U.S. health regulators ordered two medical device companies to stop selling surgical mesh used in pelvic repair surgeries, saying there isn’t enough evidence that the product embroiled in thousands of lawsuits is safe or effective.
The Food and Drug Administration told Boston Scientific and Coloplast “to stop selling and distributing their products in the U.S. immediately.”
“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. Boston Scientific shares slid 4.3% to $36.17, while Coloplast’s American depositary receipts fell 2.5%. Coloplast has settled the lawsuits brought against it by women who said they were harmed by the devices. Boston Scientific has set aside more than $900 million for legal liabilities, with most of it tied to mesh lawsuits.Boston Scientific decried the decision and said it would work with the agency to determine its next steps.
Vaginal mesh accounts for about 0.2% of group revenue for Coloplast, said company spokeswoman Lina Danstrup, who declined to comment further. The company generated $2.6 billion in sales last year.
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