Update: The third-to-last paragraph was added to include a statement from Ethicon spokesperson Samantha Lucas.
Attorney General Andy Beshear filed a lawsuit this week in Franklin Circuit Court in Kentucky against Johnson & Johnson and its medical device unit Ethicon. The suit claims deceptive marking of surgical transvaginal mesh under the Kentucky Consumer Protection Act.
According to the suit, the synthetic woven fabric--which is implanted through the vagina to treat pelvic floor conditions--was used to treat more than 15,000 women in Kentucky. However, Johnson & Johnson and Ethicon did not provide sufficient information on the hazards and risks associated with the mesh, which is necessary for women and their healthcare providers to make the most informed decision. Recommendations were made by Johnson & Johnson’s own staff to include more complete disclosures, which were ignored by the company, Beshear said.
According to the suit, this warning came first in 2005 through an email from Johnson & Johnson’s medical director asking for stronger disclosures on the product. “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.
“The way this company clearly chose profits over people is outrageous,” Beshear said in the announcement. “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.”
In 2006 an additional medical director made note of post-operative patients who were concerned that they had not, prior to surgery, been given adequate information regarding possible complications.
Beshear said in the suit that not only did the company fail to incorporate any of this information in its marketing, the company purposely concealed and misrepresented to doctors and patients many risks and complications that could come along with the device. Those risks include chronic pelvic pain, urinary and/or defacatory dysfunction, pain with sexual intercourse or total loss of sexual function.
In addition, Johnson & Johnson allegedly told doctors the products were FDA approved, while they were only FDA cleared.
Samantha Lucas, a spokesperson for Ethicon, shared the following statement with FierceMedicalDevices: "The lawsuit against Ethicon and Johnson & Johnson is unjustified, and the company plans to vigorously defend itself against the allegations. The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products. 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."
This is far from the first time Johnson & Johnson has had problems with the marketing of their vaginal mesh products. Just this past May, the states of Washington and California filed suits against the device maker for similar reasons.
"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,” said Washington State Attorney General Bob Ferguson at a conference. “These women were robbed of their ability to live and work in the way they once did."
- here’s the announcement