The settlement includes 47 states and the District of Columbia. Thousands of lawsuits claimed Boston Scientific deceptively marketed its transvaginal surgical mesh devices to women by failing to disclose the full range of potentially serious and irreversible complications caused by surgical mesh.
Surgical mesh is used to treat conditions in women such as stress urinary incontinence and pelvic organ prolapse. The use of surgical mesh involves the risk of serious complications and hasn’t been proven to be more effective than traditional tissue repair, according to a news release from the attorney general’s office. Thousands of women are alleged to have suffered serious injuries from the devices.
Under the settlement, Boston Scientific is also required to complete a number of marketing, training and clinical trial reforms.
Since 2018, the devicemaker has faced more than 48,000 lawsuits related to its surgical mesh. The FDA ordered the company to pull the products from the market after determining Boston Scientific hadn’t demonstrated the safety and efficacy of the devices.
Read the full news release here.
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