The Food and Drug Administration (FDA) announced the potential risks posed by surgical mesh systems in 2008. Since then, over 1,000 reports of complications were reported to the FDA within the last three years from nine surgical mesh manufacturers. Their reports related to problems created by surgical mesh devices associated with transvaginal placement used to help alleviate the symptoms of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).
Some of the most common adverse affects of the surgical mesh systems, including the Bard Avaulta Mesh, include erosion through vaginal epithelium, pain, infection, urinary problems, and the return of prolapse and/or incontinence. In some instances, woman suffered bowel, bladder, and blood vessel perforation during insertion of the mesh. And if these conditions are not serious enough, other woman endured vaginal scarring and mesh erosion, which led to a considerable decrease in women’s quality of life caused by severe pain and discomfort, including painful sexual intercourse (dyspareunia).
Considering the severity of these complications, many women have needed to undergo additional surgical procedures (some of which were initiated to remove the mesh), hematoma or abscess draining, blood transfusions, and IV therapy.
Manufacturers of medical devices, including surgical mesh systems, are responsible for designing and creating products that are safe and will not pose any risk of injury or recurrence in patients. The types of adverse reactions associated with these mesh systems can present several emotional, financial, and physical challenges. Experienced Jacksonville Bard Avaulta surgical mesh injury attorneys can help women who have suffered serious complications as a result of a surgical mesh system.