The Verdict - The Lombardi Law Firm Blog
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Steve Lombardi, 515-222-1110 or sdlombardi@aol.com
Unsafe Products - Transvaginal Placement of Surgical Mesh
FDA informed healthcare professionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also 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. FDA provided recommended actions for both physicians and patients to reduce the risks.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Public Health Notification regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Mesh