Scientific Schemed to Make Counterfeit Materials For Transvaginal Mesh Investigation. According to Mass Device, a grand jury has been impaneled in a case alleging Boston Scientific schemed to produce counterfeit materials for its pelvic mesh products.
The federal government and the U.S. Food and Drug Administration (FDA) are both probing allegations that the company used counterfeit resin in its Advantage mesh used in all its transvaginal mesh products.
Reportedly, the grand jury has already sent subpoenas for documents related to the purchase of the resin. The purported class-action racketeering lawsuit was filed in the U.S. District Court for Southern West Virginia.
“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,” sources told the Boston Globe. Boston Scientific denies the allegations.
Boston Scientific Plotted Subsidiaries To Use Not Supposed to Be Implanted in Humans
According to the lawsuit, Boston Scientific allegedly plotted with subsidiaries in Ireland and Belgium to use counterfeit resin in their Advantage mesh after its original supplier refused to supply the product, stating it is not supposed to be implanted in humans. Attorneys for the plaintiff petitioned the FDA to ban Boston Scientific transvaginal mesh products containing the allegedly counterfeit resin.
The FDA approved transvaginal mesh implants to treat pelvic organ prolapse and stress urinary incontinence, conditions that stem from sagging organs and weakening pelvic muscles. However, thousands of lawsuits allege that the devices caused serious injuries, including mesh erosion.
The FDA has said more testing is needed to determine whether the mesh made from allegedly counterfeit material is equivalent to the mesh with the original resin.