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Mentor OB Tape Vaginal Sling: A Cure Far Worse Than the Cause
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The OB Tape vaginal sling, made by Mentor Corporation of California, is the subject of rigorous investigation across the United States. Why? Hundreds of women have reported vaginal extrusions, infections, abscesses, discharge, and worse after having the device implanted. Worse, many women have had to undergo extensive surgeries to remove the device and many others have suffered permanent injuries.
The OB Tape vaginal sling was originally approved for the treatment of female stress urinary incontinence in 2003 and was taken off the market in 2006, less than 3 years later. But by this time some 35,000 women had already had the device implanted. Unbelievably, Mentor never actually recalled the device, instead allowing it to just fizzle out: they stopped marketing the device in March 2006.
Ironically, a study published in October 2006, in the Journal of Urology, found a 13 percent incidence of vaginal extrusions in women who had received the device. Others developed chronic vaginal discharge, and 1 patient developed an abscess that led to complications. Of note, none of the women in the control group who used another type of vaginal sling had any of the complications seen with the OB Tape product.
The OB Tape Vaginal Sling: What was it supposed to do?
The OB Tape Vaginal Sling was a new design consisting of a non-woven surgical mesh developed to treat female stress urinary incontinence. The device was surgically implanted in order to strengthen or replace muscles that were not working properly in the urethra and, therefore, support the bladder, and prevent stress-related incontinence.
What went wrong?
The material the mesh was made of did not allow the tissue to which the sling was attached to heal following implantation. Vital biological nutrients and oxygen were prevented from reaching the injured tissue. This resulted in infection, scarring, painful intercourse, mesh extrusions, abscess in literally hundreds of women. Not to mention the ongoing problem of urinary incontinence. Additionally, there are also reports of the sling pushing into and through the vaginal wall resulting in cutting and tearing of the tissue, as well as permanent erosion of the vaginal tissues.
The OB Tape Vaginal Sling did not go through clinical trials
While it could be argued that Mentor Corporation was trying a new design in an effort to help women, not harm them, the company allegedly did not perform due diligence in the form of clinical trials and design research. This is extraordinary, especially given the fact that they were using a kind of material for the sling that was not currently in use. Had the OB Tape Sling been adequately researched and tested, problems such as the failure of the tissue to heal due to the type of mesh that was used would almost certainly have come to light.
Equally alarming is the fact that Mentor did not provide women with adequate warnings about any of the potential problems that began to surface.
Symptoms of Mentor OB Tape Sling injury
While some women have reported medical problems stemming from the OB Tape sling shortly after having it implanted, other women do not develop symptoms indicative of problems for months or years afterward.
Common symptoms include:
Mentor OB Tape Vaginal Sling Legal HelpIf you or a loved one has suffered damages as a result of a Mentor OB Tape Vaginal Sling, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on Nov-21-08