Mentor Lawsuit Says Company Lied about Defective ObTape
January 28th, 2008 joshua
Mentor Corp. is facing a lawsuit after knowingly misleading the Food and Drug Administration about the design, manufacture, safety and efficacy of its ObTape.
According to MarketWire.com, the suit alleges “four women needlessly suffered significant pain and multiple surgeries because Mentor obtained approval to bring ObTape to market.”
ObTape is a transobulator sling used my mostly aging women to control the symptoms of Stress Urinary Incontinence. The device is surgically implanted into women. SUI is an involuntary leakage of urine caused by abdominal pressure brought on by coughing, sneezing or exercise.
Typical rates of ineffectiveness with the transobulator rings equal zero to five percent. Mentor’s ObTape registers a 20 percent ineffective rate. Complications from this device include the ring protruding into the vaginal wall. This painful result requires women with ObTape to have multiple corrective surgeries.
About 50,000 women have received ObTape since it was introduced. Mentor stopped marketing the device in 2006. It approached the FDA calling ObTape “substantially equivalent” to other rings on the market. It also applied for a patent for the product, claiming it was new and unique. Because of this, the FDA expedited its approval process.
