Consumers Misled About Safety, Effectiveness, and Potential Risks of Transvaginal Mesh Devices
New York Attorney General Letitia James today announced a multistate settlement, along with 41 additional attorneys general, requiring Johnson & Johnson and its subsidiary Ethicon, Inc. to pay nearly $117 million for the deceptive marketing of transvaginal surgical mesh devices that endangered the health of women across New York and the rest of the nation. A multistate investigation found the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and failing to sufficiently disclose risks associated with their use.
“Health and safety must come before profits,” Attorney General 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. My office will never waver in its efforts to hold companies accountable for risking the health of its consumers.”
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 that Johnson & Johnson and its subsidiary were aware of the possibility for serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted the devices.
Under the settlement, Johnson & Johnson has agreed to pay $116.86 million to the 41 participating states and the District of Columbia. New York State will receive $5,203,122.50 under the settlement.
The settlement also provides injunctive relief, requiring full disclosure of the device’s risks and accurate information on promotional material, in addition to the product’s “information for use” package inserts.
Among the specific requirements, the companies must:
- 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.
- Stop claiming: that surgical mesh stretches or remains soft after implantation, that foreign body reactions are temporary, and that foreign body reactions “may” occur, when studies show that they do, in fact, occur.
- Disclose that mesh risks include: fistula formation and 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, may not resolve complications, and are also associated with a risk of adverse reactions.
Joining Attorney General James in this multistate settlement are the 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, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Wisconsin, and the District of Columbia.