STORY FROM: Drugs & Medical Devices
FDA Eyeing Allegations Concerning Boston Scientific’s Use of Counterfeit Mesh
April 5, 2016
WASHINGTON, D.C. — The Food and Drug Administration says it is looking into allegations that Boston Scientific Corp.’s urogynecologic surgical mesh may contain counterfeit raw material and that the manufacturer will perform additional testing “relevant to the safety and effectiveness of the finished product.”
In an April 1 notification, the agency added that “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 own appropriate evaluation of potential suppliers and raw material, to change the source of a raw material after the ...