Today FDA ordered Boston Scientific and Coloplast to remove all remaining transvaginal surgical meshes intended for pelvic organ prolapse (POP) repair from the U.S. market. The agency stated these manufacturers have not demonstrated that the devices provide “reasonable assurance of safety and effectiveness”. Boston Scientific and Coloplast have 10 days to submit their plan to FDA on how they will get the products off the market.
“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, said CDRH Director Jeff Shuren, M.D. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”
According to today’s FDA statement, the agency reviewed the PMAs submitted by Boston Scientific and Coloplast (the two manufacturers marketing surgical mesh products for transvaginal repair of POP) and decided that the assessment of the long-term safety of the devices was not adequate. In addition, they didn’t show that these devices posed a long-term benefit versus native tissue repair. “Since the FDA has not received sufficient evidence to assure that the probable benefits of these devices outweigh their probable risks, the agency has concluded that these products do not have a reasonable assurance of safety and effectiveness,” stated the FDA news release.
Boston Scientific’s PMAs were for its Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System; Coloplast’s PMA was for the Restorelle DirectFix Anterior.
In January 2016, FDA ordered that surgical mesh used for transvaginal POP repair be classified as a Class III device, thus adding the requirement for a PMA application. The agency’s latest move is part of an initiative announced in November 2018, part of which included making women’s health a priority.