Mentor Corporation, which is being acquired by Johnson & Johnson, was founded in 1969 and is headquartered in Santa Barbara, CA. It has principally focused on products for cosmetic surgery, but between 2003 and 2006, its now discontinued Urology Division marketed Obtape® in the United States. The mesh tape was designed as a surgical treatment for stress urinary incontinence (primarily a women’s health issue) which affects approximately 14 million women in the U.S. Mentor marketed the product in Europe for several years before it obtained FDA approval to market the product in the U.S. FDA approval was based upon Mentor’s representation that its product was substantially equivalent to other products already on the market. This is the lower standard of review which the Court most recently addressed in Riegel v. Medtronic, Inc. is insufficient to cloak the manufacturer with immunity from suit.
Obtape® was financially successful in the United States but, as in Europe, physicians quickly began reporting unacceptable rates of complications for this product compared to competitive devices. A review of the FDA adverse event reporting system reveals 270 adverse events have been reported for this device. Obtape® is essentially an extruded polypropylene mesh that is placed beneath the urethra to support and stabilize it in the correct position to alleviate stress incontinence. Consulting experts tell us Obtape® was favored by some hospitals and surgeons in part because of its price and speed of installation. They also say that it was defectively designed in that its relatively smaller pore size and more dense material was not well absorbed into the body’s tissue. The result is vaginal extrusion and urinary tract erosion that manifests itself in extreme vaginal pain, vaginal discharge, and infections. Most women suffering from these side effects must undergo one or more lengthy surgeries, and many are left with a lifetime of pain and unable to have intercourse or bear children.
It is estimated that 36,000 women have Obtape® implanted in them and that 10 to 20% of them will suffer a significant adverse reaction to it. Experts tell us that this failure rate is many times higher than competitive products. It was withdrawn from the market in 2006 amidst very public criticisms of its failure rates. A MDL was created recently for Mentor Obtape® cases and was assigned to the Middle District of Georgia. If you want more information on this subject, contact Russ Abney at 800-898-2034.
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