Thousands of women who decided to get a bladder sling to treat stress urinary incontinence have filed lawsuits after they were seriously injured by bladder sling problems. The first two lawsuits were awarded multi-million dollar judgements against the manufacturers, and new lawsuits continue to be filed. Many women allege that manufacturers did not adequately warn them about problems with bladder slings — including chronic pain, erosion, organ perforation, additional surgery, and more.
Do I have a Bladder Sling Lawsuit? If you or your loved one was injured by bladder sling problems, 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 a bladder sling?
A bladder sling is a medical implant that treats stress urinary incontinence (SUI). This common condition is caused by weakened muscles in the pelvic floor, which allow the urethra to sag downward and leak small amounts of urine when a woman coughs, laughs, sneezes, or moves vigorously. The sling is made of a narrow strip of material that is implanted through tiny incisions in the vagina and/or abdomen. When it is placed under the bladder, it acts like a “hammock” to support the urethra and prevent incontinence.
The most common types of bladder slings include:
- Tension-Free Vaginal Tape (TVT): Approved in 1998, the Ethicon / Gynecare TVT Sling was based on Boston Scientific’s ProteGen Sling, which was recalled in 1999 due to safety problems. Although the TVT and ProteGen were “substantially equivalent,” the TVT was never recalled — it was only “withdrawn” from the market in July 2012 amid more than 5,000 lawsuits and growing concerns about safety problems.
- Transobturator Tape (TOT): Approved in 2002, this design improves upon the TVT because surgeons do not need to blindly pass a large needle through the retropubic space, which reduces the risk of problems like bleeding and organ perforation (especially the bowel and bladder).
- Mini-Sling: Approved in 2006, this minimally-invasive U-shaped sling has only transvaginal incisions and no abdominal incisions. Although it improves upon the TVT and TOT Slings, women with the Mini-Sling are still at risk of serious bladder sling problems and complications.
What is the problem with the bladder sling?
The problem with bladder slings is that they have been associated with severe side effects that may be permanent, despite multiple corrective surgeries. Many of these complications were only discovered after thousands of women were injured by a bladder sling. Shockingly, because bladder slings were approved under the FDA 510(k) approval process, most bladder slings were only tested in small studies in animals (rats, rabbits, and sheep) before they were implanted in women. More than 10,000 women have filed lawsuits alleging that the manufacturers did not adequately test bladder slings or warn about the potential problems.
Bladder slings have been sold in the United States since the 1990s, but the U.S. Food and Drug Administration (FDA) only warned about the dangers in 2009 and again in 2011. In the meantime, the FDA received more than 5,000 injury reports.
Bladder sling problems can include:
- Erosion of the sling into the vagina
- Organ perforation
- Recurrent incontinence
- Vaginal scarring, disfigurement, shortening, etc.
- Pain during sexual intercourse (dyspareunia)
- Additional surgery to remove sling
- Psychological injuries
- And more
Bladder Slings “Equivalent” to Recalled Product
Many bladder sling lawsuits allege that the manufacturers should have anticipated serious bladder sling problems. The original bladder sling, Boston Scientific’s ProteGen, was recalled in 1999 after hundreds of women were injured. After the recall, the FDA continued approving new bladder slings that were “substantially equivalent” to the ProteGen without requiring new safety studies — including the TVT. Today, nearly all bladder slings can trace their design back to a recalled product. Not surprisingly, many women with “equivalent” implants suffered from the same devastating bladder sling problems.
Do I Have a 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 bladder sling lawsuits. We are handling individual litigation nationwide and currently accepting new lawsuits in all 50 states.
Free Bladder Sling Lawsuit Evaluation: Again, if you or a loved one was injured by bladder sling problems, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.