FDA Flips the Switch on Pelvic Mesh Manufacturers

After years of controversy surrounding the use of surgical mesh for transvaginal repair of pelvic organ prolapse (POP), FDA has ordered Boston Scientific and Coloplast to stop selling the mesh on the U.S. market immediately. The agency said the manufacturers have not demonstrated a reasonable assurance of safety and effectiveness for these devices, which is the premarket review standard that now applies to them since FDA decided they were high risk in 2016. “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, MD, 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." But considering how long these devices were on the market, and how many women have complained of major health problems since having transvaginal procedures that use surgical mesh, some say the action is too little, too late. "Everyone at Medical Device Problems applauds this decision, but we feel it was not made soon enough," Amanda Dykeman, co-founder...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news