SAN DIEGO (CN) — Stepping in after more than 1,500 civil lawsuits, California’s attorney general sued Johnson & Johnson and Ethicon on Tuesday, claiming they sold pelvic mesh implants knowing that the devices lead to severe complications and injuries in women.
The attorney general cites one woman’s story, from 2008, as “illustrative of the toll that surgical mesh has taken on people’s lives.”
“The pelvic pain was keeping me awake at night, and the only relief was to sit on a tennis ball. The thought of living like that, sitting on a ball, wearing a diaper, splinting my perineum to have a bowel movement, having infrequent miserable sex, and marital problems was almost more than I could bear.”
Pelvic mesh implants are used to treat pelvic floor conditions such as stress urinary incontinence and pelvic organ prolapse. Stress urinary incontinence occurs when muscles that control urine flow are weakened or damaged, causing unintended leakage, especially when laughing, coughing or exercising. Pelvic organ prolapse occurs when muscles of the pelvic floor cannot support pelvic organs, causing them to drop down or even bulge out the vagina, according to the Mayo Clinic.
Johnson & Johnson manufactures medical devices to treat the conditions. The devices are made with polypropylene threads derived from crude oil — chemicals used in a tremendous number of products, from rugs to car parts.
Women who get the implants have reported a variety of complications, ranging from sexual dysfunction to permanent disfigurement. The Courthouse News database contains more than 1,500 civil lawsuits involving the devices.
“Complications associated with the use of synthetic mesh in transvaginal repair include the following: erosion, exposure and intrusion …; a chronic foreign body response to the mesh and resulting chronic inflammation; bacterial colonization of mesh and mesh infections; and mesh contracture or shrinkage inside the body,” Attorney General Kamala Harris says in the May 24 lawsuit in Superior Court. “These mesh-related complications can lead to further problems for women, including severe, chronic pain, permanent dyspareunia and sexual, urinary and defecatory dysfunction. The risk of these mesh-related complications is lifelong; mesh complications can arise years – or even decades – after insertion.”
Complete mesh removal is difficult and in many cases impossible. The complaint compares it to trying to get gum out of hair or “trying to remove rebar from concrete without damaging the overall structure.”
There are non-surgical options to treat the conditions, including mesh devices and non-mesh surgical alternatives that “do not pose the same risks that surgical mesh does,” the attorney general says.
She says Johnson & Johnson marketed though it knew of the risks, and touted them as “FDA approved,” though the Food and Drug Administration had only “cleared” the product, meaning the devices “need only demonstrate that they are ‘substantially equivalent’ to a device already on the market.”
FDA “approval,” however, requires “rigorous” evaluation, involving about 1,200 hours of intense FDA review.
“Johnson & Johnson made these misrepresentations understanding that the ‘FDA approved’ designation leads doctors and patients to believe that a medical product has been well studied and scrutinized,” the complaint states.
The state also claims that Johnson & Johnson hid the risks and complications associated with the devices, “which would have been material information in considering treatment options.”
“Johnson and Johnson deceptively marketed its surgical mesh devices as safe with minimal risk when in fact these devices exposed women to a host of dangerous complications,” the complaint states. “By concealing this information, Johnson & Johnson took away doctors’ ability to accurately counsel patients and women’s ability to make informed choices about whether or not to have this risky device permanently implanted in their bodies.”
Deputy Attorney General Jinsook Ohta could not be reached for comment after hours Wednesday.
An Ethicon spokeswoman called the lawsuit “unjustified.”
“The decision by the attorneys general to file suit against Ethicon and Johnson & Johnson is unjustified, and the company plans to vigorously defend itself against the allegations,” Ethicon’s Samantha Lucas said in an email. “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.”
Lucas said the mesh slings are “the worldwide standard of care for surgical treatment of stress urinary incontinence,” and noted that the American Urogynecologic Society has said “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.”
She added, “Ethicon is concerned that the attorneys general’s decision to file its lawsuit will keep women from obtaining treatment for the often-debilitating symptoms of stress urinary incontinence.”
The state seeks an injunction, damages for unfair competition and false advertising, and civil penalties of $2,500 against each defendant for each violation of California’s Business and Professions Code 17200 and 17500, and another $2,500 against each defendant for each violation of section 17200 “perpetrated against a senior citizen or disabled person.”
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