Mentor ObTape Bladder Sling Pulled From the Market After Causing Crippling Complications



Posted: Tuesday, February 17, 2009

by
Bernstein Liebhard LLP

In the past three years, the Food and Drug Administration (FDA) has received over a thousand reports of complications caused by the use of the Mentor ObTape Bladder Sling. Introduced in 2003, the manufacturer of the Mentor ObTape Bladder sling stopped marketing it just three years later in 2006.

Obtape bladder slings are used primarily to treat urinary incontinence. Patients who suffer from this condition cannot control when they urinate, and experience problematic leakage. Approximately 12 million adults in the United States suffer from this condition, most commonly women over 50 years old, or women who have just given birth.

There are four different types of incontinence: stress incontinence, urge incontinence, overflow incontinence, and functional incontinence. The Mentor ObTape Bladder Sling was marketed toward stress incontinence. This particular type of incontinence is urine leakage due to sudden pressure on the lower stomach muscles, mainly caused by laughing, coughing, lifting, or exercise. When a patient has just had surgery or given birth, these muscles may be weakened, allowing leaks.

This condition is easily treatable, and has been treated with bladder slings for about 100 years. Bladder slings have been the most common and most effective treatment for this affliction. The bladder slings function as a hammock to support the bladder and reinforce the muscles that control the flow of urine from the body. This requires minimally invasive surgery, and can be done on an outpatient basis.

However, almost as soon as the Mentor ObTape bladder sling was introduced, patients began to complain of serious complications. Most bladder slings are made with a woven or mesh design to allow surrounding tissue to receive nutrients and oxygen. The Mentor Bladder Sling did not have this design, which not only impaired healing, but actually contributed to the erosion of the tissue of the vaginal wall, as well as erosion of the urethra. This breakdown of tissue leads to chronic vaginal discharge and painful vaginal extrusions. After such widespread complications, Mentor was forced to pull the ObTape Bladder Sling from the market.

The Consumer Injury Lawyers website is a consumer advocacy website that provides information about ObTape Bladder Sling lawsuits The site also provides information about lawsuits involving transvaginal placement of potentially defective surgical mesh used to treat Pelvic Prolapse (POP) and Stress Urinary Incontinence (SUI), including Bard Avaulta Mesh lawsuits .

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Top-level comments on this article: (1 total)
» left by Susan Thom
 2 years 354 days ago.
175 fans.
hi kelly,
 
i know of this problem, and it can be very debilitating.
 
i hope researchers find something to help women who have this problem.
 
thanks for shaing and i hope you continue writing,
 
welcome to searchwarp,
 
best regards,
 
sue thom
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