FDA Investigating Whether Boston Sci Used Counterfeit Resin

The agency is investigating whether it needs to take any "necessary and appropriate next steps" when it comes to potential counterfeit resin used in transvaginal mesh.

Chris Newmarker

Things may be getting more serious for Boston Scientific when it comes to accusations that the medical device giant used counterfeit raw material in urogynecologic surgical mesh.

FDA in a recent safety alert disclosed that it is aware of allegations, and is "examining these allegations to determine any necessary and appropriate next steps."

"We are currently not aware that the alleged counterfeit raw material contributes to adverse events associated with these products," FDA added.

The news comes about three months after a federal lawsuit filed in West Virginia accused Boston Sci of orchestrating a conspiracy to sell misbranded transvaginal mesh made from counterfeit plastic smuggled from China.

The company said at the time that the lawsuit has no merit, and that it would vigorously fight the suit.

The smuggling campaign required deceiving Chinese customs, U.S. customs, the FDA, and the patients who ultimately receive the adulterated products, according to the lawsuit. The suit claims Boston Sci engaged in the smuggling after it had difficulties in 2011 obtaining the polypropylene Marlex HGX-030-1 from its supplier, Chevron and Phillips/Sumika in LaPorte, TX. Bostin Sci allegedly smuggled some 34,000 pounds of counterfeit Marlex material out of China. 

FDA says additional testing over the next several months will allow it to determine whether or not the surgical mesh made from the alleged counterfeit raw material is equivalent to the mesh manufactured from the original raw material supplier. The agency is not recommending that women have surgical meshes removed. FDA said it "believes the additional risks associated with mesh removal outweigh any risk that may be associated with the use of mesh manufactured from alleged counterfeit raw material."

Houston-based Mostyn Law, which is handling the federal lawsuit in West Virginia, disagrees, according to Qmed's sister UBM media outlet Plastics Today. Mostyn is petitioning FDA to recall the mesh products, citing an "urgent need to protect the health of women."

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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