The Food and Drug Administration (FDA) has ordered manufacturers of all surgical mesh products used for the transvaginal repair of pelvic organ prolapse to immediately stop selling and distributing their products in the United States, citing a lack of “reasonable assurance” that the devices are safe and effective.

The action to protect women’s health targets the two remaining makers of transvaginal mesh products, Boston Scientific and Coloplast. The companies have 10 days to submit to the FDA their plan to withdraw these products from the market.

Due to escalating concerns over adverse events related to transvaginal mesh, the agency, in 2016, reclassified the products as high-risk, and required manufacturers to submit applications to the FDA in order to get approval to keep selling their devices. The agency wanted evidence that transvaginal mesh was safer and more effective than surgery without the mesh.

“That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

About 1 in 8 women has surgery to repair pelvic organ prolapse, which is a condition that occurs when the muscles supporting the pelvic organs weaken, allowing the organs to fall into or out of a woman’s vagina. Transvaginal mesh has been available as a treatment since the 1950s, but in recent years there have been escalating reports of adverse events including the mesh eroding into the tissue and causing chronic and disabling pain. The FDA issued warnings about the devices. As sales waned, other manufacturers, including Johnson & Johnson, stopped selling transvaginal mesh products.

Boston Scientific alone faced more than 48,000 lawsuits from women claiming the devices injured them. BSX, Coloplast, Johnson & Johnson, and Becton, Dickinson’s C.R. Bard are still dealing with transvaginal mesh litigation.

FDA News Release
CBS News
Seeking Alpha

We're here to help!

We live by our creed of “helping those who need it most” and have helped thousands of clients get the justice they desperately needed and deserved. If you feel you have a case or just have questions please contact us for a free consultation. There is no risk and no fees unless we win for you.

Fields marked * may be required for submission.

Number one firm

I really appreciate the law firm, they look into every detail, they review everything with you not just once but several times to make sure everything is correct. They are a very good law firm and I would highly recommend them. They'll always call you back when you call with questions. They're number one in my book.