Beginning in 2008, thousands of plaintiffs started filing lawsuits against manufacturers and sellers of defective pelvic mesh products, commonly referred to as transvaginal mesh (“TVM”). Cases involving injuries caused by the devices are pending in state and federal court, but all of the cases in federal court are coordinated under U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.
TVM is a surgical mesh typically made from polypropylene, a plastic material surgically implanted into or attached to the vaginal wall. Gynecologists started using the medical device in the 1990s to treat women who suffered from conditions such as pelvic organ prolapse (“POP”) or stress urinary incontinence (“SUI”), which both involve the weakening of a woman’s vaginal walls after childbirth, aging or other causes.
In 1996, the FDA cleared the first TVM device specifically designed for SUI patients, and in 2002, the FDA approved the first POP-specific device. Over the years, TVM products evolved into kits, adding new insertion tools, tissue fixation anchors, surgical techniques, and absorbable and biologic materials.
Since TVM was first introduced into the market over 20 years ago, millions of women have undergone the procedure. However, in October 2008, the FDA issued a Public Health Notification that informed clinicians and patients of the risks associated with TVM after receiving over 1,000 adverse event reports. The FDA issued another warning in 2011 following receipt of over 1,500 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007. The FDA concluded that serious complications from TVM products were not rare.
Plaintiffs in this litigation assert that as a result of TVM, they experienced mesh contraction and mesh erosion causing severe pain, vaginal scarring, infection, urinary problems, sexual dysfunction, and perforations of the bowel, all of which often require one or more revision surgeries. In addition, men have asserted claims in the litigation for injuries sustained during sexual relations, as well as derivative claims for loss of consortium.