When a transvaginal mesh device fails after it has been surgically implanted in a patient, devastating consequences can result. According to the FDA, a range of complications have been reported by thousands of women who have experienced mesh failure since the introduction of the medical device into the market.
FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence
“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.”
For more information about Serious Complications Associated with Transvaginal Placement of Surgical Mesh, please visit http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm.
The administration has further stated that risks of using the medical device for the repair of conditions such as pelvic organ prolapse and stress urinary incontinence in a number of cases outweigh the benefits.
FDA: Repairing Pelvic Organ Prolapse With Mesh Risky
“We do not see conclusive evidence that using mesh for the transvaginal approach to pelvic organ prolapse improves clinical outcomes anymore than transvaginal procedures that do not use mesh,” says William Maisel, MD, the deputy center director for science at the FDA’s Center for Devices and Radiological Health in Silver Spring, Md. “These devices appear to expose patients to greater risks.”
For more information about the risks of repairing pelvic organ prolapse with vaginal mesh, please visit http://www.webmd.com/urinary-incontinence-oab/news/20110713/fda-surgical-mesh-for-pelvic-prolapse-risky-unnecessary.
For women who have experienced a problem like mesh erosion, the road to recovery is often long. Not only do most patients in these circumstances suffer debilitating pain from their injury, they are also typically faced with having to endure multiple additional surgeries for removal of the device. Mental health support is sometimes needed for women in these cases because the challenges they face with their physical health complications leads emotional struggles like depression and anxiety.