A grand jury has reportedly been selected to weigh allegations that Boston Scientific used counterfeit resin to manufacture its pelvic mesh products, Mass Device reports. The allegations stem from a purported class-action racketeering lawsuit filed in the U.S. District Court for Southern West Virginia. The federal government is probing the accusations.
West Virginia is the location of the transvaginal mesh multidistrict litigation, in which thousands of plaintiffs allege the pelvic inserts caused severe pain and other injuries. Pelvic mesh implants are approved to treat stress urinary incontinence and pelvic organ prolapse. They are intended to provide support to sagging organs and muscle walls, but there has been some controversy about their safety. Some women allege that the mesh eroded through the vagina and became embedded, leading to a host of complications.
In the reported racketeering lawsuit, the plaintiff alleges Boston Scientific plotted with subsidiaries in Ireland and Belgium to use counterfeit resin in their Advantage mesh, used in all pelvic mesh products. According to the lawsuit, the company devised this plan because the original supplier allegedly refused to supply the mesh after learning that it is not supposed to be implanted in humans. Attorneys for the plaintiff petitioned the U.S. Food and Drug Administration (FDA) to ban Boston Scientific transvaginal mesh products containing the allegedly counterfeit resin.
The FDA is also investigating the allegations. Earlier this month, the agency said more testing was needed to determine if the mesh made from allegedly counterfeit material is the same as the mesh with the original resin.
Two sources told The Boston Globe that the grand jury has already sent out several subpoenas seeking documents involving the resin purchase. “Among other things, 1 of the people said, investigators are examining whether the Marlborough medical device company engaged in deceptive trade practices by knowingly receiving substandard resins from China in packaging from a vendor whose materials had been approved by federal regulators, and whether it fraudulently sold defective products to health care providers,” Boston Globe reports. Boston Scientific denies the allegations.