Mentor ObTape Problems with Erosion Raise Questions About Approval Process

By Harvey Kirk
Posted May 20, 2009

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Three years after the Mentor ObTape vaginal sling was discontinued, it continues to cause problems with vaginal erosion for many women who had the device implanted to treat stress urinary incontinence. The complications have raised many questions about the FDA approval process, which allowed the ObTape to be cleared as a substantial equivalent to other products that have been traced back to a vaginal sling that was recalled.

>>INFORMATION: Mentor ObTape Lawsuit

A vaginal sling is a medical device which acts like a hammock to keep the urethra from opening unexpectedly due to stress urinary incontinence, which can be caused by weakened muscles after child birth or other conditions.

Mentor introduced the ObTape sling in 2003. Although there was never an ObTape recall, Mentor suddenly stopped selling the product only three years after it was approved.

Amid growing reports of women experiencing problems with vaginal erosion and infections, a New York Times article earlier this month outlined some of the serious questions that have been raised by the ObTape problems. Devices which are deemed to be a “substantial equivalent” to other products already in use are not required to go through the same stringent pre-market approval process, and are often approved with only minimal testing. According to the New York Times:

The process has been criticized by the agency’s scientists and in a recent Government Accountability Office report concluding that most devices on the market have never been proved safe and effective.

In ObTape’s case, the chain of similarity claims can be traced back to an older product that caused so much harm it was taken off the market. That recall did not stop the F.D.A. from clearing a new generation of vaginal slings whose only claim to safety was their similarity to the flawed device.

The problems with ObTape vaginal slings have been linked to the device’s non-woven design, which is not as porous as earlier slings, blocking oxygen and nutrients. This could cause vaginal extrusions, urinary tract erosions and infections, with symptoms like:

• Vaginal Pain
• Pelvic Pain
• Pain During Sex
• Chronic Infections
• Perineal Cellulitis
• Severe Pain in the Back, Hips and Legs

Medical providers have seen extraordinarily high complication rates, with at least one facility indicating that over 13% of women who received the ObTape sling developed vaginal extrusion and other problems.

LAWYERS FOR OBTAPE VAGINAL SLING PROBLEMS

The Mentor ObTape lawyers at Saiontz & Kirk, P.A. are reviewing potential vaginal sling lawsuits throughout the United States for women who have experienced medical issues that may be related to the defective design of the device. There are no fees or expenses unless a recovery is obtained.

To review a potential case for yourself, a friend or family member, request a free consultation and claim evaluation.