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Bladder Sling Recall


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Bladder Sling RecallIn recent years, bladder slings have continued gaining popularity as a treatment for stress urinary incontinence despite the devastating risks. Unfortunately, thousands of women have been injured by these implants. In 1999, Boston Scientific issued the first bladder sling recall, and since then, many products have been “withdrawn.” Today, dozens of products currently on the market are very similar to the ProteGen, and thousands of lawsuits allege that the manufacturers did not adequately warn about the danger.

Do I have a Bladder Sling Lawsuit? If you or your loved one was injured by a 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 expenses, and more.

Bladder Slings and Stress Urinary Incontinence

A bladder sling is a medical device that is implanted in women who suffer from stress urinary incontinence (SUI), which is a common type of incontinence that affects hundreds of thousands of women. SUI occurs when weakened muscles in the pelvic floor allow the urethra to sag downward. This can cause the involuntary loss of urine when a woman coughs, laughs, sneezes, or moves vigorously.

Bladder slings are made from a narrow strip of synthetic and/or biological material. The surgeon makes transvaginal incisions through the vagina and tiny abdominal incisions. Then, using special needles, the surgeon threads the sling under the urethra to provide support.

Boston Scientific Develops First Bladder Sling

Boston Scientific developed the first bladder sling in 1996 — the ProteGen Sling. It was approved under the FDA 510(k) approval process, which allows “new” devices that are “substantially equivalent” to an approved device to avoid rigorous clinical safety studies. The ProteGen was “substantially equivalent” to hernia mesh, which had never been used to treat incontinence before. The manufacturers tested the ProteGen for 90 days in rodents, and within two years, it was implanted in 17,000 women.

First Bladder Sling Recall

The first bladder sling recall was the Boston Scientific ProteGen Sling in January 1999 — after just two years and two months on the market. Boston Scientific faced an FDA investigation and more than 500 lawsuits from women who suffered injuries, such as:

  • Chronic pain
  • Infection
  • Erosion
  • Organ perforation
  • Vaginal dehiscence
  • Bleeding
  • Need for additional surgery
  • And more

After Bladder Sling Recall, New Slings with “Equivalent” Design

Soon after the ProteGen bladder sling recall, other manufacturers gained approval for bladder slings that were “substantially equivalent” to the ProteGen — all under the FDA 510(k) process. Today, dozens of bladder slings can trace their design back to the ProteGen. Most of these slings have only been tested in small studies involving rats, rabbits, and sheep.

When Ethicon / Gynecare sought approval for the Tension-Free Vaginal Tape (TVT Sling) in 1998, they named the ProteGen as the “substantially equivalent” predicate device:

“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.”

Although the TVT and the ProteGen were essentially the same product, Johnson & Johnson / Ethicon continued selling the TVT and similar products for more than 13 years after the ProteGen bladder sling recall. The TVT was finally “withdrawn” from the market in July 2012 — officially due to “changing market dynamics” and not safety concerns.

List of Bladder Sling Recalls

The following types of bladder slings and vaginal meshes have been recalled or withdrawn. All of these manufacturers (and more) are currently facing thousands of lawsuits from women who were injured before they issued a bladder sling recall.

Boston Scientific:

  • ProteGen
  • Pinnacle Pelvic Floor Repair Kit

C.R. Bard Inc.:

  • Avaulta Solo Synthetic Support System
  • Avaulta Solo Biosynthetic Support System
  • Avaulta Plus Biosynthetic Support System
  • Avaulta Biosynthetic Support System

Johnson & Johnson / Ethicon:

  • Gynecare Prolift (sold from March 2005 until May 2008 without FDA approval)
  • Gynecare Prolift + M Kit
  • Gynecare TVT Secure
  • Gynecare Prosima Pelvic Floor Repair System Kit
  • Gynecare Gynemesh (changed label to limit use to abdominal procedures)

Mentor:

  • Mentor ObTape (please note, the Mentor ObTape product has not been recalled, however our law firm is currently accepting injury claims for this product.)

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 a bladder sling, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

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