When the Ethicon TVT (“Tension-free Vaginal Tape”) was introduced in the 1990s, it revolutionized the treatment of incontinence and prolapse. Suddenly thousands of women were getting mesh implants. Unfortunately, many of them were seriously injured when the mesh eroded into their bodies, perforated organs, caused infections, or required additional surgery to remove.
Do I have an Ethicon TVT Lawsuit? If you or your loved one was injured by the Ethicon TVT, 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 the Ethicon TVT?
The Ethicon TVT, also known as “Tension-free Vaginal Tape,” is an implant that was approved in 1998 for the surgical treatment of stress urinary incontinence and pelvic organ prolapse. TVT is a sling-like device that is implanted through transvaginal incisions in the vagina and abdominal incisions. It treats incontinence and prolapse by supporting and stabilizing muscles in the pelvic floor and preventing abdominal organs from sagging downward.
The Ethicon TVT was the first implant to popularize the use of mesh in surgery for incontinence and prolapse. Before the TVT was invented, surgeons used minimally-invasive laparoscopic techniques that tightened muscles in the pelvis without mesh. Today, there is no clear evidence that surgical mesh provides any benefits over non-mesh surgery using laparoscopic techniques. However, there is an additional risk of complications.
What is the Problem with the Ethicon TVT?
Thousands of women have been injured by the Ethicon TVT and similar products. This is not surprising. When the Ethicon TVT was approved in 1998, the FDA did not require rigorous safety studies because Ethicon claimed the TVT was “substantially equivalent” to the Boston Scientific ProteGen — the first vaginal mesh, which was approved in 1996. Although the ProteGen was recalled in 1999, Ethicon did not recall the TVT.
When Ethicon was bought out by Johnson & Johnson, the companies expanded their line of TVT slings and did not explicitly warn about the design similarities to a recalled product. Many women who were implanted with the Ethicon TVT and other slings suffered from the same complications as women who were injured by the ProteGen.
Ethicon TVT Sling Withdrawn From Market
Johnson & Johnson / Ethicon voluntarily “withdrew” the TVT sling from the market in June 2012 — along with several other meshes that were very similar to the TVT — about four months after the FDA asked for additional safety studies. A “withdrawal” is not the same as a recall. However, because the companies are now facing 5,000+ lawsuits from women who were injured, many people are outraged that a TVT recall has not been issued.
The following products have been withdrawn:
- 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)
Ethicon TVT Complications and Side Effects
One of the most serious problems with the Ethicon TVT is that it is difficult to implant in women. A surgeon must use a large needle and blindly pass it over a woman’s pubic bone. This area, called the retropubic space is close to the vagina, bladder, bowel, and also contains a complex network of blood vessels. There is a high risk of organ damage, incontinence, and severe bleeding, especially when an inexperienced surgeon implants the Ethicon TVT.
Another serious problem is erosion of the TVT into tissues. According to the FDA, this is the most common serious complication of vaginal mesh. If the mesh protrudes into the vagina or perforates an internal organ, corrective surgery will be necessary to cut out the mesh. However, even this may not cure all complications.
Ethicon TVT complications include:
- Erosion of the mesh into the vagina
- Organ perforation
- Pain (chronic or only during sexual intercourse)
- Recurrent problems with incontinence or prolapse
- Mesh shrinkage or contraction
- Vaginal scarring and disfigurement
- Need for additional surgery to remove mesh
- Permanent complications
- And more
Do I Have an Ethicon TVT 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 Ethicon TVT lawsuits. We are handling individual litigation nationwide and currently accepting new lawsuits in all 50 states.
Free Ethicon TVT Lawsuit Evaluation: Again, if you or a loved one was injured by the Ethicon TVT, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.