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OBTape removed from market--despite and after FDA approval

The Mentor Company of Santa Barbara, California, devised a "simple" solution to manage urinary incontinence it called a "vaginal sling."  The trade name is "OB Tape."  It stopped selling the product in 2006, and Mentor, a California company, was sold to Johnson & Johnson not long after.  Now, the device is a subject of litigation brought by women claiming that they would have been better off living with incontinence, after enduring ugly complications and undergoing as many as five operations to remove elements of the device.

The FDA "cleared" the OB Tape vaginal sling for sale in 2003 (it does not need to "approve" grandfathered medical devices--just "clear" them if a previously similar device was approved) based on its similarity to two older products, the Johnson & Johnson Tension Free Vaginal Tape System and the American Medical System Spare Sling System.  These devices previously had been "cleared" based on their similarity to the Johnson & Johnson Protegen Sling, manufactured by Boston Scientific.  That sling, however, had been recalled in 1999, with the FDA calling it an "adulterated and misbranded" product, according to the New York Times.

As soon as the manufacturers of OB Tape secured "clearance" from the FDA based on the product's similarity to the two previous generations of (now questioned) designs, it patented the new device and marketed it by touting its new, "unique" qualities.  According to Dr. Andrew L. Siegel, a Urologist who is now testifying against the Mentor device, the new device was also made of material more dense than its predecessor devices.  As a result, the device turned out not to be porous enough to allow tissue and capillaries to grow through it.  Thus it wasn't incorporated it into the body in the manner it should have been, and women's bodies continued to attempt to "reject" this foreign matter.  As a result,  according to Dr. Siegel, the device fails regularly, causing signficant medical complications.

266 adverse events have been reported to the FDA regarding OB Tape between 2004 and 2009.  Surgeons such as Dr. Siegel have discontinued using the device and published medical journal articles on negative experiences they have encountered.  In one example, the Virginia Mason Medical Center reported in the Journal of Urology that it had discontinued use of the device after observing a 13.4 percent rate of vaginal extrusion, again according to the New York Times.

The FDA has since alerted health care providers to more than 1,000 reports of medical complications from nine different incontinence and organ prolapse  devices. Attorneys for Mentor claim that its devices are not defective.  They claimed to the Times that complications result from poor surgical skill or inadequate pre-surgical warnings and consents.

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