April 5, 2016 — The FDA is investigating allegations that Boston Scientific imported counterfeit resin from China to use in vaginal mesh implants.
The FDA is not recommending removal of the implants, saying the risks of revision surgery outweigh those of counterfeit resin. Boston Scientific is conducting safety testing to determine whether the materials are equivalent. The tests are expected to take several months.
The allegations emerged earlier this year, when Boston Scientific was hit with a class action racketeering lawsuit in federal court in West Virginia, where the company is already facing 20,000 lawsuits from women who were injured by vaginal mesh products.
The class action claims Boston Scientific “smuggle[d] 15 tons of the material from China without verifying or fully testing the contents” and used the resin in Advantage Fit and Lynx implants.
In March 2016, lawyers in Texas filed a citizen petition (PDF) demanding an immediate Class I recall of counterfeit implants. They say the resin contains high levels of selenium and the change in material should require a new 510(k) approval application.
Problems began in 2004, when the American supplier of Marlex polypropylene resin declared it incompatible with human tissue and stopped selling it for permanent medical implants. Boston Scientific ran out of the material in 2011 and turned to a counterfeiter, according to lawyers.
The petition cites a number of emails from employees at Boston Scientific indicating that the resin was found on alibaba.com, the seller was a known counterfeiter of plastic goods, all of the paperwork was missing, and the company was repeatedly told that lot numbers on the counterfeit products were invalid.
This is not the first time the FDA has taken action on counterfeit polypropylene mesh. In 2010, the agency issued a Class I recall for Marlex products labeled with the C. R. Bard/Davol brand-name that were sold from October 2008 to October 2009.
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