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