The Food and Drug Administration is investigating allegations that Boston Scientific is using counterfeit raw materials in its urogynecologic surgical mesh.
For women who already have the Boston Scientific mesh implanted, the FDA is not recommending removal. The available data do not suggest any decreased benefit with the device and the risk of mesh removal outweighs any potential risk from mesh manufactured from alleged counterfeit raw materials, according to the FDA.
The investigation, announced by the FDA on April 1, 2016, comes after the agency received a citizen’s petition alleging that Boston Scientific was using a resin manufactured in China rather than the authentic Marlex HGX-030-01 resin.
Teresa Stevens, who is also involved in a federal class action lawsuit against Boston Scientific, submitted the citizen’s petition asking the FDA to begin an immediate Class I recall of all Boston Scientific mesh products made with the alleged counterfeit resin.
Boston Scientific is denying the allegations made in the petition.
“Boston Scientific does not use ‘counterfeit’ or ‘adulterated’ materials in our medical devices,” company officials wrote in an April 1 statement. “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.”
Company officials said they located a new supplier of Marlex resin in 2011 and put samples of the materials through a battery of tests to demonstrate equivalency.
The FDA acknowledged that it is not uncommon for companies to change the source of their raw materials after a device has been cleared for marketing and that the change often does not require premarket review by the agency. But due to the allegations in the citizen’s petition, the FDA will evaluate the results of new testing conducted by the company, including chemical characterization and toxicologic risk assessment of the raw material alleged to be counterfeit, as well as chemical characterization and biocompatibility of the final finished urogynecologic surgical mesh.
“The additional testing should be sufficient for the FDA to determine whether or not the urogynecologic surgical mesh manufactured from the alleged counterfeit raw material are equivalent to the urogynecologic surgical mesh manufactured from the original raw material supplier,” FDA officials wrote. “We expect that this testing will take several months to complete.”
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