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 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 recurrence 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 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 repairs with trocar-guided systems and self-tailored mesh is associated 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 transvaginal 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 conservative 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 improvement. 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 programs, 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 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).
- 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).
Key Words
Abbreviations:
CI (confidence interval), FDA (Food and Drug Administration), LSC (laparoscopic sacrocolpopexy), RCT (randomized controlled trial), RR (relative risk), OR (odds ratio)To read this article in full you will need to make a payment
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References
- Epidemiology and outcome assessment of pelvic organ prolapse.Int Urogynecol J. 2013; 24: 1783-1790
- Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence.Obstet Gynecol. 1997; 89: 501-506
- Epidemiologic evaluation of reoperation for surgically treated pelvic organ prolapse and urinary incontinence.Am J Obstet Gynecol. 2003; 189: 1261-1267
- Lifetime risk of undergoing surgery for pelvic organ prolapse.Obstet Gynecol. 2010; 116: 1096-1100
- Mid-urethral sling operations for stress urinary incontinence in women.Cochrane Database Syst Rev. 2015; 7: CD006375
- Apical prolapse.Int Urogynecol J. 2013; 24: 1815-1833
- Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse.Cochrane Database Syst Rev. 2016; 2: CD012079
- Graft and mesh use in transvaginal prolapse repair: a systematic review.Obstet Gynecol. 2016; 28: 81-91
- Classification of biomaterials and their related complications in abdominal wall hernia surgery.Hernia. 1997; 1: 15-21
- Risk factors for mesh/suture erosion following sacral colpopexy.Am J Obstet Gynecol. 2008; 199: 688.e1-688.e5
- Prevention of complications related to the use of prosthetic meshes in prolapse surgery: guidelines for clinical practice.Eur J Obstet Gynecol Reprod Biol. 2012; 165: 170-180
- Perioperative morbidity using transvaginal mesh in pelvic organ prolapse repair.Obstet Gynecol. 2007; 109: 303-308
- Outcomes of trocar-guided Gynemesh PS™ versus single-incision trocarless Polyform™ transvaginal mesh procedures.Int Urogynecol J. 2015; 26: 71-77
- FDA Safety Communication: Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.U.S. Food and Drug Administration, Silver Springs, MD2011 (Available at:) (Accessed on May 11, 2017)
- Surgical Mesh - Complications Associated with Transvaginal Implantation of Surgical Mesh for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse - Notice to Hospitals.Health Canada, Ottawa2010 (Available at:) (Accessed on May 11, 2017)
- FDA Strengthens Requirements for Surgical Mesh for the Transvaginal Repair of Pelvic Organ Prolapse to Address Safety Risks.U.S. Food and Drug Administration, Silver Springs, MD2016 (Available at:) (Accessed on May 11, 2017)
- Surgical Mesh - Complications Associated with Transvaginal Implantation for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse - Notice to Hospitals.Health Canada, Ottawa2014 (Available at:) (Accessed on May 11, 2017)
- Enmeshed in controversy: use of vaginal mesh in the current medicolegal environment.Female Pelvic Med Reconstr Surg. 2015; 21: 241-243
- Surgeon experience and complications of transvaginal prolapse mesh.Obstet Gynecol. 2016; 128: 65-72
- The GRADE Handbook.McMaster University and Evidence Prime Inc., Hamilton, ON2013 (Available at:) (Accessed on May 12, 2017)
- Anterior colporrhaphy versus repair with mesh for anterior vaginal wall prolapse: a comparative clinical study.Arch Gynecol Obstet. 2012; 286: 965-972
- Vaginal repair with mesh versus colporrhaphy for prolapse: a randomised controlled trial.BJOG. 2009; 116: 1380-1386
- Colporrhaphy compared with mesh or graft-reinforced vaginal paravaginal repair for anterior vaginal wall prolapse: a randomized controlled trial.Obstet Gynecol. 2011; 118: 1337-1344
- Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial.Obstet Gynecol. 2007; 110: 455-462
- Conventional fascial technique versus mesh repair for advanced pelvic organ prolapse: analysis of recurrences in treated and untreated compartments.J Obstet Gynaecol. 2016; 36: 410-415
- A 3-year follow-up after anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial.BJOG. 2016; 123: 136-142
- Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial.Obstet Gynecol. 2013; 122: 770-777
- Outcomes after anterior vaginal wall repair with mesh: a randomized, controlled trial with a 3 year follow-up.Am J Obstet Gynecol. 2010; 203: 235.e1-235.e8
- Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial.Am J Obstet Gynecol. 2011; 204: 360.e1-360.e7
- An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Neurourol Urodyn. 2011; 30: 2-12
- Safety of trans vaginal mesh procedure: retrospective study of 684 patients.J Obstet Gynaecol Res. 2008; 34: 449-456
- Complications of pelvic organ prolapse surgery and methods of prevention.Int Urogynecol J. 2013; 24: 1859-1872
- Prosthetic reinforcements: how to manage bladder injuries?.Int Urogynecol J Pelvic Floor Dysfunct. 2007; 18: 1215-1217
- Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 3-year prospective follow-up study.Int Urogynecol J. 2010; 21: 1455-1462
- Pelvic organ prolapse repair using the Uphold™ Vaginal Support System: a 1-year multicenter study.Int Urogynecol J. 2016; 27: 1337-1345
- Transvaginal repair of stage III-IV cystocele using a lightweight mesh: safety and 36-month outcome.Int Urogynecol J. 2015; 26: 1147-1154
- Multicenter, randomized trial comparing native vaginal tissue repair and synthetic mesh repair for genital prolapse surgical treatment.Int Urogynecol J. 2015; 26: 335-342
- Bilateral sacrospinous vault fixation with tailored synthetic mesh arms: clinical outcomes at one year.J Obstet Gynaecol Can. 2015; 37: 129-137
- Minimal mesh repair for apical and anterior prolapse: initial anatomical and subjective outcomes.Int Urogynecol J. 2012; 23: 1753-1761
- Prospective study of transobturator mesh kit (Prolift™) in pelvic reconstructive surgery with vaginal hysterectomy after 3 years' follow-up.Arch Gynecol Obstet. 2013; 288: 355-359
- Vaginal mesh for prolapse: a randomized controlled trial.Obstet Gynecol. 2010; 116: 293-303
- Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse.N Engl J Med. 2011; 364: 1826-1836
- The use of transvaginal synthetic mesh for anterior vaginal wall prolapse repair: a randomized controlled trial.Int Urogynecol J. 2013; 24: 1899-1907
- Infracoccygeal sacropexy or sacrospinous suspension for uterine or vaginal vault prolapse.Int J Gynaecol Obstet. 2008; 100: 154-159
- Comparison between trans-obturator trans-vaginal mesh and traditional anterior colporrhaphy in the treatment of anterior vaginal wall prolapse: results of a French RCT.Int Urogynecol J. 2013; 24: 1651-1661
- A multicenter, randomized, prospective, controlled study comparing sacrospinous fixation and transvaginal mesh in the treatment of posthysterectomy vaginal vault prolapse.Am J Obstet Gynecol. 2012; 207: 301.e1-301.e7
- A randomized controlled trial comparing anatomical and functional outcome between vaginal colposuspension and transvaginal mesh.Int Urogynecol J. 2014; 25: 961-970
- Outcome after anterior vaginal prolapse repair: a randomized controlled trial.Obstet Gynecol. 2008; 111: 891-898
- Anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial.BJOG. 2014; 121 (discussion 10–1): 102-110
- Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized controlled trial.Ultrasound Obstet Gynecol. 2014; 43: 365-371
- Treatment of anterior vaginal wall prolapse with and without polypropylene mesh: a prospective, randomized and controlled trial - Part I.Int Braz J Urol. 2013; 39: 519-530
- Anatomical and functional assessment of anterior colporrhaphy versus polypropylene mesh surgery in cystocele treatment.Eur J Obstet Gynecol Reprod Biol. 2013; 170: 555-558
- Primary surgical repair of anterior vaginal prolapse: a randomised trial comparing anatomical and functional outcome between anterior colporrhaphy and trocar-guided transobturator anterior mesh.BJOG. 2011; 118: 1518-1527
- Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial.Obstet Gynecol. 2011; 117: 242-250
- Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review.Int Urogynecol J. 2011; 22: 789-798
- Mesh complications in female pelvic floor reconstructive surgery and their management: a systematic review.Indian J Urol. 2012; 28: 129-153
- Effects of preoperative vaginal estrogen therapy for the incidence of mesh complication after pelvic organ prolapse surgery in postmenopausal women: is it helpful or a myth? A 1-year randomized controlled trial.Menopause. 2016; 23: 740-748
- Long-term outcome after transvaginal mesh repair of pelvic organ prolapse.Int Urogynecol J. 2016; 27: 1069-1074
- Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: a multicenter study.Am J Obstet Gynecol. 2014; 210: 163.e1-163.e8
- The influence of BMI, smoking, and age on vaginal erosions after synthetic mesh repair of pelvic organ prolapses. A multicenter study.Acta Obstet Gynecol Scand. 2009; 88: 772-780
- [Risk factors of mesh exposure after transvaginal repair of genital prolapse].Gynecol Obstet Fertil. 2009; 37: 470-475
- Exploring predictors of mesh exposure after vaginal prolapse repair.Female Pelvic Med Reconstr Surg. 2013; 19: 206-209
- Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse.JAMA. 2013; 309: 2016-2024
- Lower exposure rates of partially absorbable mesh compared to nonabsorbable mesh for cystocele treatment: 3-year follow-up of a prospective randomized trial.Int Urogynecol J. 2013; 24: 749-758
- Complications of transvaginal monofilament polypropylene mesh in pelvic organ prolapse repair.Int Urogynecol J Pelvic Floor Dysfunct. 2009; 20: 919-925
- Risk factors for mesh extrusion after prolapse surgery: a case-control study.Female Pelvic Med Reconstr Surg. 2012; 18: 357-361
- Transvaginal mesh technique for pelvic organ prolapse repair: mesh exposure management and risk factors.Int Urogynecol J Pelvic Floor Dysfunct. 2006; 17: 315-320
- Risk factors for mesh complications after trocar guided transvaginal mesh kit repair of anterior vaginal wall prolapse.Neurourol Urodyn. 2012; 31: 1165-1169
- Risk factors for exposure, pain, and dyspareunia after tension-free vaginal mesh procedure.Obstet Gynecol. 2011; 118: 629-636
- Age and sexual activity are risk factors for mesh exposure following transvaginal mesh repair.Int Urogynecol J. 2011; 22: 307-313
- Postoperative pain outcomes after transvaginal mesh revision.Int Urogynecol J. 2015; 26: 65-69
- Vaginal mesh contraction: definition, clinical presentation, and management.Obstet Gynecol. 2010; 115: 325-330
- Managing chronic pelvic pain following reconstructive pelvic surgery with transvaginal mesh.Int Urogynecol J. 2014; 25: 313-318
- Medium-term clinical outcomes following surgical repair for vaginal prolapse with tension-free mesh and vaginal support device.Int Urogynecol J. 2012; 23: 487-493
- One-year clinical outcomes after prolapse surgery with nonanchored mesh and vaginal support device.Am J Obstet Gynecol. 2010; 203: 587.e1-587.e8
- Prolapse repair using the Elevate™ kit: prospective study on 70 patients.Int Urogynecol J. 2012; 23: 1421-1428
- Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study.Am J Obstet Gynecol. 2016; 216: 38.e1-38.e11
- Single-incision vaginal approach to treat cystocele and vault prolapse with an anterior wall mesh anchored apically to the sacrospinous ligaments.Int Urogynecol J. 2012; 23: 85-91
- Utero-vaginal suspension using bilateral vaginal anterior sacrospinous fixation with mesh: intermediate results of a cohort study.Int Urogynecol J. 2015; 26: 1803-1807
- Single-incision apical and posterior mesh repair: 1-year prospective outcomes.Int Urogynecol J. 2012; 23: 1413-1419
- Elevate anterior/apical: 12-month data showing safety and efficacy in surgical treatment of pelvic organ prolapse.Female Pelvic Med Reconstr Surg. 2013; 19: 79-83
- A multicenter, prospective trial to evaluate mesh-augmented sacrospinous hysteropexy for uterovaginal prolapse.Int Urogynecol J. 2015; 26: 743-748
- Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 5-year prospective follow-up study.Int Urogynecol J. 2013; 24: 1679-1686
- Botulinum toxin type A for chronic pain and pelvic floor spasm in women: a randomized controlled trial.Obstet Gynecol. 2006; 108: 915-923
- Complications of vaginal mesh: our experience.Int Urogynecol J Pelvic Floor Dysfunct. 2009; 20: 893-896
- Trans-vaginal mesh revision: a comprehensive review on etiologies and management strategies with emphasis on postoperative pain outcomes.Low Urin Tract Symptoms. 2014; 6: 69-75
- Mesh removal following transvaginal mesh placement: a case series of 104 operations.Int Urogynecol J. 2010; 21: 423-430
- Prolapse recurrence after transvaginal mesh removal.J Urol. 2015; 194: 1342-1347
- Native tissue repair or transvaginal mesh for recurrent vaginal prolapse: what are the long-term outcomes?.Int Urogynecol J. 2016; 27: 1313-1320
- Recurrent pelvic organ prolapse: International Urogynecological Association Research and Development Committee opinion.Int Urogynecol J. 2016; 27: 1619-1632
- Informed surgical consent for a mesh/graft-augmented vaginal repair of pelvic organ prolapse. Consensus of the 2nd IUGA Grafts Roundtable: optimizing safety and appropriateness of graft use in transvaginal pelvic reconstructive surgery.Int Urogynecol J. 2012; 23: S33-S42
Article info
Publication history
No. 351, November 2017 (Replaces No. #254, February 2011)
Footnotes
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.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.
Competing interests: None declared.
Identification
Copyright
© 2017 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.
