Boston Scientific Pays $189M To Resolve Pelvic Mesh Cases
The settlement puts to rest product liability and patient safety suits in 47 states and the District of Columbia.
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The US FDA says final data from two Boston Scientific postmarket studies have reinforced the agency’s position that the company’s transvaginal mesh to treat pelvic organ prolapse (POP) has a poor benefit-risk profile. The firm’s mesh has been off the US market since 2019.
Johnson & Johnson and subsidiary Ethicon will pay $117m to settle state lawsuits alleging that their marketing misrepresented the safety and risks of transvaginal mesh devices.
FDA Yanks Transvaginal Mesh From US Market; Boston Sci 'Surprised'; Firms Have 10 Days To Submit Withdraw Plan
Transvaginal mesh products made by Boston Scientific and Coloplast were ordered pulled from US shelves by the agency on Aug. 16. Under the rare FDA order, the two firms must immediately stop selling the mesh and have 10 days to submit plans to the agency outlining how they will recall their unimplanted devices.