Update: Response from Samantha Lucas, spokesperson for Ethicon
Kentucky Attorney General Andy Beshear is suing Johnson and Johnson alleging deceptive marketing of a surgical mesh for women.
Beshear said Tuesday the company and its medical device unit Ethicon failed to provide sufficient information about risks associated with transvaginal mesh.
The lawsuit seeks ‘millions of dollars’ in civil penalties. According to Drugwatch.com, transvaginal mesh is an implanted synthetic woven fabric used to treat pelvic organ prolapse and stress urinary incontinence that can occur after a hysterectomy, menopause or childbirth. The product can cause serious complications like erosion and organ perforation.
According to the lawsuit, more than 15,000 women in Kentucky had the transvaginal mesh implanted. Beshear said Johnson & Johnson failed to follow recommendations by staff to include more disclosures, citing an email by the company’s medical director proposing stronger warnings for doctors and patients.
The lawsuit does not seek restitution for individuals. Beshear asks women not already represented to contact his office at 502-696-5389.
The suit was filed in the Franklin Circuit Court.
Nearly 70,000 lawsuits have been filed by women injured by the mesh.
Update with Response from Ethicon:
“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. Synthetic midurethral slings are the worldwide standard of care for surgical treatment of stress urinary incontinence. The American Urogynecologic Society (AUGS), the nation's leading association of urogynecology doctors, in a statement supported by six other leading medical associations, has noted that ‘the polypropylene midurethral sling has helped millions of women with [stress urinary incontinence] regain control of their lives by undergoing a simple outpatient procedure that allows them to return to daily life very quickly.’ Ethicon is concerned that this lawsuit will keep women from obtaining treatment for the often-debilitating symptoms of stress urinary incontinence. “ – Samantha Lucas, spokesperson for Ethicon
