Graft and Mesh Use in Transvaginal Prolapse Repair: A Systematic Review EDITORIAL COMMENT

摘要

In 2008, the US Food and Drug Administration (FDA) issued the first safety communication regarding serious complications associated with the use of transvaginal mesh for pelvic organ prolapse (POP) repair. Since this first safety communication, there have been increasing reports of debilitating mesh complications such as erosion, chronic pain, and dyspareunia, as well as high recurrence rates. These reports led the FDA in 2014 to mandate premarket studies to evaluate the safety and effectiveness of vaginal mesh implants, issue a second safety communication in 2015, and, in January 2016, to reclassify them as class III high- risk devices. The use of vaginal mesh has come under considerable public scrutiny, and a large number of class action lawsuits have been filed. In recent years, the American Urogynecologic Society and other national organizations have published guidelines stating that placement of vaginal mesh should be performed only by experienced, knowledgeable surgeons who track their outcomes. The aim of this systematic review was to update the 2008 clinical practice guidelines on graft and mesh use in transvaginal POP repair. A search was performed to identify eligible studies published up to April 15, 2015, using MEDLINE, Cochrane, and ClinicalTrials. gov database. A bibliography search was also conducted. Studies were included that compared anatomic and symptomatic outcomes following graft or mesh use with either native tissue repair or use of a different graft or mesh, with a minimum of 12 months of follow-up. Data from each study were extracted by one reviewer and confirmed by a second. Studies were categorized based on vaginal compartment (anterior, posterior, apical, or multiple), type of graft (biologic, synthetic absorbable, synthetic nonabsorbable), and anatomic and symptomatic outcomes, as well other outcomes (sexual function, mesh complications, and return to the operating room). A total of 66 comparative studies reported in 70 articles (including 38 randomized trials) were identified that met the study criteria. Although the quality of the literature has improved over time, heterogeneity of studies and inadequate power for some outcomes limit the ability to detect differences and draw conclusions. Meta-analyses showed that in the anterior compartment synthetic nonabsorbable mesh consistently improved anatomic and bulge symptom outcomes compared with native tissue repairs. No evidence suggested differences for subjective outcomes, including urinary and sexual function. Use of biologic grafts or synthetic absorbable mesh did not improve anatomic or subjective outcomes in any vaginal compartment. In the posterior or apical compartments, synthetic mesh use did not improve success. Across studies, mesh erosion rates ranged from 1.4% to 19% at the anterior vaginal wall and 3% to 36% for mesh placed in multiple compartments. Operative mesh revision rates across studies ranged from 3% to 8%. This updated review provides strong evidence that use of synthetic mesh augments anterior wall prolapse repair, improving anatomic outcomes and bulge symptoms, compared with native tissue repair. There is high-quality evidence of improvement in anatomic repair when synthetic mesh is used in multiple compartments. Despite this, however, there is strong evidence that sexual function and quality of life are not improved with mesh over native tissue repair in the anterior, or any other compartment. Use of biologic grafts does not improve POP repair outcomes in any vaginal compartment.