Boston Scientific is anticipating a $25 million hit to its 2019 revenue after the FDA ordered device makers to pull surgical pelvic mesh products from the market, according to The Worcester Business Journal.
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.