WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) issued an order to all companies that manufacture transvaginal mesh to stop selling and distributing the medical device immediately. Surgical mesh designed to repair pelvic organ prolapse manufactured by Boston Scientific and Coloplast fail to satisfy the FDA’s safety requirements, nor have the products demonstrated the appropriate level of effectiveness. Accordingly, the FDA issued the proper order. The most recent order issued by the FDA regarding surgical mesh is another in a series of safety measures taken on behalf of women who have experienced significant health problems after receiving the mesh implant.
According to the FDA’s announcement and order, the surgical mesh designed to repair pelvic organ prolapse manufactured and distributed by Boston Scientific and Coloplast fail to meet the premarket standards of safety and effectiveness. Since Boston Scientific and Coloplast each has been unable to satisfy the safety and effectiveness standard, the FDA has ordered both companies to submit detailed plans to the FDA explaining how each company will recall all of the products falling under the FDA order. Boston Scientific and Coloplast each have ten days to submit their plans.
The FDA reclassified surgical mesh designed to repair pelvic organ prolapse in 2016. In 2016, the FDA raised the surgical mesh’s classification level to Level III or high risk. To continue to market and sell their products, companies manufacturing surgical mesh for pelvic organ prolapse repair were obligated to submit their premarket plan for reapproval because of the risks involved. This is the FDA’s most stringent level of review, and both Boston Scientific and Coloplast failed the FDA’s heightened scrutiny.
A physician working for the FDA stated that neither Boston Scientific nor Coloplast could justify the use of their products because of the attendant safety risk. In essence, the companies had to prove to FDA regulators that women who used their products had a better outcome than not having surgery at all. Now unable to meet these minimum requirements, Boston Scientific and Coloplast must withdraw their products from the marketplace.
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