April 5, 2016 — The FDA has opened a safety investigation into allegations that Boston Scientific sold vaginal mesh implants with resin that was counterfeited in China.
Boston Scientific will spend several months conducting tests to determine whether the materials are equivalent. In the meantime, the FDA believes the risks of removing vaginal mesh outweigh any risk associated with counterfeit raw materials.
Even if the materials are equivalent instead of low-grade knockoffs, serious safety concerns remain. In 2004, the original American supplier stopped selling the resin to Boston Scientific because it was incompatible with human tissue and unsafe for permanent medical implants.
Lawyers say Boston Scientific ran out of the resin in 2011, jeopardizing $120 million in vaginal mesh products the company sold each year. The company then turned to counterfeiters and “smuggle[d] 15 tons of the material from China without verifying or fully testing the contents” for use in Advantage Fit and Lynx mesh implants.
The accusations emerged when Boston Scientific was hit with a class action racketeering lawsuit in federal court in West Virginia, where another 20,000 lawsuits are centralized. The litigation is overseen by U.S. District Judge Joseph Goodwin, who advised plaintiff Teresa Stevens to pursue an FDA review of the counterfeit mesh allegations.
In March 2016, the FDA received a citizen petition (PDF) from lawyers in Texas who are demanding an immediate Class I recall for all counterfeit implants. Lawyer say the implants contain high levels of toxic selenium. They also say FDA must approve any change in materials.
This is not the first time counterfeit materials have been used in surgical mesh. In June 2010, the FDA issued a Class I recall for products that were falsely labeled as C. R. Bard/Davol mesh and sold from October 2008-October 2009.
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