On Tuesday, New York's Attorney General (AG) announced that Boston Scientific Corp. has agreed to resolve deceptive marketing claims over its pelvic mesh devices by paying $188.6 million to 47 states and the District of Columbia.
According to the announcement, New York will receive $6.3 million and the settlement comes after a multistate investigation, which affirmed that the company violated state consumer protection laws by claiming its mesh products safe.
The manufacturer denied any misconduct or liability and the payment will be covered by the Marlborough, Massachusetts-based company’s existing reserves.
Additionally, as a part of the settlement, the company has agreed to several marketing reforms, including revealing the complications in understandable terms in its marketing materials and refraining from representing that the risks of mesh can be eliminated or are common to other types of treatment for the same conditions.
In 2019, a similar multistate settlement was made by Johnson & Johnson (J&J) and its subsidiary Ethicon for $117 million, which was followed by another settlement of $60 million, last September, by Becton Dickinson and Co. and its C. R. Bard, Inc. unit.
Pelvic mesh devices, also called transvaginal mesh devices, are surgical net-like implants used in the form of a sling to treat stress urinary incontinence (SUI) and Pelvic organ prolapse (POP) in women. The Food and Drug Administration (FDA) approved the first surgical mesh specifically designed for SUI in 1996. Later, in 2004, the FDA approved the first surgical mesh specifically for use in POP.
Several lawsuits were filed by women against the manufacturers for covering serious risks associated with the devices, which include chronic pain, urinary dysfunction, and new onset of incontinence.
Around four million women have vaginal mesh implants, and more than 150,000 have alleged complications associated with it. There are in all 7 MDLs to handle Transvaginal Mesh Litigation, overseen by U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia for coordinated discovery and early bellwether trials.
