Surgical vaginal mesh (aka surgical tape or sling) is an implantable medical device used to reinforce soft tissue or bone where weakness exists.
Most surgical vaginal mesh devices cleared for urogynecologic procedures, such as the surgical treatment of involuntary urine leakage (SUI) and Transvaginal repair of pelvic organ prolapsed (POP) in women, are composed of non-absorbable synthetic mesh.
Levin Simes settles AMS transvaginal mesh lawsuits:
Levin Simes LLP announced an agreement to settle approximately 20,000 claims related to American Medical Systems, Inc. (AMS) products. AMS is a subsidiary of Endo Pharmaceuticals. These claims include women and families represented by Levin Simes as well as other law firms. Endo Pharmaceuticals will pay approximately $830 to resolve these claims.
UPDATE: Endo International PLC disclosed it is officially closing it’s women’s health division and stopping manufacture and sale of transvaginal mesh products. Levin Simes attorney Amy Eskin was the co-lead attorney in the national litigation against AMS. Read more about Endo stopping AMS mesh production here.
UPDATE: In January 2014, the FDA has reclassified POP surgical mesh as a Class III high-risk devices. The FDA has issued new recommendations to patients on how to speak with their doctor to decide if high-risk surgical mesh is right for them.
In October of 2008, the FDA issued initial warnings about the potential side effects of the use of Transvaginal mesh.
In February of 2009, the FDA began warning healthcare professionals of the “rare” but serious compilations associated with the use of Transvaginal mesh.
On July 13, 2011, after a search of its Manufacturer and User Device Experience (MAUDE) database as well as its own systematic review of the scientific literature in regards to POP and SUI surgical mesh safety and efficacy, the FDA issued an Updated Safety Communication. The updated alert warns that surgical placement of mesh through the vagina, specifically to repair POP, may expose patients to greater risk than other surgical options.
The FDA determined that:
- Serious adverse events are NOT rare. It is estimated that 10 percent of all Transvaginal mesh clients experience adverse effects within the first 12 months.
- Transvaginally placed mesh in POP does NOT improve clinical outcomes over traditional non-mesh repair.
On April 29, 2014 the FDA issued two proposed orders suggesting that transvaginal mesh for repair of Pelvic Organ Prolapse be reclassified from a moderate-risk device (Class II) to a high-risk device (Class III) because the FDA had identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse.
As the FDA’s Deputy Director of Science and the chief scientist at the FDA’s Center for Devices and Radiological Health William Maiser, M.D M.P.H., observed “The FDA is now proposing to address those risks for more safe and effective products.” If these proposals are finalized, the FDA will require mesh manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.
Symptoms and Complications:
- Vaginal mesh erosion (ie. extrusion or protrusion of the mesh out of vaginal tissue)
- Pain, infection, bleeding, and pain during intercourse (dyspareunia)
- Urinary problems
- Organ (bowel, bladder, blood vessel) Perforation
- Recurrent prolapsed
- Neuromuscular problems
- Vaginal scarring/shrinkage caused by mesh contraction
- Emotional distress
- Decreased quality of life
If you have experienced any of the complications above and have a transvaginal mesh implant, you may be eligible for financial compensation for lost wages, medical bills and other expenses, either through a lawsuit or a settlement. Please contact the attorneys at Levin Simes LLP today regarding a vaginal mesh lawsuit at 1 (888) 426-4156 or by filling out the form on this page for a free consultation.