
wall for
efficient tissue
integration.
mit größter Umsicht erfolgte. SOFRADIM PRODUCTION lehnt jegliche Haftung für Verluste, Schäden oder Kosten ab,
• the smooth and continuous side facing the structures on which the tissular attachment is to be limited.
die sich direkt oder indirekt aus dem Gebrauch dieses Produkts ergeben mögen. Die Konditionen und Bedingungen
• Should
it beersetzen
used in aalle
laparoscopic
approach,
PARIETEX™
Composite
is to be rolled
after hydration, with
der hier ausgeführten
Garantie
nicht in diesem
Dokument
aufgeführten
Garantien
(ob ausdrücklicher
the film
inside, oder
so thatin the
film isWeise
protected
when insertedundin machen
the trocardiese
(minimum
of 10 mm).
oder stillschweigender
Art,face
gesetzlich
sonstiger
vorgeschrieben)
hinfällig.diameter
SOFRADIM
PRODUCTION haftet• The
nichtbi-dimensional
für anderweitige
produktbezogene
die von
seiner statt
textile
flap assembledMaßnahmen,
to the textile side
cananderen
help thean
placement
andergriffen
the fixation of
werden und untersagt
dies hiermit
jeglichen
Parteien.
the mesh
when used
in open
approach.
• The edge of the reinforcement is to be at least 5 cm over the edges of the orifice(s). The technique used to
anchor the mesh (suture or staples) is left up to the practitioner. The technique used must be anchored on
the textile base and not only on the absorbable film.
STERILIZATION TECHNIQUE
PARIETEX™ Composite is intended as a single-use device. Sterilized by gamma radiation.
RETE A DUE SUPERFICI CHE ASSOCIA UN RINFORZO INTEGRABILE
STORAGE
PERMANENTE
E UN FILM IDROFILO ASSORBIBILE
Recommended conditions for storing the product: between +2°/+25°C (36/77°F), in a dry area. However,
IMPORTANTE the product is stable at 40°C (104°F) during 2 months.
Il presente opuscoloDohanotlo use
scopo
rendere
di questo
strumento,
non è pertanto da intendersi
thedidevice
pastpiùthesemplice
last dayl’utilizzo
of the labeled
month
of expiration.
come materiale di consultazione per l’esecuzione di tecniche chirurgiche.
Upon receipt of shipment, ensure that the packaging is not open or damaged and retains its sealed
Questo dispositivointegrity.
è stato progettato,
e fabbricato
per l’utilizzo
un singolo
paziente. L’utilizzo
Do not usetestato
the device
if the integrity
of theesclusivo
packagingsuappears
compromised.
e i trattamenti ripetuti possono danneggiare il dispositivo e causare lesioni al paziente. Trattamenti ripetuti e/o
GUARANTEE
risterilizzazioni del dispositivo possono determinare il rischio di contaminazione e di infezione a carico del paziente.
SOFRADIM PRODUCTION certifies that every precaution has been taken when choosing material and the
Non riutilizzare, trattare ripetutamente o risterilizzare questo strumento.
manufacturing method used for this product. SOFRADIM PRODUCTION is not liable in the case of any
DESCRIZIONE loss, damage or cost directly or indirectly linked to the use of the product. The terms and conditions of
Rete composita costituita
da un rinforzo
parietale
tridimensionale
the guarantee
set out herein
cancel
and replace in
anypoliestere
guaranteemultifilamento,
which does notcoperta
appeardainun
thisfilm
document,
assorbibile, continuo
e idrofilo
uno dei orsuoi
lati. contained
Questo filmwithin
è costituito
da collagene
glicole e
whether
it besuexplicity
tacitly
the legislation
or in porcino,
any otherpolietilene
means. SOFRADIM
glicerolo e sporge di
5 mm dal bordo
rinforzo.
rinforzo
tridimensionale
è dotatobydiany
unparty
lembowith
tessile
in poliestere
PRODUCTION
is notdel
liable
for anyIl other
action
taken on its behalf
regard
to the product
multifilamento bidimensionale.
and hereby forbids any party to do so.
INDICAZIONI
La rete PARIETEX™ Composite è utilizzata per il rinforzo tissutale durante la riparazione chirurgica. É indicata per il
trattamento di laparoceli, riparazione della parte addominale e rinforzo parietale (cioè riguardante le pareti) dei tessuti.
La rete in poliestere tridimensionale non assorbibile fornisce rinforzo dei tessuti molli a lungo periodo da una lato; dall’
altro il film idrofilo assorbibile riduce al minimo l’attacco del tessuto alla rete in caso di contatto diretto con i visceri.
CONTROINDICAZIONI
RENFORT BIFACE ASSOCIANT RENFORCEMENT REHABITABLE
Tutte le consuete controindicazioni
per l’uso del rinforzo
applicano all’utilizzo di RESORBABLE
PARIETEX™ Composite. Le
PERMANENT
ETparietale
FILMsi HYDROPHILE
controindicazioni includono, ma non sono limitate a: paziente in fase di crescita. L’estensibilità limitata della rete può
IMPORTANT !
essere insufficiente a seguire la crescita di un bambino/intervento chirurgico in un sito contaminato o infettato.
Cette notice est destinée à faciliter l’utilisation de ce produit. Elle ne constitue pas une référence en matière
POSSIBILI COMPLICANZE
de techniques chirurgicales.
Dopo l’impianto di PARIETEX™ Composite si possono osservare le complicanze causate dalla ricostruzione con rinforzo
Ce dispositif a été conçu, testé et fabriqué pour un usage chez un seul patient. Sa réutilisation ou son
parietale. Le complicanze includono, ma non sono limitate a: sieroma, ematoma, ricadute, infezione, aderenza
retraitement peut provoquer un dysfonctionnement et des blessures chez le patient. Son retraitement et/ou
viscerale, reazioni allergiche ai componenti del prodotto.
sa restérilisation peuvent entraîner un risque de contamination et d’infection du patient. Ne pas réutiliser,
AVVERTENZE E retraiter
PRECAUZIONI
ou restériliser ce dispositif.
1. PARIETEX™ Composite è fornito in un a confezione sterile. Prima dell’uso controllare la confezione per verificare che
DESCRIPTION
non presenti danni. Non utilizzare la rete, se la confezione è aperta o danneggiata.
Prothèse composite constituée d’un renfort tridimensionnel de polyester multibrins couvert sur une face
2. Esaminare con attenzione
blister per controllare
non si sia
danneggiato
durante
il trasporto.
par un filmilhydrophile,
continu et che
résorbable
à base
de collagène
d’origine
porcine, de polyéthylène glycol
3. Si raccomanda dietusare
il rinforzo
nelladéborde
forma indecui5 mm
è stata
non tagliarlo
per textile
garantire
il filmmultifibre
che
de glycérol.
Le film
lesfornito
limitesedudi renfort.
Un rabat
en che
polyester
protegge il bordo, bidimensionnel
sia intatto.
est fixé sur le renfort tridimensionnel.
4. Per mantenere l’INDICATIONS
elasticità e la porosità del rinforzo, si raccomanda di non tendere eccessivamente la rete al
momento dell’applicazione,
ma di esercitare
una tensione
moderata
equivalentedes
in tutte
direzioni.lors de réparations
Le renfort PARIETEX™
Composite
est utilisé
pour le ed
renforcement
tissuslenaturels
Il est indiquédidans
le traitement
des éventrations,
les réparations
de la paroi
abdominale et le
5. Per manipolare lachirurgicales.
protesi, si raccomanda
utilizzare
guanti senza
talco o accuratamente
sciacquati,
per evitare
renforcement
infiammazioni causate
in generepariétal
dal talco.des tissus (c’est-à-dire, au niveau des parois). Le renfort en polyester tridimensionnel
non résorbable permet le renforcement à long terme des tissus mous. Sur la face opposée, le film
6. La rete è fornita in una doppia confezione sterile. Si raccomanda di aprire l’ultima confezione solo per il
résorbable hydrophile réduit les phénomènes d’adhérence pouvant survenir entre la prothèse et les tissus
posizionamento della rete e di maneggiare quest’ultima con guanti e strumenti puliti.
en cas de contact direct avec les viscères.
7. Questa rete deve essere utilizzata solo da medici esperti sotto la loro esclusiva responsabilità.
CONTREINDICATIONS
INTERVENTI  POSIZIONAMENTO
Toutes les contre-indications habituelles à l’emploi des renforts de paroi s’appliquent aussi lors de
• Prima della manipolazione,
idratare
la rete PARIETEX™
Composite
nel sans
blisterpour
originale,
l’implantation
de PARIETEX™
Composite.
Cela inclut,
autantimmergendola
s’y limiter : patient en période de
completamente incroissance
un siero fisiologico
sterilelimitée
per diversi
per fare inpour
modo
che larecuperi
la propria
flessibilità
: l’extensibilité
peutsecondi
être insuffisante
suivre
croissance
d’un enfant
/ une chirurgie
e adattabilità. en site contaminé ou infecté.
• Per eseguire il posizionamento
corretto,EVENTUELLES
è fondamentale distinguere il lato continuo e liscio da quello poroso e
COMPLICATIONS
integrabile:
Les complications consécutives aux reconstructions pariétales avec renforts peuvent également être
• il lato poroso deveobservées
stare contro
parete per un’de
efficiente
integrazione
tessutale,
aprèsla implantation
PARIETEX™
Composite.
Ces complications comprennent sans pour
autantdeve
s’y limiter
hématome,
récidives,
• il lato liscio e continuo
stare di: sérome,
fronte alle
strutture sulle
qualiinfection,
va limitataadhérence
l’aderenza.viscérale, réactions allergiques aux
composants du produit.
• Se si ricorre a intervento in laparoscopia, arrotolare PARIETEX™ Composite dopo l’idratazione in modo che il lato
rivestito dal film siAVERTISSEMENTS
trovi all’interno e il filmETsiaPRECAUTIONS
protetto durante l’inserimento nel trocar (diametro minimo 10 mm).
1. PARIETEX™ Composite est livrée sous emballage stérile. Vérifier l’intégrité de l’emballage avant toute
• Il lembo tessile bidimensionale montato sul lato tessile aiuta il posizionamento e la fissazione della rete durante le
utilisation. Ne pas utiliser le renfort si l’emballage est ouvert ou endommagé.
procedure a cielo aperto.
2. Examiner le blister avec soin pour vérifier s’il n’a pas été abîmé pendant le transport.
• Il bordo del rinforzo deve sporgere di almeno 5 cm dai bordi degli orifizi. Spetta al chirurgo la scelta della tecnica
Product Introduction—Instructions for Use
PARIETEX™ COMPOSITE OS
DUAL-FACING MESH COMBINING REHABITABLE PERMANENT
REINFORCEMENT AND ABSORBABLE HYDROPHILIC FILM
10000-37163
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
9
IMPORTANT!
This booklet is designed to assist in using this product. It is not a reference to surgical techniques.
This device was designed, tested and manufactured for single patient use only. Reuse or reprocessing of this
device may lead to its failure and subsequent patient injury. Reprocessing and/or resterilization of this device
may create the risk of contamination and patient infection. Do not reuse, reprocess or resterilize this device.
DESCRIPTION
A composite mesh made out of a three-dimensional multi-fiber polyester for wall reinforcement, covered
with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen
from porcine origin, polyethylene glycol and glycerol and juts out 5 mm over the edge of the reinforcement.
A bidimensional multi-fiber polyester textile flap is assembled to the three-dimensional reinforcement.
INDICATIONS
The PARIETEX™ Composite mesh is used for the reinforcement of tissues during surgical repair. It is
indicated for the treatment of incisional hernias, abdominal wall repair, parietal (i.e. pertaining to the
walls) reinforcement of tissues. The non-absorbable three-dimensional polyester mesh provides long
term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue
attachment to the mesh in case of direct contact with the viscera.
CONTRAINDICATIONS
All the usual contraindications for the use of wall reinforcements apply to the use of PARIETEX™ Composite.
This includes, but may not be limited to: patient in a period of growth : the limited extensibility may be
insufficient for the growth of a child / surgery in an infected or contaminated place.
POSSIBLE COMPLICATIONS
The complications arising from wall reconstruction with reinforcements can also be seen after PARIETEX™
Composite has been used. These complications include, but may not be limited to : seroma, hematoma,
recurrence, infection, visceral adherence, allergic reactions to the components of the product.
WARNINGS AND PRECAUTIONS
1. PARIETEX™ Composite is provided in a sterile packaging. The packaging is to be checked for any damage
before use. Do not use the mesh if the packaging is open or damaged.
2. Carefully examine the blister to check that it has not been damaged during transportation.
3. It is recommended that the reinforcement be used in the form in which it is provided without being cut.
This will ensure that the film protecting the edge is left intact.
4. In order to maintain the elasticity and the porosity of the reinforcement, it is recommended that the
mesh should not be overly stretched when it is being put in place. A moderate and equal tension in all
directions, should be applied.
5. Due to the pro-inflammatory properties of talcum powder, it is recommended that gloves without
talcum powder or which have been thoroughly rinsed are used to handle the reinforcement.
6. The mesh is provided in a double sterile packaging. It is recommended to open the last packaging only
for the placement of the mesh and to handle the latter using clean gloves and instruments.
7. This mesh should only be used by experienced practitioners who do so under their own responsibility.
OPERATING STEPS  POSITIONING
• PARIETEX™ Composite must be hydrated in its original blister before being handled. This is carried
out by immersing it completely in a sterile saline serum for several seconds in order for it to recover its
conformability and flexibility.
• When putting it in place, it is essential to perfectly pinpoint the smooth and continuous side from the
porous and rehabitable side in order to situate it correctly :
• the porous side against the wall for an efficient tissue integration.
• the smooth and continuous side facing the structures on which the tissular attachment is to be limited.
• Should it be used in a laparoscopic approach, PARIETEX™ Composite is to be rolled after hydration, with
the film face inside, so that the film is protected when inserted in the trocar (minimum diameter of 10 mm).
• The bi-dimensional textile flap assembled to the textile side can help the placement and the fixation of
the mesh when used in open approach.
• The edge of the reinforcement is to be at least 5 cm over the edges of the orifice(s). The technique used to
anchor the mesh (suture or staples) is left up to the practitioner. The technique used must be anchored on
the textile base and not only on the absorbable film.
STERILIZATION TECHNIQUE
PARIETEX™ Composite is intended as a single-use device. Sterilized by gamma radiation.
STORAGE
Recommended conditions for storing the product: between +2°/+25°C (36/77°F), in a dry area. However,
the product is stable at 40°C (104°F) during 2 months.
Do not use the device past the last day of the labeled month of expiration.
Upon receipt of shipment, ensure that the packaging is not open or damaged and retains its sealed
integrity. Do not use the device if the integrity of the packaging appears compromised.
GUARANTEE
SOFRADIM PRODUCTION certifies that every precaution has been taken when choosing material and the
manufacturing method used for this product. SOFRADIM PRODUCTION is not liable in the case of any
loss, damage or cost directly or indirectly linked to the use of the product. The terms and conditions of
the guarantee set out herein cancel and replace any guarantee which does not appear in this document,
whether it be explicity or tacitly contained within the legislation or in any other means. SOFRADIM
PRODUCTION is not liable for any other action taken on its behalf by any party with regard to the product
and hereby forbids any party to do so.
B ANGR K
w
RETE A DUE SUPERFICI CHE ASSOCIA UN RINFORZO INTEGRABILE
PERMANENTE E UN FILM IDROFILO ASSORBIBILE
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Product Introduction—Instructions for Use
m
m
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™ m
m
m
m
m
m
m
m
w
m
m
w
IMPORTANTE
mm
m m
m
ffi
w
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Il presente opuscolo ha lo scopo di rendere più semplice l’utilizzo di questo strumento, non è pertanto da intendersi
B HR NG
ND A ON
come materiale di consultazione per l’esecuzione di tecniche chirurgiche.
PO m B OMP A ON
m
m
m
m
m
w
™ m
KON RA ND KAA O
m
mw
w
m
™
Questo dispositivo è stato progettato, testato e fabbricato per l’utilizzo esclusivo su un singolo paziente. L’utilizzo
m
m
m
™ mm
m
m
m
m
m
m m
mm
m
w m
m
m
e i trattamenti ripetuti possono danneggiare il dispositivo e causare lesioni al paziente. Trattamenti ripetuti e/o
m
m m
m
m
m
risterilizzazioni del dispositivo possono determinare il rischio di contaminazione e di infezione a carico del paziente.
m
m
m
Non riutilizzare, trattare ripetutamente o risterilizzare questo strumento.
WARN NG AND PR AU ON
ND A
MAHDO
KOMP KAA O
™ m
m
™ m
m w
w
DESCRIZIONE
m
m
mON RO ND ™ A mON
m
m
m
w
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Rete composita costituita da un rinforzo parietale tridimensionale in poliestere multifilamento, coperta da un film
m
m m
m m m
m
w
w
m
m
assorbibile, continuo e idrofilo su uno dei suoi lati. Questo film è costituito da collagene porcino, polietilene glicole e
m
mm
m
m
m
w
m
m
m
glicerolo e sporge di 5 mm dal bordo del rinforzo. Il rinforzo tridimensionale è dotato di un lembo tessile in poliestere
ffi
mm
m UK
w
w
ARO
A AROmO M
w
m
m
multifilamento bidimensionale.
w
m
PO B
OMP AN
™ m
m
INDICAZIONI
METODA
STERYLIZACJI
TÉCNICA
DE ESTERILIZAÇÃO
GARANTION RA™ND A
Empfohlene Lagerbedingungen
Trocken,
bei +2 ° bis +25 °C. Das Produkt
m
™ m
m für das Produkt:
m bleibt jedoch
mm bei 40 °C
w
La reteComposite
PARIETEX™éComposite
è utilizzata
il rinforzo
tissutale
riparazione chirurgica. É indicata per il
Siatka PARIETEX™
Composite przewidziana
SOFRADIM PRODUCTION garanterer, at der er taget alle nødvendige forholdsregler ved valg
af materialer
A PARIETEX™
um dispositivo
de usoper
único.
Esterilizado
pordurante
radiaçãolagama.
2 Monate
lang stabil.
m
mog
w
m jest do jednorazowego użytku.
w Sterylizowane promieniami gamma.
™
m
m
m
trattamento di laparoceli, riparazione della parte addominale e rinforzo parietale (cioè riguardante
le pareti) dei tessuti.
produktionsmetode.
SOFRADIM
PRODUCTION er ikkePERMANENT
ansvarlig for tab, beskadigelse ellerDieudgifter,
opstår
m
DUAL-FACING
MESH
COMBINING
REHABITABLE
ARMAZENAMENTO
Produktdernicht
übersom
denenletzten Tag des inPRZECHOWYWANIE
der Kennzeichnung ausgewiesenen Verfallsmonats
hinaus
m
m verwenden.
m
La reterecomendadas
in poliestere tridimensionale
non assorbibile
fornisce
dei tessuti (36/77°F),
molli a lungo
da una
eller indirekte
følge af brugenHYDROPHILIC
af produktet. Vilkårene ogFILM
betingelserne i denne garanti tilsidesætter ogmerstatter
Zalecane
warunkiungeöffnet
przechowywania
produktu:
pomiędzy
+2°/+25°C (36/77°F),
REINFORCEMENT
AND
RESORBABLE
As condições
para armazenamento
do produto
são: rinforzo
entre +2°/+25°C
emperiodo
ambiente
seco.lato; dall’ direkte
A Rsuchym
N
PR AU ON
mmdass
m und
w unbeschädigt
mmwisttemperaturze
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Nach
Eingang
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Lieferung
sicherstellen,
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Packung
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Dichtigkeit/
M
altrooilproduto
film idrofilo
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riduce
al minimo
l’attacco
del tessuto alla rete in caso di contatto diretto con i visceri.
enhver anden
ikke er indeholdt
i dette dokument, hvad enten denne forekommer udtrykkeligt eller
MOG garanti,
K derOMP
A
Niemniej
zachowuje
trwałość werscheint.
temperaturze
40°C (104°F) przez okres 2DUBBELLAAGS
miesięcy.
Entretanto,
fica estável
a 40°C
(104°F)
durante
2 meses.
™ mNie
m blieb.
w Diesew Produktpomieszczeniu.
m
Unversehrtheit
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nicht verwenden,
wennprodukt
die Packung
nicht unversehrt
underforstået
SOFRADIM m
PRODUCTION er ikke ansvarlig
for andre handlinger
udført
mi forskrifter eller andre retsmidler.
w
™ m
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stosować urządzenia po upływie
dnia miesiąca terminu ważności podanego naPERMANENTE
etykiecie. Po otrzymaniuMESH E
10000-37287
Não useCONTROINDICAZIONI
o dispositivo após o término da data de validade.
m
mm
GARANTIE
MET
ELK
foretage
m vedrørende produktetmog forbyder hermed andre parter
m at m
m sådanne handlinger.
Tutte le consuete controindicazioni per l’uso del rinforzo parietale si applicano all’utilizzo di PARIETEX™ Composite. Le på deres vegne af andre parter
przesyłki sprawdzić, czy opakowanie nie zostało otwarte ani uszkodzone oraz czy jest szczelne. Nie stosować
m
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m die Wahl der Materialien und Herstellungsmethoden für dieses
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Após o controindicazioni
recebimento, certifique-se
a embalagem
esteja aberta
SOFRADIM PRODUCTION bescheinigt,
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includono,demaquenon
sono limitatenão
a: paziente
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BELANGRIJK!
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estiver
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Produkt
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erfolgte.
SOFRADIM
PRODUCTION lehnt jegliche Haftung
für Verluste, Schäden
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WAAR HUW NG N N OOR ORG MAA R G N
Deze
brochure
dient als gebruiksaanwij
GWARANCJA
Kosten
Gebrauch
Produkts ergeben mögen. Die hier aufgeführten
GARANTIA
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RAwoder
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ON
NG dieses
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m ab, die sich
BEFORE USING PRODUCT, READ THE
PO B
OMP AN
Firma
SOFRADIM
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zaświadcza,
że
podjęto
wszelkie
środki
ostrożności
podczas
wyboru
materiałów
m
Dit product is ontworpen,i getest en gef
Garantiebedingungen
bzw.
-beschränkungen
ersetzen
alle
nicht
in
diesem
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aufgeführten
Garantien
(ob
A SOFRADIM PRODUCTION
garante
que
todas
as
precauções
foram
tomadas
em
relação
à
escolha
dos
materiais
e
™ m
mmetod wytwarzania niniejszego produktu. SOFRADIM
m
m
m
™ m
m
m undPRODUCTION
product kan leidenzatotstraty,
falen met eve
ausdrücklicher odermm
stillschweigender
oder in sonstiger Weise
machen diesezrzeka się wszelkiejditodpowiedzialności
métodos de fabricaçãomdeste produto. A SOFRADIM
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caso de perda,
IMPORTANT!
m Art, gesetzlich
m lubvorgeschrieben)
m m gwarancji lub
m
m isenta-semde responsabilidade
m m
szkodyHaftung
lub koszty
bezpośrednio
pośrednio
związane
z użyciem
produktu.
Wymienione
warunki
w
product
kan risico op besmetting en pa
mjeglichen
hinfällig. SOFRADIM PRODUCTION
lehnt
jegliche
bezüglich
sonstiger,
von
Personen
im
Namen
des
danos ou custos directa ou indirectamente
relacionados
ao
uso
do
produto.
Os
termos
de
garantia
ou
as
restrições
This
booklet
is
designed
to
assist
in
using
this
product.
It
is
not
a
reference
to
surgical
techniques.
m
KAKSIPUOLINEN
VERKKO,
JOSSA
ON
KUDOKSEN
SISÄÄNKASVUA
m
ograniczenia
unieważniają
i
zastępują
wszelkie
gwarancje
nie
pojawiające
się
w
niniejszym
dokumencie,
wyrażone
m
of
opnieuw
steriliseren.
W
m
mw
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Unternehmens gemachter Zusicherungen ab, die dieses
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KÄ Produkt
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aqui listadas anulam e substituem quaisquer garantias que não estejam no presente documento,This
explícitas
JA RESORBOITUVA HYDROFIILINEN
deviceouwas designed, tested and EDISTÄVÄ
manufactured for PYSYVÄ
single patient VAHVIKE
use only. Reuse
lub dorozumiane
obowiązujących
W
m
m
mm
A porRmeios
N legaisPRou qualquer
AU ONoutro meio. A SOFRADIM PRODUCTION isenta-se de responsabilidade
m or reprocessing of this
BESCHRIJVING
™ odpowiedzialności
m
m
implícitas,
e nega,
KALVO
device may lead
to its failure and subsequent patient injury. Reprocessing and/or resterilization
of this device
nie przyjmuje żadnej
za jakiekolwiek wzobowiązaniaffiwyrażone w jej imieniu przez dowolną
osobę
™
m
m
Een composite
mesh van driedimension
m
m
w
m
m
m
m
m
m
por meio desta, qualquer compromisso feito em seu nome por qualquer pessoa ligada a este produto.
may create the risk of contamination
and patient infection. Do not reuse, reprocess or resterilize this device.
m w związku z niniejszym produktem.
w
m
m
m
TÄRKEÄÄ!
resorbeerbare, continue, hydrofiele laag
m
m
w
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m
DESCRIPTION
Tässä tuoteselosteessa on tuotteen käyttöohjeet. Siinä ei anneta kirurgisia menetelmiä koskevia ohjeita.
glycerol en steekt 5 mm uit over de ran
m
mm
w
RETE A DUE
SUPERFICI CHE ASSOCIA UN RINFORZO
PERMANENTEwE
A composite mesh made out of aTämä
three-dimensional
multifilament
for potilaskohtaiseen
wall reinforcement,käyttöön. Laitteen uudelleenkäyttö
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laite on tarkoitettu,
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valmistettu
tai -sterilointi
INDICATIES
m
m
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N R N PO ONAM
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covered with an absorbable, continuous
hydrophilic filmjaonpotilasvammaan.
one of its sides. This
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m johtaa UN FILM
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voi johtaaand
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Laitteen
PARIETEX™mComposite
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m andwglycerol and juts out 5 mm over the edge of the W
m
m
collagen from porcine origin, polyethylene
glycol
m
m
tartuntavaaraan ja potilasinfektioon. Laitetta ei saa käyttää, puhdistaa tai steriloida uudelleen.
IMPORTANTE
is geïndiceerd voor de behandeling van
m
m
m
m
m
m
reinforcement.
m
m
Il presente opuscolo ha lo scopo di rendere più semplice l’utilizzo di questo strumento, non è pertanto da intendersi
wanden) weefselversteviging. De
niet r
PERMANENTE
KUVAUS
m m DUBBELLAAGS
m MESH, COMBINEERT
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TAKVİYE
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m m
w
w di consultazione per l’esecuzioneKALICI
INDICATIONS
m VE EMİLEBİLİR
m HİDROFİL FİLMİ
™ m BİRLEŞTİREN
come materiale
di tecniche chirurgiche.
versteviging van zacht weefsel. Aan de
WEEFSELVERSTERKING
on valmistettu kolmiulotteisesta monikuituisesta seinämän vahvistamiseen
tarkoitetusta
TARAFLI AĞ
m
mMET EEN RESORBEERBARE HYDROFIELE
m The PARIETEX™ Composite meshYhdistelmäverkko
is
used
for
the
reinforcement
of
tissues
during
surgical
repair.
It
is
OP
RA
PRO
DUR
PO
ON
R
N
m
weefselhechting aan de mesh in geval v
A ON testato
HN QU
LAAG
polyesteriverkosta, jonka toinen puoli on peitetty resorboituvalla, jatkuvalla hydrofiilisellä
kalvolla.
Kalvo on
Questo
dispositivo
è Rstato progettato,
e fabbricato per l’utilizzo esclusivo su un singolo paziente. L’utilizzo
mm
indicated for the treatment of incisional
hernias,
pertainingjatose ulottuu 5 mm verkon reunojen yli.
™ m wallpolyeteeniglykolista
mrepair and parietal ja(i.e.
wglyserolista,
mm e causare lesioni al paziente. Trattamenti
™w mdanneggiareÖNEMLİ!
mm
valmistettu
sian abdominal
kollageenista,
e i trattamenti ripetuti possono
il dispositivo
ripetuti e/o
CONTRA-INDICATIES
BELANGRIJK!
the walls) reinforcement of tissues.
The
non-absorbable
three-dimensional
polyester
mesh
provides
long
m
m
w
w
m
m
Bu kitapçık,
ürünündi kullanılmasında
olmaka carico
amacıyla
Kolmiulotteiseen vahvikkeeseen on kiinnitetty kaksiulotteinen monikuituinen polyesteritekstiililäppä.
miçin bir başvuru
mkaynağı mvoor
risterilizzazioni del ORAG
dispositivo possono determinare
il rischio
contaminazione yardımcı
e di infezione
del tasarlanmıştır.
paziente. Cerrahi teknikler
Alle gebruikelijke
contra-indicaties
m
Deze brochure dient
technieken. of soft tissues. On the opposite side, the absorbable hydrophilic filmw minimizesmtissue
term reinforcement
m als gebruiksaanwijzing
m voor dit product.mHet is geen naslagwerk
m voor chirurgische
m
w Non riutilizzare, trattare ripetutamente o risterilizzare
değildir. mquesto strumento.
PARIETEX™ Composite.
mm
w + +
w
INDIKAATIOT
attachment
to the
Dit product is ontworpen, getest en gefabriceerd ommte worden gebruikt bij één patiënt. Hergebruik
of recycling
vanmesh in case of direct contact with the viscera.
m
Bu araç, yalnızca bir hastada kullanılacak
şekilde tasarlanmış, test edilmişmve üretilmiştir.Deze
Bu aracın
kullanılması
PARIETEX™-Composite käytetään kudoksen m
vahvistamiseen kirurgisen korjaustoimenpiteen
aikana. Se on tarkoitettu
mzijn nietmbeperkt
DESCRIZIONE
bestaantekrar
uit, maar
dit product
falen met
eventueel
van dit
CONTRAINDICATIONS
ya da tekrar
düzgün
ve bunun
sonucunda
hastanın yaralanmasına
neden
Bu aracın
N kan
R leiden
N totPO
ONAM
N Opatiëntletsel tot gevolg. Recycling en/of opnieuw steriliseren
arpityrien hoitoon, vatsaontelon seinämän korjaustoimenpiteeseen ja kudoksen parietaaliseen
(ts. seinämiin
liittyviin)
m işlenmesi, in
m multifilamento,
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costituita
da un rinforzo parietale
tridimensionale
poliestere
coperta
da un film
voor een
kindolabilir.
in de mgroei
en/of voor chi
m çalışmamasına
product kanmrisico opmbesmetting en patiëntinfectie met zich meebrengen.
Dit
product
niet
hergebruiken,
recyclen
All
the
usual
contraindications
for
the
use
of
wall
reinforcements
apply
to
the
use
of
PARIETEX™
Composite.
işlenmesi
tekrar
edilmesi,
kirlenme
ve hastada
enfeksiyon
riskine neden olabilir. Bu aygıtı tekrar
™ m
mm
w
ffi
m pehmytkudoksia
w assorbibile,
vahvistamiseen. Resorboitumaton kolmiulotteinen
polyesteriverkko
vahvistaa
pitkäaikaisesti.
continuo e idrofilico su uno
dei tekrar
suoi lati.
Questo
film
costituito
daMÄ
collagene
porcino,
polietilene
glicole
e
R Ove/veya
N èM
N sterilize
MOGELIJKE
COMPLICATIES
m
m
of opnieuw
steriliseren.
N
A
D
R
A ON
These include, but may not be limited
to: patient
in aon
period
of growth:
themlimited extensibility
be kiinnittymistä
kullanmayın, tekrar
ya da tekrar sterilize etmeyin.
m m
m
Sen toisella
puolella
resorboituva
hydrofiilikalvo,
joka minimoimay
kudoksen
verkkoon,
jos verkko
di 5 mmon
w wglicerolo
m e sporge
mdal wbordo del rinforzo.
™ işlemeyin
m
mm
De complicaties™ alsmgevolg van wandrec
m m
BESCHRIJVING
insufficient for the growth of a child
/ surgery
in an infected
or contaminated
place.
suorassa
kontaktissa
sisäelinten
kanssa.
TANIM
INDICAZIONI
gebruikt. Deze complicaties bestaan uit
m
™ m
w
m
Ä
GUARAN
Een composite mesh van driedimensionaal
multifilamentmpolyester voor wandversterking, bedektPOSSIBLE
met een COMPLICATIONS
R AfilmON
Duvar takviyesi için üç boyutlu multifiber –polyesterden
bir
veON
hidrofilli
kaplı
m
KONTRAINDIKAATIOT
chirurgica. Éyapılmış,
indicata
pertarafı emilebilir, sürekli
adhesie
/ allergische
reacties op bestan
w
m
m
m
mmLa rete PARIETEX™ Composite
M è utilizzata per il rinforzo tissutale durante la riparazione
m
resorbeerbare, constante en hydrofiele laag aan één zijde. Deze laag bestaat uit varkenscollageen,The
polyethyleenglycol
m
complications arising from wall
reinforcements can also
be seen after koskevat
PARIETEX™
bir ağdır. Bu
film, porsinden
elde
edilen
kolajen,lepolietilen
glikol ve gliseroldan yapılmıştır ve takviyenin
Kaikkireconstruction
tavanomaisetwith
seinämänvahvikkeiden
käyttörajoitukset
myös PARIETEX™-Composite
käyttöä.
Näitäriparazione dellakompozit
il
trattamento
di
laparoceli,
parte
addominale
e
rinforzo
parietale
(cioè
riguardante
pareti)
dei
WAARSCHUWINGEN EN VOORZO
m
m
M
m
m but may not be limited to : seroma, haematoma /
en glycerol en steekt 5 mm uit over de meshrand. Een tweedimensionale multifilament polyesterComposite
textielflaphas
is been used. These complicationswinclude,
5 mmfornisce
çıkıntı yapmaktadır.
Üç boyutlu
takviyeye,
iki boyutlu
polyester bir kapak takılmıştır.
ovat muun muassa seuraavat: kasvava potilas: verkko ei veny riittävästi lapsen kasvaessa
/ leikkaus
tessuti.
La reteinfektoituneessa
in poliestere
tridimensionalekenarından
non assorbibile
rinforzo dei tessuti
lungo periodo
da un multifiber
ffi
m
m
m / allergic reactions to the components of the product.
bevestigd aan de driedimensionale mesh.
m molli a m
m 1. PARIETEX™ Composite wordt gelever
recurrence / infection / visceral adherence
tai kontaminoituneessa
kohdassa.
lato mentre dall’altro il film idrofilico assorbibile
riduce al minimo
l’attacco del tessuto alla rete in casomdi contatto
ENDİKASYONLARI
gecontroleerd op schade. De mesh nietm
w
w
m
m
m
m
m
m m
INDICATIES
m
diretto con i visceri.
WARNINGS AND PRECAUTIONS
PARIETEX™ Composite ağ,
Kesiğe bağlı fıtığın
MAHDOLLISET KOMPLIKAATIOT
m
m cerrahi
w müdahale sırasındaM dokuların güçlendirilmesi
m için kullanılır.
2. Controleermde blisterverpakking nauw
™ weefsel
m tijdens chirurgische
m
w
m
De PARIETEX™ Composite mesh wordt gebruikt voor de versteviging van
reparaties.
Het
is
1. PARIETEX™ Composite is provided
in a sterile packaging.
The packaging
is to be checked
any damage
tedavisi,mm
abdominal
duvara yapılanmmüdahaleler, paryetal (örn. duvarla ilgili) doku takviyeleri için kullanılır.
Seinämänkorjauksesta
aiheutuvia
komplikaatioita
verkkoa for
käytettäessä
on havaittu myös
PARIETEX™-Composite
CONTROINDICAZIONI
w
m m
m
m reparatie van maagwanden,
m pariëtale (d.w.z.
m
m
m
mm
w
geïndiceerd voor de behandeling
van littekenbreuken,
deel
uitmakend
Wij radenDiğer
aan de
mesh te gebruiken
AKUU
before use. Do not use the meshkäytön
if the packaging
is open
or damaged.ovat muun muassa seuraavat: serooma, hematooma,
üçparietale
boyutlusipolyester
yumuşakdidokuların
uzun
vadede güçlendirilmesini3.sağlarlar.
taraftan,
jälkeen. Näitä
komplikaatioita
uusiutuminen,
Tutte tyrän
le consuete
controindicazioni per l’usoEmilmeyen,
del rinforzo
applicanoağ,all’utilizzo
PARIETEX™
Composite.
GARAN
van de wanden)
biedt een
deA randindirir.
beschermt, inta
m versterkingmvan de weefsels.
m De niet-resorbeerbare driedimensionale
m polyester mesh
R A sisäelimiin,
HN Kallergiset reaktiot tuotteen valmistusaineisiin.
M film, iç organlarla doğrudanmtemas durumunda,
m dokunun ağa
m tutunmasını
mdat de laag
men altdieseviyeye
emilebilir
hidrofilli
infektio, kiinnittyminen
2. Carefully
M
Le
controindicazioni
includono,
ma
non
sono
limitate
a:
paziente
in
fase
di
crescita:
l’
e
stensibilità
limitata
della
rete
langdurige versterking van weke delen. Aan de andere zijde minimaliseert de resorbeerbare hydrofiele
film deexamine the blister to check that it has™notmbeen damaged during transportation.
m
m
mm
m
M
m
4. Om de elasticiteit en poreusheid
van
VAROITUKSET
JA inVAROTOIMET
può essere insufficiente a seguire la crescitaKONTRAENDİKASYONLAR
di un bambino/intervento chirurgicomin un sito contaminato o infettato. m
3. It is recommended that the reinforcement
be used
the form in which it is provided without being cut.
aanhechting van weefsel aan de mesh bij direct contact met de organen.
m enm gelijkmatig
aanbrengen.
Eenmmatige
m
m
OP edge
AGis left intact.
Duvar takviyelerinin kullanımına bağlı tüm olağan kontraendikasyonlar PARIETEX™ Composite
kullanımı
sırasında
m
1. PARIETEX™-Composite
toimitetaan steriilissä pakkauksessa. Pakkaus on tarkastettavaPOSSIBILI
vaurioiden varalta
ennen
This
will
ensure
that
the
film
protecting
the
COMPLICANZE
CONTRAINDICATIES
m
m değildir: gelişme
M
m
+ +
m
5. Door
de pro-inflammatoire
eigensch
Kontraendikasyonlar
aşağıda verilmiştir
ancak bunlarla
sınırlı
çağında
olan hastalarda:
käyttöä.
ei saaofmkäyttää,
jos pakkausiton
avattu tai vaurioitunut.
Dopo l’impianto di PARIETEX™ Composite sigörülebilir.
possono osservare
le complicanze
dalla ricostruzione
con rinforzo
4. Ingebruik
order to maintain the elasticity
and Verkkoa
the porosity
the reinforcement,
is recommended
that the
Alle gebruikelijke contra-indicaties
voor het gebruik van wandversterking zijn van toepassing bij het
m sınırlı
m olması bir causate
m
m
m
handschoenen
die zorgvuldig
zijn uitge
çocuk
tümörü
/ enfeksiyonlu
ya da mikroplu bölgede
yapılan ameliyat
için
m
FACE
ASSOC
ANT
RENFORT
REHAB
TABLE
2. Kuplapakkaus
on tarkastettava
aikaisten
vaurioiden varalta.parietale. Le complicanzeMPLANT
includono, ma B
nongenişletilebilirliğin
sono limitate
a: sieroma,
ematoma,
ricadute,
infezione,
aderenza
mesh
should not be overly stretched
when it is being
put in place.huolellisesti
A moderatekuljetuksen
and equal tension
whatever
van PARIETEX™ Composite. Deze bestaan uit, maar zijn niet beperkt tot: patiënt in groeistadium: de
beperkte
m
yetersizET
olabilir
N AD
R
A ON
PERMANENT
F LM HYDROPH LE RESORBABLE
m m
6. De meshmwordt geleverd in een dubb
viscerale, m
reazioni
the direction
uitrekbaarheid kan onvoldoende zijn bij de groei van een kind / chirurgie in een geïnfecteerd of besmet
gebied.should be applied. 3. Verkko suositellaan käytettäväksi toimitetussa muodossa, eikä sitä saa leikata. Näin varmistetaan,
että allergiche
reunaa ai componenti del prodotto.
™ m
m
m
mm
MPOR AN
gebruik van de mesh te openen en deze
OLASI KOMPLİKASYONLAR
pysyypowder,
ehjänä. it is recommended that gloves without
AVVERTENZE E PRECAUZIONI
5. Due to the pro-inflammatory suojaava
propertieskalvo
of talcum
MOGELIJKE COMPLICATIES
m
PARIETEX™sterile.
Composite
sonra latakviye
ile duvar
komplikasyonlar
ON R A ON
De mesh
mag alleen worden gebruik
1.
PARIETEX™
Composite
Primakullanıldıktan
dell’uso controllare
confezione
perrekonstrüksiyonu
verificare che nedeniyle7.oluşan
talcum
powder
or
which
have
been
thoroughly
rinsed
are
used
to
handle
the
reinforcement.
De complicaties als gevolg van wandreconstructie met versterking kunnen ook optreden nadat PARIETEX™ Composite
4. Jotta verkko pysyy kimmoisena ja huokoisena, sitä ei saa venyttää liikaa asennuksen aikana. Verkkoa voidaan è fornito in un a confezione
da
görülebilir.
Bu
komplikasyonlar
aşağıda
verilmiştir
ancak
bunlarla
sınırlı
değildir:
seroma,
hematom, nüksetme,
m
+ +
m
m
non presenti danni. Non utilizzare la rete se la confezione è aperta o danneggiata.
OPERATIEPROCEDURE - POSITIO
is gebruikt. Deze complicaties bestaan uit, maar zijn niet beperkt tot: seroma, hematoom, recidief,6.infectie,
viscerale
venyttää
jonkin
verranIttasaisesti
joka suuntaan.
The mesh
is provided in a double
sterileGARAN
packaging.
is recommended
to open the last packaging only
enfeksiyon,
viseral
yapışma,
ürün
bileşiklerine
karşı
alerjik
reaksiyonlar.
m
Mlatter using clean gloves and instruments. m
m
1. PARIETEX™ Composite moet gehydra
adhesie, allergische reacties op de componenten van het product.
2. Esaminare
con attenzione
che non simsia danneggiato durante il trasporto.
for the placement of the mesh and
to handle
theon
5. Koska
talkilla
tulehdusta edistäviä ominaisuuksia, vahvikkeita tulisi käsitellä talkittomilla
tai huolellisesti
m il blister per controllare
m
UYARILAR
VE ÖNLEMLER
m
m
m
m
w
M
DitΜΗ
wordtΕΝ
gedaan
door de m
ΠΛΕΓΜΑ
ΔemdiΠΛΗΣ
ΟΨΗΣ
ΤΟ che
ΟΠΟ
ΟcheΣΥΝΔΥΑΖΕverwijderd.
ΜΟΝ
ΣΧΥΣΗ
WAARSCHUWINGEN EN VOORZORGSMAATREGELEN
käsineillä.
3. Si raccomanda di usare il mrinforzo nella forma
in
cui
è
stata
fornito
non
tagliarlo
per
garantire
il
film
7. The mesh should only be usedhuuhdelluilla
by experienced
practitioners who do so under their own responsibility.
MALLA
DEzodat
DOBLE
1. PARIETEX™ΕΝΣΩΜΑΤΩΣΗΣ
Composite steril bir ambalajda
Ambalaj, kullanımdanΜΗ
önceΥΔΡΟΦ
herhangi
bir fysiologisch
hasara
karşı serum
kontrol
steriel
het wee
m
ΚΑverilir.
ΑΠΟΡΡΟΦΗΣ
ΛΗ ΜΕΜΒΡΑΝΗ
1. PARIETEX™ Composite
wordt geleverd in een steriele verpakking. Voor gebruik moet de verpakking
worden
protegge
il
bordo,
sia
intatto.
PERMANENTE
6.
Verkko
toimitetaan
steriilissä
kaksoispakkauksessa.
Sisin
pakkaus
tulee
avata
vasta
verkkoa
asennettaessa,
ja
sitä
edilmelidir. Ambalaj açılmış ya da zarar görmüşse ağı kullanmayın.
m
m
m mis. OPERATING STEPS - POSITIONING w
2. Bij het plaatsen, is het belangrijk om
gecontroleerd op schade. De mesh niet gebruiken als de verpakking beschadigd of geopend
käsitellä
puhtain
käsinein
ja
instrumentein.
ΗΜΑΝ
ΚΟ
1. PARIETEX™ Composite must betulee
hydrated
in
its
original
blister
before
being
handled.
This
is
carried
out
4.
Per
mantenere
l’
e
lasticità
e
la
porosità
del
rinforzo,
si
raccomanda
di
non
tendere
eccessivamente
la
rete
al
D R Pm ON
w
m
m
m
2. Nakliye esnasında hasar görmediğini kontrol etmek için blisteri dikkatlice inceleyin. poreuze en rehabiliteerbare zijde. Voor e
GARAN
A
2. Controleer
de blisterverpakking
nauwkeurig op schade die is ontstaan tijdens het vervoer. by immersing it completely in a 7.sterile
foromalla
severalvastuulla
seconds invain
order
for itjatokokeneet
recover itslääkärit.
momento
una tensione moderata emomogenea in tutte le ωdirezioni. m
M serum
m wdell’applicazione.mEsercitare
m
Tätä physiological
verkkoa saavat
käyttää
pätevät
MPOR
ANweefsel;
integratie
van het
3. Takviyenin verildiği biçimde kesilmeden kullanılması önerilir. Böylece, filmin koruyucu
kenarı
bozulmadan
kalır.de gladde en
M
m and flexibility.
conformability
m di utilizzare guanti senza talco o accuratamente sciacquati, per evitare
m
3. Wij raden aan de mesh te gebruiken in de vorm waarin het wordt geleverd, zonder het te verknippen. Dit zorgt
5. Per manipolare la protesi, si raccomanda
KÄYTTÖVAIHEET  SIJOITUS
weefseladhesie
beperkt moet worden.
m
M
4.
Takviyenin
esnekliğini
ve
gözenekli
yapısını
muhafaza
etmek
için
yerine
yerleştirilirken
ağın
fazla
gerilmemesi
m
mm m
ervoor dat de laag die de rand beschermt, intact blijft.
2. When putting it in place, it is essential
to perfectly pinpoint
the smoothalkuperäisessä
and continuouskuplapakkauksessa
side from the ennen käsittelyä.
infiammazioni
causate in genere dal talco.
• PARIETEX™-Composite
on kostutettava
Tämä suoritetaan
m
m
3. Bij een laparoscopie moet PARIETEX™
önerilir. Her yönden, orta seviyede ve eşit şekilde gerilmelidir.
and rehabitable
to situatesecorrectly:
porouskeittosuolaseerumiin
side against the wallmuutamaksi
for an efficient
ON confezione sterile. Si raccomanda di aprire l’ultima confezione solo per il
4. Om de elasticiteit
en poreusheid van de mesh te behouden, raden wij aan de mesh niet teveel porous
uit te rekken
bij het side in order
upottamalla
kokonaanthesteriiliin
sekunniksi verkon6.mukautuvuuden
jain unaA doppia
La rete è fornitaND
m
folie eldivenlere
wordt beschermd
bij het inbrengem
5.
Talk
pudrasının
enflamatuar
özellikleri
talk pudrası
ω kullanılan
tissue integration / the smooth and
continuouspalauttamiseksi.
side facing the structures on which the tissular attachment
™ m quest’ultima con guanti e strumenti
m puliti.olması nedeniyle, takviyeyi tutmak için
aanbrengen. Een matige en gelijke spanning mmoet in alle richtingen
wordenmtoegepast.
joustavuuden
posizionamento della rete e di maneggiare
m
m
4.
De
rand
van
de
mesh
moet ten minst
sürülmemesi
ya
da
eldivenlerin
iyice
yıkanması
önerilir.
ω
Μ
to be limited.
m la loro esclusiva responsabilità.
M
m zonderis talkpoeder
5. Door de pro-inflammatoire
eigenschappen van talkpoeder raden wij aan handschoenen
of
• Kun verkko laitetaan paikalleen, on tärkeää erottaa sileä, jatkuva puoli huokoisesta, kudoksen
7. Questasisäänkasvua
rete deve essere usata solo da medici esperti che la utilizzino
de için
mesh
te bevestigen
ώ sotto
6. Ağm ikili steril bir ambalajda
verilmektedir. Sonuncu ambalajın sadece ağ yerleştirilmesi
açılması
ve temiz(hechtingen of t
m
3. Should it be used in a laparoscopic
approach,
PARIETEX™
is to beoikein.
rolled after hydration, with the
handschoenen die zorgvuldig zijn uitgespoeld te gebruiken bij de ingreep.
edistävästä
puolesta,
jotta Composite
verkko asetetaan
INTERVENTI - POSIZIONAMENTO
eldivenler
tutmak
m
m kullanılarak sonuncuyu
m
m için kullanılması
m önerilmektedir. textielbasis worden gefixeerd en niet al
DUBBELS
Dtrocar
GT (minimum
NÄT MED
ENof 10
KOMB
Π ve
Ρ aletler
ΡΑΦΗ
film face inside, this way the film is protected when
inserted in the
diameter
mm). NAT ON AV PERMANENT
D R P ÓN
6. De mesh wordt geleverd in een dubbele steriele verpakking. Wij raden aan om de laatste verpakking net voor het
• Huokoinen puoli asetetaan seinämää vasten kudoksen sisäänkasvua varten.
1. Prima
della manipolazione, idratare
Composite nel blister originale,
immergendola completamente ωin
STERILISATIETECHNIEK
m PARIETEX™
mait olmak
FÖRSTÄRKN
NG
FÖR
VÄVNADS
NVÄXT
OCH
RESORBERBAR
ω ω
7.
Bu
ağ,
sorumluluğu
kendilerine
üzere
yalnızca
deneyimli
kullanılmalıdır.
4.
The
edge
of
the
reinforcement
is
to
be
at
least
5
cm
over
the
edges
of
the
orifice(s).
The
technique
used
m
m
gebruik van de mesh te openen en deze verpakking te hanteren met schone handschoenen en instrumenten.
un siero fisiologico sterile per diversi secondi per fare in modo che recuperi la propria flessibilità e adattabilità. uzmanlar tarafından
• Sileä, jatkuva puoli asetetaan niitä kudosrakenteita vasten, joihin verkon
haluta kiinnittyvän.
PARIETEX™ Composite is bedoeld voor e
L FeiLM
to anchor the mesh (suture or staples) is left up to the practitioner. The technique usedHYDROF
must be anchored
KULLANIM
ADIMLARI

KONUMLANDIRMA
7. Deze mesh mag alleen worden gebruikt door ervaren artsen die de ingreep op eigen verantwoordelijkheid uitvoeren.
2.
Per
eseguire
il
posizionamento
corretto,
è
fondamentale
distinguere
il
lato
continuo
e
liscio
da
quello
poroso
e
käytetään laparoskooppisissa toimenpiteissä, PARIETEX™-Composite kääritään kostutuksenON
jälkeen
OPSLAG
R ND A ON PARIETEX™ Composite kullanılmadan önce orijinal blisterinin içinde suyla karıştırılmalıdır.
on the textile base and not only •onJostheverkkoa
absorbable
Bu işlem, bileşiğin mm mm
K G film.
integrabile: il lato poroso deve essere posto •contro
la parete per
efficace del tessuto, mentre il lato ω
OPERATIEPROCEDURE  POSITIONEREN
rullalle kalvopuoli sisäänpäin, jotta kalvo
omstandigheden voor de o
m un’integrazione
m pysyy suojattuna työnnettäessä rulla troakaarin sisään (läpimitta vähintään
uygunluksuvecuiesnekliğini
kazanmasını
sağlamak
için birkaç saniye süreyle steril bir salin Aanbevolen
serumND
içineAtamamen
STERILIZATION TECHNIQUE
ON
liscio e continuo deve
essere
di
fronte
alle
strutture
si
deve
limitare
l’adesione
tessutale.
• PARIETEX™ Composite moet gehydrateerd worden in de oorspronkelijke blisterverpakking voordat het wordt
10 mm).m
Het product is echter stabiel op 40°C (1
m yapılabilir. m
m
m
batırılarak
MALLA DE DOBLE REVEST M ENTO QUE COMB NAPARIETEX™
UN REFUERZO
Composite is intended as a single-use device. Sterilized by gamma radiation.
m
™ m
verwijderd. Dit wordt gedaan door de mesh in het geheel gedurende enkele seconden onder te dompelen in een
3. Sejasi kiinnittämistä
ricorre a intervento
in laparoscopia, arrotolareΝΔ
PARIETEX™ Composite
dopo l’idratazione in ffimodo che il lato
• Tekstiilipuolelle kiinnitetty kaksiulotteinen tekstiililäppä voi helpottaa verkon sijoittamista
avoimessa
Het
product
niet
gebruiken na de laatst
m
PERMANENTE REHAB TABLE Y UNA PEL CULA H
DRÓF
LA
m
• Yerine
yerleştirilirken
doğru şekilde
için yumuşak
ve sürekli tarafının gözenekli ve tekrar
STORAGE
steriele fysiologische zoutoplossing zodat het weer in vorm komt en flexibel wordt.
rivestito dal film si trovi all’interno e il film sia
protetto
durante l’inserimento
del konumlandırmak
trocar (diametro minimo
10 mm).
™
m
ώ
toimenpiteessä.
ABSORB BLE
Bij
levering
controleren
of de verpakkin
yerleştirilebilir tarafından ayırt edilmesi önemlidir:
Recommended conditions for storing the product: between
m +2°/+25°C (36/77°F), in a dry area.However,
• Bij het plaatsen, is het belangrijk om de gladde en ononderbroken zijde perfect te onderscheiden van de poreuze en
ώ ώ
ω
ω ω bescha
4. Il bordo
del rinforzo deve sporgere di almeno 5 cm m
dai bordi degli orifizi. Spetta al chirurgo la scelta della tecnica
• Verkon
on ofulotuttava
aukkojen reunojen yli vähintään 5 cm. Lääkäri valitsee verkon
kiinnitysmenetelmän
niet gebruiken
alsώde verpakking
the product is stable at 40°C (104°F)
for Bareunan
duration
2 months.
•
etkin
bir
doku
entegrasyonu
için
duvarın
karşısındaki
gözenekli
kısım.
MPOR
AN
KR
N
NG
rehabiliteerbare zijde voor een goede aanbrenging:
ω
ώ alla base tessileωe nonώ
usata per
ancorare la rete
(sutura o punti metallici). I dispositivi
usati devono essere ancorati
(ompeleet tai hakaset). Ompeleet tai hakaset on kiinnitettävä tekstiilipuoleen, ei pelkästään
resorboituvaan
kalvoon.
GARANTIE
OMP
N• doku
U bağlantısının sınırlandığı yapılara dönük yumuşak
m
m device past the last day of the labeled
mm month of expiration.
m
m applicati sul film assorbibile.
m A ON
Do not use the
ve
devamlı
kısım.
ω
ώ ώ
• de poreuze zijde tegen de wand voor een efficiënte integratie met het weefsel.
STERILOINTIMENETELMÄ
m
m
PRODUCTION
da
ON RA
ND A garandeert
ON
m
ώ m
ω SOFRADIM
Upon receipt of shipment, ensure that the packaging is not open or damaged andmm
retains its sealed
• PARIETEX™ Composite laparoskopik uygulamalardaω kullanıldığında,
ıslatma işleminden
film yüzeyi içeride
TECNICA DI
m STERILIZZAZIONE
• de gladde en ononderbroken zijde moet in de richting van de structuren wijzen waarmee adhesie beperkt moet worden.
PARIETEX™-Composite on kertakäyttöinen tuote. Steriloitu gammasäteilyllä.
en sonra
fabricagemethoden
van
™ ditm product.
m
m
m
m
m
integrity. Do not use the device if the integrity
of the packaging appears compromised.
kalacak
şekildeΝΔ
yuvarlanmalıdır;
böylece gamma.
film trokara takıldığında korunur (minimum çap
10
mm).
ΑΝ
PARIETEX™
Composite
è
un
dispositivo
medico
monouso.
Sterilizzato
con
radiazioni
m
m
of kosten die direct of indirect verbonde
m
• Bij een laparoscopie
binnen, zodat de m
SÄILYTYS
m moet PARIETEX™ Composite worden gerold na hydratatie, met de folie naarGUARANTEE
ω yaklaşımda
ω ω kullanıldığında
• Kumaş kısmına monte edilen iki boyutlu dokuma kapak, açık
ağın die
konumlandırılmasına
ND säilytysolosuhteet:
KA ON R
CONSERVAZIONE
garantie
in dit document worden ™ge
folie wordt beschermd bij het inbrengen in de trocar (min. diameter van 10 mm).
Suositeltavat
2–25 °C, kuivassa tilassa. Tuote pysyy kuitenkin stabiilina
40 °C:ssa 2 kuukauden
m m m
m
m
ωzona asciutta. Tuttavia
SOFRADIM PRODUCTION certifies that all precautions
have
been taken in the choice of materials and
ve
sabitlenmesine
yardımcı
olabilir.
™
m
Condizioni
raccomandate
per
la
conservazione
del
prodotto:
tra
+2°/+25°C
(36/77°F),
in
una
worden vermeld, ongeacht expliciet of
ajan.
• De tweedimensionale textielflap die is bevestigd op de textielzijde, kan helpen bij de plaatsing en
fixatie
van
de
PO
B
OMP A ON
manufacturing methods for this product. SOFRADIM PRODUCTION disclaims all liability
m in case of loss,
il prodotto è stabile a 40°C (104°F) per 2 mesi.
PRODUCTION
niet verantwoordelijk
v
• Takviyenin kenarı delikten (deliklerden) en az 5 cm uzakta olmalıdır. Ağı sabitlemek için
kullanılacakisteknik
(dikiş ya
mesh bijD openRchirurgie.
Tuotetta
ei saa
käyttää
merkityn
viimeisenterms
käyttökuukauden
päivän jälkeen.
™ m
P ÓN
damage or costs directly or indirectly
linked
tomthe
use ofetikettiin
the product.
The guarantee
or restrictionsviimeisen
m
m
met
betrekking
tot
dit product.
da
zımba)
uzmanin
sorumluluğundadır.
Kullanılan
teknik
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tabanı
üzerine
sabitlenmelidir;
yalnızca
emilebilir
Non
usare
il
dispositivo
dopo
l’ultimo
giorno
della
scadenza
indicata
sull’
e
tichetta.
m
m
m
m
m
• De meshrand moet tenminste 5 cm over de randen van de opening(en) liggen. De gebruikte techniek
om cancel
de mesh
on varmistettava,
pakkauswhether
ole auki eikä vaurioitunut. Sen
listed here
and replace anyLähetystä
guaranteevastaanotettaessa
which does not appear
document,
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Π Π ΟΚ
min the presentettei
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Al ricevimento del prodotto, verificare che lafilm
confezione
non sia aperta o danneggiata e che sia in grado ωdi conservare
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saa käyttää,
jos pakkaus
ei olePRODUCTION
ehjä.
or tacit by means of legislation
any othereimeans
whatsoever.
SOFRADIM
disclaims all
ω
KON RA ND KA ON R
STERİLİZASYON
TEKNİĞİ
l’integrità. Non utilizzare il dispositivo, se l’integrità
della confezione
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m liability with
m respect to any otherTAKUU
worden gefixeerd en niet alleenmm
aan de resorbeerbare laag.
commitments made in its name by any person in reference to this product.
AD 10
R N A PR
ω AU O
m
™ ONm D MP PARIETEX™
Composite
tek
kullanımlıktır.
Gama
ışını
yoluyla
sterilize
edilmiştir.
m
m
PR
AU
O
GARANZIA
™ m
ώ
ω
ω
ωm
STERILISATIETECHNIEK
SOFRADIM PRODUCTION takaa,
m että tämän tuotteen materiaalien ja valmistusmenetelmän valinnassa on toteutettu m
SAKLAMA
m
m
SOFRADIM
PRODUCTION
certifica
che
sono
state
adottate
tutte
le
precauzioni
nella
scelta
dei
materiali
e
dei
metodi
di
m
NDComposite
A ON is bedoeld voor eenmalig gebruik. Gesteriliseerd met behulp van gammastraling.
PARIETEX™
kaikki varotoimet.
m SOFRADIM PRODUCTION ei vastaa tuotteen käyttöönm suoraanmtai välillisesti liittyvistä menetyksistä,
Ürünün
depolanması
için
önerilen
koşullar:
kuru
bir
yerde
+2°/+25°C
(36/77°F)
arasında.
Bununla
birlikte,
ürün
2
ay
m
mm
fabbricazione
del
presente
prodotto.
SOFRADIM
PRODUCTION
declina
ogni
responsabilità
in
caso
di
perdita,
danni
o
™ m
vahingoista tai kuluista. Tässä mainitut takuun ehdot tai rajoitukset mitätöivät ja korvaavat kaikki nimenomaiset ja
DUBBELSIDIGT
NÄT
m
m
ΠΡΟ ΔΟΠΟ Η
ΚΑ ΠΡΟΦΥ Α
OPSLAG m
MÖ GA KOMP KA ON R
m
PARIETEX Composite
Technical Data
Technical Data
Clinical literature
Clinically Proven Protection22
Parietex™ composite (PCO) mesh has demonstrated positive patient
outcomes and has been compared favorably to other ventral hernia repair
A resorbable collagen barrier limits visceral
attachments to the abdominal wall.
meshes in more than 45 clinical papers worldwide.
Intraperitoneal Treatment
of Incisional and umbilical
hernias using an Innovative
Composite mesh: four-year
results of a Prospective
multicenter Clinical Trial5
Before resorption of the collagen barrier
results of a Prospective, multicenter Clinical study:
Transversal section 1 week after implantation
• 80patientswithmeanfollow-upof4years(range,3.5–4.5)
abdominal wall
mesh deep thread
After resorption, a neoperitoneum is
formed on the visceral surface.7
After resorption of the collagen barrier
Transversal section 6 weeks after implantation
Intimate attachment of
the mesh to the wall
abdominal wall
mesh deep thread
• After12months,86%ofthepatientswereultrasonically
adhesion-free
• At48months,noocclusion,fistulaormeshsepsisreported
inthelong-termfollow-up
80 patients
48 months
Hernia: The World Journal of
Hernia and Abdominal Wall
Surgery 2005
Polyester-based mesh for
ventral hernia repair: Is It
safe?4
The American Journal of
Surgery 2009
long-term results of
laparoscopic repair of
Incisional hernias using an
Intraperitoneal Composite
mesh10
neoformed
mesothelial layer
results of a retrospective Clinical study:
Hernia 2010
hydrogelic film
differentiated tissue
ingrowth
Continuous
neoperitoneum
mesh superficial thread
• 109complexventralherniarepairs
• Polyestermeshprovidesdistinctadvantagesforventral
herniarepair,withexcellenttissueincorporationand
minimalshrinkage
• Forpatientsundergoinglaparoscopicrepair,nodelayed
meshinfections,fistulasorherniarecurrencesatmean
follow-upof14months
109 patients
14 months
• In an animal study comparing meshes with and without a protective barrier, collagen-protected meshes
had significantly fewer visceral attachments than did the non-protected meshes (p<0.01), with complete
recolonization of the mesh and film resorption after 45 days.
• Small bowel adhesion was never observed in all groups receiving the composite mesh.
• The anti-adhesive collagen barrier was intact after 7 days.
results of a 12-Year Prospective Clinical study:
• 200patientswithmeanfollow-upof6years(range,1–12)
• Postoperativepainwaslimited
• Nomeshinfectionsweredetected,includinginthosewho
receivedintestinalinjuryrepair
200 patients
6 years
source: Therin, m., et al. (1998). “Preclinical evaluation of a new Composite mesh (collagen-polyester) for Intraperitoneal Hernia repair With the selective Property of Tissue Ingrowth
on One side and Adhesion Prevention on the Opposite side.” Paper presented at 14th european Conference on Biomaterials, 15-18 september, The Hague, The netherlands.
Surgical Endoscopy 2009
eighty-five redo surgeries
after 733 laparoscopic
Treatments for ventral and
Incisional hernia: adhesion
and recurrence analysis23
mesh superficial thread
results of a retrospective study of visceral attachments and recurrence:
• 89%ofpatientswerefreeofvisceralattachments(47%)
orshowedonlysimpleattachmentsoftheomentum(42%)
• Perfectintegrationofthepolyesterlayerintotheanterior
abdominalwallwasobserved
• Themeshwascoveredwithtotalneoperitoneumandwas
wellvascularized,withoutanyapparentsignofshrinking
orwrinkling
733 patients,
85 second look
cases
52 months
Parietex™ Composite mesh significantly reduced the risk of postsurgical visceral attachments
compared to conventional meshes and could be a valuable solution for intraperitoneal incisional
hernia repair.
• 97%ofpatientsinthecontrolgroupwerepainfree3months
postoperatively,withnoinfectionandnoresidualpain
11
12
Technical Data
Technical Data
Clinically Proven Integration2
In a retrospective review of visceral attachments and recurrence in 85 re-operated patients with a mean
follow up time of 52 months, Parietex™ composite (PCO) mesh proved effective with nearly 90% of patients
developing no or only mild visceral attachments.
In vitro polyester showed 58% greater cell
quantification than polypropylene at day 2.
Nearly 90% of patients
develop no or only mild
visceral attachments.
Observations on mesh-related
visceral attachments
Number
Adhesion-free
40
47.05
Minor adhesion (Mueller I)
36
42.35
Serosal adhesion (Mueller II)
9
10.58
Mean follow-up
52 months
(range 1–101 months)
Cell Quantification
at Day 2
Cell/Mesh (2cm2)
3,000
120,000
2875
2,500
2,000
1,500
1200
1,000
0
• Ninety-seven percent of patients in the control group were pain-free 3 months postoperatively, with no infection
and no residual pain.
109,111
100,000
80,000
60,000
47,001
40,000
20,000
500
Polyester
Polypropylene
Day 2
• The mesh was covered with total neoperitoneum and was well vascularized, without any apparent sign of shrinking
or wrinkling.
Cell Quantification
at Day 7
3,500
Percentage
• Perfect integration of the polyester layer into the anterior abdominal wall was observed.
In vitro polyester showed 57% greater cell
quantification than polypropylene at day 7.
Cell/Mesh (2cm2)
Clinically Proven Effectiveness23
0
Polyester
Polypropylene
Day 7
• Study compared cell behavior in contact with polyester and polypropylene mesh over 2 hours, as well
as 3, 6, and 10 days.
• Cell staining and SEM observation of incubated meshes showed good cell viability, adhesion and proliferation
on polyester meshes, but poor proliferation on polypropylene meshes despite good cell viability.
• Polyester meshes favor cell colonization as compared with polypropylene meshes under in vitro conditions.
• The major improvement observed in this method of laparoscopic inscisional and ventral hernia repair (LIVHR) is
highlighted by the absence of prosthesis migration, limited visceral attachments, and a low recurrence rate.
Source: Chelala, E., et al. (2010). “Eighty-five Redo Surgeries After 733 Laparoscopic Treatments for Ventral and Incisional Hernia: Adhesion and Recurrence Analysis.”
Hernia; 14: 123-129.
Source: Lefranc, O., et al. (2009). “PET vs. PP Mesh Constructs and Their Influence on L929 Fibroblasts Adhesion and Proliferation.” HS/AHS. Springer. Berlin, Hernia; 13: 64–72.
A Second Look Case Report24
• 65-year-old patient presented with a ventral hernia that was repaired with
Parietex™ Composite (PCO) mesh.
• 2 years, 10 months later, patient underwent a laparoscopic procedure that
provided a second look at the hernia repair.
• Minimal attachments were observed and easily taken down.
At Day 2 and Day 7, cell proliferation on the polyester mesh was more than twice as robust
as that on the polypropylene mesh.
• Revascularization and neoperitoneum were present.
13
14
reimbursement
Competitive Information
reimbursement Codes
Competitive Products overview
Covidien has developed online reimbursement resources for hernia and abdominal wall repair. You can reference the interactive
Us Hernia reimbursement Guide at covidien.com/hernia/reimbursement for the most up-to-date codes and reimbursement rates.
Parietex™ Composite (PCO) mesh enables advanced treatment for complex ventral hernias. The clinically proven PCO mesh
combines Parietex™ three-dimensional polyester mesh with a resorbable collagen film to limit visceral attachments. In more than
10 years of market data, Parietex™ Composite mesh has demonstrated less shrinkage, fewer and less-dense visceral attachments,
and significantly stronger abdominal wall adherence and tissue ingrowth than competitive polypropylene meshes.
ProduCT
CovIdIen
ParIeTeX™
ComPosITe
(PCo) mesh
eThICon
ProCeed™*
bard
sePramesh™* IP
bard
ComPosIX™*
aTrIum
C-Qur™*
maTerIal
3-DPET+
collagen,PEG,
glycerol
PROLENE™*
PP+PDS
(polydioxanone)+
ORC(Oxidized
regenerated
cellulose)
PP+PGA
Coating
HA+CMC+PEG
PP+PTFE
HA+CMC+PEG
_
launCh
1999
2004
2000
1997
2006
PorosITY
2.5x1.7mm
3-4mm
-
NA
0.8mm
densITY
78g/m²
45g/m²
-
NA
85g/m²
ThICKness
1.5-2mm
0.7mm
-
-
0.48mm
TransParenCe
+++
--
-
--
++
elasTICITY
(chain/weft)
21/42%
NA
-
+
-
resIsTanCe
(chain/weft)
22/15daN
66N/cm²
-
NA
-
resorPTIon delaY
2weeks
2weeks
14daysORC
90daysPDS
14days
PGA28days*
NA
3-6months
30daysfor
C-Qurlight
11.2%
38.5%
10.4%
–
–
sPeCIfICaTIons
PerformanCe
adhesIon surfaCe
aT 30 daYs3
15
16
Competitive Information
Competitive Information
evIdenCe-based medICIne
Competitive Products overview
ParIeTeX™ ComPosITe (PCo) mesh vs. eThICon ProCeed™* surgICal mesh
Ethicon: Proceed™* surgical mesh
maTerIal ComPosITIon
Comprised of an oxidized regenerated cellulose (OrC) fabric and PrOLene™* soft mesh, a monofilament, nonabsorbable
polypropylene encapsulated with polydioxanone (PDs)
Tissue Ingrowth and
Bowel Adhesion
Formation in an Animal
Comparative Study:
Polypropylene vs.
PROCEED™* vs. Parietex™
Composite7
With less shrinkage, fewer and less-dense visceral attachments, and significantly stronger
abdominal wall adherence and tissue ingrowth at 28 days in this animal study, Parietex™
Composite (PCO) mesh was superior to PROCEED™* surgical mesh in all categories.
Attachments
Tissue Ingrowth
20
60
50
ParIeTeX™ ComPosITe (PCo) mesh vs. eThICon ProCeed™* surgICal mesh
Surgical Endoscopy 2007
15
40
10
30
Parietex™ Composite (PCo) mesh
bioabsorbable
Component
• Resorbablecollagenbarrierononeside
tolimitvisceralattachments
• Comprisedofporcinecollagen,polyethylene
glycolandglycerol
Proceed™* mesh
• Oxidizedregeneratedcellulose(ORC)fabric
physicallyseparatesthepolypropylenemesh
fromunderlyingtissueandorgansurfaces12
• PROLENE™*softmeshcomponentconstructedof
knittedfilamentsofextrudedpolypropylene12
shrinkage
• Uniquepolyestermaterialoptimizedto
minimizeshrinkage
• ContractionofPROLENE™*SoftPolypropylene
meshby34%within4weeks13
Interaction with
blood
• Transparentbarrierforvisualization
• Meticuloushemostatismustbeachieved
(ifnot,meshturnsdarkandtendstoadhere
totissue)14
surface Properties
• Verysmoothand
continuousbarrier
• Integratedintomesh
• Hassmoothsurface
designedtoprevent
adhesionformation;
however,itislesssmooth
thanothercomposite
meshes3
• Collagenbarrierextends5mmbeyond
meshedge
• Barriercoatendsatmeshedgewith
nooverlap
Surgical Endoscopy 2006
Degradation of
Mesh Coatings and
Intraperitoneal Adhesion
Formation in an
Experimental Model15
British Journal
of Surgery 2009
120-Day Analysis of
Intraperitoneal Fatty Acid
Barrier–Coated Mesh16
Surgical Innovation 2009
Ifu Warning
“PROCEED Mesh has an ORC component that should not be used in the presence of
uncontrolled and/or active bleeding, as fibrinous exudates may increase the chance of
adhesion formation.”
™*
Proceed™* surgical mesh—Instructions for Use
17
0
0
Evaluation of New
Prosthetic Meshes for
Ventral Hernia Repair3
• Polyester,withathree-dimensionalweave,is
flexibleandsoft
Protection
5
10
• Morethan10yearsofdocumentedclinical
effectiveness
flexible material
20
The Use of Composite
Meshes in Laparoscopic
Repair of Abdominal
Wall Hernias: Are
There Differences in
Biocompatibility?17
Comparative results In vivo: fewer attachments, greater Incorporation
• Parietex™Composite(PCO)meshhadsignificantly • Parietex™Composite(PCO)meshhadsignificantly
fewerattachmentsthanPROCEED™*surgicalmesh
greaterincorporationthanPROCEED™*surgical
at7days(3.9%vs.33.6%;p=.001)
meshat30days(49.8%vs.29.7%;p=.027)
• Parietex™Composite(PCO)meshhadsignificantly
fewerattachmentsthanPROCEED™*surgicalmesh
at30days(11.2%vs.38.5%;p=.002)
Comparative results In vivo: few to no attachments
• Parietex™Composite(PCO)meshhada
significantlysmallerpercentageofmeshcovered
withattachments(p=.041)andlowertotal
attachmentscores(p=.015)thanPROCEED™*
surgicalmeshat7days
• Parietex™Composite(PCO)meshwasthe
onlymeshthatshowednovisceralattachments
atboth7daysand30days.PROCEED™*surgical
mesh:5of6at7days;3of5at30days
• Parietex™Composite(PCO)meshhadsignificantly
lowertotalattachmentscores(p=.017)than
PROCEED™*surgicalmeshat30days
Comparative results In vivo : lower attachment grade and surface attachment Coverage
• PROCEED™*surgicalmeshexhibitedboththe
highest-gradeattachments(2.8)andthelargest
surfaceareacoveredbyattachments(28.8%)
• Parietex™Composite(PCO)meshattachment
gradewas1.2,andsurfaceareacoveredby
attachmentswasjust0.8%
Comparative results in vivo: fewer visceral attachments and shrinkage
• PROCEED™*surgicalmeshhadasignificantly
highermeanadhesionscore(0.33)than
Parietene™Composite(PCO)mesh(0.12)
• Parietene™Composite(PCO)meshexhibitedmuch
lessshrinkage(0.13)toPROCEED™*surgicalmesh
(0.25)
Surgical Endoscopy 2009
18
Competitive Information
Competitive Information
Davol: bard sepramesh™* IP Composite (2nd generation, 2005)
evIdenCe-based medICIne
ParIeTeX™ ComPosITe (PCo) mesh vs. bard sePramesh™* IP ComPosITe
maTerIal ComPosITIon
Transactional Procedure
Data, 2005-20086
Polypropylene and polyglycolic acid (PGA) mesh with hydrogel safety coating
Recurrence Rate
5.0%
ParIeTeX™ ComPosITe (PCo) mesh vs. bard sePramesh™* IP ComPosITe
bioresorbable
Component
• Morethan10yearsofdocumentedclinical
effectiveness
sepramesh
™*
4.0%
IP
• Nohumanclinicaldata
• Inconsistentanimalclinicalresults
• Resorbablecollagenbarrierononesidetolimit • Hydrogelbarrierminimizestissueattachment
visceralattachments
totheprosthesis18
• ComprisedofoxidizedatelocollagentypeI
PolyethyleneglycolGlycerol
• Incitesexcellentfibrousingrowthand
neoperitoneum7
• Deeptissueincorporation
handling Properties
• Optimizedtominimizeshrinkage
• Requiresminimum:18
-12mmtrocarfor15.2cmx7.6cmandlarger
-15mmtrocarfor20.3cmx15.2cmandlarger
-18mmtrocarfor35.6cmx30.5cm
3.0%
2.5%
2.0%
0.5%
0.0%
• Comprisedofsodiumhyaluronate(HA),
carboxymethylcellulose(CMC)and
polyethyleneglycol(PEG)basedhydrogel18
Tissue Integration
3.5%
1.5%
10.0%
8.0%
5.4%
6.0%
1.4%
4.0%
2.0%
Parietex™ Composite
(PCO) mesh
Bard Sepramesh™*
• Theventralherniarecurrencerate
withParietex™meshwas3xless
thenBardSepramesh™*IPinthe
outpatientsetting
Abdominal Wall Hernia
Repair: A Comparison
of Sepramesh™* and
Parietex™ Composite
mesh in a Rabbit Hernia
Model19
Journal of the American
College of Surgeons 2007
0.0%
p<0.001
p<0.05
12.0%
60.0
10.0%
50.0
8.0%
40.0
6.0%
4.0%
20.0
2.0%
10.0
0.0
Bard Sepramesh™*
Visceral Attachments
14.0%
80.0
70.0
Parietex™ Composite
(PCO) mesh
• Theamountofpostoperativesurgery
painmedicationwithParietex™meshwas
halfofBardSepramesh™*IPforVentral
HerniaRepair.
Attachment Strength (N)
30.0
19
12.7%
12.0%
1.0%
• Bioresorbablefibersreinforcemeshstrength
andbindthemeshtothehydrogelcoating18
• Largersizescanberolledupand
insertedthroughastandard12mmtrocar
(37cmx28cm)
14.0%
% Patients
Clinical Proof
4.7%
4.5%
% of Recurrences
Parietex™ Composite (PCo) mesh
Use of Pain Medication
Parietex™ Composite
(PCO) mesh
Bard Sepramesh™*
0.0%
Parietex™ Composite
(PCO) mesh
Bard Sepramesh™*
20
Competitive Information
Competitive Information
Davol: bard Composix™*
evIdenCe-based medICIne
ParIeTeX™ ComPosITe (PCo) mesh vs. bard ComPosIX™*
maTerIal ComPosITIon
Transactional Procedure
Data, 2005-20086
Polypropylene mesh and sub-micronic ePTFe, stitched with PTFe monofilament
• Resorbablecollagenbarrierononesideto
limitvisceralattachments
• ComprisedofoxidizedatelocollagentypeI
PolyethyleneglycolGlycerol
mesh
• PolypropyleneBardMeshononesideto
promotetissueingrowthandsub-micronic
ePTFEontheothersidetominimizevisceral
attachmentstotheprosthesis
• Collagenbarrierextends5mmbeyond
meshedge
handling Properties
• Incitesexcellentfibrousingrowthand
neoperitoneum7
• Optimizedtominimizeshrinkage
• Largersizescanberolledupand
insertedthroughastandard12mmtrocar
(37cmx28cm)
8.0%
5.4%
6.0%
0.0%
• Sealededgepreventsexposureofthe
polypropylenemeshsidefromcontactwith
thebowel,thuspotentiallyreducingthe
chancesofvisceralattachmentsaroundthe
edgeoftheprosthesis20
• Deeptissueincorporation
3.5%
3.0%
2.5%
2.0%
1.5%
1.4%
1.0%
2.0%
• HolesintheePTFEsidemadebythePTFE
stitchesmaycreatevisceralattachments20
Tissue Integration
10.0%
4.0%
• Morethan10yearsofdocumentedclinical
effectiveness
Protection
4.0%
10.3%
% of recurrences
barrier Composition
Composix
4.5%
4.5%
12.0%
™*
% Patients
Parietex Composite (PCo) mesh
5.0%
14.0%
ParIeTeX™ ComPosITe (PCo) mesh vs. bard ComPosIX™*
™
Recurrence Rate
Use of Pain Medication
Parietex™ Composite
(PCO) mesh
Bard Composix™*
• Theamountofpostoperativesurgery
painmedicationwithParietex™mesh
washalfofBardComposix™*forVentral
HerniaRepair.
0.5%
0.0%
Parietex™ Composite
(PCO) mesh
Bard Composix™*
• Theventralherniarecurrenceratewith
Parietex™meshwas3xlessthenBard
Composix™*intheoutpatientsetting.
Case Reports24
Patient exploratory laparotomy
surgical repair
• Cannotbecut,asthepolypropylenelayerwill
bewidelyexposed
• ventral hernia repair with Bard Composix™® four years postop
• ventral hernia repair with Parietex™ Composite (PCO) mesh two years postop
Clinical result
Parietex™ Composite (PCo) mesh
bard Composix™* mesh
• no visible contraction
• experienced significant shrinkage
• no visceral attachments to mesh
• numerous grade I visceral attachments
(mueller scale)
• minimal visceral attachments to tacks
Surgeon noted that when running a grasper over both repairs
the Bard Composix™* mesh was very rigid and hard while the
Parietex™ Composite (PCO) mesh was soft and compliant.
21
22
Competitive Information
Hernia: The World Journal of
Hernia and Abdominal Wall
Surgery 2004
Comparative results In vivo: fewer less-dense visceral attachments
Percentage Area of Visceral Attachments
0.7
0.6
53.4%
“Microscopy showed a new mesothelial
layeronthevisceralsurfaceofthePCObut
mainlyinflammatorytissuewithonlyalittle
mesotheliumcoveringthevisceralsurfaceof
theBC™*.”
Atrium Medical Corporation: C-Qur™* mesh
maTerIal ComPosITIon
Polypropylene mesh with Omega-3 fatty acid bioabsorbable coating
0.5
Area
Comparison of Two
Composite Meshes Using
Two Fixation Devices in
a Porcine Laparoscopic
Ventral9
Competitive Information
0.4
ParIeTeX™ ComPosITe (PCo) mesh vs. aTrIum C-QurTm* mesh
0.3
0.2
Parietex™ Composite (PCo) mesh
14.5%
0.1
barrier Composition
0.0
Parietex™ Composite
(PCO) Mesh
%AreaofAttachments
AttachmentDensity
Bard Composix™*
14.5±12.4%
53.4±9.8%
1.75N
3.6N
• ComprisedofoxidizedcollagentypeI
PolyethyleneglycolGlycerol
% of rats with visceral attachments
Hernia: The World Journal of
Hernia and Abdominal Wall
Surgery 2004
• Incitesexcellentfibrousingrowthand
neoperitoneum7
• Notissueintegrationat30days11
Protection
• Resorbablecollagenbarrierononeside
tolimitvisceralattachments
• C-Qur™*showedhigheradhesionscorethan
Parietex™composite(PCO)mesh15
material Properties
• Largersizescanberolledupand
insertedthroughastandard12mm
trocar(37cmx28cm)
• Thickmaterialisdifficulttorollandinsert
intotrocar
Comparative results In vivo: fewer attachments
Presence of Visceral Attachments (%)
50.0%
45.0%
40.0%
35.0%
30.0%
25.0%
20.0%
15.0%
10.0%
5.0%
0.0%
41.7%
Parietex™ Composite
(PCO) Mesh
“Composix™*E/Xhadproblemswithvisceral
attachmentsmostlyatitsunprotectededges
andbecausetheprotectivelayerwasso
looselyconnectedtothemesh,allowing
tissueingrowthbetweenthetwolayers.”
“Parietex™composite(PCO)meshwas
aseffectiveasBardComposix™*E/Xin
preventing1:1visceralattachments,but
wasbetterincorporatedintothehealed
tissuethentheBardComposix™*E/X.”
8.3%
• All-naturalcoatingsignificantlyimproves
anatomicalconformancebyreducing
aggressive,denseacellularcollagenformation
duringmaterialhealing21
• Morethan10yearsofdocumented
clinicaleffectiveness
Tissue Integration
Resistance to Adhesion
Formation: A Comparative
Study of Treated and
Untreated Mesh Products
Placed in the Abdominal
Cavity8
• Resorbablecollagenbarrierononeside
tolimitvisceralattachments
C-Qur™* mesh
Bard Composix™*
• Two-sidedfattyacidcoatingcreatesabarrier
onbothsidesofthemesh
animals with visceral
attachments at 30 days15
0of6(0%)
3of6(50%)
Incorporation score
at 30 days15
2(1-4)
1.5(1-3)
“The use of a composite mesh of polypropylene and expanded
polytetrafluoroethylene (Composix™*) for open ventral hernia repair
imparts a real risk of mesh infection and its use should be reconsidered.”
Dr. W.s. Cobb, (2009). “Infection risk of Open Placement of Intraperitoneal composite mesh” Vol. 75, 762-768, The American surgeon september 2009.
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materials management Information
Packaging overview
materials management Information
Product order Codes
laparoscopic ventral hernia repair: Parietex™ Composite (PCO) mesh
Box Dimensions
sizes will vary depending on order code.
each box contains a single, individually
packaged mesh.
order Code
description
order Code
description
PCO9
9cm Round
PCO2015
20cm x 15cm
PCO12
12cm Round
PCO2520
25cm x 20cm
PCO15
15cm Round
PCO3020
30cm x 20cm
PCO20
20cm Round
PCO3728
37cm x 28cm
PCO1510
15cm x 10cm
open ventral hernia repair: Parietex™ Composite Open skirt (PCO Os) mesh
ordering Information
CovIdIen ProduCTs WebsITe:
CusTomer servICe:
www.covidien.com/hernia
1-800-722-8772
order Code
description
order Code
description
PCO8OS
Skirted 8cm Round
PCO2520OS
Skirted 25cm x 20cm
PCO1510OS
Skirted 15cm x 10cm
PCO3020OS
Skirted 30cm x 20cm
PCO2015OS
Skirted 20cm x 15cm
Parastomal hernia repair: Parietex™ Composite Parastomal (PCO Pm) mesh
order Code
description
order Code
description
PCOPM15
Parastomal 15cm Round
NO HOLE
PCOPM15H35
Parastomal 15cm Round
HOLE 35mm
PCOPM20
Parastomal 20cm Round
NO HOLE
PCOPM15H50
Parastomal 15cm Round
HOLE 50mm
hiatal hernia repair: Parietex™ Composite Hiatal (PCO 2H) mesh
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order Code
description
PCO2H1
Hiatal Heart-Shaped Mesh
8cm x 8cm
order Code
PCO2H3
description
Hiatal Horseshoe-Shaped
Mesh 9cm x 8cm
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references
1.
estour, e. (2005). “Tolerance of Hernia repair meshes: Biological Characteristics of the main materials Used.” Osp. Ital. Chir, 11, 00-00. 4.
2.
Lefranc, O., et al. (2009). “PeT vs. PP mesh Constructs and Their Influence on L929 Fibroblasts Adhesion and Proliferation.”, Hs/AHs, springer,
Berlin, Hernia; 13: 64-72.
3.
Burger, J.W., et al. (2006). “evaluation of new Prosthetic meshes for Ventral Hernia repair.” surgical endoscopy; 1323, Table 4.
4.
rosen, m.J. (2009). “Polyester-based mesh for Ventral Hernia repair: Is it safe?” American Journal of surgery; 197, 353-359.
5.
Balique et al. (2005). “Intraperitoneal Treatment of Incisional and Umbilical Hernias Using an Innovative Composite mesh: 4-year results of a
Prospective, multicenter Clinical Trial.” Hernia: The World Journal of Hernia and Abdominal Wall surgery; 9: 68-74.
6.
sDI transactional procedural data, June 2005 – June 2008. Data on file with Covidien.
7.
Jacob et al. (2007). “Tissue Ingrowth and Bowel Adhesion Formation in an Animal study: Polypropylene vs. Proceed vs. Parietex Composite.”
surgical endoscopy; 21: 629-633.
8.
Gonzalez, r., et al. (2004). “resistance to Adhesion Formation: A Comparative study of Treated and Untreated mesh Products Placed in the
Abdominal Cavity.” Hernia: The World Journal of Hernia and Abdominal Wall surgery; 218, C2, L53-56.
9.
Duffy, A., et al. (2004). “Comparison of Two Composite meshes Using Two Fixation Devices in Porcine Laparoscopic Ventral Hernia monde.”
Hernia: The World Journal of Hernia and Abdominal Wall surgery; 8, 358-364.
10. moreno-egea, A., et al. (2009). “Long-term results of Laparoscopic repair of Incisional Hernias Using an Intraperitoneal Composite mesh.”
surgical endoscopy; January 2009.
11. Chelala, e., et al. (2006). “The suturing Concept for Laparoscopic mesh Fixation in Ventral and Incisional Hernia repair: mid-term Analysis of
400 Cases.” surgical endoscopy; 21: 3, 391-395.
12. ethicon PrOCeeD™ surgical mesh. Instructions for Use. ethicon. www.ethicon360.com. Accessed August 11, 2010.
13. Klinge, U., et al. (1998). “shrinking of Polypropylene mesh in Vivo: An experiment study in Dogs.” eur J surg; 164 (12): 965-9.
14. Wiseman, D.m., et al. (2001). “Collagen membrane/Fleece Composite Film in the Presence of Bleeding in a rabbit Uterine Horn model.”
Fertility and sterility Journal; 76 (1): 175-80.
15. schreinemacher, m.H.F, et al. (2009). “Degradation of mesh Coatings and Intraperitoneal Adhesion Formation in an experimental model.”
British Journal of surgery; 96: 305-313.
16. Pierce, r. A., et al. (2009). “120-Day Comparative Analysis of Adhesion Grade and Quantity, mesh Contraction, and Tissue response to a
novel O mega-3 Fatty Acid Bioabsorbable Barrier macroporous mesh After Intraperitoneal Placement.” surgical Innovation; 16: 46–54.
17. schug, C. et al. (2009). “The Use of Composite meshes in Laparoscopic repair of Abdominal Wall Hernias: Are There Differences in Biocompatibility?
experimental results Obtained in a Laparoscopic Porcine model.” surgical endoscopy; 23: 487-495.
18. Bard sepramesh™* IP Composite. Davol. www.davol.com/content/sepramesh. Accessed August 11, 2010.
19. Judge, T.W., et al. (2007). “Abdominal Wall Hernia repair: A Comparison of sepramesh and Parietex Composite mesh in a rabbit Hernia model.”
Journal of the American College of surgeons; 204(2): 276-81.
20. Bard Composix™*. Bard. www.bardnordic.com/main/product. Accessed August 11, 2010.
21. Atrium C-QUr™ mesh. Atrium medical Corporation. www.atriummed.com/Products/General_surgery/cqur.asp. Accessed August 11, 2010.
22. Therin, m., et al. (1998). “Preclinical evaluation of a new Composite mesh (collagen-polyester) for Intraperitoneal Hernia repair With the selective
Property of Tissue Ingrowth on One side and Adhesion Prevention on the Opposite side.” Paper presented at 14th european Conference on
Biomaterials, 15-18 september, The Hague, The netherlands.
23. Chelala, e., et al. (2010). “eighty-five redo surgeries After 733 Laparoscopic Treatments for Ventral and Incisional Hernia: Adhesion and recurrence
Analysis.” Hernia; 14: 123-129.
24. Data on file.
We hope that this comprehensive information packet has
been helpful to you in facilitating your decision-making
process. If you have any questions or concerns or if you
would like additional information, please contact your
Covidien sales representative.
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