For the past few years, the FDA has been investigating the safety of surgical mesh used for repairing a condition called pelvic organ prolapse. A recent article from The Washington Post contained the latest development stating that the FDA has ordered manufacturers to immediately stop selling the products. This includes Boston Scientific and Coloplast, neither of which has demonstrated a “reasonable assurance” of safety and effectiveness for long-term use of the devices. The companies have 10 days to submit plans for withdrawing them from the market.
FDA Says to Stop Selling Vaginal Mesh
An increase in ‘adverse events’ linked to surgical mesh used in pelvic procedures prompts action from the FDA.
Apr 22nd, 2019