The agency said it was “examining these allegations” to determine the next steps, but said it is currently not away that the alleged counterfeit raw material is contributing to adverse events with the 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 device has been cleared by the FDA, and such a change often does not require FDA premarket review. However, in light of the allegations, Boston Scientific will conduct additional testing relevant to the safety and effectiveness of the finished product,” the FDA wrote in its update.
The FDA said the additional testing would be sufficient to determine whether or not the mesh made from alleged counterfeit raw material are equivalent to meshes manufactured with material from the original supplier. The agency said it expects the testing will take several months to complete.
Health care professionals and their patients should be “aware of the investigation,” the FDA said, and plan for the FDA to review to make the “most informed health care decisions.”
The FDA advised against removal of the surgical mesh in women who already have it implanted as “available data do not suggest any decreased benefit associated with the device.”
The federal watchdog said it will update with any new information.
In January, a class-action racketeering lawsuit was filed against Boston Scientific accusing it of illegally smuggling counterfeit resin made in China to make pelvic mesh, after its original supplier allegedly refused to continue providing the product because it’s not supposed to be implanted in humans.
The lawsuit was filed Jan. 12 in the U.S. District Court for Southern West Virginia, the venue for multi-district litigation against a clutch of companies over their respective mesh products for treating female urinary incontinence and pelvic organ prolapse.
Plaintiff Teresa Stevens alleged that Marlborough, Mass.-based Boston Scientific conspired with subsidiaries in Belgium and Ireland to use the counterfeit resin to make the Advantage mesh used in all of its pelvic mesh products.
Boston Scientific told CNNMoney that “patient safety is of the utmost importance, and we dedicate significant resources to deliver safe, high-quality products. We don’t believe the case has merit and intend to vigorously defend these claims.”