RALEIGH, N.C. (WNCT) Attorney General Josh Stein announced a $116.9 million multistate settlement with Johnson & Johnson and its subsidiary Ethicon Inc. over its deceptive marketing of transvaginal mesh devices.
North Carolina will receive $3,348,052.63.
A multistate investigation among 41 states and the District of Columbia found the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and failing to sufficiently disclose associated risks.
“Doctors and patients need to be able to make medical decisions based on accurate, honest information,” said Attorney General Josh Stein. Johnson & Johnson and Ethicon knew that these devices could harm patients and they still didn’t warn people or their doctors. Companies cannot prioritize their own profits over people’s health and well-being, and my office will hold them accountable when they do.”
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 multistate investigation found the companies misrepresented or failed to adequately disclose the products’ possible side effects, including the risk of chronic pain and inflammation, mesh erosion through the vagina, incontinence developing after surgery, painful sexual relations, and vaginal scarring.
Evidence shows the companies were aware of the possibility of serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted the devices.
The settlement also requires Johnson & Johnson and Ethicon to:
- 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 transvaginal implantation, and vaginal scarring.
- 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
Attorney General Stein is joined in this settlement by the Attorneys General of Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, and Wisconsin.
“The settlements announced today with State Attorneys General resolve a previously disclosed multi-state investigation of Ethicon’s sales and marketing practices for transvaginal mesh in the United States. This settlement with 41 states and the District of Columbia involves no admission of liability or misconduct on the part of Ethicon, which remains focused on meeting the significant surgical care needs of health care providers and patients,” said Ethicon.
A copy of the consent judgment is available here.