The FDA, on July 13, 2011, issued a safety update concerning “serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse.” The FDA concluded that serious complications associated with the use of surgical mesh for transvaginal pelvic organ prolapse (POP) repairs were “not rare.” The agency said it was not clear that transvaginal mesh repair was safer than traditional non-mesh repairs and that transvaginal mesh repair could present greater risks to the patient.
As we have written in previous issues, transvaginal mesh products are used to repair conditions in women such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Pelvic organ prolapse occurs when muscles in the pelvic floor weaken and pelvic organs such as the bladder, rectum, uterus, etc. slip out of place. Stress urinary incontinence is the involuntary leaking of urine while exercising, coughing, sneezing, laughing or lifting.
The FDA’s safety bulletin noted that the most common reported complication from the transvaginal placement of mesh is erosion of the mesh material. Complications can lead to severe pelvic pain as well as painful sexual intercourse or the inability to engage in intercourse. Other serious complications can include organ perforation, bleeding, urinary incontinence, fecal incontinence, infection and the need for corrective surgeries.
The 2011 FDA report may trigger the deadline to file a claim in states that have a two-year statute of limitations. Because a potential claim may expire by July 13, 2013, it’s extremely important to get sound legal advice on this issue. Failing to file suit within the time frame would result in the suit being untimely.
Lawyers in our Mass Torts Section have been investigating claims where women have experienced organ perforation, bleeding, urinary incontinence, fecal incontinence, pelvic pain, infection, discomfort during intercourse and the need for corrective surgeries following the transvaginal placement of mesh for pelvic organ prolapse (POP) or stress urinary incontinence (SUI) repair. If any of our readers, a loved one, or a friend or coworker has suffered such an injury, contact Leigh O’Dell or Chad Cook, lawyers in our Mass Torts Section. They can be reached at 1-800-898-2034 or by email at Leigh.Odell@beasleyallen.com or Chad.Cook@beasleyallen.com.
