FDA Advisory Issued Regarding Serious Complications with Mesh Vaginal Slings
October 31, 2008 – The United States Food and Drug Administration (FDA) issued a public health alert notifying healthcare professionals of serious complications associated with surgical mesh vaginal slings, including the Mentor OB Tape. Over the past three years, the FDA says it has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh slings.
Surgical mesh vaginal slings, such as the Mentor OB Tape, are medical devices used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Through a minimally invasive surgical procedure, mesh vaginal slings are implanted under the bladder and essentially serve as hammocks for the vaginal wall. Once in place, mesh vaginal slings support the bladder and reinforce the muscles that control urine flow from the body.
According to the FDA health alert, 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 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 dyspareunia.
Treatment of the various complications with mesh vaginal slings included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
The FDA recommends that physicians be vigilant for potential adverse side effects caused by vaginal slings, inform patients that complications associated with the slings may require additional surgery that may not correct the problem, and inform patients “about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse [and] scarring….
Mesh Vaginal Sling Side Effects Attorney
If you received a surgical mesh vaginal sling, such as the Mentor OB Tape, and suffered serious side effects, you may be entitled to monetary compensation for your injuries. Contact our law firm today for a free and confidential case evaluation from one of our experienced personal injury attorneys.
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