Devices

Testing Required on Surgical Mesh Made with Fake Materials

The FDA says it is aware of allegations that Boston Scientific’s urogynecologic surgical mesh may contain counterfeit raw material, and it is requiring the company to conduct additional testing to determine whether or not mesh manufactured from the alleged counterfeit raw material are equivalent to mesh manufactured from the original raw material supplier. The testing will take several months to complete, the agency says.

The additional testing comes one day after a citizen petition was filed seeking an FDA recall order on the mesh products allegedly made of defective, counterfeit material from China (see story). The petition, filed on behalf of a West Virginia woman who suffered health problems from a Boston Scientific pelvic mesh implant, accuses the company of smuggling from China more than 34,000 pounds of unverified synthetic resin to make the mesh. It cites internal Boston Scientific emails that say the company bought the resin stock in 2011 and 2012 from a suspected counterfeiter in China without fully testing it or getting FDA approval for its use as a vaginal implant.

“We are examining these allegations to determine any necessary and appropriate next steps,” an FDA notice says. “We are currently not aware that the alleged counterfeit raw material contributes to adverse events associated with these products.”

The additional tests Boston Scientific will conduct include “chemical characterization and toxicological risk assessment of the raw material alleged to be counterfeit, as well as chemical characterization and biocompatibility of the final finished urogynecologic surgical mesh,” FDA says. “The chemical characterization tests will identify and assess the chemicals present in the raw material and mesh, while the toxicological risk assessment will estimate the toxicity risks associated with each chemical. The biocompatibility tests will assess the ability of the mesh to come in contact with the human body without producing an adverse effect.

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