New York 3/5/2009 6:41:24 AM
Mentor ObTape Complications result in Recall and Litigation
Information Portal Consumer Injury Lawyers, one of the most comprehensive legal websites on the internet, continues to update its Mentor ObTape Vaginal Sling information portal with new articles providing more detail and insight relating to ObTape Vaginal Sling Side Effects.
The FDA has received over a thousand reports of complications caused by the Mentor ObTape Vaginal Sling in the past three years. Mentor just one manufacturer out of nine that market the medical devices known as surgical mesh vaginal slings, used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).
The most frequent complications reported with mesh vaginal slings include erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. The FDA has also received reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including painful sexual intercourse.
Almost as soon as the Mentor ObTape vaginal sling was introduced, patients began to complain of serious complications. Most vaginal slings are made with a woven or mesh design to allow surrounding tissue to receive nutrients and oxygen. The Mentor sling did not have this design, which not only impaired healing, but actually contributed to the erosion of the tissue of the vaginal wall, as well as erosion of the urethra. This breakdown of tissue leads to chronic vaginal discharge and painful vaginal extrusions. After such widespread complications, Mentor was forced to pull the ObTape Vaginal Sling from the market.
There has since been so many lawsuits as a result of the complications that the company that manufactured the OB Tape vaginal sling, Lawyers for Mentor Corporation, filed a motion to establish a multidistrict litigation (MDL), that will allow all OB Tape vaginal sling lawsuits to be coordinated and centralized during pretrial litigation. In their motion, the Mentor’s lawyers argued that this will help avoid duplicative discovery and depositions, inconsistent rulings and conserve the resources of the parties.
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