On September 9, 2011, an FDA Advisory Panel recommended that vaginal mesh products be reclassified to Class III devices and that more stringent pre-market testing be required prior to approval. Class III devices are required to undergo full pre-market approval which includes safety testing. In addition, Special Controls may be instituted such as physician labeling, patient labeling, pre-market studies, performance standards, patient registry, and importantly, enhanced postmarket surveillance. Most mesh products currently are exempt from pre-market testing. Instead, they are approved under 510(k) review which only requires a showing that a device is substantially similar to another device previously approved.
Transvaginal mesh products are used to repair conditions in women such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Pelvic organ prolapse is the bulge of organs/structures surrounding the vagina into the vaginal opening or extending beyond the vaginal opening, caused by a laxity of supporting tissue of the vagina. Stress Urinary Incontinence is the involuntary leaking of urine associated with an increase in intraabdominal pressure which may be caused by straining, physical activity, coughing or sneezing.
From 1992 until 2010, the FDA approved 168 vaginal mesh devices used for repair of POP or SUI. These products were approved using the 510(k) process and they did not undergo preclinical testing. Most of these devices were approved between 2001 and 2010. Serious complications associated with surgical mesh for vaginal repair of pelvic organ prolapse and stress urinary incontinence have increased dramatically along with the flood of additional mesh devices onto the market. From 2008 until 2010, nearly 3,000 adverse events have been associated with surgical repair of POP and SUI using the transvaginal placement of mesh. These adverse events include organ perforation, bleeding, urinary incontinence, fecal incontinence, pelvic pain, infection, discomfort during intercourse, and the need for corrective surgeries.
Our Mass Torts Section is investigating claims where women have experienced any of the above conditions following the transvaginal placement of mesh for POP or SUI repair. If you or a loved one has suffered such an injury, please contact Leigh O’Dell, a lawyer in our Mass Torts Section, at Leigh.Odell@beasleyallen.com.
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