Vaginal Mesh FDA Warning

VAGINAL MESH COMPLICATIONS?

 If you or a loved one has suffered harm relating to transvaginal mesh patch surgery, you may be able to recover your medical expenses, lost earnings, as well as compensation for physical pain and suffering, mental anguish and physical impairment.

On July 13, 2011, the FDA said in a Safety Communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh procedures from January 2008 through December 2010.   The FDA reported that of these, 1,503 reports were associated with Prolapse Organ Prolapse repairs and that 1,371 were associated with Stress Urinary Incontinence repairs.  Studies reviewed by the FDA also indicated that about 10 percent of women who had the mesh placed transvaginally experience mesh erosion within 12 months of surgery, and that more than half of these women require additional surgeries to remove the mesh.

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bladder prolapse

The FDA emphasized that transvaginal mesh complications associated with POP repair are not rare, which is clearly a change from the position it took in 2008.  The agency also said it was not clear that POP repair involving transvaginal mesh was better than traditional non-mesh procedures, and could actually expose patients to a greater risk of complications.

The FDA issued this Public Health Notification in July 2011, discussing Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence. Read More: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM061976