Boston Scientific, Coloplast ordered to stop sale of transvaginal mesh in U.S.
The U.S. Food and Drug Administration announced that it has ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse to stop selling and distributing their products in the U.S. immediately. "The order is the latest in a series of escalating safety actions related to protecting the health of the thousands of women each year who undergo surgery transvaginally to repair POP," the FDA said. The FDA has determined that the manufacturers, Boston Scientific and Coloplast, 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 in 2016. As part of the 2016 reclassification, manufacturers were required to submit and obtain approval of premarket approval applications, the agency's most stringent device review pathway, in order to continue marketing their devices in the U.S. The companies will have 10 days to submit their plan to withdraw these products from the market, the FDA said. Reference Link