Product Liability

FDA panel supports closer review of vaginal mesh products

A Food and Drug Administration (FDA) advisory panel expressed support for the FDA’s plans to conduct post-marketing studies on risks associated with transvaginal mesh products, but refused to recommend the devices be banned despite pleas from advocacy groups.

The FDA’s Obstetrics & Gynecology Devices Advisory Committee met last week to discuss new controversy surrounding surgical mesh used to treat pelvic floor disorders including pelvic organ prolapse (POP) and urinary incontinence. Vaginal mesh for such uses has been associated with problems including organ perforation and bleeding. Long-term risks may include mesh exposure into the vagina, bladder or rectum.

Other reported problems include urinary incontinence, vaginal scarring or shrinkage, recurrent prolapse and neuromuscular problems. This can cause patients to experience pelvic pain, infection, pain during sex, and the need for additional corrective surgeries. In some cases, the injuries have been permanent.

About 300,000 women underwent surgeries to address POP and incontinence in 2010, and an estimated 75,000 of those involved the transvaginal implantation of surgical mesh. The FDA has received 1,503 reports of complications associated with the devices from January 2008 to December 2010. In July, the FDA issued a safety warning about potential problems involving transvaginal mesh.

The FDA says it will review data on the safety of surgical mesh used for pelvic floor disorders, and is considering asking manufacturers of the products to submit reports for the agency’s review. Advocacy groups such as Public Citizen hope to persuade the agency to recall the products.

Although the advisory committee did not vote to make recommendations to the FDA on recalling transvaginal mesh, the committee was in support of the agency conducting post-marketing studies on the devices.

Source: MedScape