UPDATE 3-U.S. FDA orders transvaginal surgical mesh pulled from market
The U.S. Food and Drug Administration on Tuesday ordered makers of transvaginal surgical mesh implants to immediately stop their sale and distribution in the United States, the latest action by the agency to tackle safety issues related to the devices. The FDA said Boston Scientific Corp and Coloplast A/S did not demonstrate a reasonable assurance of safety and effectiveness of these devices in their premarket applications. The companies will have 10 days to submit their plan to withdraw these products from the market, the FDA said in a statement https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636114.htm.