FDA investigates alleged fake materials in surgical mesh

Boston Scientific flagThe US FDA has said it is "aware" of allegations that Boston Scientific's surgical mesh products contain counterfeit materials and will investigate the matter.

The statement by the regulator is the latest development in a long-running saga, which escalated earlier this year when Bostin Scientific was sued by lawfirm Mostyn Law claiming the company had knowingly sourced substandard Marlex polypropylene resin from China.

The latest development follows a petition filed with the FDA by Mostyn Law at the end of March. The company filed its original complaint on behalf of plaintiff Teresa Stevens who claims to have been injured by a vaginal mesh product.

"We are examining these allegations to determine any necessary and appropriate next steps," says the FDA, whilst pointing out that it is not uncommon for companies to change the source of a raw material used in an approved device and "such a change often does not require FDA premarket review."

For its part, Boston Scientific insists that it does not use counterfeit or adulterated materials in its medical devices.

"Large scale manufacturers of raw materials like resin sell products directly and through diverse networks of distributors," it says.

"Changing suppliers of raw materials is not unusual for medical device companies, and when Boston Scientific makes such a change, we follow the processes required by our quality system."

Boston Scientific has agreed to carry out additional testing that the FDA says "should be sufficient … to determine whether or not the uro-gynaecologic surgical mesh manufactured from the alleged counterfeit raw material are equivalent to the … mesh manufactured from the original raw material supplier."

It is anticipated that the testing will take several months to complete.

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