On Tuesday, April 16, the U.S. Food and Drug Administration (FDA) ordered Boston Scientific and Coloplast to stop the sale of their pelvic mesh products in the U.S., typically used to treat pelvic organ prolapse (POP) and incontinence.
The agency had reclassified the devices as high-risk in 2016 when the manufacturers were required to submit premarket approval applications to keep their pelvic mesh product in the U.S. market. The order is applicable to Boston's Uphold Lite Vaginal Support System and Xenform Soft Tissue Repair System and Coloplast AS' Restorelle DirectFix Anterior Mesh. Both the manufacturers are given 10 days to submit a plan about the product withdrawal from the market. According to the agency, all other mesh products meant for repair pelvic organ prolapse were pulled out from the market in 2018 when their manufacturers failed to submit premarket approval applications. Talking about the market withdrawals, Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said, in order to keep the devices on the market, evidence need to be added in the premarket applications that indicate them as a safer alternative to surgery. Boston Scientific & Coloplast are the only two remaining makers of the mesh devices, and they failed to prove the long-term safety and effectiveness of their devices. The FDA suggested that women who are planning to have transvaginal mesh repair of POP must discuss other treatment methods with their doctors.
