By Shirley S. Wang Surgical mesh kits used to repair a condition called pelvic organ prolapse should be more closely regulated, the Food and Drug Administration announced on Tuesday, signaling heightened recognition of the safety issues associated with the devices currently on the market. The FDA’s proposed changes, if finalized, would reclassify the medical devices […]Read More
Consumer Inquiries: 888-INFO-FDA, DICE@fda.hhs.gov FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify […]Read More