FDA May Reclassify Vaginal Mesh Implants as High-Risk Medical Devices

On Tuesday, the FDA announced a proposed order to reclassify vaginal mesh implants as high-risk medical devices. This reclassification, if approved, would force implant manufacturers to submit premarket approval (PMA) applications to the agency, which require companies to conduct studies to determine the safety and efficacy of their products.

Laura V. Yaeger said that the new PMA process will consist of four steps:

1. The manufacturer must undergo an administrative and limited scientific review by the FDA.

2. The FDA will perform an in-depth scientific, regulatory and quality system review of the product.

3. The appropriate advisory committee will review the product and make recommendations involving its use.

4. The FDA will discuss final deliberations and provide documentation and notification regarding its decision.

Currently, vaginal mesh implants are considered moderate-risk devices, a classification that does not require the devices to be rigorously tested. They were first approved and classified as moderate-risk devices in the 1990s when the FDA’s fast-track program, also known as the 510k program, approved them based on their similarity to meshes used to treat hernias, according to ABC News.

Thousands of women, however, have complained about mesh-related injuries in recent years, spurring litigation against major mesh manufacturers including Johnson & Johnson, C.R. Bard and Boston Scientific, as well as several notices from the FDA.

Ms. Yaeger said that while the new PMA process would be much more thorough than the 510k program, the damage has already been done.

“I have spoken to hundreds of women whose lives have been forever changed because of transvaginal mesh,” she said. “The response, in my opinion, is too little too late.”

The most common complaint among women with vaginal mesh implants is that they can erode and cause pain, infections, urinary problems and recurrence of prolapse, the medical condition which the implant is meant to treat. Between 2005 and 2008, the FDA received reports from more than 1,000 women experiencing these serious complications with their implants and issued a Public Health Notification to warn doctors about these side effects. Then, in 2011, the agency updated that notification to warn women and physicians that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” Moreover, the FDA said that these implants may even expose patients to greater risks than traditional non-mesh surgeries.

The first suggestion to reclassify mesh implants as a high-risk medical device came from the FDA’s Obstetrics and Gynecology Devices Panel in 2011.

The following year, the FDA ordered mesh manufacturers to conduct postmarket surveillance studies on their products, but did not publish any other updates regarding the devices until now.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., the deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”

According to Ms. Yaeger, the announcement should not have any effect on the ongoing litigation, but it may help prospective patients gain a better understanding of the devices.

“My hope is that it will inform women of the risks associated with transvaginal mesh,” she said.

The FDA will take comments regarding the proposal for 90 days, which consumers can access here beginning May 1, 2014.