Boston Scientific Accused of Using Counterfeit Parts From China In Its Vaginal Mesh Implants

Boston Scientific Accused of Using Counterfeit Parts From China In Its Vaginal Mesh ImplantsA class action racketeering lawsuit against Boston Scientific, a leading manufacturer of vaginal mesh implants, accuses the company of smuggling counterfeit materials into the country from China to use in its medical devices.

The complaint claims that the company smuggled in 15 tons of resin from China after its FDA-approved supplier stopped selling resin to Boston Scientific. The complaint alleges that the resin was used to make vaginal mesh implants even though the resin was not tested or approved for use in this country. The complaint describes company executives conspiring to bribe Chinese officials to smuggle out the materials, and recounts discussions about splitting up shipments of the resin into smaller batches to avoid suspicion.

The plaintiffs believe that the resin was smuggled into the country between June of 2011 and the fall of 2012. The resin smuggled from China was tested against the resin approved for use by the FDA, and tests showed significant differences between the products. Nevertheless, the company is accused of using the resin anyway, and the plaintiffs believe that the company is still creating vaginal mesh implants using counterfeit materials. The complaint seeks an injunction to force Boston Scientific to stop the sale of the implants.

The vaginal mesh implants are meant to reinforce the walls of the vaginal canal in order to treat conditions like pelvic organ prolapse or urinary incontinence. The devices have been heavily scrutinized after thousands of women reported that the vaginal mesh implants eroded through the walls of the vagina, leaving them with constant pain, sexual dysfunction, and/or frequent bladder and urinary tract infections. Many women needed multiple surgeries to correct the problems caused by the devices.

In April 2015, Boston Scientific agreed to settle nearly 3,000 cases for $119 million. The company still has over 30,000 cases pending against it around the country. Boston Scientific is not the only company under fire. Other medical device manufacturers like Johnson & Johnson and Endo International are also facing thousands of lawsuits. In 2014, Endo International also agreed to pay $830 million to settle 20,000 claims relating to its vaginal mesh products.

While lawsuits over vaginal mesh implants are depressingly common, this class action case is the first to accuse Boston Scientific of criminal wrongdoing. If the lawsuit is successful and the plaintiffs can prove that Boston Scientific used counterfeit products, other plaintiffs’ cases could benefit tremendously.

If you or a loved one has suffered an injury or injustice, the experienced personal injury legal team at Roberts & Roberts is here to help with compassionate, aggressive representation. Please call 800-248-6000 or contact us for a free consultation.

Free Consultation

For a free, immediate attorney review of your case, contact us using the form below or call us at (903) 597-6000.

Contact Us
icon icon icon

From one former client:
"I am so happy to have chosen the best law firm around. The staff is amazing in handling your questions promptly. I hope I don't ever need them again, but if I do, there is no question I will be back. Thank y'all so much for helping me." - Heather N.