The U.S. Food and Drug Administration is investigating allegations that Boston Scientific’s urogynecologic surgical mesh contains counterfeit raw materials. Pelvic mesh is used to treat pelvic organ prolapse and stress urinary incontinence in women. The device, which is made by various manufacturers, is the subject of thousands of personal injury lawsuits.
In a safety alert issued April 1st, the FDA said Boston Scientific would conduct additional safety testing. The agency notes that “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 device has been cleared by the FDA, and such a change often does not require FDA premarket review.” However, the allegations have prompted the FDA to ask for further testing.
Based on the additional safety tests, the FDA can conclude whether the product is equivalent to the mesh manufactured from the initial raw supplier. The testing is expected to take several months. Patients and healthcare professionals should be aware of the probe and the FDA review of additional data so they can make an informed decision moving forward, the agency said.
The FDA is not advising women who already have Boston Scientific surgical mesh to remove it. According to the notification, removing the product may cause more harm than good and data do not indicate decreased benefit thus far.
According to the Boston Globe, Boston Scientific faces about 30,000 lawsuits over its transvaginal mesh. Last year, it settled about 3,000 cases for $119 million.