Download FDA Update on the Serious Complications Associated with TVM Transvaginal Mesh Timeline
Women Implanted with Transvaginal Mesh Suffer from Painful, Permanent Injuries
Transvaginal Mesh, Vaginal Mesh, Pelvic Mesh, | Lawsuit Lawyer Attorney | Side Effects / Complications : Mesh Erosion, Infection, Bleeding, Incontinence, Painful Intercourse and more | Medical Device used to repair Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI).
Millions of women have received a transvaginal mesh implant or mesh sling to help repair pelvic organ prolapse (POP) or stress urinary incontinence (SUI). POP is when the organs in the pelvis slide out of place, and SUI is the involuntary release of urine during activities such as sneezing or coughing. These conditions can severely impact your quality of life; transvaginal mesh is supposed to help fix POP and SUI by providing the pelvic organs and muscles with extra support. These devices, however, have been linked to a high rate of serious complications.
The U.S. Food and Drug Administration (FDA) reports that the most common side effects associated with transvaginal mesh may include:
- Mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
Transvaginal Mesh Lawsuits
Pelvic mesh lawsuits have been filed on behalf of women around the country against several manufacturers of transvaginal mesh (TVM) and sling devices, including:
- American Medical Systems: sold under the names Elevate, Perigee and Apogee
- Boston Scientific: sold under the names Advantage Transvaginal Mid-Urethral Sling System, Pinnacle Posterior Pelvic Floor Repair Kit, Obtryx Transobturator Mid-Urethral Sling System, Polyform Synthetic Mesh, Prefyx Mid U Mesh Sling System, Prefyx PPS System, Uphold Vaginal Support System
- C.R. Bard, Inc.: sold under the names Avaulta, Pelvisoft BioMesh, Pelivicol Acellular Collagen Matrix, Pelvitext and Pelvilace
- Johnson & Johnson/Ethicon: sold under the names Gynecare, Gynemesh, Gynecare Prolift, Gynecare Prolift + M, Gynecare Prosima and Gynecare TVT
Victims of vaginal mesh implant and sling failures who file a transvaginal mesh lawsuit may be compensated for the following:
- Additional surgery
- Emotional distress
- Loss of ability to have sexual relations, loss of consortium on behalf of spouse
- Loss of quality of life
- Lost wages
- Out-of-pocket medical, surgical and hospital expenses
- Pain and suffering
As evidence increasingly emerges about safety issues with transvaginal mesh devices, it is expected that the litigation surrounding these products will continue to grow.
Safety Issues with Transvaginal Mesh
On July 13, 2011, the U.S. Food and Drug Administration (FDA) said in a Safety Communication that complications associated with transvaginal mesh implants are “not rare” and that there is no conclusive evidence showing that transvaginal mesh is more effective than non-mesh repairs in all patients with POP. In fact, the agency said that the mesh device “may expose patients to greater risk.” The FDA said it had received 2,874 new reports of complications linked to transvaginal mesh between January 2008 and December 2010. Of these, 1,503 were associated with POP repairs and 1,371 with SUI repairs. Studies reviewed by the agency show that about 10 percent of women who have a transvaginal mesh experience erosion (meaning the mesh cuts through their body’s tissues) within 12 months of surgery; more than half of them needed additional surgery to remove the mesh. In some cases, even multiple surgeries did not resolve complications.
On August 25, 2011, the watchdog group Public Citizen, founded by Ralph Nader, stated that the FDA should recall transvaginal mesh products due to safety concerns and the painful side effects. The FDA itself stated in an Executive Summary released on August 31, 2011 that it “believes that vaginal placement of surgical mesh for Pelvic Organ Prolapse (POP) repair inherently introduces risks of complications that are unique to the mesh itself.”
During a meeting convened by the FDA on September 8th and 9th of 2011, a majority of the Obstetrics and Gynecology Medical Device advisory panel agreed that the safety, effectiveness and benefits of transvaginal mesh devices in POP repair is not well established and warrants long term prospective follow-up of patients. The agency proposed reclassification of mesh devices used in the repair of POP from Class 2 to Class 3. This would mean that surgical mesh for POP repair would no longer be able to go through the FDA’s lax 510(k) approval route, and manufacturers would actually have to do clinical tests to prove that the products are safe and effective.
If you or someone you know suffered painful injuries after being implanted with a transvaginal mesh device, you may have valuable legal rights. We’re here to answer any questions you may have. For a free case review, please fill out our online form to the right or call our office at 1-800-YOURLAWYER (1-800-968-7529).