No. 351-Transvaginal Mesh Procedures for Pelvic Organ Prolapse

ObjectiveThis 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 UsersGynaecologists, residents, urologists, urogynaecologists, and other health care providers who assess, counsel, and care for women with pelvic organ prolapse.Target PopulationAdult women with symptomatic pelvic organ prolapse considering surgery and those who have previously undergone transvaginal mesh procedures for the treatment of pelvic organ prolapse.OptionsThe 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).OutcomesThe 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.EvidencePubMed, 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.Resultswere 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.ValuesThe 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 CostsIt 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 UpdateEvidence 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 Statements1.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).Recommendations1.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).