Surgical Pelvic Mesh Lawsuits
The American College of Obstetricians and Gynecologists (ACOG) issued an opinion today recognizing the problematic complications associated with the use of mesh for pelvic organ prolapse surgery. ACOG opines that pelvic mesh use “should be reserved for high-risk women for whom the benefit may justify the risk.” As the scientific community and the FDA is now pointing out, those risks include risks not present in traditional surgical techniques such as mesh erosion and vaginal scarring and shrinkage caused by mesh implants.
Pelvic mesh, also known as transvaginal mesh, is mesh that is surgically placed for the treatment of women’s gynecological and urogynecological issues such as pelvic organ prolapse or stress urinary incontinence. Pelvic 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.
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. 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 Organ Prolapse Conditions Treated by Pelvic Mesh
- Vaginal Vault Prolapse
Transvaginal Mesh Side Effects
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