FDA Halts Sales of Surgical Mesh by 2 Firms Over Injury Claims

By | April 17, 2019

U.S. health regulators ordered two medical device companies to stop selling a surgical mesh used in pelvic repair surgeries, after thousands of claims by women that they were injured by the products.

The Food and Drug Administration said it had told Boston Scientific Corp. and Humlebaek, Denmark-based Coloplast A/S “to stop selling and distributing their products in the U.S. immediately.” The order applies to the companies’ surgical mesh products for the transvaginal repair or pelvic organ prolapse, which we recategorized as high-risk devices in 2016.

Boston Scientific shares were down 3.8 percent to $36.37 at 12:26 p.m. in New York. The company has faced thousands of lawsuits over the mesh inserts, which are used by surgeons to buttress the pelvic wall. Coloplast’s American depositary receipts fell 2.8 percent.

“The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices,” the agency said in a statement. The finding may complicate the outcome of lawsuits against the companies, which have continued to sell the mesh even as women claimed they caused permanent pain and damage.

Kelly Leadem, a Boston Scientific spokeswoman, didn’t immediately return a phone call seeking comment.

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