FDA Reclassifies Pelvic Mesh Devices As High-Risk, Orders Premarket Approval
(January 4, 2016, 1:30 PM EST) -- SILVER SPRING, Md. — The Food and Drug Administration on Jan. 4 issued final orders reclassifying pelvic mesh devices intended to treat pelvic organ prolapse (POP) from moderate-risk Class II to high-risk Class III devices and requiring manufacturers of the devices to obtain premarket approval (PMA) to show the safety and effectiveness of using surgical mesh to treat pelvic organ prolapse.
The FDA proposed the two orders in 2014.
“The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through...