Pelvic Mesh Made of Counterfeit Material—Which Surprises No One, Really.
Following growing health concerns over the dangers of transvaginal mesh implants, a new lawsuit in a West Virginia federal court claims Boston Scientific, a manufacturer of the device, used unapproved, counterfeit material in its implants.
According to the complaint, the suit concerns an ingredient called resin. When the FDA-approved supplier of the substance stopped selling resin to Boston Scientific, the company switched to a manufacturer in China, then illegally smuggled the unvetted resin into the U.S. According to a statement from Mostyn law, the company “smuggle[d] 15 tons of the material from China without verifying or fully testing the contents.”
Boston Scientific released a statement, asserting that “patient safety is of the utmost importance, and we dedicate significant resources to deliver safe, high-quality products. We don’t believe the case has merit and intend to vigorously defend these claims.” Since then, the company has declined to make anymore comments.
This suit comes on the heels of tens of thousands of complaints about the dangers of transvaginal mesh implants, which are designed to support muscles and ligaments in women with weakened pelvic organs. In 2008, the FDA issued a warning about the possible complications of these commonly-placed devices, saying it had received numerous reports of pain, infection, bleeding, organ perforation, urinary problems, and other health concerns caused by mesh implants. The FDA has since upgraded the status of mesh implants, warning of serious complications associated with the device. Some of these complications require surgical removal of the implants, sending patients into hospitals and courtrooms alike.
To date, more than 70,000 civil lawsuits have been brought against manufacturers of transvaginal mesh devices, so many, that the cases are now consolidated under a massive class-action suit playing out in federal court. Boston Scientific is facing 30,000 cases relating to mesh implants, but if the allegations of counterfeit resin turn out to be true, these civil cases are only the beginning of the company’s legal troubles.