Medical device manufacturer C.R. Bard has agreed to pay $60 million to settle claims brought by attorneys general of 48 states and Washington, D.C., that the company deceived consumers by downplaying the serious and life-altering risks associated with its transvaginal mesh, Law360 reported.
“Women should be able to trust the health products they use are safe,” California Attorney General Xavier Becerra said in a statement. “Misleading patients and neglecting to disclose risks or side effects of medical products is dangerous, irresponsible, even deadly. Bard was caught engaging in these shameful practices and, for that, they now pay.”
Transvaginal mesh is a type of surgical device used to treat stress urinary incontinence and pelvic organ prolapse, a condition in which organs like the bladder prolapse outside the vagina. The devices have been linked to severe pelvic pain and organ perforation.
In January 2016, the Food and Drug Administration (FDA) strengthened its requirements for transvaginal mesh to address safety risks and reclassified the devices to Class III, its high-risk category. Later that year, Bard discontinued sales of its transvaginal mesh products.
On April 16, the FDA ordered all manufacturers of transvaginal mesh to stop selling and distributing the products immediately after finding that manufacturers whose products were currently on the market had not demonstrated reasonable assurance of safety and effectiveness for their devices.
The case against Bard was led by California AG Becerra. The lawsuit claimed that “thousands of women implanted with surgical mesh have suffered serious complications resulting from these devices.” The only states that didn’t participate in the case were Wyoming and Georgia.
Earlier this year, Johnson & Johnson’s Ethicon Inc. was ordered by a California judge to pay nearly $344 million in civil penalties for misleading consumers about the risks with its pelvic mesh implants.