Boston Scientific (NYSE:BSX) has agreed to pay $188.6 million to 47 states and the District of Columbia to resolve claims that it deceptively marketed transvaginal surgical mesh devices, state AGs announced today.
Pelvic mesh products have been one of the medical device industry’s worst failures so far in the 21st century. First cleared nearly two decades ago, pelvic mesh products were meant to treat the weakening of the muscles and ligaments supporting a woman’s pelvic organs. But they became the subject of thousands of lawsuits and millions of dollars in settlements as women reported pain, excessive bleeding and loss of sexual function.
Boston Scientific and Coloplast were the final two companies to sell the devices. FDA ordered a halt to pelvic mesh sales in 2019.
The multistate complaint against Boston Scientific claimed that it failed to disclose the full range of potentially serious and irreversible complications caused by mesh. On top of paying the money, the company has agreed to marketing, training and clinical studies reforms when it comes to mesh.
Boston Scientific said in a statement shared with MassDevice that the settlement, which is not an admission of misconduct or liability, was in the best interests of the company and its shareholders. “We are pleased to resolve this dispute and to continue focusing on delivering innovative products and solutions to physicians and patients.”
The states of California and Washington led the investigation that resulted in the settlement. Other states involved include Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, Wisconsin, and the District of Columbia.
Boston Scientific logged $330 million and $278 million in litigation-related charges in 2019 and 2020 respectively, with most of the changes related to transvaginal mesh products, according to the company’s recent annual reports.