January 15, 2016 — Boston Scientific has been accused of illegally smuggling resin from China to make vaginal mesh in a scheme likened to a “drug deal” by attorneys who filed a class action racketeering lawsuit.
Boston Scientific was using Marlex polypropylene resin for the Advantage Fit and Lynx vaginal mesh products, which generated $120 million in annual sales, according to the lawsuit.
Problems began in 2005, when the supplier stopped selling Marlex resin to Boston Scientific. The supplier warned that it was not compatible with human tissue and should not be used in permanent implants.
According to MassDevice, the lawsuit alleges that Boston Scientific “smuggle[d] 15 tons of the material from China without verifying or fully testing the contents. … Interestingly, Boston Scientific appears to have approached this problem like a drug deal.”
Boston Scientific allegedly purchased 34,000 pounds of resin from a Chinese supplier and used counterfeit labels to avoid customs. The purchase was split into five separate shipments and processed through Belgium and Ireland before shipment into the United States.
The plaintiff, Teresa Stevens, says Boston Scientific “concocted a scheme” to import counterfeit products and defraud regulators, CNN Money reports.
The goal of the lawsuit is an injunction that would stop sales of Boston Scientific’s vaginal mesh products. Plaintiffs are also seeking class action status on behalf of potentially thousands of women who received the implants.
The lawsuit was filed in West Virginia federal court, where Boston Scientific is facing a consolidated litigation involving nearly 20,000 women who were injured by vaginal mesh. All of the lawsuits accuse the device-maker of selling an unreasonably dangerous device and failing to warn about severe complications.
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