FDA issued two proposed orders to address the health risks associated with surgical mesh devices. The U.S. Food and Drug Administration (FDA) today issued two proposed orders to address the health risks associated with surgical mesh devices used for repair of pelvic organ prolapse (POP).
These orders, if finalized, would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and would require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness, according to the FDA news release. Transvaginal mesh devices would no longer be able to go through the FDA’s more streamlined 510(k) approval route. Manufacturers would be required to do clinical testing to prove that the devices are safe and effective.
POP occurs when the internal structures that support the pelvic organs become weak, stretched, or broken, and the organs drop from their normal position and bulge (prolapse) into the vagina. Women with POP often experience pelvic discomfort, disruption of urinary, defecatory, and sexual functions, and an overall reduction in quality of life.
Surgical mesh devices are implanted to provide support for the organs
Surgical mesh devices are implanted to provide support for the organs, but the devices themselves have been shown to cause serious problems. Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, said, “The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products.”
Thousands of lawsuits have been filed against transvaginal mesh implant makers including Boston Scientific, C.R. Bard, Endo, and Johnson & Johnson’s Ethicon division. In July 2011, the FDA issued an updated safety communication about serious complications associated with transvaginal mesh, and in 2012 the agency ordered manufacturers to conduct postmarket surveillance studies to address safety and effectiveness concerns related to transvaginal mesh implants.