January 6, 2020 | Mass Torts
Transvaginal mesh has been the subject of more than 100,000 lawsuits, with thousands still pending. Marketed as a solution for incontinence and pelvic organ prolapse (POP), many women have undergone procedures to implant the mesh devices, which have ended up causing serious complications and debilitating pain. Several countries have now banned and ruled transvaginal mesh as unsafe, including Australia and New Zealand in 2017, and the U.K. is likely not far behind. Many believe and are pushing for pelvic mesh products to be banned globally. Now we are left waiting to see whether the U.S. will follow suit, since more transvaginal mesh surgeries are completed here than anywhere else in the world.
Despite strong urges from consumer advocates, the FDA acknowledges the risks of transvaginal mesh, but has decided not to ban the devices. They are still considered favorable treatment for stress urinary incontinence (SUI).
In April 2019, the U.S. Food and Drug Administration (FDA) did ban sales from two manufacturers of the three surgical mesh products left on the market for the transvaginal repair of POP. This was due to the companies failing to demonstrate the long-term safety and benefits of the devices. This requirement came as part of the premarket approval process for existing and new mesh devices designed to treat POP, which the FDA mandated in 2016 after reclassifying vaginal mesh as a high-risk medical device.
Transvaginal mesh is a surgically implanted medical device, typically made from either porous synthetic material or animal tissue. It is generally used to repair weakened or damaged tissue, but more specifically to treat POP or SUI. POP occurs when the muscles that are supposed to hold the pelvic organs in place are weakened, thus causing the badder to drop or prolapse down towards the vagina. Whereas, SUI is when urine unintentionally leaks out of the urethra, often caused by activities such as sneezing or coughing. A vaginal mesh device is meant to provide extra support to those weakened muscles or tissue.
The following devastating injuries have reportedly been associated with vaginal mesh implantation:
According to a 2017 study, researchers suggest that up to 40% of women suffer injuries from medical instruments used to implant transvaginal mesh. Unfortunately, once surgical mesh is implanted, it can be very difficult to remove. At times, multiple surgeries may be required to remove an entire device, especially if there has been tissue growth or if the material as broken down into pieces.
There have been at least 20 verdicts in state and federal courts since 2012, in favor of transvaginal mesh victims, with awards totaling over $300 million. Thousands of other claims have been settled for millions as well. One of the largest settlements to date was announced by Endo International in May 2019, when the company stated they will resolve 20,000 cases with $830 million in compensation. More than 2,000 lawsuits are still pending.
If you or a loved one has suffered harm from a surgical pelvic mesh implant, or any other medical device, contact the mass tort attorney from Dunken Law Firm. Our experienced and compassionate lawyers will help you receive the compensation you and your family deserve. Call (713) 554-6780 today and schedule a free case evaluation.