FDA Says It’s Aware Of Allegations Boston Scientific May Use ‘Counterfeit’ Marlex

(April 4, 2016, 9:56 AM EDT) -- SILVER SPRING, Md. — Two days after getting a citizen petition from a plaintiffs law firm, the Food and Drug Administration on April 1 said it is aware of allegations that Boston Scientific’s urogynecologic surgical mesh may contain counterfeit raw material.

“We are examining these allegations to determine any necessary and appropriate next steps,” the FDA said. FDA is not currently aware that the alleged counterfeit raw material contributes to adverse events associated with these products.”

“It is not uncommon for a firm, based on its...
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