TRENTON, N.J. — Johnson & Johnson has agreed to a $117 million multistate settlement over allegations it deceptively marketed its pelvic mesh products, which support women’s sagging pelvic organs.
Ohio’s attorney general said Thursday an investigation found that 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, infections and other complications.
Johnson & Johnson and its Ethicon surgical products unit reached the settlement with 41 states and the District of Columbia.
“These companies didn’t paint a clear picture of the device’s medical risks, preventing patients from making well-informed decisions,” Ohio Attorney General Dave Yost said in a statement.
The products, also called transvaginal mesh, are a synthetic material surgically implanted through the vagina of women whose pelvic organs have sagged or who suffer from stress urinary incontinence — bladder leakage when they cough, sneeze or lift heavy objects.
Such incontinence is estimated to affect 3 percent to 17 percent of women and sometimes becomes severe after age 70.
Some of the products are still on the U.S. market, and hundreds of thousands of women have had the devices surgically implanted, according to Yost’s office.
An Ethicon spokeswoman noted the settlement doesn’t include admission of any misconduct, and said the devices “are considered by many to be the gold standard for the treatment of stress urinary incontinence.”
“Ethicon has acted appropriately and responsibly in the research, development and marketing of our transvaginal mesh products,” which were launched around the world in 1998, she added.
About 25,000 U.S. women with complications have sued Johnson & Johnson, the company said. Those lawsuits aren’t affected by the settlement.
