Boston Scientific has agreed to pay $21.5 million to a group of 325 women who suffered side-effects of their medical device called transvaginal mesh.
According to Ontario Superior Court Justice Paul Perell, the proposed class-action settlement will get final approval in June. The share of money between the plaintiffs would depend on the severity of their medical issues.
The lead plaintiff in the class action and her husband sued Boston Scientific, claiming that the devices were defective and unsafe. The allegations also included that the mesh was negligently designed and sold and that recipients had to undergo intensive surgical interventions to reduce the side-effects.
Boston Scientific, the Canadian subsidiary of its Delaware-based parent, is the sole distributor of the company’s transvaginal mesh devices in Canada, which has been implanted in thousands of Canadian women.
Transvaginal mesh is a surgical net-like implant, manufactured by various companies such as Ethicon, C.R. Bard, American Medical Systems, Boston Scientific, Coloplast, Cook Medical, Neomedic. It is used in the form of a sling to treat stress urinary incontinence (SUI) and Pelvic organ prolapse (POP) in women since the 1990s. The insertion of this mesh or a bladder sling through the vagina is known as a transvaginal mesh. 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.
FDA began issuing warnings for complications in 2008 and 2011. The FDA focused its regulatory efforts on transvaginal mesh for POP, a procedure that the agency finds riskier. In 2016, it classified mesh for POP as a high-risk, Class III device. Then in April 2019, the Food and Drug Administration (FDA) ordered manufacturers to stop selling all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse. The agency said it did not find adequate evidence to assure that the probable benefits of these devices outweighed the probable risks.
