Download FDA Update on the Serious Complications Associated with TVM Transvaginal Mesh Timeline
Transvaginal Mesh, Vaginal Mesh, Pelvic Mesh, Complications Lawsuit
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).
Transvaginal surgical mesh implants or slings, which have been implanted in millions of women in urogynecologic procedures to repair pelvic organ proplase (POP) and stress urinary incontinence (SUI), have been linked to a high rate of serious mesh complications. Women throughout the country have filed transvaginal or pelvic mesh lawsuits seeking compensation for serious injuries, including erosion and extrusion of mesh, perforation of organs, vaginal bleeding, chronic infection, pain and emotional distress.
Surgical pelvic mesh products are implanted to provide support for a woman’s organs in the pelvis, which drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. In extreme cases, the vagina can even fall to the point where the vagina is outside of the body. Mesh can be placed to repair prolapse of the following pelvic organs: bladder (cystocele), top of the vagina (apical prolapse), uterus (procidentia), rectum (rectocele), bowel (enterocele) and urethra.
Stress urinary incontinence (SUI) is an involuntary loss of urine that occurs during physical activity, such as coughing, sneezing, laughing, or exercise. Stress urinary incontinence (SUI) may occur as a result of weakened pelvic muscles that support the bladder and urethra. The condition is most common in women who have had multiple pregnancies and vaginal childbirths, and who suffer from pelvic organ prolapse (POP). The implanted mesh or sling is intended to work as a hammock which will support the prolapsed organs and to address the symptoms associated with POP and SUI.
Transvaginal and Pelvic Mesh Complications and Failures
Adverse events from pelvic mesh implanted transvaginally may include:
- Erosion of the mesh through the vaginal tissue
- Exposure or extrusion of mesh, which can require multiple surgeries
- Feeling a lump in the vaginal opening or something protruding from vagina
- Painful sexual intercourse (dyspareunia).
- Perforation or puncture of the bladder, intestines and bowels, as well as blood vessels around the vaginal wall
- Recurrent Pelvic Organ Prolapse (POP)
- Urinary problems
- Vaginal bleeding
- Vaginal chronic drainage, discharge and infections
- Vaginal pain
- Vaginal scarring and shortening
In many cases, women require surgical excision to remove the mesh or sling and may even require two or three additional surgeries. Despite removal of the mesh, complications may not be reversed, and women continue to suffer with vaginal pain and an impaired quality of life.
Transvaginal Mesh Lawsuits
Victims of vaginal mesh implant and sling failures who file a transvaginal mesh lawsuit may be able to collect damages for:
- Additional surgery and multiple surgical revisions
- Emotional distress
- Loss of ability to have sexual relations
- Loss of quality of life
- Lost wages
- Out-of-pocket medical, surgical and hospital expenses
- Pain and Suffering
- Spousal loss of consortium
Pelvic mesh lawsuits have been filed on behalf of women around the country against several manufacturers of transvaginal mesh (TVM) and sling devices for POP and SUI repair 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
As the U.S. Food & Drug Administration (FDA) continues to investigate the safety risks, complications and failures of surgical mesh implanted transvaginally to treat POP and SUI, it is expected that the litigation surrounding transvaginal mesh products complications and painful side effects will only continue to grow. Lawyers at Parker Waichman LLP who specialize in defective medical device are offering free lawsuit evaluations to victims of vaginal surgical mesh implant failures. To learn how you may be able to recover damages for your pelvic mesh injuries, emotional distress, and pain and suffering, we urge you to contact our transvaginal mesh failure lawyers today for your free consultation by completing our online form or calling us at 1-800-LAW-INFO (1-800-529-4636).
News About Transvaginal Mesh
On July 13, 2011, the FDA said in a Safety Communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh procedures from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. Studies reviewed by the agency indicated that about 10 percent of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half of them require additional surgeries to remove the mesh. In some cases, even multiple surgeries will not resolve the complications.
The FDA stated that there was no conclusive evidence showing that transvaginally placed mesh in POP repair is more effective than traditional non-mesh repair in all patients with POP and that “it may expose patients to greater risk”.
On August 25, 2011, the watchdog group, Public Citizen, founded by Ralph Nader, stated that the U.S. Food & Drug Administration (FDA) should recall transvaginal mesh products due to safety considerations and painful side effects.
In an "Executive Summary" released on August 31, 2011, the FDA said 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 8 and 9, 2011, a majority on the Obstetrics & Gynecology (OB/GYN) Medical Device advisory panel agreed that the safety, effectiveness and benefit of transvaginal mesh devices in Pelvic Organ Prolapse (POP) repair is not well established and warrants long term prospective follow-up of patients. The FDA proposed reclassification of transvaginal mesh devices used in the repair of pelvic organ prolapsed from a Class 2 to a Class 3 medical device, which would make surgical mesh for POP repair ineligible for the FDA’s less-stringent 510(k) approval protocols, and require that they be subjected to human clinical trials in order to gain FDA approval.
Transvaginal Mesh Complication Victims - Legal Help
If you or a loved one suffered painful injuries as a result of POP or SUI repair that involved a vaginal mesh implant, you may have valuable legal rights. To learn more about obtaining compensation for transvaginal mesh injuries, please fill out our online form, or call 1 800 LAW INFO (1-529-4636) today.