FDA is investigating the potential presence of counterfeit raw materials in Boston Scientific’s urogynecologic surgical mesh implants. The agency is unaware of any adverse events related to the products. It also points out that at present, these are allegations, and it is further looking into the matter to determine the next course of action.
Boston Scientific will conduct additional tests to assess the safety and effectiveness of the finished product, including chemical characterization, biocompatibility and toxicological risk assessment of the raw material in question. It is anticipated that the testing process will take several months.
“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,” according to a statement on FDA’s website.
Although FDA does want healthcare professionals and patients to be aware of the situation, it is not recommending removal of the device in women who already have the urogynecologic surgical mesh implanted.