Forty-seven U.S. states plus the District of Columbia will collectively receive nearly $189 million from Boston Scientific, to resolve claims that it used deceptive marketing practices for its transvaginal surgical mesh devices, reports MassDevice.com, which calls the devices “one of the medical device industry’s worst failures so far in the 21st century.”
There have been thousands of claims filed against pelvic mesh makers since the device was cleared by the FDA roughly two decades ago. Plaintiffs allege that the device, which was designed to support weakened pelvic muscles and connective tissue, caused them to develop pain, excessive bleeding and loss of sexual function.
In 2019, because of the widespread problems associated with pelvic mesh, the FDA ordered that the devices stopped being sold. Boston Scientific was one of the last two remaining manufacturers of the device. (Coloplast was the other.)
Attorneys General of several states accused Boston Scientific of “failing to disclose the full range of potentially serious and irreversible complications caused by mesh.”
MassDevice.com reports that in addition to the settlement money, “the company has agreed to marketing, training and clinical studies reforms when it comes to mesh.”
In an email statement, a spokesperson from Boston Scientific said that the settlement was not an admission of liability or misconduct, and that the company agreed to the settlement because it was in their best interest and that of their shareholders. “We are pleased to resolve this dispute and to continue focusing on delivering innovative products and solutions to physicians and patients,” the statement, shared with MassDevice.com, reads.
Only the states of Maryland, Florida and Indiana were not involved with the settlement. California and Washington were the lead states in the investigation that led to the settlement with Boston Scientific, which accumulated $608 million dollars in litigation related-charges over the last two full years, per MassDevice.com. The bulk of those claims were related to transvaginal mesh devices.