Transvaginal Mesh Lawsuit
Transvaginal mesh, also known as pelvic mesh, is a mesh device that is surgically placed for the treatment of women's gynecological and urogynecological issues, such as pelvic organ prolapse or stress urinary incontinence. Transvaginal mesh is made of synthetic material, usually polypropylene, and is made of porous or micro- porous weave. Some products even claim to have a "biologic element" made of a collagen blend.
Vaginal Mesh Recall
Surgical mesh has been used in gynecology since the 1990's. By using the FDA's 510(k) expedited approval process, the mesh industry would produce dozens of these products each year without having to prove the safety or efficacy of these devices. In 2004, the industry began producing "pelvic organ prolapse kits" under the premise that these products were a safe and effective alternative to proven traditional surgical techniques.
Pelvic Organ Prolapse is the downward descent of the pelvic organs, usually after childbirth. Statistics show that pelvic organ prolapse affects approximately 50% of women who have given birth. Many treatments are available to treat pelvic organ prolapse, including surgical repair. Traditional surgical repairs are available to physicians and surgeons, either through Colporrhaphy (use of native tissue and sutures) or Sacrocolpopexy (laparoscopic surgery). Since the inception of mesh prolapse kits in 2004, doctors have increasingly turned to pelvic mesh over traditional surgery due to the false premise created by the mesh industry that mesh is a better alternative. In 2010, it is estimated that 100,000 pelvic organ prolapse procedures were performed using pelvic mesh.
Vaginal Mesh Warnings
In July 2011, the FDA issued heightened warnings regarding the use of transvaginal mesh for the repair of pelvic organ prolapse. Three months later, in September, 2011, an FDA panel recommended that pelvic organ prolapse mesh be reclassified to prevent any more clearance of these products through the 510(k) expedited clearance process.
Pelvic mesh is used to treat pelvic organ prolapse conditions known as:
- Vaginal Vault Prolapse
If you received a mesh product during a surgery to repair pelvic organ prolapse, that product could be responsible for serious complications such as:
- Mesh erosion
- Mesh-related infections
- Pain during sexual intercourse (dyspareunia)
- Vaginal scarring or shrinkage