August 17, 2016 — The Kentucky Attorney General has filed a lawsuit seeking millions of dollars in penalties on behalf of thousands of women who were injured by vaginal mesh.
Johnson & Johnson and Ethicon are accused of deceptively marketing vaginal mesh in violation of the Kentucky Consumer Protection Act.
Over 15,000 women in Kentucky received vaginal mesh implants from the company. Many complained they did not get enough information about the risks to make an informed decision about their health.
Attorney General Andy Beshear issued the following statement:
“The way this company clearly chose profits over people is outrageous. My office has talked to victims whose lives have been devastated by this company’s deceitful practices.”
The company is accused of deceptively marketing vaginal mesh and concealing risks like chronic pain, erosion, vaginal disfigurement, and the need for follow-up surgery.
The lawsuit cites an email from in 2005 in which the company’s medical director proposed the following warning:
“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.”
Johnson & Johnson failed to incorporate this information into any of its marketing materials. The company is accused of purposely concealing these risks from patients and their doctors.
Synthetic mesh has been used since the 1950s for hernia repairs. In the 1970s, gynecologists began trying it on women with incontinence and prolapse. The first vaginal mesh products were approved with few safety studies based on their “equivalence” to hernia mesh.
In women with complications like pain or erosion, researchers found that vaginal mesh caused a pro-inflammatory response that persisted for years after implantation, according to a study published in the American Journal of Obstetrics & Gynecology.
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