The FDA has ordered Boston Scientific (NYSE:BSX) and Coloplast — the only remaining companies that sell pelvic mesh in the U.S. — to immediately halt sales and distribution of those products.
The two companies have not demonstrated a “reasonable assurance of safety and effectiveness for these devices” since the agency reclassified them as high-risk in 2016, the FDA said. As part of the reclassification, manufacturers were required to obtain premarket approval (PMA) applications, the agency’s most stringent device review pathway.