There is no evidence that TVT surgery provides any benefits over non-mesh surgery for stress urinary incontinence (SUI), but there is a significantly higher risk of complications. Johnson & Johnson / Ethicon withdrew its entire line of TVT implants about four months after the FDA asked the company to conduct safety studies. Thousands of TVT lawsuits have been filed by women who suffered complications including pain, incontinence, erosion of the mesh into the vagina, organ damage, additional surgery, and more.
Do I have a TVT Surgery Lawsuit? If you or your loved one was injured by vaginal mesh, contact our law firm immediately for a free case consultation. If you file a lawsuit, you could receive compensation for your injury, medical expenses, and more.
What is TVT Surgery?
Tension-free vaginal tape (TVT) or transvaginal tape is an implant designed to treat stress urinary incontinence. SUI occurs when weakened pelvic muscles (a common complication of pregnancy and aging) allow the bladder and urethra to leak small amounts of urine under pressure, such as when a woman coughs, laughs, or moves vigorously.
TVT surgery is a minimally-invasive procedure that uses transvaginal incisions in the vagina and small incisions in the groin and abdomen. During the procedure, a surgeon passes the tape (a narrow band of synthetic material) through the incisions and around the urethra to lift and support the bladder.
Potential Complications of TVT Surgery
Unfortunately, TVT surgery has been linked to severe complications, including:
- Chronic pain
- Pain during sexual intercourse (dyspareunia)
- Perforated bladder, blood vessels, or organs during implantation
- Erosion of the mesh into organs
- Extrusion into the vagina
- Recurrent incontinence or problems urinating
- Vaginal disfigurement, scarring, shortening
- Mesh contraction or shrinkage
- Need for excision surgery, which may not cure complications
- And more
TVT Sling Design “Equivalent” to Recalled Product
Boston Scientific’s ProteGen Sling, approved in 1996, was the first surgical mesh approved to treat SUI. However, the use of mesh in SUI repair did not become common until Ethicon / Gynecare introduced the Tension-Free Vaginal Tape (TVT) in 1998.
Both products were cleared under the FDA 510(k) approval process. This allows manufacturers to avoid conducting safety studies so long as their new device is “substantially equivalent” to an existing device. The “equivalent” product for the ProteGen was hernia mesh, which had never been used in urological procedures before. The “equivalent” device for the TVT System was the ProteGen Sling. In the 510(k) application for the TVT, manufacturers stated:
“Technologically both the new device and predicate device are the same (i.e., both are meshes that provide pubourethral support). … Any differences between the two devices do not raise new questions of safety and effectiveness.”
Boston Scientific recalled the ProteGen in January 1999 (after two years and two months on the market) amid serious safety concerns, FDA investigations, and more than 500 lawsuits from women who suffered infections, erosion, chronic pain, excision surgery, and other complications.
However, Ethicon never recalled the TVT Sling — it was “withdrawn” from the market by Johnson & Johnson more than 13 years after the ProteGen recall, in June 2012. In the meantime, the FDA continued approving new meshes that were “equivalent” to the ProteGen or the TVT Sling. At least 40 vaginal meshes used in SUI and prolapse repair can trace their design back to a recalled product. Not surprisingly, thousands of women have been injured by TVT surgery and vaginal mesh, and more than 10,000 lawsuits have been filed by women who allege the manufacturers should have known better.
Has the TVT Sling Been Recalled?
No. However, Johnson & Johnson / Ethicon voluntarily “withdrew” their complete line of TVT slings and mesh in June 2012, four months after the U.S. Food and Drug Administration (FDA) asked the company to conduct new safety studies. Johnson & Johnson said the move was based on the products’ commercial viability “in light of changing market dynamics, and is not related to safety or efficacy.”
Johnson & Johnson withdrew the following products:
- Gynecare TVT Secur
- Gynecare Prosima Pelvic Floor System
- Gynecare Prolift Pelvic Floor System
- Gynecare Prolift+M Pelvic Floor System
- Gynecare Gynemesh PS (changed label to only allow abdominal implantation)
Do I Have a TVT Surgery 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 vaginal mesh lawsuits. We are handling individual litigation nationwide and currently accepting new lawsuits in all 50 states.
Free TVT Surgery Lawsuit Evaluation: Again, if you or a loved one was injured by vaginal mesh, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.