Product News and Recalls

Boston Scientific Faces Smuggling Accusations as Resin Supply Comes into Question

boston scientific to face smuggling allegationsA major class action vaginal mesh lawsuit was filed earlier this year in West Virginia against Boston Scientific, a worldwide manufacturer and marketer of medical devices based in Massachusetts. The suit alleges that the corporation knowingly used counterfeit ingredients in the production of its transvaginal mesh products, going so far as to illegally smuggle tons of counterfeit resin into the country from China when its legitimate supplier ended their relationship.

Transvaginal mesh devices are intended to help repair vaginal prolapsing once surgically inserted through a patient’s abdomen. Over time, however, numerous side effects associated with the use of transvaginal meshes have come to light; including pain, infection, sexual dysfunction, and organ perforation.

In all, some 15 tons of counterfeit Chinese resin was allegedly smuggled into the country for Boston Scientific’s manufacturing processes, starting approximately three and a half years ago. And, given the volume of resin smuggled and the lack of accurate record keeping as a result, it’s entirely possible that Boston Scientific is still using Chinese resin to manufacture transvaginal mesh devices today according to the attorney behind the recent suit.

The original FDA-approved resin manufacturer made a point of saying that their resin was not intended for use in patients requiring permanent implants. Whether Boston Scientific’s mesh marketing had anything to do with the termination of the relationship has not been stated.

Boston Scientific issued a statement saying 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.” If the allegations of smuggling untested, potentially sub-standard Chinese resin prove true, however, it becomes next to impossible to view such a statement as anything but an outright insult to the intelligence of the American consumer.

In all, Boston Scientific faces tens of thousands of transvaginal mesh related cases for a wide variety of reasons including faulty design and deceptive business practices. Many suits allege that the company failed to properly inform women of the risks associated with the use of such a device.

The West Virginia class action suit is seeking for nothing less than a halt to the production of Boston Scientific vaginal mesh devices so that no one else is injured and is forced to endure what those in the suit have endured. At the very least, it should shine a very bright light onto the production of a life-changing medical device; both in its design, function, marketing, and production.