Transvaginal Mesh Not a Good Choice for Most Women in POP Repair, Medical Groups WarnNov 22, 2011 | Parker Waichman LLP
Two prominent physician groups have recommended that transvaginal mesh devices not be used in the majority of women who undergo surgical repair for pelvic organ prolapse (POP). According to a joint statement issued by the American College of Obstetricians and Gynecologists and (the College) the American Urogynecologic Society (AUGS), transvaginal placement of surgical mesh may cause some women to suffer "permanent and life-altering problems, including pelvic pain and painful sexual intercourse because the mesh erodes through the vaginal wall."
In their joint statement, the two groups issued the following recommendations:
• Continued audit and review of outcomes as well as the development of a surveillance registry for all current and future vaginal mesh implants;
• Outcome reporting for prolapse surgical techniques clearly defining success, complications, and total reoperation rates;
• Surgeon training for vaginal mesh placement specific to each device, including surgical experience with reconstructive surgery and thorough understanding of pelvic anatomy;
• Rigorous comparative effectiveness trials of synthetic mesh and native tissue repair and long-term follow-up;
• Patient counseling that there are alternative native tissue repairs and that synthetic mesh is permanent, as well as discussion of the risks, benefits, and alternatives to the procedure;
• Limiting use of POP vaginal mesh repair to high-risk women for whom the benefit may justify the risk;
• Adoption of new mesh products and devices only with clinical long-term data demonstrating equal or improved safety and efficacy compared with existing products and devices.
Surgical pelvic mesh products are implanted to provide support for a woman’s organs in the pelvis, which drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. In July, the U.S. Food & Drug Administration (FDA) said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.
FDA staff has proposed that such devices be moved to the agency's high -risk medical device category, which does not allow 510(k) clearances. Under the FDA proposal, transvaginal mesh devices already on the market would be allowed to remain, but manufacturers would have to conduct studies to asses their safety and effectiveness.
In many cases, women require surgical excision to remove defective transvaginal mesh devices, and may even require two or three additional surgeries. Despite removal of the mesh, complications may not be reversed, and women continue to suffer with vaginal pain and an impaired quality of life.