TRENTON, N.J. (AP/WILX) -- Johnson & Johnson has agreed to pay $117 million multi-state settlement over allegations it deceptively marketed its pelvic mesh products, which support women's sagging pelvic organs.
Michigan Attorney General Dana Nessel announced a multi-state settlement that requires Johnson & Johnson and its subsidiary Ethicon, Inc. to pay the state of Michigan $3,269,523 million, according to Nessel's office.
“It is essential that companies that provide medical devices live up to their obligation to provide accurate and up-to-date information to both doctors and patients,” said Nessel. “This settlement will help ensure doctors are provided with better information for use when caring for their patients.”
Ohio's attorney general said an investigation found J&J, the world's biggest health products maker, violated state consumer protection laws by not fully disclosing the devices' risks.
Numerous women who had the once-popular, hammock-like devices implanted claim they caused severe pain, bleeding and infections.
The settlement, which covers 41 states and the District of Columbia, requires the company to fully disclose risks and stop making inaccurate safety claims.
It comes as J&J is swamped with thousands of lawsuits claiming patients were harmed by products including baby powder, opioid painkillers and prescription drugs.
J&J said that the settlement doesn't include admission of any misconduct.
According to Nessel's office, under the companies must also:
• Refrain from referring to the mesh as “FDA approved” when that is not the case;
• Refrain from representing in promotions that risks associated with mesh can be eliminated with surgical experience or technique alone;
• Ensure that product training provided to medical professionals covers the risks associated with the mesh;
• Omit claims that surgical mesh stretches after implantation, that it remains soft after implantation, that foreign body reactions are transient and that foreign body reactions “may” occur (when in fact they will occur);
• Disclose that mesh risks include: fistula formation, inflammation, as well as mesh extrusion, exposure and erosion into the vagina and other organs;
• Disclose risks of tissue contraction, pain with intercourse, loss of sexual function, urge incontinence, de novo incontinence, infection following trans-vaginal implantation and vaginal scarring; and
• Disclose that risks include that revision surgeries may be necessary to treat complications, that revision surgeries may not resolve complications, and that revision surgeries are also associated with a risk of adverse reactions.
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