The law firm that’s bringing a racketeering lawsuit against Boston Scientific (NYSE:BSX) accusing it of smuggling counterfeit resin asked the FDA to ban the medical device maker’s pelvic mesh products made with the allegedly impure resin.
Teresa Stevens sued Boston Scientific in January, alleging that the Marlborough, Mass.-based company conspired with subsidiaries in Belgium and Ireland to use counterfeit resin imported from China to make the Advantage mesh used in its pelvic mesh products.
A federal judge ruled that the FDA has jurisdiction over the case, as “many of the factual allegations contained in the complaint and supporting documents are based on alleged violations of statutes and regulations over which the FDA exercises its expertise and impressive administrative dominance.”
Now the law firm representing Stevens, Houston-based Mostyn Law, is petitioning the FDA to ban Boston Scientific’s mesh products made with the purportedly counterfeit resin.
Boston Scientific commented, saying it “Does not use ‘counterfeit’ or ‘adulterated’ materials in our medical devices.”
“The company rejects the allegations in the petition to the Food and Drug Administration filed by a Texas-based law firm on March 31, 2016. Boston Scientific has a robust quality system and dedication to patient safety. We stand behind our products, the materials used in those products and our commitment to women’s health,” the company wrote in a press release.
The company said that in 2011, it shifted its supplier of Marlex resin, and in doing so put the resin through a “rigorous battery of tests to demonstrate equivalency,” as well as conducting extensive mechanical tests to ensure the products made with the new material meets product specifications.
“We have the highest confidence in the safety of our mesh devices. We have shared our test data with the Food and Drug Administration, and are fully cooperating with the agency’s requests for information as part of our ongoing discussions. Additionally, we have offered to conduct further biocompatibility and chemical characterization testing to complement the results from existing tests. This entire process is expected to take several months, depending on the individual tests,” Boston Scientific wrote.
The FDA today released an update on allegations that Boston Scientific’s urogynecologic surgical mesh may contain counterfeit raw material.
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.
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.