Friday, 29 March, 2024
HomeMedico-LegalBoston Scientific settles claims over deceptive surgical mesh marketing

Boston Scientific settles claims over deceptive surgical mesh marketing

Boston Scientific Corporation has agreed to pay $188.7m to settle claims by most US states that it deceptively marketed its surgical mesh devices to consumers, reports Reuters. The settlement with 47 states and Washington DC was announced 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 $117m multi-state settlement over the devices in 2019, while Becton Dickinson and Co and its CR Bard unit reached a $60m accord last September.

Reuters reports that 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 $11bn.

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 is quoted in the Reuters report as saying.

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 US 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.

 

Full Reuters report (Open access)

 

 

 

See also MedicalBrief archives:

J&J: Australia court awards damages for faulty pelvic mesh implants

Many more mesh sling insertions should be reversed

Mesh surgery exposed UK women to ‘unacceptable risk’

UK launches review into NHS treatment and medical device scandals

UK safety review damns interventions that ruined women’s lives

Implant investigation shows costs of poor regulation and testing

Mandatory clinical trials needed for implanted medical devices — Oxford study

SA specialists argue for bladder sling surgery despite NICE ban recommendation

Scottish courts prepare for legal wave

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