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 occurs 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 meant to help correct 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 II to Class III. This would mean that surgical mesh for POP repair would no longer be able to receive clearance through the FDA’s lax 510(k) approval route, and manufacturers would actually have to conduct clinical trials to prove that the products are safe and effective.
FDA Proposes Upgrade to Transvaginal Mesh Device Classification, Pre-Market Device Approval
The FDA issued two proposed orders in April 2014 that were meant to address the health risks often seen when surgical mesh is used in the transvaginal repair of POP. If the agency’s proposed orders are finalized, a re-classification of surgical mesh and the surgical instruments used in transvaginal repair of POP would be upgraded and the makers of these devices would be required to submit pre-market approval (PMA) applications to the FDA for safety and efficacy evaluation.
According to William Maisel, MD, MPH, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, “The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products.” Dr. Maisel added, “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”
The re-classification involves the mesh used in transvaginal repair of POP being changed from Class II (moderate risk) to Class III (high risk) and a re-classification of urogynecologic mesh instrumentation being changed from Class I (low risk) to Class II, as well as the establishment of special controls for surgical instrumentation when used with urogynecologic mesh.
The PMA change would mean that the devices would not longer be able to be cleared through the FDA’s 510(k) process and would be required to undergo pre-market approval, which would enable the agency to conduct safety and efficacy evaluations on the surgical mesh used in transvaginal POP repair. The 501(k) route enables device clearance with no clinical trials if the device is found to be significantly similar to a previously approved device. This process has drawn increasing criticism due to the release of a number of controversial medical devices, including transvaginally implanted pelvic mesh.
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).