FDA Advisory Panel to Investigate Transvaginal Mesh Complications in Pelvic Organ Prolapse Repair

Published on December 17, 2018 by Sandy Liebhard

Members of the U.S. Food & Drug Administration’s (FDA) Obstetrics and Gynecology Devices Advisory Committee will soon gather to discuss transvaginal mesh implants, specifically those used to treat pelvic organ prolapse.

According to a notice posted at the Federal Registry, the February 12th meeting is open to the public.

“FDA is convening this meeting to seek expert opinion on the evaluation of the risks and benefits of these devices,” the notice states. “The Committee will be asked to provide scientific and clinical input on assessing the effectiveness, safety, and benefit/risk of mesh placed transvaginally in the anterior vaginal compartment, as well as identifying the appropriate patient population and physician training needed for these devices.”

The FDA will accept public comments on this issue until January 27^th.

FDA Warnings for Transvaginal Mesh Complications.”

The FDA has been investigating transvaginal mesh complications for over a decade. According to the agency, the most common injuries associated with these devices include:

• Mesh erosion through the vagina
• Chronic pain
• Infection
• Bleeding
• Pain during sexual intercourse (dyspareunia)
• Organ perforation
• Urinary problems

The FDA has also received complaints involving recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these transvaginal mesh complications required, including additional surgery and hospitalization.

In July 2011, the agency warned that transvaginal mesh complications associated with prolapse repair are not rare.

“This is a change from what the FDA previously reported on Oct. 20, 2008,” the agency stated. “Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

Many Device Makers Stopped Selling Transvaginal Mesh for Prolapse Repair

In 2016, the FDA reclassified transvaginal mesh implants used in prolapse repair as high-risk medical devices, which subjected those products to greater regulatory scrutiny.

As a result, device manufacturers stopped selling transvaginal mesh for posterior compartment placement. However, three products are still available for placement in the anterior vaginal compartment.

Over the past decade, more than 100,000 women have filed transvaginal mesh lawsuits for complications associated with these devices. American Medical, Systems, Inc., Boston Scientific Corp., C.R. Bard, Ethicon, Inc., and other defendants have either settled or are in the process of settling many of these claims.