Transvaginal mesh and bladder slings are used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women.
Prolapse is a condition where the organs in the body tend to drop, or “prolapse.” Stress urinary incontinence is a condition where a leakage of urine occurs at times of physical stress causing abdominal pressure, such as coughing, sneezing or exercise. To treat these conditions, vaginal mesh or bladder slings are implanted through the vagina to lift the prolapsed organs or support the bladder.
While these mesh implants have helped some patients, countless women have suffered serious side effects and life-altering complications. Some have ended up with permanent damage and chronic pain, as well as a drastic decrease in the quality of their lives.
Tens of thousands of vaginal mesh lawsuits have been filed in both state and federal courts across the United States against the manufacturers of these dangerous medical devices. Many cases have already settled.
Transvaginal Mesh Complications
In 2008, due to over 1000 reports of adverse effects regarding the vaginal mesh and the bladder sling, the FDA issued a public health notification stating that complications were arising from the use of these devices but the complications are rare.
Following this notification, implementation of the vaginal mesh devices increased. However, over the next two years, 2,874 new reports of complications associated with surgical mesh devices used to repair POP and SUI were received by FDA.
This caused the FDA to issue a follow-up safety notification in 2011, substantially revising its previous announcement. This time, the FDA reported that serious complications associated with the mesh are not rare and that it is not clear whether Transvaginal prolapse repair with mesh improves the outcome over traditional non-mesh repair in all patients with POP, and it may expose patients to greater risk.
Recent FDA News Release on Transvaginal Mesh Health Risks
The FDA has continued to monitor the effects and safety of surgeries with Transvaginal mesh. On April 29, 2014, the FDA issued a press announcement regarding two proposed orders to address the health risks associated with surgical mesh used for Transvaginal repair of pelvic organ prolapse. If finalized, the orders would reclassify surgical mesh for Transvaginal pelvic organ prolapse from a moderate-risk device (class II) to a high-risk device (class III).
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