California Attorney General Sues Johnson & Johnson Over Transvaginal Mesh

The complaints allege J&J “neglected to inform both patients and doctors of possible severe complications and misrepresented the frequency and severity of risks” from surgical mesh.

Attorney General Kamala Harris and Washington State Attorney General Bob Ferguson filed two separate consumer lawsuits against Johnson & Johnson. The complaints allege J&J “neglected to inform both patients and doctors of possible severe complications and misrepresented the frequency and severity of risks” from surgical mesh.

The mesh, also known as transvaginal mesh or pelvic sling, is commonly used to treat women for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The lawsuit alleges that J&J misrepresented the safety of these devices by concealing the possibility of serious and irreversible complications caused by mesh, including permanent pain with intercourse and/or loss of sexual function, chronic pain, permanent urinary or defecatory dysfunction, and potentially devastating impact on overall quality of life.

As the NBC Bay Area Investigative Unit reported in February, more than 3,000 women have filed complaints with the Food and Drug Administration about serious health concerns related to mesh.

“Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products,” Attorney General Harris said. “Johnson & Johnson’s deception denied women the ability to make informed decisions about their health and well-being. My office will continue to hold companies accountable for misleading consumers and patients for financial gain.”

California co-led a multistate investigation that included 45 other states and the District of Columbia. The investigation looked into J&J’s surgical mesh products for women. The lawsuit seeks injunctive relief and monetary penalties.

The suit claims J&J misrepresented the severity and frequency of common complications, and that “J&J knew about potential risks and side effects prior to the launch of their mesh products, yet omitted that information from educational and marketing materials provided to doctors and patients.”

According to Harris’ office, J&J sold 787,232 devices nationally from 2008 to 2014, including more than 42,000 in California for that same time period. Worldwide, more than 2 million women had been implanted with these mesh products.

In a statement Johnson and Johnson said:

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. 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, has stated “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 the Attorneys General’s decision to file its lawsuit will keep women from obtaining treatment for the often-debilitating symptoms of stress urinary incontinence.

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