SOGC CLINICAL PRACTICE GUIDELINE

No. 351, November 2017 (Replaces No. #254, February 2011)

No. 351-Transvaginal Mesh Procedures for

Pelvic Organ Prolapse
This Clinical Practice Guideline* has been prepared by the
Urogynaecology Committee, reviewed by the Guideline
Management and Oversight and Medico-Legal
Committees, and approved by the Board of The Society of
Obstetricians and Gynaecologists of Canada.
Maryse Larouche, MD MPH, Montréal, QC
Roxana Geoffrion, MD, Vancouver, BC
Jens-Erik Walter, MD, Montréal, QC
*Members of the Urogynaecology Committee: Kelly-Anne Buck,
RN, Ottawa, ON; Queena Chou, MD, London, ON; Phaedra
Diamond, MD, Scarborough, ON; Sinéad Dufour, PhD, Hamilton,
ON; Annette Epp, MD, Saskatoon, SK; Roxana Geoffrion, MD,
Vancouver, BC; Marie-Andrée Harvey, MD, MSc, Kingston, ON;
Annick Larochelle, MD, Saint-Lambert, QC; Maryse Larouche, MD,
MPH, Montréal, QC; Kenny Maslow, MD, Winnipeg, MB; Dante
Pascali (co-chair), MD, Ottawa, ON; Marianne Pierce, MD, Halifax,
NS; Jens-Erik Walter, MD, Montréal, QC; David Wilkie (co-chair),
MD, Vancouver, BC. Disclosure statements have been received
from all principal authors and committee members.
Key Words: Pelvic organ prolapse, pelvic organ prolapse/surgery,
surgical mesh, surgical mesh/adverse effects, transvaginal mesh
Competing interests: None declared.
Corresponding Author: Maryse Larouche, Department of
Obstetrics and Gynaecology, McGill University, Montreal, QC,
Canada. ml.larouche@gmail.co
J Obstet Gynaecol Can 2017;39(11):1085e1097
https://doi.org/10.1016/j.jogc.2017.05.006
Copyright ª 2017 The Society of Obstetricians and Gynaecologists of
Canada/La Société des obstétriciens et gynécologues du Canada.
Published by Elsevier Inc. All rights reserved.
Abstract
Objective: This guideline reviews the evidence related to the risks and
benefits of using transvaginal mesh in pelvic organ prolapse repairs
in order to update recommendations initially made in 2011.
Intended Users: Gynaecologists, residents, urologists,
urogynaecologists, and other health care providers who assess,
counsel, and care for women with pelvic organ prolapse.
Target Population: Adult women with symptomatic pelvic organ
prolapse considering surgery and those who have previously
undergone transvaginal mesh procedures for the treatment of pelvic
organ prolapse.
Options: The discussion relates to transvaginal mesh procedures
compared with other surgical options for pelvic organ prolapse
(mainly about vaginal native tissue repairs and minimally about
other alternatives such as biological and absorbable vaginal mesh
and abdominally placed surgical mesh).
Outcomes: The outcomes of interest are objective and subjective
success rates and intraoperative and postoperative complications,
such as adjacent organ injury (urinary, gastrointestinal), infection,
hematoma/bleeding, vaginal mesh exposure, persistent pain,
dyspareunia, de novo stress urinary incontinence, and reoperation.
Evidence: PubMed, Medline, the Cochrane Database, and EMBASE
were searched using the key words pelvic organ prolapse/surgery*,
prolapse/surgery*, surgical mesh, surgical mesh*/adverse effects,
transvaginal mesh, and pelvic organ prolapse.
Results: were restricted to English or French language and human
research. Articles obtained through this search strategy were
included until the end of June 2016. Pertinent new studies were
added up to September 2016. Grey literature was not searched.
Clinical practice guidelines and guidelines of specialty societies
were reviewed. Systematic reviews were included when available.
Randomized controlled trials and observational studies were
included when evidence for the outcome of interest or in the target
population was not available from systematic reviews. New studies
not yet included in systematic reviews were also included. Only

This document reflects emerging clinical and scientific advances on the date issued and is subject to change. The information should not be
construed as dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions.
They should be well-documented if modified at the local level. None of these contents may be reproduced in any form without prior written
permission of the publisher.

Women have the right and responsibility to make informed decisions about their care in partnership with their health care providers. To facilitate
informed choice, women should be provided with information and support that are evidence based, culturally appropriate, and tailored to their
needs. The values, beliefs, and individual needs of each woman and her family should be sought, and the final decision about the care and
treatment options chosen by the woman should be respected.

NOVEMBER JOGC NOVEMBRE 2017 l 1085

SOGC CLINICAL PRACTICE GUIDELINE
publications with study groups larger than 20 individuals were
selected because this criterion was used in the largest meta-
analysis referenced in this guideline. A total of 1470 studies were
obtained; after selecting only applicable studies and excluding
duplicates, 68 manuscripts were reviewed and included.
Values: The content and recommendations were drafted and
agreed upon by the principal authors and members of the
Urogynaecology Committee. The Board of the Society of
Obstetricians and Gynaecologists of Canada approved the final
draft for publication. The quality of evidence was rated using the
criteria described in the Grading of Recommendations
Assessment, Development and Evaluation methodology
framework. The Summary of Findings is available upon request.
Benefits, Harms, and/or Costs: It is expected that this guideline will
benefit women with pelvic organ prolapse by ensuring that health
care providers are aware of outcomes related to transvaginal mesh
procedures and steps in the management of related complications.
This should guide patient-informed consent before such procedures
are undertaken. The benefits clearly outweigh the potential harms or
costs of implementation of this guideline, although no direct harms
or costs are identified.
Guideline Update: Evidence will be reviewed 5 years after publication
to decide whether all or part of the guideline should be updated.
However, if important new evidence is published prior to the 5-year
cycle, the review process may be accelerated for a more rapid
update of some recommendations.
Summary Statements
1. Compared with other non-absorbable synthetic graft materials for
use in vaginal prolapse repair, polypropylene type I monofilament,
macroporous synthetic mesh is associated with lower complication
rates (low).
2. Transvaginal mesh repairs using trocar-guided systems or self-
tailored mesh have resulted in lower anatomical prolapse recur-
rence and marginally reduced symptoms of bulge compared with
native tissue repairs. However, quality of life does not seem to differ
between transvaginal mesh and native tissue repairs. Anatomical
benefit is mostly observed when mesh is used in the anterior
compartment. Outcomes of multicompartment transvaginal mesh
placement are inconsistent. Transvaginal mesh repair for posterior
vaginal wall prolapse is not superior to native tissue repair (low).
3. Transvaginal mesh repairs using trocar-guided systems or self-
tailored mesh result in a risk of vaginal mesh exposure averaging
12%, with the lowest risk being in the anterior compartment
(compared with multicompartment placement) (moderate).
4. The most significant risk factors for mesh exposure include
concomitant hysterectomy and current smoking (low).
5. Preoperative low-dose vaginal estrogen in postmenopausal
women does not appear to reduce mesh exposures (moderate).
6. The de novo dyspareunia rate after transvaginal mesh procedures
with trocar-guided systems or self-tailored mesh is comparable to
ABBREVIATIONS
CI confidence interval
FDA Food and Drug Administration
LSC laparoscopic sacrocolpopexy
RCT randomized controlled trial
RR relative risk
OR odds ratio
1086 l NOVEMBER JOGC NOVEMBRE 2017
native tissue repairs. The risk of non-sexual pelvic, vaginal,
buttock, or groin pain is increased (low).
7. The improved anatomical success rate of transvaginal mesh re-
pairs with trocar-guided systems and self-tailored mesh is associ-
ated with an increased overall reoperation rate compared with
native tissue repairs. The main indications for reoperation after
transvaginal mesh procedures include prolapse recurrence, mesh
exposure, de novo stress urinary incontinence, and pain
(moderate).
8. Evidence for currently commercially available trocarless trans-
vaginal mesh systems is so far limited to observational studies, but
outcomes appear to be similar to or better than those obtained with
trocar-guided systems (very low).
9. If mesh exposures are small or asymptomatic, an attempt at con-
servative management is possible. Only one third of women will be
cured with this approach. Most will require surgical management
(low).
10. Of those who undergo surgery for complications of transvaginal
mesh procedures, the cure rate will depend on the nature of the
complication. Many with mesh exposure will be cured. Some
women will require more than 1 surgery for symptom improve-
ment. Complications such as chronic pain may not be curable
(very low).
Recommendations
1. Training specific to transvaginal mesh procedures, such as via
subspecialty urogynaecology training or individual mentorship pro-
grams, should be undertaken before transvaginal mesh procedures
are performed (strong, very low).
2. Placement of transvaginal mesh in the rectovaginal space after
rectal injury is not recommended (weak, low).
3. Clinically significant preoperative chronic pelvic pain is a relative
contraindication to the placement of permanent transvaginal
mesh. Pain can worsen postoperatively, and surgical revision to
relieve pain is more likely to fail in these patients (strong, very
low).
4. Patient selection for permanent polypropylene transvaginal mesh
procedures should be further researched. Use of transvaginal
mesh procedures outside of clinical trials should be limited to
cases with significant risk factors for recurrence (such as levator
avulsion, weak pelvic floor muscles, prolapse stage 3 or 4 before
index surgery, and chronic strain on the pelvic floor [e.g., chronic
constipation]) or for treatment of recurrent pelvic organ prolapse
(strong, very low).
5. To assist women in making informed decisions regarding trans-
vaginal mesh procedures, clinicians should provide thorough pre-
operative counselling. Counselling should include a discussion
about (1) improved anatomical outcomes, (2) marginal expected
improvement in bulge symptoms, (3) insufficient evidence for
improvement in quality of life, (4) risk of mesh exposure and non-
sexual pain, and (5) possible need for reoperations compared with
native tissue repair (strong, moderate).
6. Patients should be counselled about smoking cessation prior to
undergoing transvaginal mesh repair (strong, very low).
7. Informed consent should be clearly documented in the patient’s
records (strong, very low).
8. Patients who experience complications from a transvaginal mesh repair
should be promptly assessed and managed by surgeons who are
experienced in dealing with those complications (strong, very low).
 No. 351-Transvaginal Mesh Procedures for Pelvic Organ Prolapse
INTRODUCTION
T he prevalence of pelvic organ prolapse increases with
age and reaches up to 50% of women across all age
groups.1 Six percent to 19% of women undergo surgery for
pelvic organ prolapse, and up to 29% undergo reoperation
within 3 to 5 years.1e4 Native tissue reconstructive vaginal
prolapse repair techniques include, but are not limited to,
anterior and posterior colporrhaphy, McCall culdoplasty,
and sacrospinous and uterosacral ligament apical suspen-
sions. Vaginal hysterectomy alone is not an acceptable
surgical option for treatment of apical prolapse. Native
tissue suspensions for apical prolapse typically use per-
manent synthetic sutures for ligamentous attachment; less
frequently, delayed absorbable sutures are used. Failure
rates of native tissue repairs and surgical success with the
use of synthetic mesh for hernia repair, mid-urethral sling,
and abdominal sacrocolpopexy have led to the transvaginal
use of grafts for pelvic organ prolapse. Grafts can be used
in the anterior vaginal wall, posterior vaginal wall, vaginal
apex (vault or uterus), or a combination of these.5,6
VAGINAL GRAFT TYPES
Various types of graft material can be used for vaginal
surgery, including biological; absorbable synthetic (e.g.,
polyglycolic acid and polyglactin); and non-absorbable
synthetic mesh materials (e.g., polytetrafluoroethylene,
polyester, and polypropylene). There does not seem to be a
benefit to the use of biological grafts compared with native
tissue repair.7,8 Overall, low-quality evidence supports a
possible role for absorbable synthetic grafts in reducing the
risk of recurrent objective prolapse. However, no differ-
ence has been demonstrated in post-operative patient
awareness of prolapse or in the risk of reoperation.7,8
Evidence concerning the most suitable type of perma-
nent synthetic mesh material comes from studies of
abdominal sacrocolpopexy, transvaginal mesh procedures
for prolapse, and mid-urethral slings. The literature reports
that polypropylene type I monofilament, macroporous
synthetic mesh9 is associated with lower complication rates
compared with a few other non-absorbable synthetic ma-
terials used for this indication (multifilament polypropylene
or polyester).10,11 This guideline focuses on the use of type
I polypropylene permanent transvaginal mesh, including
mesh systems (also known as mesh kits) and self-tailored
mesh, for repair of prolapse in various compartments.
Summary Statement
1. Compared with other non-absorbable synthetic graft
materials for use in vaginal prolapse repair, poly-
propylene type I monofilament, macroporous
synthetic mesh is associated with lower complication
rates (low).
EVOLUTION OF SYNTHETIC TRANSVAGINAL MESH
USE
Transvaginal mesh systems have been part of a surgical
evolution that attempts to maintain durability of repair,
minimize morbidity and invasiveness, allow use of regional
anaesthesia, and address appropriate anatomical defects of
pelvic floor dysfunction.12 First-generation systems were
designed as minimally invasive surgical techniques for pelvic
organ prolapse repair that facilitated tension-free placement
of a broad-coverage polypropylene implant without trim-
ming of the vagina or suturing the mesh to the vagina. The
system allowed the selective application of anterior, poste-
rior, or total (anterior, posterior, and apical combined)
vaginal implants. The implants were delivered with trocars
through surface anatomical landmarks. Newer systems use
light-weight polypropylene mesh, allow placement of the
mesh through a single incision in the vaginal mucosa
without the use of trocars, include apical fixation points, and
cover a smaller surface area.13 Currently, all mesh systems
using trocars have been withdrawn from the market. The
only transvaginal systems currently on the market are Up-
hold (Boston Scientific, Marlborough, MA) and Restorelle
DirectFix (Coloplast, Minneapolis, MN), both of which are
trocarless systems. Mesh for off-label transvaginal self-
tailored use is also available.
In October 2008, the U.S. FDA released its first statement
regarding potential serious complications associated with
transvaginal placement of surgical mesh in pelvic floor
surgery.14 Health Canada followed in 2010 by issuing
important safety information on surgical mesh for stress
urinary incontinence and pelvic organ prolapse.15 The
FDA then published additional statements in 2011 and
2016, and Health Canada’s latest notice to hospitals was
released in 2014.14,16,17 In both recent Canadian and
American statements, a clear distinction was made between
the use of mesh for mid-urethral slings and use for pelvic
floor repair. Mid-urethral slings have been extensively
studied and are known to yield long-term benefits, with low
associated risks of complications.5,16,17 However, trans-
vaginal mesh systems used for pelvic organ prolapse
remain under scrutiny.
Recommendations made in 2010 and 2014 by Health Can-
ada include the following: (1) obtaining specialized training
to perform these procedures, (2) being vigilant for adverse
events associated with device placement and the mesh, and
(3) obtaining informed consent for surgery by advising the
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SOGC CLINICAL PRACTICE GUIDELINE
patient of potentially uncorrectable sequelae of mesh
placement, including mesh exposure, pain, and dyspar-
eunia.17 Documentation of device labelling should be pro-
vided in writing to the patient, when possible. Health Canada
also suggests that any serious or unexpected adverse events
related to surgically implanted mesh be reported to the
Health Products and Food Branch Inspectorate.17
In early 2016, the FDA reclassified transvaginal mesh sys-
tems from class II (moderate-risk devices) to class III (high-
risk devices).16 The FDA now requires that device manu-
facturers conduct pre-market and post-market studies of the
safety and effectiveness of transvaginal mesh devices.16
Since the initial FDA statements, numerous litigious claims
against surgeons using vaginal mesh and device manufac-
turers have been initiated. Public awareness of potential
complications associated with vaginal mesh use has also
been raised, in part through litigation advertisement.18
However, Health Canada acknowledges the fact that
“some of these complications are not unique to mesh sur-
gery and are known to occur with non-mesh procedures.”17
There appears to be a role for mesh use in vaginal pelvic
floor repair procedures, especially for women with recur-
rent prolapse and for those with risk factors for failure
after native tissue repairs. Surgeons across the country
continue to use these products, albeit more selectively. In
Ontario alone, over 400 transvaginal mesh procedures still
were performed in 2012 for the repair of pelvic organ
prolapse.19 However, more rigorous, comparative research
is needed to guide clinicians as to when the use of mesh
would be warranted during vaginal surgery for prolapse.
Recommendation
1. Training specific to transvaginal mesh procedures, such
as via subspecialty urogynaecology training or
individual mentorship programs, should be undertaken
before procedures are performed (strong, very low)
(Tables 1 and 2).20
TRANSVAGINAL MESH OUTCOMES
Trocar-guided mesh systems and self-tailored
mesh
Table 3 presents the main outcomes associated with
transvaginal mesh procedures. The average operative time
required for native tissue repairs appears to be somewhat
shorter than that for transvaginal mesh procedures (up to
53 minutes shorter), although this was inconsistently
found.7 There is no difference in postoperative length of
stay between the 2 types of procedures.7
1088 l NOVEMBER JOGC NOVEMBRE 2017
Table 1. Key to grading of recommendations,
assessment, development and evaluation (GRADE)20
Strength of the
recommendation Definition
Strong Highly confident of the balance between
desirable and undesirable consequences
(i.e., desirable consequences outweigh the
undesirable consequences; or undesirable
consequences outweigh the desirable
consequences).
Weaka Less confident of the balance between
desirable and undesirable consequences.
Quality level of a body
of evidence Definition
Highjþþþþ We are very confident that the true effect lies
close to that of the estimate of the effect.
Moderatejþþþ0 We are moderately confident in the effect
estimate: The true effect is likely to be close
to the estimate of the effect, but there is a
possibility that it is substantially different.
Lowjþþ00 Our confidence in the effect estimate is
limited. The true effect may be substantially
different from the estimate of the effect.
Very Lowjþ000 We have very little confidence in the effect
estimate: The true effect is likely to be
substantially different from the estimate of
effect.
Examples: Strong, Moderatejþþþ0: Strong recommendation, moderate quality
of evidence. Weak, Lowjþþ00: Weak recommendation, low quality of evidence.
a
Weak recommendations should not be misinterpreted as weak evidence or
uncertainty in the recommendation.
Success rates
Numerous RCTs and a few systematic reviews have evaluated
outcomes of transvaginal mesh procedures. Overall, evidence
shows that polypropylene mesh (either placed using trocar-
guided systems or self-tailored mesh), when compared with
native tissue repair, improves both objective and subjective
success rates in the anterior vaginal wall but not posteriorly
(RR of recurrent anterior prolapse 0.33 [95% CI 0.26-0.40]
and RR of awareness of prolapse after anterior prolapse repair
0.65 [95% CI 0.51-0.84]).7,8 Multicompartment transvaginal
mesh outcomes are less consistent. Because trocar-guided
systems are now off the market, outcomes associated with
self-tailored transvaginal mesh were also analyzed separately
and are presented in Table 3.7,21e24
A recent Cochrane meta-analysis estimated an overall 60%
reduction in the risk of recurrent objective prolapse after
transvaginal mesh (trocar-guided system or self-tailored
mesh) use in any compartment at 1 to 3 years (21 RCTs,
including 2494 women) (Table 3).7 Recurrent objective
prolapse was defined as stage 2 or greater in any
compartment on examination.7 This commonly used
 No. 351-Transvaginal Mesh Procedures for Pelvic Organ Prolapse

Table 2. Judgement and interpretation of strong and conditional recommendations20

Judgement/interpretation
Judgement by guideline panel
Implications for patients
Implications for clinicians
Implications for policy makers
Strong recommendation
“We recommend .”
It is clear to the panel that the net desirable
consequences of a strategy outweighed the
consequences of the alternative strategy.
Most individuals in this situation would want the
recommended course of action, and only a small
proportion would not.
Most individuals should receive the intervention.
Adherence to this recommendation according to
the guideline could be used as a quality criterion
or performance indicator.
The recommendation can be adopted as policy
in most situations.
Conditional recommendation
“We suggest .”
It is less clear to the panel whether the net
desirable consequences of a strategy
outweighed the alternative strategy.
Most individuals in this situation would want the
suggested course of action, but many would
not.
Clinicians should recognize that different
choices will be appropriate for each individual
and that clinicians must help each individual to
arrive at a management decision consistent
with his or her values and preferences.
Policy making will require substantial debate
and involvement of various stakeholders.

definition has recently been questioned because it does not
seem to correlate with symptomatic outcomes. The less-
stringent criterion of using the hymen as a threshold ap-
pears to be more clinically meaningful.1 For vaginal mesh
repair of the anterior compartment, a similar benefit was
noted in the mesh group (RR of recurrent prolapse 0.36
[95% CI 0.28-0.47]).7 The systematic review by Schimpf
et al. was also consistent with those findings.8 There was
no evidence of a difference in objective outcomes for
multicompartment transvaginal mesh or posterior mesh.7,8
Since the publication of those systematic reviews, an
additional RCT with 2 years of follow-up was published,
but results did not reach significance (overall success rate
80% in the permanent mesh group using Avaulta Solo [CR
Bard Inc, Convington GA] [30 patients] and 72.9% after
native tissue repair [59 women]).25 Three-year outcomes,
based on pooled data from 3 RCTs, demonstrated
persistently superior objective outcomes using either
trocar-guided systems or self-tailored mesh compared with
native tissue repairs (success rate 76% [among 195 women]
vs. 46% [in 186 women], respectively, P < 0.0001).26e28
The wide variation in success rates is due in part to the
varying definitions of success and various types of mesh
systems used among studies.
Subjective success, or symptomatic improvement of pro-
lapse symptoms, is also marginally more likely in women
after transvaginal mesh repair compared with native tissue
repair (12 RCTs including 1614 patients) (Table 3).7 This is
true for mesh placed in the anterior compartment and in
multiple compartments but not for posterior vaginal
mesh.7,8 The odds of postoperative symptoms of a bulge
after anterior trocar-guided or self-tailored transvaginal
mesh were 0.47 (95% CI 0.34-0.64) compared with native
tissue repair.8 Scant literature exists concerning the quality
of life of women who undergo transvaginal mesh repair
compared with native tissue repair.7 However, available
evidence does not show a difference in quality of life or in
overall patient satisfaction between transvaginal mesh
procedures and native tissue repairs.7
A single RCT compared total vaginal mesh (Prolift;
Gynecare/Ethicon, Johnson & Johnson, Somerville, NJ)
with LSC for the management of vault prolapse.29 During
LSC, a permanent polypropylene mesh material is placed to
support the vagina from an abdominal approach instead of
a transvaginal approach. At 2 years postoperatively, the
LSC group had significantly better anatomical success
(77% vs. 43%, P < 0.001), although symptomatic out-
comes were similar between the groups (98% vs. 93%
success, P ¼ 0.18).29 The LSC group also had a lower rate
of mesh exposure (2% vs. 13%), although the difference
was not statistically significant. Reoperations were more
common in the Prolift vaginal mesh group (22% vs. 5%,
P ¼ 0.006).29 Overall, the LSC group had better outcomes
than did the transvaginal mesh group in this RCT.
Summary Statement
2. Transvaginal mesh repairs using trocar-guided
systems or self-tailored mesh have resulted in lower
recurrence of anatomical prolapse and marginally
reduced symptoms of bulge compared with native
tissue repairs. However, quality of life does not seem to
differ between transvaginal mesh and native tissue
repairs. Anatomical benefit is mostly observed when
mesh is used in the anterior compartment. Outcomes
of multicompartment transvaginal mesh placement
are inconsistent. Transvaginal mesh repair for
posterior vaginal wall prolapse is not superior to native
tissue repair (low).

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SOGC CLINICAL PRACTICE GUIDELINE

Table 3. Outcomes of transvaginal mesh prolapse repairs in any compartment at 1 to 3 years

RR (95% CI) for Currently available
transvaginal mesh mesh types
Transvaginal mesh procedures (trocar-
Native tissue (trocar-guided or guided or self-tailored only) Self-tailored mesha Trocarless systems,a,b
Outcome repair, % self-tailored only), % vs. native tissue repairs (off-label), % mean (range), %
Success rates
Anatomic/objective success 61.9 84.8 1.37 (1.30-1.45) 84.4 84.9 (69-98)
Symptomatic success 81.2 87.6 1.07 (1.04-1.12) 91.6 92.5 (91-98)
Complications/adverse events
Urinary tract injury or 0.5 2.1 3.92 (1.62-9.5) 0.8 1.2 (0-3.9)
perforation
Rectal or bowel compromise, Not estimated 0.8a,b N/A 0.4b 0.1 (0-0.7)
perforation or fistula
Infection or abscess (other 0.3a 0.8a NS 0.4 1.2 (0-2.9)
than urinary tract infection)
Hematoma or bleeding over 2.3 5.0 2.17 (1.33-3.52) 6.1 2.6 (0-5.3)
500 mL
Vaginal mesh exposure or N/A 12.2 N/A 13.0 4.8 (0-9.1)
extrusion
Musculoskeletal pain (pelvic, 1.5a 3.6a 2.44 (1.03-5.74) No data 3.1 (2.4-6.1)
vaginal, buttock, groin)
De novo dyspareunia 9.5 8.8 NS 12.8 4.8 (0.6-11.9)
De novo stress urinary 9.6 13.3 1.39 (1.06-1.82) 12.1 8.7 (0.8-18.3)
incontinence
Reoperation 4.8 11.4 2.40 (1.51-3.81) 15.9 5.8 (0-10.4)
7
Meta-analysed data from RCTs for native tissue and overall transvaginal mesh outcomes unless otherwise indicated.
a
From pooled data.
b
From observational study data.

Potential complications fistula is very low.12,31,34e41 Placement of mesh in the

Complication classifications were adapted from the Interna-
tional Urogynecological Association/International Continence
Society joint classification of complications related to pros-
theses and graft use in pelvic floor surgery.30 Most of the
evidence regarding potential complications of transvaginal
mesh procedures comes from studies using trocar-guided
systems or self-tailored mesh.
Intraoperative complications include a 4-fold increased risk
of bladder injury associated with transvaginal mesh place-
ment compared with native tissue repair for prolapse
(among 1514 patients in 11 RCTs).7 There is insufficient
evidence to make recommendations regarding the place-
ment of mesh in the vesicovaginal space after bladder
injury. Small case series report positive outcomes when the
injury is identified and repaired intraoperatively prior to the
placement of mesh.11,31e33 Rare cases of vesicovaginal
fistulas have been reported and are postulated to be
associated with unrecognized intraoperative bladder
injury.31,34 The risk of rectal or bowel injury or rectovaginal
rectovaginal space after rectal injury is not recommended
due to reported complications occurring in those cases.11,32
Postoperative infection risk (other than urinary tract
infection) at 1 to 3 years is very low after both transvaginal
mesh and native tissue repair procedures (2406 women in
20 RCTs, P ¼ 0.08).21e23,25,28,37,41e54 Some infections
occurred in the immediate postoperative period, and some
were diagnosed months later. No difference in the risk of
requiring a blood transfusion was found between trans-
vaginal mesh and native tissue repair (among 723 patients
in 6 RCTs).7 However, the risk of bleeding over 500 mL or
of postoperative hematoma seems to be higher after
transvaginal mesh repair (5.0% vs. 2.3% [2006 women in
16 RCTs]; P ¼ 0.0006).21,22,28,41e47,49e54
Recommendation
2. Placement of transvaginal mesh in the rectovaginal
space after rectal injury is not recommended
(weak, low).

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 No. 351-Transvaginal Mesh Procedures for Pelvic Organ Prolapse
Vaginal mesh exposure is a unique complication of pro-
cedures that use synthetic mesh material. The average
reported incidence after either trocar-guided system or
self-tailored transvaginal mesh procedures is 12%.7 Mesh
exposures are less common when mesh is placed in the
anterior compartment, occurring in 10% of cases (range
1.4% to 19%) compared with multicompartment placement
(average 17%, range 3% to 36%).7,8 Mesh exposures usually
present with vaginal discharge, bleeding, pain, dyspareunia,
or partner discomfort with intercourse.55,56 Many cases are
asymptomatic and are identified on examination.57,58
Average time to presentation is 5 months, ranging from a
few days to 5 years postoperatively.37,58e62 Studies with
longer follow-up may find persistent risk after 5 years
because new mesh exposures continue to be diagnosed
during follow-up of up to 7 years after sacrocolpopexy.63
The most consistently cited risk factors for transvaginal
mesh complications are concomitant hysterectomy (OR
3.72-5.17)19,31,55,61,64e67 and smoking (OR 3.1 to
3.7).55,60,68,69 Other potential risk factors, which have not
been consistently found to increase mesh exposure risk,
include inverted “T” colpotomy,55,67 less surgical experience
or surgical volume,19,55,61,69 being sexually active,70 and
somatic inflammatory disease (most commonly rheumatoid
arthritis).68 Associations of age and body mass index with
mesh exposure rates are inconsistent.19,60e62,64,66,68e70
Perioperative use of low-dose vaginal estrogen has not
been shown to reduce the risk of mesh exposure. In an
RCT that compared 2 types of transvaginal mesh, a logistic
regression determined that perioperative vaginal estrogen
use was associated with a doubled risk of mesh exposure at
3 years compared with no use of vaginal estrogen.64 Others
have found a possible protective role.61 A single non-
inferiority RCT addressed perioperative vaginal estrogen
use. In this trial of 186 women, a 6-week course of pre-
operative low-dose vaginal estrogen was compared with no
vaginal estrogen.57 At 1 year, no use of preoperative vaginal
estrogen was non-inferior to use of vaginal estrogen (mesh
exposure rate of 16% in the estrogen group compared with
13% in the no-estrogen group).57 No RCT was found
comparing postoperative vaginal estrogen to no estrogen.
Summary Statements
3. Transvaginal mesh repairs using trocar-guided sys-
tems or self-tailored mesh result in a risk of vaginal
mesh exposure averaging 12%, with the lowest risk
being in the anterior compartment (compared with
multicompartment placement) (moderate).
4. The most significant risk factors for mesh exposure
include concomitant hysterectomy and current
smoking (low).
5. Preoperative low-dose vaginal estrogen in post-
menopausal women does not appear to reduce mesh
exposures (moderate).
Both perforation and extrusion of mesh in the urinary or
gastrointestinal tracts are uncommon, unless an intra-
operative perforation was missed.
Risk of pain other than dyspareunia, including pelvic,
vaginal, buttock, and groin pain, is inconsistently reported
in studies. Pooled data show that the incidence of non-
sexual pain after pelvic floor repair procedures is higher
after transvaginal mesh compared with native tissue repair
(7 RCTs, 1015 patients).25,42,44e46,48,54 In 1 series, 56% of
women with pain from slings or transvaginal mesh also had
associated mesh exposure on examination.71 In some cases
(approximately 12% in a retrospective review of 684
transvaginal mesh procedures), pain seemed to be associ-
ated with contraction of the mesh.30,31 This could have
been associated with the transvaginal placement of large
pieces of mesh, which was common with trocar-guided
mesh systems, and could predispose mesh to folding and
rolling up. Anecdotally, mesh contraction appears to be less
common when a smaller size of mesh is used. Pain sec-
ondary to mesh contraction usually does not respond to
conservative measures, such as non-steroidal anti-inflam-
matory agents, and is reproduced by vaginal palpation of a
contracted area or band of mesh.72 Other causes of pain
after transvaginal mesh procedures include pelvic floor
muscle spasm, pudendal neuralgia, and infection.73
Rates of de novo dyspareunia after transvaginal procedures
and native tissue repairs appear to be similar (764 patients in
11 RCTs).7 Few studies have compared prolapse-specific
sexual function scores among different vaginal surgery
techniques for prolapse repair. In a meta-analysis, no differ-
ence was found in sexual function scores between trans-
vaginal mesh and native tissue repairs (7 RCTs, 341 women).7
Summary Statement
6. The de novo dyspareunia rate after transvaginal mesh
procedures with trocar-guided systems or self-tailored
mesh is comparable to native tissue repairs. The risk of
non-sexual pelvic, vaginal, buttock, or groin pain is
increased (low).
De novo stress urinary incontinence is more likely after
transvaginal mesh procedures compared with native tissue
repairs (13.3% vs. 9.6%, respectively; 12 RCTs, 1512
women).7 Most cases are managed conservatively, with
only 0% to 30% of women with de novo stress urinary
incontinence being treated surgically.28,45
NOVEMBER JOGC NOVEMBRE 2017 l 1091
SOGC CLINICAL PRACTICE GUIDELINE
Reoperation rates
Overall, the risk of requiring at least 1 additional sur-
gery for recurrent prolapse, stress urinary incontinence,
or mesh exposure is more than doubled after trans-
vaginal mesh repair in any compartment compared with
native tissue repair (7 RCTs including 867 patients).7
When only anteriorly placed mesh is considered, reop-
eration rates are similar between the 2 types of
procedures.8
Risk of reoperation for prolapse is reduced by almost half
with the use of transvaginal mesh (either a trocar-guided
system or self-tailored mesh) compared with native tis-
sue repair (12 RCTs including 1675 patients).7 Risk of
reoperation for continence surgery is similar between the
groups. Average risk of reoperation for mesh exposure in
any compartment is 8% after transvaginal mesh proced-
ures.7 A Canadian retrospective, population-based cohort
study found a reoperation rate for mesh-associated
complications of 4% (5448 patients, median of 5.4
years).19
Summary Statement
7. The improved anatomical success rate of transvaginal
mesh repairs with trocar-guided systems and
self-tailored mesh is associated with an increased
overall reoperation rate compared with native tissue
repairs. Main indications for reoperation after trans-
vaginal mesh procedures include prolapse recurrence,
mesh exposure, de novo stress urinary incontinence,
and pain (moderate).
Trocarless transvaginal mesh systems
Evidence for trocarless transvaginal mesh systems is
mainly limited to observational studies, and few of those
include a control group. The 1- to 2-year anatomical
success in all compartments (defined as stage 0 to 1)
averages 84.9% (8 studies, 810 patients).35,39,74e79
Symptomatic success has been reported in 91% to 98%
(4 studies, 427 patients).35,39,77,78 Objective and subjec-
tive success rates thus appear similar to results obtained
with trocar-guided systems. However, the mesh exposure
rate appears to be somewhat lower than that with trocar-
guided systems and averages 4.8% (range 0% to 9.1%,
among 1109 patients).35,39,74e78,80e82 One retrospective
study compared Prolift with 2 trocarless system-
sdPinnacle (now off the market) (Boston Scientific) and
Uphold (Boston Scientific)dand found a significantly
lower mesh exposure rate in the trocarless group (OR
0.16 [95% CI 0.03 to 0.97]).13 Reoperation rates also
appear to be lower after trocarless procedures than after
trocar-guided procedures.13,35,76e79
1092 l NOVEMBER JOGC NOVEMBRE 2017
A very limited literature addresses prolapse repairs with
uterine preservation. A recent, prospective cohort study
compared trocarless vaginal mesh hysteropexy (76
women, with Uphold device) with laparoscopic sacral
hysteropexy (74 women). At 1 year, objective and
symptomatic success rates were similar between the
groups (80% and 77% objective success and 95% and
90% symptomatic success, respectively). Mesh expo-
sures were diagnosed in 6.6% after Uphold hysteropexy
and in 2.7% after laparoscopic sacral hysteropexy dif-
ference not statistically significant (P > 0.05).77
Due to the limited literature available, RCTs comparing the
currently available trocarless systems with other prolapse
repairs are needed to determine their role in the prolapse
treatment algorithm.
Summary Statement
8. Evidence for currently commercially available
trocarless transvaginal mesh systems is limited to
observational studies so far, but outcomes appear to
be similar to or better than those obtained with trocar-
guided systems (very low).
MANAGEMENT OF MESH-RELATED
COMPLICATIONS
A systematic review of complications associated with
transvaginal mesh revealed successful treatment of vaginal
mesh exposure with vaginal estrogen, antiseptic agents,
and/or office excision in up to one third of women and
with a single surgical excision in the operating room in 56%
(76 studies, 795 women with mesh exposure).55 Some
women required more than 1 surgical procedure.55 Most
surgical interventions for mesh exposures are done as
outpatient procedures. Women with small, asymptomatic
mesh exposures can be managed conservatively.31,57,83 In
women with mesh exposure, ruling out concomitant organ
perforation and mesh exposure into adjacent organs with
cystoscopy, rectal examination, and/or proctoscopy is
recommended.56
Summary Statement
9. If mesh exposures are small or asymptomatic, an
attempt at conservative management is possible. Only
one third of women will be cured with this approach.
Most will require surgical management (low).
Based on case series and expert opinion, in women with
pain after transvaginal mesh procedures (including pelvic,
vaginal, buttock, and groin pain and dyspareunia),
conservative management can include pelvic floor
 No. 351-Transvaginal Mesh Procedures for Pelvic Organ Prolapse
physiotherapy and pharmacotherapy (non-steroidal anti-
inflammatories, muscle relaxants, and neuroleptics).73
Botulinum toxin injections for pelvic floor muscle spasm
(a postulated causal mechanism for mesh-related non-
sexual pain)73,84 and injection of anti-inflammatory agents
for mesh contractions have also been suggested.73,85
However, no studies have been published reporting
results following their use.
A few retrospective case series of women requiring reop-
eration for mesh complications describe their operative
outcomes. In all, 53% to 92% of women with pain expe-
rienced improvement or cure after mesh revision.71,72,86
History of chronic pelvic pain was identified as a risk
factor for failure of revision surgery to relieve pain in a
retrospective series (OR 0.28 [95% CI 0.12-0.64]). Fibro-
myalgia and interstitial cystitis were not associated.71
Clinically significant baseline (preoperative) chronic pelvic
pain should be considered a relative contraindication to
permanent mesh insertion and should be treated before
surgical prolapse repair is undertaken. Prolapse recurred in
15% to 20% of patients after mesh revision for mesh
complications.87,88
Recommendation
3. Clinically significant, preoperative, chronic pelvic pain
is a relative contraindication to the placement of
permanent transvaginal mesh. Pain can worsen
postoperatively, and surgical revision to relieve pain is
more likely to fail in these patients (strong, very low).
The preferred surgical approach for mesh complications is
the vaginal route.56,71,72 Revision techniques differ based
on patient symptoms and can include excision of exposed
area, release of contracted/tender mesh arm, partial mesh
excision, and total mesh excision.71,72 Abdominal or
laparoscopic approaches can be considered when the
vaginal approach has failed.56,71,72 Of women who require
surgery to treat mesh complications, such as exposure and
pain, approximately 20% require at least 1 additional
surgery, and some women require multiple
surgeries.55,59,87
Summary Statement
10. Of those who undergo surgery for complications of
transvaginal mesh procedures, the cure rate will
depend on the nature of the complication. Many with
exposure or erosion will be cured. Some women will
require more than 1 surgery for symptom
improvement. Complications such as chronic pain
may not be curable (very low).
PATIENT SELECTION FOR POLYPROPYLENE
TRANSVAGINAL MESH PROCEDURES
Limited evidence is available to guide patient selection for
transvaginal mesh procedures. Few studies have specifically
examined the outcomes of transvaginal mesh repair in
women with recurrent prolapse. Outcomes of transvaginal
mesh repair for recurrent prolapse seem to be comparable
with those reported for all prolapse cases.54,89 Due to the
potential risk of significant adverse events associated with
the use of transvaginal mesh, its use outside of clinical trials
should be limited to patients with significant risk factors
for recurrence or for women with recurrent prolapse of the
index compartment. Specific risk factors for prolapse
recurrence need to be researched further and quantified,
including levator avulsion, weak pelvic floor muscles,
prolapse stage 3 or 4 before index surgery, chronic con-
stipation, chronic obstructive lung disease, and chronic
heavy lifting.90
The literature is insufficient to inform recommendations
for immunocompromised women or women who have not
completed childbearing.
Recommendation
4. Patient selection for permanent polypropylene
transvaginal mesh procedures should be researched
further. Use of transvaginal mesh procedures outside
of clinical trials should be limited to cases with
significant risk factors for recurrence (such as levator
avulsion, weak pelvic floor muscles, prolapse stage 3
or 4 before index surgery, and chronic strain on the
pelvic floor [e.g., chronic constipation]) or for
treatment of recurrent pelvic organ prolapse (strong,
very low).
INFORMED CONSENT FOR PROCEDURES
As for any other surgical procedure, preoperative patient
counselling should address all aspects of informed consent.
Consent should include discussion of the route of mesh
placement (vaginal vs. abdominal).17 Physicians should
discuss why they are suggesting the option of transvaginal
mesh in each specific case.91 It should be emphasized that
the main expected outcome of prolapse repair is a reduc-
tion of bulge symptoms and that transvaginal mesh pro-
cedures are more likely than native tissue repairs to cure
these symptoms.7 Other associated pelvic floor complaints,
such as bladder, bowel, and sexual dysfunction, are not
consistently improved after prolapse repairs.91 Alternative
management options, such as expectant management,
pessary fitting, pelvic floor physiotherapy, and other types
NOVEMBER JOGC NOVEMBRE 2017 l 1093
SOGC CLINICAL PRACTICE GUIDELINE
of surgical repairs (e.g., native tissue repairs, sacrocolpo-
pexy) should also be discussed.17,91
The risk of complications should be reviewed, including
prolapse recurrence, organ injury (and mesh perforation
into other organs), infection, bleeding, mesh exposure,
persistent pelvic pain, dyspareunia, and new urinary
symptoms.17,91 Personal risk factors for complications
should be addressed. Smoking cessation should be rec-
ommended in smokers.32 Health Canada also recommends
informing women contemplating a transvaginal mesh
procedure that some complications may require multiple
additional surgeries, which may not fully address their
symptoms.17 The overall reoperation rate is more than
doubled after transvaginal mesh procedures (using trocar-
guided or self-tailored mesh) in any compartment
compared with that after native tissue repair. However, this
does not seem to be the case after anterior placement of
vaginal mesh.7,8 Women should also be made aware that
the usual surgical complications of any prolapse repair,
such as bleeding, infection, pain, dyspareunia, and new
urinary/bowel symptoms, may occur regardless of whether
mesh is used.91 Documentation of the informed consent
process should be clear in patients’ medical records.
Recommendations
5. For women to make informed decisions regarding
transvaginal mesh procedures, clinicians should
provide thorough preoperative counselling.
Counselling should include a discussion about (1)
improved anatomical outcomes, (2) marginal expected
improvement in bulge symptoms, (3) insufficient
evidence for improvement in quality of life, (4) risk of
mesh exposure and non-sexual pain, and (5) possible
need for reoperations compared with native tissue
repair (strong, moderate).
6. Patients should be counselled about smoking
cessation prior to undergoing transvaginal mesh repair
(strong, very low).
7. Informed consent should be clearly documented in
the patient’s records (strong, very low).
FOLLOW-UP FOR WOMEN AFTER TRANSVAGINAL
MESH PROCEDURES
After their normal postoperative visits have excluded
adverse events, women who have undergone vaginal mesh
procedures can resume normal well-women follow-up by
their health care provider, which would include pelvic ex-
aminations as needed.
Women should be asked to report to their health care
provider for symptoms such as pelvic/vaginal/buttock/
1094 l NOVEMBER JOGC NOVEMBRE 2017
groin pain, dyspareunia, vaginal discharge/bleeding, and
partner discomfort with intercourse. During the visit, pa-
tients should let their provider know that they underwent a
transvaginal mesh procedure. After taking a careful history,
the physical examination should specifically examine for
abdominal trigger points, vulvodynia, atrophy, vaginal/
rectal mesh exposure, infection, and pelvic floor muscle
spasm.73,91 Women who experience complications related
to the use of transvaginal mesh should be referred to a
specialist experienced in dealing with mesh complications.
Recommendation
8 Patients who experience complications from a
transvaginal mesh repair should be promptly assessed
and managed by surgeons who are experienced in
dealing with those complications (strong, very low).
SUMMARY
Transvaginal mesh procedures using trocar-guided systems
or self-tailored mesh reduce the risk of recurrent prolapse
compared with native tissue repairs. However, the associ-
ated increased risk of reoperation, including the risk of
mesh exposure, needs to be considered. Evidence
regarding currently available trocarless transvaginal mesh
systems is limited but promising and needs to be followed
as these systems replace trocar-based procedures. Patients
enrolled in clinical trials, those with recurrent prolapse, or
those with significant risk factors for recurrence could be
offered these procedures. Thorough preoperative patient
counselling about the possible risks and benefits of trans-
vaginal mesh procedures compared with alternative man-
agement options is essential.
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