Johnson & Johnson and its medical unit Ethicon are once again facing allegations of deceptive marketing over its transvaginal mesh. Kentucky Attorney General Andy Beshear filed a lawsuit in Franklin Circuit Court under the Kentucky Consumer Protection Act, alleging the company ignored warnings from its medical staff and obscured data from patients and their doctors.
Transvaginal mesh is used to treat stress urinary incontinence and pelvic organ prolapse, conditions caused by the weakening of pelvic walls and muscles. Pelvic mesh is supposed to treat these conditions by providing additional strength to the pelvic walls.
The lawsuit alleges that more than 15,000 women in Kentucky were implanted with the device without adequate warning from J&J. The company is accused of failing to disclose all the available information, preventing women and their physicians from making an informed decision.
The suit alleges that J&J first gained knowledge of the risks in 2005, when the company’s medical director wrote an email calling for stronger warnings. “WARNING: Early clinical experience has shown that the use of mesh through a vaginal approach can occasionally/uncommonly lead to complications such as vaginal erosion and retraction which can result in an anatomical distortion of the vaginal cavity that can interfere with sexual intercourse,” the email read.
Furthermore, the suit states, Johnson & Johnson received information from another medical director in 2006 who noted that patients were worried they were not fully informed of the risks after the procedure.
The Kentucky AG alleges in the suit that J&J not only omitted this information in its marketing, the company also allegedly hid information and misled doctors and patients about the risks. Complications associated with transvaginal mesh include chronic pelvic pain, urinary and/or defacatory dysfunction, painful intercourse and loss of sexual function.
“The way this company clearly chose profits over people is outrageous,” said Beshear, according to WKYT. “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.”
Erosion is when the mesh goes through the soft tissues and becomes embedded in the body. Erosion can lead to severe pain and exposure, also known as extrusion of protrusion, meaning the device is externally visible. Some women allege the need to undergo multiple surgeries for erosion without complete success.
“For many victims, their health and their quality of life were forever changed as a result of this deception. Sitting upright, lying on their side, walking all became incredibly painful,” Washington State Attorney General Bob Ferguson said at a conference. “These women were robbed of their ability to live and work in the way they once did.”