Phoenix, Arizona - Attorney General Mark Brnovich Friday announced that Ethicon, Inc. and its parent company Johnson & Johnson have agreed to pay $2.8 million to Arizona in penalties and reform how Ethicon markets and trains healthcare providers on its transvaginal surgical mesh devices and stop making inaccurate safety claims.
The settlement with the Arizona Attorney General’s Office is part of a $116.9 million settlement with 41 total States and the District of Columbia to resolve allegations that Ethicon deceptively promoted its transvaginal surgical mesh devices.
The lawsuit filed by the Arizona Attorney General’s Office alleges that Ethicon engaged in unfair and deceptive practices promoting its transvaginal surgical mesh devices by making misleading claims regarding the safety and efficacy of the devices. 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 lawsuit further alleges that the companies misrepresented or failed to adequately disclose the products’ possible side effects, including the risk of chronic pain and inflammation, mesh erosion, incontinence developing after surgery, scarring, and pain during sex. Additionally, the State alleged that the companies failed to disclose to healthcare providers and patients that complications likely were irreversible because the mesh was nearly impossible to remove after being implanted.
Pursuant to the Consent Judgment, Ethicon has agreed to reform how it markets and promotes transvaginal surgical mesh devices. Accordingly, the company must:
- Refrain from referring to the mesh as “FDA approved” when that is not the case.
- Refrain from representing in advertisements 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.
- Provide full disclosure of the device’s risks and accurate information on advertisement material, in addition to the product’s “information for use” package inserts.
Joining Arizona in this multistate settlement are Alabama, Alaska, 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 Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, and Wisconsin.
Assistant Attorney General Kaitlin Hollywood handled this case for Arizona.