January 9, 2013 — Johnson & Johnson is facing the first trial of more than 1,800 vaginal mesh lawsuits that have been filed in New Jersey. The lawsuit, filed by Linda Gross of South Dakota, alleges that the company failed to warn about the risks of the Gynecare Prolift vaginal mesh. Ms. Gross was implanted with the mesh in 2006, and she now suffers from debilitating pelvic pain that make it impossible for her to sit for more than a few minutes at a time.
The jury selection process began today, and opening statements will begin tomorrow. The trial is expected to take at least one month.
The Gyncare Prolift is designed to be implanted into the abdomen through incisions in the vagina. It is intended to help support weakened pelvic muscles as a treatment for incontinence or organ prolapse. Unfortunately, after more than 70,000 of the devices were implanted in women in the U.S., thousands of women began reporting severe, debilitating complications.
The FDA had previously asked J&J to withdraw the Prolift in 2007, after they determined that the Prolift was being sold without proper clearance. J&J had independently determined that the device was “substantially equivalent” to another type of vaginal mesh, and therefore did not require a new approval application. The FDA disagreed and asked J&J to stop selling the device. For the next nine months, J&J continued to sell the Prolift, and faced no sanctions from the FDA.
In January 2012, the FDA asked 31 manufacturers of vaginal mesh to conduct additional safety studies to further investigate the risk of complications. Two months later, J&J stopped selling four of its vaginal mesh products, including the Gynecare Prolift.
The Prolift and other types of vaginal mesh have been linked to many complications, including:
- Chronic pelvic pain
- Erosion of the mesh into the vaginal wall
- Recurrent prolapse or incontinence
- Disfigurement of the vagina
- Inability to engage in sexual intercourse
- Nerve damage
- Need for multiple revision surgeries
- And more
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