Johnson & Johnson and its subsidiary Ethicon, Inc. must pay almost $116.9 million in a multistate settlement for their deceptive marketing of transvaginal surgical mesh devices, according to a news release from Attorney General Tim Fox.
Montana will receive $1,460,022 under the settlement, which the Office of Consumer Protection will use for education, investigations, and enforcement of Montana’s consumer protection laws, the release said.
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.
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.
“Today’s announcement is the result of several years of negotiations, and we are pleased with not only the monetary award, but also with the transparency aspect of the settlement,” Fox said in the release.
“Johnson & Johnson will be required to train physicians on the risks associated with these surgical mesh devices, which ultimately means patients can make more informed decisions about what’s right for them. If the company fails to do so, Montana, along with other states, would have the ability to enforce our consent judgment,” he added.
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 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 District of Columbia. 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;
- 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; and
- Disclose that risks include revision surgeries, which may be necessary to treat complications. They must also disclose that revision surgeries may not resolve complications, and that revision surgeries are also associated with a risk of adverse reactions.