The Food and Drug Administration on Tuesday ordered Boston Scientific and Coloplast to stop selling surgical mesh used for some pelvic operations.
The agency said the companies “have not demonstrated a reasonable assurance of safety and effectiveness for these devices.” The companies have 10 days to submit their plans to withdraw the products from the market.
Boston Scientific said it was “deeply disappointed by the FDA’s decision “and believe the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives.”
“Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps,” it added.
Coloplast said it will comply with the FDA’s order and stop selling the product and said it represents only 0.2% of its total revenue.
The FDA said about 1 in 8 women has surgery to repair the condition, and a subset of these surgeries are completed transvaginally with the use of surgical mesh. However, the percentage of women undergoing transvaginal POP mesh procedures has decreased in recent years after the FDA began issuing warnings about risks associated with the procedure.
From FDA: “Women who have received transvaginal mesh for the surgical repair of prolapse should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having any complications or symptoms.”
“On April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the agency reclassified them into class III (high risk) in 2016. “