The settlement with 47 states and Washington, D.C. was announced on
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.
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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.
(Reporting by Jonathan Stempel in New York;
Editing by Dan Grebler and Marguerita Choy)
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