FDA orders manufacturers to stop selling surgical mesh
The FDA ordered two manufacturers to immediately stop selling and distributing surgical mesh products intended for the transvaginal repair of pelvic organ prolapse, according to a press release issued by the agency.
Boston Scientific and Coloplast failed to demonstrate adequate long-term safety and effectiveness for their surgical mesh devices, including Uphold LITE Vaginal Support System, Xenform Soft Tissue Repair System and Restorelle DirectFix Anterior, according to the FDA.
“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 pelvic organ prolapse,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term. Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions.”
The FDA reported a marked increase in adverse events associated with the use of surgical mesh for transvaginal pelvic organ prolapse repair.
Boston Scientific and Coloplast have 10 days to submit their plan on how they will remove their surgical mesh products from the market, according to the FDA.
Disclosure: Shuren is the director of the FDA’s Center for Devices and Radiological Health.