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*** MENTOR OBTAPE VAGINAL SLING *** The Fox Law Firm is Reviewing Potential MENTOR OBTAPE VAGINAL SLING Claims Have you experienced severe health issues – such as any, or all, of the above - following the use of the Mentor Obtape Vaginal Sling? Have your loved ones suffered adversely from the Mentor Obtape Vaginal Sling? If so, you should contact us immediately to protect your legal rights. If you or your loved ones have experienced any of these side effects you may have a claim for legal compensation. Contact The Fox Law Firm for superior legal representation. A product that had been designed to assist in alleviating both Stress Urinary Incontinence and Pelvic Organ prolapse in women may have made the problems worse and proven harmful to many patients. The Mentor ObTape was a product classed as a transoburator vaginal sling. It was regularly and widely utilized in the period 2003 to 2006. The purpose of the sling was to provide support to the wall of the patient’s vagina and to assist in strengthening the muscles that help control the flow of urine. The sling in question contained a surgical mesh tape that may not have permitted surrounding tissues to receive required levels of both nutrients and oxygen - which may have led to seriously impaired healing. In a large number of cases, multiple corrective surgeries were needed to deal with the problems that resulted from the use of the sling. The ObTape vaginal sling product has been reported to have a significant complication rate of between 17 and 20 percent, and resulted in such problems as: impaired healing; vaginal extrusion; urinary tract erosion; extreme vaginal pain and discharge; and a variety of infections. A study that was published in 2006 in the Journal of Urology highlighted the experiences of nearly 70 patients who had received the ObTape vaginal sling product. The study found that 9 of the women had vaginal extrusions, and 8 had reported persistent vaginal discharge. Moreover, 1 patient displayed a left-thigh abscess that was directly traceable to the left inguinal incision site. In each of these particular examples, corrective surgery was required and undertaken to remove the surgical mesh tape. As a result of the elevated rate of problems associated with the product, Mentor withdrew it from the market in 2007. Although the product was withdrawn, the inventory that was already on the market was never withdrawn. As a result, many physicians continued to use the product; only to find out recently about the serious complications associated with ObTape. On October 21, 2008, the Food and Drug Administration (FDA) alerted healthcare professionals to what it detailed as “rare but serious complications” associated with the surgical meshes used in the treatment of Pelvic Organ Prolapse and Stress Urinary Incontinence. The FDA revealed that over the course of a three-year time-span, it had received more than one-thousand reports of complications. The most frequent problems cited, the FDA added, included erosion of the mesh through the vaginal epithelium, infection, pain, urinary problems, and recurrence of the prolapse, or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion had resulted in a significant decrease in quality of life, as a result of discomfort and pain, including dyspareunia. Treatment for the problems, stated the FDA, included IV therapy, blood transfusions, drainage of hematomas or abscesses, and additional surgical procedures, in some cases to remove the mesh. The FDA advised clinicians who were using mesh for treatment of Pelvic Organ Prolapse and Stress Urinary Incontinence that they should: - Secure specialized training for each mesh placement technique, and be fully aware of its potential hazards.
- Remain aware of possible adverse events from the mesh, including erosion and infection, and also from the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
- Advise patients of the possibility of serious complications developing, and their effect on quality of life, including scarring, and pain during sexual intercourse.
- Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the mesh may require additional, correct surgery that may or may not be successful.
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