Urinary stress incontinence is a common problem for women - some 13 million of them in this country alone - particularly after childbirth and as they age. There are diaper-like products on the market for such women, but many choose to medically correct the problem so they no longer have this inconvenient embarrassment in their life. Imagine their horror when the very procedure meant to help them ends up harming them far worse than the original incontinence. This is what has happened to many women who had the Mentor ObTape Vaginal Sling surgically inserted.
Mentor is a California company that manufactured an ObTape Vaginal Sling, an implanted device that is designed to replace eroded or weakened muscles in the urethra and support the bladder. The problems occur because the material the sling is made of doesn’t allow the tissue where the sling is attached to heal; the material itself prevents the needed nutrients and oxygen from reaching the tissue. Women have suffered infection, scarring, painful intercourse, vaginal discharge, pain, mesh extrusions, abscess, and return of the very condition meant to be rectified by this device – urinary stress incontinence. The complications from the Mentor ObTape Vaginal Sling often required patients to undergo surgery and, unfortunately, often serious and permanent injuries. Mentor’s ObTape Vagina Sling came on the market in 2003, and in less than 3 years was taken off the market. Mentor never stepped up and issued a recall; Mentor simply stopped marketing the Ob Tape in March, 2006, but it never actually recalled the product – Mentor just let it die a slow death.
In October, 2006, the Journal of Urology reported on a study which looked at 67 women who had been implanted with the Mentor ObTape Vaginal Sling. More than 13% developed vaginal extrusions. Others had chronic vaginal discharge, and one patient developed an abscess that led to complications. The most telling part of the study was that none of the control group of 56 women who used another type of vaginal sling experienced the complications seen with the Mentor ObTape Vaginal Sling.
This Mentor ObTape Vaginal Sling tried a new innovative design, which is commendable, but you cannot put a product on the market without adequate testing. Apparently, the ObTape Vaginal Sling pushed into and through the vaginal wall causing tearing, cutting, and sometimes permanent erosion of the vaginal tissues.
ObTape lawyers intend to argue that although Mentor won approval of ObTape from the FDA because it was "substantially equivalent" to slings already on the market, the ObTabe Sling is actually a very different product grounds ObTape was a new and unique product. But the Mentor ObTape Vaginal Sling was different because vaginal slings had historically been made with a mesh design, allowing the sling to breathe and get nutrients to the body’s tissue.
Mentor ObTape Vaginal Sling lawyers will argue to consolidate for discovery purposes the 22 filed Mentor ObTape Vaginal Sling lawsuits in an MDL (basically a class action for discovery purposes). Oral arguments will be held in late November in Charleston, South Carolina.
There are approximately 35,000 women used the Mentor ObTape Vaginal Sling between 2003 and 2006. This means that 7,000 women have potential OBTape Vaginal Sling lawsuits. Why only 22 ObTape lawsuits? Of course, many women have a hard time coming forward because this is such a private issue. There are 13 million women with this problem, yet many – between 50-70% in some studies – do not receive any treatment for urinary incontinence, most likely because of the privacy issues involved (and because they don’t realize how many others – including their friends and family - suffer from the same condition). But I also think many women do not realize that there are ObTape lawsuits pending around the country and there is a great possibility these women will receive the financial compensation they deserve for the Mentor ObTape Sling injuries.