FDA MedWatch: Transvaginal Placement of Surgical Mesh- Serious Complications Associated With Transvaginal Placement Of Surgical Mesh In Repair of Pelvic Organ Prolapse And Stress Urinary Incontinence

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----- Forwarded Message ----From: "carwol@..." <carwol@...>=============Date: Tue, 21 Oct 2008 19:46:19 -0400This ailment is quite common --do not know if any have this surgery??but better to be informed...In todays' Washington Post (Health section) there is a very good article (too long for me to type) --"Patients Test the Line Between "Assertive" and "Difficult" about a woman in North Carolina with scleroderma and her fight for care.. well worth reading, since it's the same fight (for health care and recognition of our silicone induced

illnesses) we've been fighting for so long...Nurses, especially, should read the article and the page from her diary -- we don't often enough, say , "Thank you for being so special!"TheWashingtonPost.com page F5Carolyn Wolf ---I really will not be online for several days!!=============Date: Tue, 21 Oct 2008 15:02:22 -0500 (CDT)From: "U.S. Food & Drug Administration (FDA)" <fda@...>Subject: FDA MedWatch: Transvaginal Placement of Surgical Mesh- Serious Complications Associated With Transvaginal Placement Of Surgical Mesh In Repair of Pelvic Organ Prolapse And Stress Urinary Incontinencecarwol@...MedWatch logo MedWatch -

The FDA Safety Information and Adverse Event Reporting Program Transvaginal Placement of Surgical Mesh * Audience: Hospital surgical staff, OB/GYN physicians, other healthcare professionals 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 ________________________________________________________________________Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page [ https://service.govdelivery.com/service/user.html?code=USFDA ]. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please

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