FDA Orders Withdrawal of Surgical Mesh Products
In the latest of escalating actions to protect women's health, the FDA ordered the manufacturers, Boston Scientific and Coloplast, of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately. The FDA determined that the manufacturers, have not demonstrated a reasonable assurance of safety and effectiveness for these devices, which is the premarket review standard that now applies to them since the agency reclassified them in class III (high risk) in 2016. Individuals, who have endured injury for mesh products, may pursue legal actions against manufacturers. Click here to read more about the mesh products stop sales.