Did Boston Scientific Smuggle Pelvic Mesh from China?
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A new lawsuit accuses transvaginal mesh manufacturer Boston Scientific of smuggling counterfeit pelvic mesh materials from China. Boston Scientific is charged with intentionally defrauding and endangering women by secretly importing defective polypropylene resin that wasn’t approved by the FDA.
According to the suit, the FDA gave 510(k) approval to Boston Scientific’s pelvic mesh devices made with polypropylene resin pellets (known as “Marlex”) manufactured by Chevron Phillips Chemical Co. But in 2005 Chevron Phillips stopped selling Marlex to them, warning that polypropylene resin should not be used in any product “involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”
In 2011, running out of their supply of Marlex (the only mesh ingredient the FDA had approved), Boston Scientific embarked on a worldwide search for a replacement product. Their search led them to Chinese supplier EMAI Plastic Raw Materials Inc., a “known counterfeiter of plastic products,” in Guangzhou, China, which claimed to have Marlex manufactured by Chevron Phillips in storage. According to the suit, “EMAI had no paperwork documenting that the product was authentic Marlex.”
To avoid detection, the material was packaged into 500 separate bags and shipped by three ocean shipments on three different dates. The complaint charges that “The deception went to high levels within BSC. There is evidence that a BSC executive made separate and contradictory reports about the origin of the resin in order to clear Chinese Customs, and then U.S. Customs.” After being smuggled, the resin was processed at Boston Scientific subsidiaries around the world and marketed to the as many as 55,000 women per year who receive transvaginal mesh implants manufactured by Boston Scientific.
Filed as a RICO (Racketeering and Corrupt Organizations Act) action, the lawsuit seeks class action status for all women who have received Boston Scientific mesh since September 2012. In addition to Boston Scientific, the defendants include Chinese supplier EMAI Plastics Raw Materials Inc., and two Boston Scientific subsidiaries, Proxy Biomedical Limited of Galway, Ireland and Luxilon Industries NV of Belgium. The lawsuit was filed in federal court in West Virginia, where all federal lawsuits for defective mesh claims are consolidated.
Boston Scientific issued a statement denying the lawsuit’s claims.
Earlier this month, the FDA reclassified surgical mesh for Pelvic Organ Prolapse (POP) a “high-risk” medical device. The agency has received tens of thousands of complaints of side effects from transvaginal mesh implants, including bleeding, pain, infection, mesh contraction, mesh erosion, mesh protruding into the vagina, urinary problems, severe pelvic pain, vaginal tightening or shortening, additional surgeries, painful sexual intercourse, inability to engage in sexual intercourse, or organ perforation. More than 70,000 lawsuits have been filed by women who have suffered complications after receiving pelvic mesh implants.
Women who have been injured by a defective transvaginal mesh implant can contact the transvaginal mesh lawyers at Thornton Law Firm for a free, no-obligation consultation. You can tell us your story online or call Attorney Marilyn McGoldrick at 888-341-1405 for a confidential evaluation of your legal case. Time limits for filing claims are short, so don’t delay seeking legal advice.