The FDA determined that the two makers of surgical mesh for women's pelvic repair haven't demonstrated a reasonable assurance of safety and effectiveness for these devices
The U.S. Food and Drug Administration ordered the two makers of surgical mesh for women’s pelvic repair to take their products off the market, responding to years of complaints about pain, bleeding and scarring from the devices.
The federal agency, following a safety hearing on the topic in February, said that Boston Scientific Corp. and Coloplast Corp. hadn’t demonstrated reasonable evidence that the mesh products worked better than surgery without the products.
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