An investigation by 42 attorneys general found the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the mesh and failing to disclose the risks of their use.
“Health and safety must come before profits,” New York Attorney General Letitia James said. “While Johnson & Johnson and its subsidiary were putting income before the health of people in need of care, women were put in danger.”
Transvaginal surgical mesh is a synthetic material that is surgically implanted through the vagina to support the pelvic organs of women who suffer from stress urinary incontinence or pelvic organ prolapse.
The investigation found the companies didn’t disclose the products’ possible side effects, including the risk of chronic pain and inflammation, the mesh protruding from the opening of the vagina, incontinence developing after surgery, painful sexual relations, and vaginal scarring. Evidence shows that Johnson & Johnson and its subsidiary were aware of the possibility for serious medical complications but didn’t provide sufficient warnings to consumers or surgeons who implanted the devices, according to the investigation.
Under the settlement, Johnson & Johnson has agreed to pay $116.86 million to 41 states and the District of Columbia.
The settlement also requires disclosure of the device’s risks and accurate information on promotional material, in addition to the product’s “information for use” package inserts. The companies are required to:
- Stop referring to the mesh as “FDA approved,” when that isn’t the case.
- Stop 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.
- Stop claiming: that surgical mesh stretches or remains soft after its put in, that foreign body reactions are temporary, and that foreign body reactions “may” occur, when studies show that they do occur.
- Disclose that mesh risks include: fistula (an abnormal connection between two organs) formation and inflammation, as well as mesh moving into the vagina and other organs.
- Disclose risks of: tissue contraction, pain with intercourse, loss of sexual function, urge incontinence, new incontinence, infection following transvaginal implantation, and vaginal scarring.
- Disclose that risks include that revision surgeries: may be necessary to treat complications, may not resolve complications, and are also associated with a risk of adverse reactions.
On April 16, the U.S. Food and Drug Administration banned the sale of pelvic mesh to treat organ prolapse. Johnson & Johnson stopped selling pelvic mesh to treat it in 2012, but the company and other manufacturers continue to sell similar products to treat urinary incontinence in women.
Participating in the investigation and settlement are attorneys general of Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, North Carolina, North Dakota, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Wisconsin, and the District of Columbia.