Transvaginal mesh devices have become the subject of thousands of lawsuits alleging that they are to blame for serious and painful injuries. As litigation has mounted, a number of cases have been settled. As recently as June 2015, Covidien agreed to settle lawsuits over its pelvic mesh inserts.
Our firm represents numerous clients in lawsuits over transvaginal mesh injuries, and continues to offer free legal consultations to anyone with questions about their legal rights. If you or someone you know suffered injuries or complications related to transvaginal mesh, contact Parker Waichman LLP today.
Settlement Agreement Reached for Covidien Transvaginal Mesh Lawsuits
There are some 11,300 lawsuits naming Covidien transvaginal mesh devices, according to a regulatory filing with the United States Securities and Exchange Commission (SEC). According to a Reuters article published June 2015, Covidien agreed to settle some of these cases. For third-quarter 2014, transvaginal mesh litigation resulted in a pre-tax charge of $180 million for the company, Reuters reports.
Transvaginal mesh devices were approved to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh devices are meant to counteract sagging pelvic organs, providing additional strength to the pelvic walls and muscles. Thousands of lawsuits, however, allege that the devices have caused serious injuries. The U.S. Food and Drug Administration (FDA) reports that the most common side effects associated with transvaginal mesh devices include:
- Mesh erosion through the vaginal wall, also called exposure, extrusion, or protrusion
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
Transvaginal mesh devices were mostly approved through a regulatory loophole known as the 510(k). This approval route allows certain devices to be approved without certain clinical testing for safety or efficacy if manufacturers can show that the product is “substantially equivalent” to an older, previously approved device.
Other Transvaginal Mesh Settlements and Verdicts
Approximately 100,000 transvaginal mesh lawsuits have been filed as of June 2015. A number of verdicts and settlements have resulted from the litigation. Danish manufacturer Coloplast offered to settle 400 lawsuits for $16 million in early 2014, according to Bloomberg News. In 2012, American Medical Systems (AMS) agreed to a $54.4 million settlement; the number of cases to be resolved was not disclosed. The company reached another settlement in May 2014, agreeing to pay $830 million to settle 20,000 lawsuits.
In September 2014, a West Virginia jury ordered Johnson & Johnson’s Ethicon unit to pay $3.27 million to a woman who suffered injuries, allegedly due to her Ethicon Gynecare TVT mesh. Her lawsuit alleged that the company failed to warn about the risks. An $11 million verdict was also handed down in 2013 over its Gynecare Prolift device.
In July 2013, C.R. Bard faced its first federal trial over a transvaginal mesh case. The jury handed down a $2 million verdict, finding that the company did not adequately test the device. Bard settled the second case hours before trial was slated to begin.
Legal Help for Individuals Implanted with Covidien Transvaginal Mesh
If you or someone you know has been implanted with Covidien transvaginal mesh or other pelvic mesh implants, you may have valuable legal rights. Our firm is representing numerous clients in lawsuits over injuries allegedly caused by transvaginal mesh devices. To find out more about filing a lawsuit or to receive a free, no-obligation legal consultation, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).