The FDA has ordered all manufacturers of surgical mesh for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling their products immediately. According to the agency, the manufacturers Boston Scientific and Coloplast have not provided sufficient evidence that the benefits of these products outweigh their high, class III risks, compared with transvaginal surgical tissue repair without the use of mesh.
Women who have received transvaginal mesh for pelvic organ prolapse (POP) should continue routine care. However, if symptoms arise such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex, they should promptly inform their health care providers. Patients planning a future prolapse procedure with transvaginal mesh require alternative treatments.
“In order for these mesh devices to stay on the market, we determined [in 2016] that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, stated in a news release.
Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheets and are absorbable, non-absorbable, or a combination of both. Animal-derived mesh are absorbable.
FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices (news release). FDA; April 16, 2019.