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Boston Scientific reaches settlement over surgical mesh devices

Boston Scientific

(Reuters) — Boston Scientific Corp. agreed to pay $188.7 million to settle claims by most U.S. states that it deceptively marketed its surgical mesh devices to consumers.

The settlement with 47 states and Washington D.C. was announced Tuesday by several state attorneys general. Boston Scientific also agreed to describe more accurately to consumers the safety and risks of using mesh.

Johnson & Johnson and its Ethicon unit reached a similar $117 million multistate settlement over the devices in 2019, while Becton Dickinson and Co. and its CR Bard unit reached a $60 million accord last September.

The devices have also been the subject of widespread litigation by women against manufacturers. Lawyers for some of the plaintiffs have estimated that settlements between the industry and more than 100,000 women may reach $11 billion.

Pelvic mesh devices, also called transvaginal mesh devices, were intended to be implanted in the pelvic floor to treat the common conditions of stress urinary incontinence and pelvic organ prolapse, where organs shift from their normal positions.

The states accused Boston Scientific of concealing potential serious risks of using the devices, including chronic pain, urinary dysfunction and a new onset of incontinence.

“While Boston Scientific was putting income before the health of people in need of care, women were put in danger,” New York Attorney General Letitia James said in a statement.

Boston Scientific said the settlement was not an admission of misconduct or liability, and was in shareholders’ best interest. The payment is covered by the Marlborough, Massachusetts-based company’s existing reserves.

In April 2019, the U.S. Food and Drug Administration ordered Boston Scientific and the Danish company Coloplast A/S, the two remaining makers of transvaginal surgical mesh implants for pelvic order prolapse, to halt sales.

It said neither company demonstrated a reasonable assurance of safety and effectiveness for their devices.