TVT bladder slings gained popularity in the 1990s as a treatment for stress urinary incontinence. Unfortunately, in the last decade, thousands of women have been seriously injured by infections, erosion of the mesh, chronic pain, organ damage, additional surgery, and more. The manufacturer of the mesh implant, Johnson & Johnson / Ethicon, is now facing more than 5,400 lawsuits in federal court.
Do I have a TVT Bladder Sling Lawsuit? If you or your loved one was injured by a TVT bladder sling, contact our law firm immediately for a free case consultation. If you file a lawsuit, you could receive compensation for your injury, medical treatment, and more.
What is the TVT Bladder Sling?
TVT bladder slings (also known as “Tension-free Vaginal Tape”) are a family of mesh implants used to treat stress urinary incontinence and pelvic organ prolapse. The implants consist of a thin strip of knitted polypropylene (plastic), which is designed to be implanted through 1-2 cm incisions in the vagina and under the bladder. A surgeon uses large needles to secure the edges of the sling on either side of the pelvis. The sling is designed to support the bladder and urethra in a “U”-shape or like a “hammock” in the center of the pelvis.
TVT bladder slings include:
- Tension-free Vaginal Tape (TVT)
- TVT Obturator
- TVT Exact
- TVT Abbrevo
- TVT Retropubic System
- TVT Secur (withdrawn from the market)
TVT Bladder Sling Similar to Recalled Mesh Implant
The original TVT bladder sling was created by Johnson & Johnson / Ethicon Gynecare in 1998. It was approved by the U.S. Food and Drug Administration (FDA) based on a 510(k) application, which allows approval of a new device without rigorous safety studies so long as it is “substantially equivalent” to another device on the market. The 510(k) application for the TVT cited Boston Scientific’s ProteGen bladder sling as the “equivalent” device. The ProteGen had been approved in 1996 with a 510(k) application citing hernia mesh as the “equivalent” device and a 90-day safety study in rodents.
Problems with the ProteGen emerged almost immediately. In January 1999, Boston Scientific recalled the ProteGen. Approximately 500 lawsuits were filed by women who suffered erosion, vaginal dehiscence, and other severe side effects.
Not surprisingly, many women were also injured by the TVT bladder sling. However, Johnson & Johnson / Ethicon did not recall the TVT or conduct more rigorous safety studies. Instead, they continued submitting 510(k) applications for new TVT bladder slings that cited older TVT bladder slings. Today, almost all of these products are still on the market. Many of them can trace their design back to the recalled ProteGen bladder sling.
TVT Bladder Sling “Withdrawn” From the Market
In January 2012, the U.S. Food and Drug Administration (FDA) finally asked 31 manufacturers of vaginal mesh and bladder slings to conduct additional safety studies of their products. In June 2012, Johnson & Johnson / Ethicon announced that they would “withdraw” the TVT Secur bladder sling and three other meshes. The company published a statement indicating that the withdrawal was not a recall, and it was initiated due to “changing market dynamics” and had nothing to do with safety or efficacy.
TVT Bladder Sling Lawsuits
Today, Johnson & Johnson is facing more than 5,400 lawsuits from women who were seriously injured by TVT bladder slings and other mesh implants. The majority of these lawsuits are currently centralized in the U.S. District Court for the Southern District of West Virginia in a Multi-District Litigation (MDL):
TVT Bladder Sling Complications and Side Effects
Contact a lawyer today if you were injured by any of the following TVT bladder sling complications and side effects:
- Chronic pain
- Organ damage
- Bladder / bowel perforation
- Blood vessel laceration
- Pain during sexual intercourse (dyspareunia)
- Erosion of the sling into the vagina
- Worse urinary problems or incontinence
- Nerve and/or muscular damage
- Vaginal disfigurement
- Psychological trauma, anxiety, stress
- Additional surgery, which may not correct complications
- And more
Do I Have a TVT Bladder Sling Lawsuit?
The Product Liability & Defective Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in TVT bladder sling lawsuits. We are handling individual litigation nationwide and currently accepting new lawsuits in all 50 states.
Free TVT Bladder Sling Lawsuit Evaluation: Again, if you or a loved one was injured by a TVT bladder sling, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.