The surgical mesh products are intended for transvaginal repair of pelvic organ prolapse.
The agency issued an order to remove the products from the market after determining that the manufacturers of the devices, Boston Scientific and Coloplast, did not demonstrate safety and efficacy of their devices.
Boston Scientific, which posted revenue of $9.8 billion in 2018, announced the anticipated financial hit in a U.S. Securities & Exchange Commission filing.
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