Federal Regulators Remove All Transvaginal Mesh from the Market

All transvaginal mesh manufacturers in the U.S. have been ordered to cease selling and distributing their products within the U.S. effective April 16, 2019. The U.S. Food and Drug Administration (FDA) took this drastic step after undertaking an escalating number of safety initiatives following a review that determined the makers of transvaginal mesh products were unable to demonstrate a “reasonable assurance of safety and effectiveness.” The FDA’s order affects all manufacturers of these surgical implants, including Ethicon, C.R. Bard, Boston Scientific, and Coloplast.

FDA’s action comes amidst thousands of reports of complications

Over 100,000 reports have been made regarding adverse health effects allegedly caused by the transvaginal mesh products. Many of those reports involve claims of debilitating and severely painful complications, including organ perforation and erosion of the surgical mesh.

Transvaginal mesh is surgically implanted for the purpose of giving extra support to the pelvic organs. It’s intended to treat pelvic organ prolapse (POP), which commonly affects women and can cause urinary incontinence. However, thousands of women have stepped forward after the mesh implants caused far worse problems than they solved.

The FDA stepped in to determine whether there was any evidence that surgery with mesh worked better than surgery without mesh, and whether the mesh was reasonably safe for use. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” stated Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

Back in 2016, the FDA had reclassified transvaginal mesh as a high risk medical device (class III). This reclassification meant that manufacturers were required to submit premarket approval applications and obtain approval in order to maintain the authority to market the devices in the U.S. Now that the FDA has decided to withdraw transvaginal mesh from the market entirely, the manufacturers will have 10 days to submit a plan for that withdrawal.

Litigation filed with regard to transvaginal mesh complications

Transvaginal mesh litigation has made history as being one of the largest mass torts to date in the U.S. Tens of thousands of plaintiffs have filed lawsuits against a handful of mesh manufacturers. Many of those plaintiffs filed complaints after the FDA’s July 2011 warning of a high number of adverse event reports. Some of the defendants reached settlement agreements with plaintiffs to resolve the pending lawsuits.

The FDA’s advice for women with transvaginal mesh

The removal of transvaginal mesh from the stream of commerce could be alarming for some women who have already undergone surgery to implant it. The FDA has assured these patients that there is no need to undergo revision surgery as long as they do not experience complications or symptoms and are satisfied with their surgical results. However, the FDA does recommend that these patients continue to get annual and other routine checkups, as well as any follow-up care recommended by their physicians. These patients should also contact their physicians immediately if they notice any possible signs of complications, which may include unusual vaginal bleeding, abnormal discharge, pelvic pain, or pain during intercourse.

Additional resources:

• U.S. Food and Drug Administration, FDA News Release, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636114.htm
• CNN, FDA bans sales of transvaginal mesh amid safety concerns, https://www.cnn.com/2019/04/16/health/transvaginal-pelvic-mesh-fda-bn/index.html