FDA Orders Manufacturers to Halt Sales of Surgical Mesh
On Tuesday, April 16, 2019, the U.S. Food and Drug Administration (FDA) issued an order directing Boston Scientific and Coloplast to immediately halt sales and distribution of all remaining surgical mesh products indicated for transvaginal repair of pelvic organ prolapse.
Per the FDA press release, this move is the latest in a series of escalating safety actions related to protecting the health of the thousands of women who undergo transvaginal surgery to repair pelvic organ prolapse each year.
The FDA singled out Boston Scientific and Coloplast after determining that the manufacturers “have not demonstrated a reasonable assurance of safety and effectiveness for these devices.” The release goes on to note that surgical mesh products were reclassified as class III, high risk devices in 2016. After this reclassification, manufacturers were required to submit premarket approval (PMA) applications with the FDA in order to receive approval to continue selling the devices in the U.S.
The FDA also required proof that surgical mesh devices were more successful at repairing pelvic organ prolapse than meshless surgery, which Boston Scientific and Coloplast failed to do.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. 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, M.D., director of the FDA’s Center for Devices and Radiological Health.
Boston Scientific and Coloplast will now have 10 days to submit their plan to withdraw the surgical mesh products from the market. Both manufacturers have also been ordered to continue follow-ups with subjects already enrolled in mesh studies.
Patients who have already been surgically implanted with transvaginal mesh for the repair of pelvic organ prolapse are advised to continue with their annual and routine checkups and follow-up care and should notify their doctor if they experience complications or symptoms. Common complications include persistent vaginal bleeding or discharge, pelvic or groin pain, pain during sex. The FDA is advising patients who were planning to have mesh placed transvaginally for the repair of pelvic organ prolapse to discuss other treatment options with their doctors.