Transvaginal Mesh, Vaginal Mesh, Pelvic Mesh
Transvaginal mesh is used in the transvaginal repair of a condition called pelvic organ prolapse (POP), or to surgically treat stress urinary incontinence (SUI). Pelvic organ prolapse is a condition that occurs when one of the pelvic organs such as the bladder, uterus, bowel or rectum, drops from the normal position and pushes against the wall of the vagina. This happens when the muscles and connective tissues holding the organs in place are stressed and weakened over time. When treating pelvic organ prolapse, physicians often permanently implant the mesh in order to hold pelvic organs in place. When treating stress urinary incontinence (SUI), physicians often use the mesh to support the urethra or neck of the urinary bladder.
Complications of Transvaginal Mesh: The following complications have been reported as a result of transvaginal pelvic organ prolapse (POP) procedure:
• Mesh erosion – exposure, extrusion and/or protrusion of the mesh
• Pelvic pain
• Urinary leakage
• Pain during sexual intercourse
• Recurrence of prolapse
• Organ perforation
On July 13, 2011, the FDA issued an updated safety communication to all U.S. medical providers and patients regarding a risk of serious complications resulting from the placement of transvaginal mesh to treat pelvic organ prolapse (POP).
Lawsuits have been filed against:
- American Medical Systems - Sold Under Name Elevate, Perigee, Apogee
- Boston Scientific - Sold Under Name Advantage Transvaginal Urethal Sling System, Pinnacle Posterior Pelvic Floor Repair Kit, Obtryx Transobturator Mid-Urethal Sling, Polyform Synthetic Mesh, Prefyx Mid U Mesh Sling System, Prefyx PPS System, Uphold Vaginal Support System
- C.R. Bard, Inc.
- Johnson & Johnson’s Ethicon Unit
In June 2012, Johnson & Johnsons’ Ethicon unit recalled most of its mesh brands after more than 1,000 lawsuits were filed against the mesh manufacturer. The following brands were recalled:
- Gynecare Prolift Kit
- Gynecare Prolift + M Kit
- Gynecare TVT Secure
- Gynecare Prosima Pelvic Floor Repair System Kit
On July 1, 2012, C.R. Bard Inc. stopped selling its Avaulta Plus mesh product. On July 20, a California jury awarded a patient $5.5 million after suffering from an Avaulta implant.
Resources for Victims of Transvaginal Mesh, Vaginal Mesh & Pelvic Mesh