Mentor ObTape Vaginal Sling Caused Serious Injuries to Thousands before Being Pulled from MarketOct 22, 2007 | Parker Waichman LLP
The Mentor ObTape Vaginal Sling was removed from the market in 2006, just three years after being introduced. arrangement These complications often required patients to undergo multiple invasive surgeries, but even with competent medical care, the implantation of a Mentor ObTape Vaginal Sling often left patients with permanent serious injuries.
The Mentor ObTape Vaginal Sling was first marketed by Mentor Inc. in 2003. The device was meant to treat stress urinary incontinence, an embarrassing loss of bladder control that afflicts 13 million people. The disorder occurs mostly in women, and is caused by weak muscle tone that can result from child birth, old age and other conditions. There are a number of vaginal slings on the market, and they all work much the same way. They basically act as a hammock to support the bladder and reinforce the muscles that control the flow of urine from the body. The vaginal sling technique has been around for about 100 years, and is considered the “gold standard” in stress urinary incontinence treatment. Generally, the minimally invasive treatment can be done on an outpatient basis.
But almost as soon as it was introduced, patients who received the Mentor ObTape Vaginal Sling began to complain of serious complications. The most common of these injuries were vaginal erosions, basically the breakdown of the tissue that makes up the vaginal wall. This is an extremely painful condition that leads to chronic vaginal discharge and infection. The design of the Mentor ObTape Vaginal Sling also caused erosions of the urethra, and it allowed the device to cut into the vaginal wall, causing extreme and painful vaginal extrusions.
A study published in the October 2006 Journal of Urology discussed the widespread nature of the injuries caused by the Mentor ObTape Vaginal Sling. Of 67 women who had been implanted with the Mentor ObTape Vaginal Sling, more than 13 percent developed vaginal extrusions. Another eight developed a chronic vaginal discharge, and one patient developed an abscess of the left thigh that tracked to the incision site. The study compared these patients to 56 others who had received another brand of vaginal sling. None of those patients experienced the complications seen with the Mentor ObTape Vaginal Sling.
The reason that the Mentor ObTape Vaginal Sling had such a high complication rate was because of its poor design. Most of the other vaginal slings on the market are made with a woven, or mesh design. This allows surrounding tissue to receive nutrients and oxygen. The Mentor ObTape Vaginal Sling did not have this design, and this caused impaired healing. As a result, between 17 and 18 percent of the women who were implanted with a Mentor ObTape Vaginal Sling suffered from complications, with many forced to undergo a difficult surgical procedure to have the device removed. The problems associated with the Mentor ObTape Vaginal Sling were so severe and widespread that finally, in 2006 Mentor Inc. pulled it from the market.
But that did little to help the estimated 35,000 women who received the Mentor ObTape Vaginal Sling between 2003 and 2006. Many of those women still suffer from serious crippling injuries caused by the device. Unfortunately for them, the complications caused by the Mentor ObTape Vaginal Sling are often far worse the disorder it was supposed to fix.