Boston Scientific, a U.S. medical device company, has been accused of disregarding patient safety by using counterfeit materials in the manufacturing of its already controversial vaginal mesh devices. A class action lawsuit, which was filed in West Virginia on Wednesday, claims that Boston Scientific conspired to defraud Food and Drug Administration (FDA) regulators by smuggling illegal Chinese resin into its facility to use in its medical mesh products. While the FDA previously approved a specific type of resin for use in mesh products, the administration has since banned the use of the substance in all implantable mesh devices. Due to the ban, a U.S. resin manufacturer stopped selling its products to Boston Scientific. However, instead of buying a new FDA-approved substance, Boston Scientific illegally imported more than 15 tons of potentially deadly Chinese resin. The latest class action lawsuit (which is one of several suits that implicate the company) was filed in an attempt to stop the sale of all Boston Scientific mesh devices. Vaginal mesh devices made with the counterfeit Chinese resin may have been implanted in over 10,000 patients, and Boston Scientific may still be using the counterfeit ingredient.
Vaginal Mesh Dangers
Vaginal mesh devices are commonly used to treat medical conditions, including bladder control problems and pelvic organ prolapse. Many women have reported severe medical complications resulting from the implantation of vaginal mesh devices. Medical data indicates these mesh devices can cause:- Miscarriages
- Tears, holes or lacerations in surrounding tissue
- Debilitating pain
- Urinary issues
- Internal bleeding
- Sexual discomfort
