The FDA Obstetrics & Gynecology Devices Advisory Committee supports tougher pre-market testing of vaginal mesh products and reclassifying these medical devices as Class III devices which means vaginal mesh makers can no longer end-run elaborate testing by availing themselves to the FDA’s 510(k) approval process under which a mesh device is “substantially equivalent” to other pelvic organ prolapse (POP) surgical mesh products already on the market. In other words, the FDA is going to actually require these device manufacturers to test the products properly before putting them inside a woman. How revolutionary!
This came out of an advisory committee meeting in Maryland last week to discuss the debacle that is the use of surgical mesh for treatment of pelvic organ prolapse and stress urinary incontinence. Since 2008, the FDA has received 2874 adverse event reports of complications following surgery, with 1503 adverse event reports associated with vaginal mesh implants used in POP repair and 1371 associated with stress urinary incontinence repair. The device manufacturers making these vaginal mesh devices keep asking for more time to forestall the inevitable: the conclusion that, on balance, the risk is not worth the benefits.
Certainly, some public interest groups wanted the FDA to go further and order manufacturers to recall all transvaginal mesh implants. That didn’t happen. One reason: we don’t have the studies the FDA committee wanted with randomized, controlled data or cohort studies that cover a period of three years. But here is the crazy thing: that is what we should have had BEFORE these products came on the market.