Manufactures of surgical mesh for the transvaginal repair of pelvic organ prolapse (POP) must stop selling their product following an order from the Food and Drug Administration.
Boston Scientific and Coloplast, the two makers of the mesh for POP, have not shown that the mesh is safe or effective. As a class III/ high risk classification, the manufacturers require premarket approval.
“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, director of the FDA’s Center for Devices and Radiological Health. “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 has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”
An FDA advisory panel recommended that a favorable benefit-risk profile would need to include surgical mesh for transvaginal repair of POP be better than native tissue repair with comparable safety outcomes. Since this was not included in the premarket approval applications from either company, they were denied.
Boston Scientific and Coloplast have 10 days to submit their plan to take the mesh off the market.
