As transvaginal mesh lawsuits consistently increase across the Dallas/Fort Worth area, The Food and Drug Administration (FDA) continue to warn doctors and patients of serious complications involving the surgical placement of transvaginal mesh used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).
In 2008 the FDA issued a Public Health Notification and Additional Patient Information to inform the public about the high risks of serious complications. According to the FDA, results have shown over 1,000 adverse events were reported to the FDA during a 3-year period, since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices. The most frequent complications reported for POP repair included protrusion, pain, infection, bleeding, dyspareunia, organ perforation and urinary problems. Many of these complications led to additional medical or surgical treatment and hospitalization.
Based on the results, the FDA’s concerns have significantly increased. “The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported in 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.” (FDA)
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As of now, the FDA is advising patients and surgeons to consider all other treatment options. If you or someone you know has undergone a transvaginal mesh placement in order to repair POP or SUI but has had serious complications, don’t hesitate to contact a lawyer to discuss your legal options. At Borchardt Law Firm we have seen and dealt with many medical device litigations, and we feel the work we do will continue to protect future generations of Texans. Feel free to give us a call.
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