Boston Scientific has agreed to pay $188.7m to settle claims made by most US states that it misled consumers on the risks of using its surgical mesh devices by deceptive marketing.
Pelvic mesh devices, which are also called transvaginal mesh devices, are intended for implantation in the pelvic floor.
They are meant for treatment of the common conditions of stress urinary incontinence and pelvic organ prolapse, where organs move from their normal positions.
Boston Scientific was accused by the states of hiding possible serious risks, such as chronic pain, urinary dysfunction and new onset of incontinence, by using the devices.
Several state attorney-generals announced the settlement with 47 states and Washington, District of Columbia, Reuters reported.
Furthermore, Boston Scientific agreed to provide a more accurate description to customers on the safety and risks of mesh usage.
The news agency quoted New York Attorney-General Letitia James as saying in a statement: “While Boston Scientific was putting income before the health of people in need of care, women were put in danger.”
The payment will be covered by Boston Scientific’s existing reserves. The company noted that the settlement was not an admission of misconduct or liability but in the best interest of shareholders.
In April 2019, the US Food and Drug Administration ordered the company and Coloplast to stop marketing transvaginal surgical mesh implants for pelvic order prolapse.
Earlier this month, the Federal Court of Australia dismissed Johnson & Johnson’s (J&J) appeal against a ruling that its subsidiary Ethicon misled patients and surgeons on the risks related to its pelvic mesh implants.
The full bench of the court upheld a decision given in November 2019 by a federal court judge that J&J and its Ethicon unit had to pay $117m in a multistate settlement over the devices.
Last September, Becton Dickinson reached a $60m accord to settle multistate litigation alleging that its subsidiary company C R Bard deceptively marketed transvaginal surgical mesh to patients and practitioners.