Boston Scientific urges the FDA to maintain a class II device status on transvaginal mesh amid calls from public advocates for product recalls and FDA warnings that the devices may do more harm than good. Boston Scientific Corp. (NYSE:BSX) issued an official statement urging the FDA to leave transvaginal mesh products under their current classification, despite growing concerns that the products do more harm than good. The statement comes on the heels of a two-day FDA advisory panel considering revoking 510(k) clearance status for the products and requiring them to undergo clinical testing as higher-risk Class III medical devices.
