Attorney General Lawrence Wasden announced Oct. 17 a multistate settlement with 40 other states and the District of Columbia requiring Johnson & Johnson and its subsidiary Ethicon, Inc. to pay nearly $116.9 million for their deceptive marketing of transvaginal surgical mesh devices.
Idaho’s portion of the settlement is $1.6 million. As required by state law, the money will be deposited into Idaho’s Consumer Protection Fund.
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.
“The companies did not properly disclose the risks associated with this material and, in the process, misled vulnerable patients,” Wasden said. “Together, attorneys general across the country teamed up to investigate the matter, reach a settlement and hold the companies accountable.”
Transvaginal surgical mesh is a synthetic material that is surgically implanted 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. Evidence shows the companies were aware of the possibility for serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted the devices.
In addition to the financial portion, the settlement also provides injunctive relief, requiring full disclosure of the device’s risks and accurate information on promotional material, and the product’s “information for use” package inserts.
The companies must:
n Refrain from referring to the mesh as “FDA approved” when that is not the case;
n Refrain from representing in promotions that risks associated with mesh can be eliminated with surgical experience or technique alone;
n Ensure that product training provided to medical professionals covers the risks associated with the mesh;
n 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);
n Disclose that mesh risks include: fistula formation, inflammation, as well as mesh extrusion, exposure and erosion into the vagina and other organs;
n Disclose risks of tissue contraction, pain with intercourse, loss of sexual function, urge incontinence, de novo incontinence, infection following transvaginal implantation and vaginal scarring; and
n 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.