Complications Lead to Lawsuits for Maker of Urinary Leak Device
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A purportedly quick and simple fix for urinary incontinence has led to serious complications for many women. A device called a vaginal sling, made of synthetic meshlike material, is inserted under the urethra to stop urine leaks. However, after the surgery, many women develop painful, persistent and bloody vaginal discharge. Dozens of women are suing Mentor Corporation, the maker of one vaginal sling called ObTape. Mentor Corp. is based in Santa Barbara, California, and was recently acquired by Johnson & Johnson. Though the company asserts that there is nothing wrong with ObTape, they stopped selling it in 2006.
ObTape was cleared for sale by the FDA. However, recently FDA scientists have criticized the way that the agency clears medical devices after only minimal testing if they are shown to be "substantially equivalent" to devices already in use. In the case of Mentor's ObTape, it was cleared for sale after it was found substantially equivalent to two earlier vaginal slings, one of which had been recalled in 1999. Soon after ObTape came to the market, the FDA started receiving many adverse event reports. In 2004, there were 266 reports of adverse events linked to ObTape. According to experts, the problems seem to stem from the ObTape material, which allow it to become encapsulated and expelled, rather than being incorporated into the body. Such problems often require surgical intervention. According to many of the women suing Mentor, the complications are much worse than the problem ObTape was meant to fix.