Johnson & Johnson now being sued by 3 states over vaginal mesh implants

Kentucky has filed a lawsuit against Johnson & Johnson’s medical device unit, Ethicon, alleging it concealed and purposely misrepresented the risks involved in its surgical transvaginal mesh products to physicians and patients.

California and Washington filed similar lawsuits earlier this year, accusing the large company of conducting a deceptive marketing campaign for the synthetic fabric implants, marketed under the names TVT and Prolift, which are supposed to treat conditions like stress urinary incontinence and pelvic organ prolapse.  

Kentucky Attorney General Andy Beshear said more than 15,000 women in the state had transvaginal mesh implanted without being aware of the potential complications, including chronic pelvic pain, urinary dysfunction, painful sexual intercourse or total loss of sexual function.

“The way this company clearly chose profits over people is outrageous,” Beshear said. “My office has talked to victims whose lives have been devastated by this company’s deceitful practices. We may not be able to give them back the lives they once had, but my office will do everything we can to hold this company accountable.”

The lawsuit alleges J&J ignored the advice of its own medical directors to include stronger warnings about potential complications, and did the same when physicians complained. One pelvic surgeon is quoted as saying of a patient: “She will likely lose any coital function as her vaginal length is now 3 cm. ... This patient will have a permanently destroyed vagina.”

The damage goes beyond sexual complications, according to the suit, saying patients have become permanently disabled or unable to work with accommodations. Others have said they’ve undergone multiple corrective surgeries that don’t eliminate pain because the complications may be irreversible or the mesh can’t be fully removed.

“I had no quality of life,” said one August 2011 complaint, according to the suit. “My consultant likened the mesh removal as to ‘trying to remove chewing gum from hair.’ He had to shave the mesh from my urethra because it was so badly eroded.”

The lawsuit says J&J was aware of the complications, but marketed the mesh beginning in 1997 as a minimal risk surgical option, with the product’s brochures not mentioning many of the major complications the lawsuit lists.

Additionally, the suit alleges J&J told doctors the mesh was FDA approved when it had only been “cleared” under the far less rigorous 510(k) process.

In an emailed statement, company spokeswoman Samantha Lucas called the lawsuits “unjustified.”

“The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products,” Lucas said. “The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research.”

Beshear said the suit will be seeking “millions” in damages for violations of Kentucky law on deceptive marketing practices.