Transvaginal Mesh Lawsuit

Transvaginal Mesh

Transvaginal Mesh & Women’s Health

Levin Papantonio is actively pursuing cases against the manufacturers of transvaginal mesh products. Transvaginal mesh or pelvic mesh is used to treat women’s health issues such as stress urinary incontinence or pelvic organ prolapse. In July 2011, the FDA issued heightened warnings regarding mesh used in pelvic organ prolapse, and in September 2011, the FDA special panel recommended to regulators that pelvic organ prolapse devices be reclassified and that further studies be conducted. Transvaginal mesh complications include: Read More

Transvaginal Mesh Lawsuit

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 mesh is used to treat pelvic organ prolapse conditions known as:

Cystocele
Rectocele
Enterocele
Vaginal Vault Prolapse
Procidentia

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
Pain
Bleeding
Mesh-related infections
Pain during sexual intercourse (dyspareunia)
Vaginal scarring or shrinkage

In The News

Transvaginal Mesh Lawsuit Moves Into Trial Phase

Few people realize that the vast majority of lawsuits – between 95 and 98% – never go before a judge and jury. In most cases, lawyers on both sides of an injury lawsuit are able to reach a settlement before going to trial. In fact, both sides will go to great lengths to achieve a settlement. Court trials are long, drawn-out, expensive, difficult and often messy. They can generate a lot of unwanted publicity for the defendant (the party being sued). Read More

Canadian Law Firm Files Class Action Transvaginal Mesh Lawsuit Against J&J

There was a time when “Johnson & Johnson” was one of the most trusted names in health care. Of course, unless you're on the high side of50, you wouldn't remember that. Read More

American College of Obstetricians and Gynecologists Recognizes Issues with Pelvic Mesh

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. Further, as pointed out in the ACOG opini Read More

FDA to Reclassify POP Transvaginal Mesh to Prevent 510(k) Disaster

This week the FDA Obstetrics & Gynecology Devices Panel has decided to recommend to the FDA that transvaginal mesh used to correct pelvic organ prolapse should be reclassified from a Class II to a Class III device. Under this new classification, POP mesh products would be unable to be cleared through the 510(k) premarket approval process. Under the 510(k) premarket approval process, the manufacturer of the product only has to show that the product to be approved is "substantially equivalent" to an existing device already on the market.&nbsp Read More

Mayo Clinic Doctor: Mesh Patients have "Suffered Needlessly

A Mayo Clinic urologic surgeon has recently spoken out against pelvic organ prolapse mesh and the severe ramifications caused by its use. Dr. Daniel S. Elliott has joined Public Citizen's petition to the FDA to ban the marketing of transvaginal mesh products for repair of pelvic organ prolapse. Read More

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July 13, 2011 - FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

Recently, the FDA issued an important UPDATE to its prior Public Health Notification (dated October 20, 2008). This time, the FDA cautioned both health care providers and patients, stating that serious complications associated with the use of surgical mesh were not rare. This is a much stronger position than the FDA's 2008 position where the agency described these complications as "rare." This update was supported by the fact that the FDA had recieved some 2,874 adverse event reports since 2008. The FDA continues to monitor the safety and efficacy of these products that are causing painful and debilitating complications.

October 20, 2008 - FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

In October of 2008, the FDA issued notice that the agency had recieved some 1,000 reports of adverse events related to the use of transvaginal surgical mesh. The FDA advised that, "[a]though rare, these complications can have serious consequences."

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If you were the recipient of a pelvic mesh implant, contact the lawyers at Levin, Papantonio for a free case evaluation. Our trained female legal assistants are available to discuss sensitive and complex issues that can arise from pelvic mesh complications.

Levin, Papantonio, Thomas Mitchell, Rafferty & Proctor P.A.

Call Anytime 24 Hours - (888) 435-7001

Transvaginal Mesh Lawsuit

Transvaginal Mesh

Transvaginal Mesh & Women’s Health

Transvaginal Mesh Lawsuit

Transvaginal Mesh Lawsuit

In The News

Transvaginal Mesh Lawsuit Moves Into Trial Phase

Canadian Law Firm Files Class Action Transvaginal Mesh Lawsuit Against J&J

American College of Obstetricians and Gynecologists Recognizes Issues with Pelvic Mesh

FDA to Reclassify POP Transvaginal Mesh to Prevent 510(k) Disaster

Mayo Clinic Doctor: Mesh Patients have "Suffered Needlessly

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