Boston Scientific is rejecting allegations that it used counterfeit materials in its urogynecologic surgical mesh implants, fighting back against a law firm’s claims that the company’s devices are made of defective material from China.
Houston-based Mostyn Law filed a citizen petition with the FDA on March 31, asking the agency to issue a Class 1 recall of the products. The petition was filed on behalf of Teresa Stevens, a West Virginia woman who suffered health problems after receiving a Boston Scientific pelvic mesh implant.
The law firm alleges Boston Scientific ran out of FDA-approved supplies and “started using counterfeit resin from China with no history as to when it was made, how it was made, who made it, no title, and was smuggled out” in a series of transactions.
The petition cites internal, previously undisclosed Boston Scientific emails that say the company bought the stock in 2011 and 2012 from a suspected counterfeiter in China without fully testing it for its use as a vaginal implant.
The FDA posted a safety alert on April 1 saying it is examining the allegations. “FDA is not currently aware that the alleged counterfeit raw material contributes to adverse events associated with these products,” the notice says.
The FDA says Boston Scientific will conduct additional testing that should be sufficient to determine whether the mesh manufactured from the alleged counterfeit raw material is equivalent to the mesh made from the original raw material supplier.
Attorney Amber Mostyn of Mostyn Law subsequently criticized the FDA for its “watered-down warning” of the risks of the mesh, adding “it is absurd to rely on testing by the company that is using it.”
Boston Scientific says it stands behind its products and the materials used in them.
The company says samples of the resin underwent a rigorous battery of tests to demonstrate equivalency. It also conducted extensive mechanical tests to ensure that the mesh products manufactured with the newly sourced material met product specifications.
Earlier this year, the FDA issued two final orders requiring manufacturers to address safety concerns — including severe pelvic pain and organ perforation — through a PMA pathway to demonstrate safety and effectiveness ().
Several companies — including Boston Scientific, Medtronic’s Covidien, Johnson & Johnson’s Ethicon and C.R. Bard — have faced legal action brought by women claiming personal injury while using their products ().