In July, Ethicon will go to trial in a lawsuit over alleged defects in their transvaginal mesh products. This will be the first trial in a transvaginal mesh failure lawsuit involving a state attorney general.

In the Ethicon transvaginal mesh failure lawsuit, the state of California has accused Ethicon Inc., which is owned by Johnson & Johnson, of intentionally misrepresenting vaginal mesh as safer than it really is. Allegedly, the company misrepresented the mesh to both patients and doctors.

According to Law.com, former California Deputy Attorney General Jinsook Ohta stated, “J&J 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 State of California filed its complaint against Johnson & Johnson and Ethicon in 2016, alleging that the companies violated California’s unfair competition and false advertising laws.

The California Attorney General’s Office reports that 787,232 transvaginal mesh devices were sold in the United States between 2008 and 2014. Allegedly, over 42,000 devices were sold in California.

This is not the first lawsuit launched against Johnson & Johnson and Ethicon over alleged defects in their transvaginal mesh products. Washington, Mississippi, and Kentucky have also filed transvaginal mesh complaints about the company.

The Washington lawsuit ended in a $9.9 million settlement with the state that will provide compensation to allegedly affected patients, and will require Johnson & Johnson to stop making allegedly false claims about the safety of the transvaginal mesh products.

In addition to lawsuits filed by states against Johnson & Johnson and Ethicon, patients have also filed lawsuits claiming that they were injured by the transvaginal mesh failure. Allegedly, the devices caused patients pain and a number of complications.

Some patients claim that the transvaginal mesh can degrade or fragment in a patient’s body, possibly causing infection, permanent scarring, chronic inflammation, and chronic pain. Allegedly, the vice does not reinforce a patient’s body to repair vaginal or uterine prolapse, as it is intended. Instead, patients say that the device has a tendency to contract, retract, or shrink in the body.

Unfortunately, the treatment for these complications was allegedly revision surgery, which can come with its own set of complications and risks.

Law.com reports that Ethicon and Johnson & Johnson have fought back against these claims of defects, maintaining that their transvaginal mesh products are safe and effective. According to Ethicon spokeswoman Mindy Tinsley, “the attorney general’s position is at odds with the views of leading doctors and medical groups both in California and around the world, as well as the FDA.”

Tinsley went on to claim that Ethicon conducted appropriate research into their products and represented the products faithfully. 

In 2011, the FDA issued a Safety Communication in 2011 that stated that there were “serious complications associated with surgical mesh” for transvaginal conditions, and noted that there was not a notable advantage to using mesh as opposed to other methods to treat pelvic issues. 

Later, concerns over transvaginal mesh have been spread more widely, and have caused public concern. In 2015, Women’s Health noted possible complications with the device, noting that it could be dangerous despite its rising popularity. 

More recently, the FDA has halted the sale of two remaining transvaginal mesh products in the United States, as concerns mount about their possible complications.