Bladder Slings and Transvaginal Mesh
According to a recent U.S. Food & Drug Administration (FDA) safety communication, surgical placement of bladder slings or transvaginal mesh used to repair pelvic organ prolapse (POP) may pose more risks than benefits to women. The FDA issued an update on the bladder slings and surgical mesh in July 2011.
In January 2012, the FDA ordered all manufacturers of surgical mesh used to treat pelvic floor disorders to conduct three years of clinical trials to determine safety and whether the products provide any benefit over older methods of treatment. A report published in the American Journal of Obstetrics & Gynecology finds one in six women who had mesh implants to repair vaginal prolapse experienced complications within 12 months after surgery.
Reported complications from using the mesh include the mesh becoming exposed or protruding out of the vaginal tissue, pain, infection, organ perforation and urinary problems. Some cases required additional surgery or hospitalization for treatment or to remove the sling or mesh.
Pelvic organ prolapse occurs when the internal structures that support the pelvic organs, such as the bladder, uterus and bowel, become so weak or stretched that the organs drop from their normal position and bulge, or prolapse, into the vagina.
While not a life-threatening condition, women with POP often experience pelvic discomfort; disruption of their sexual, urinary and defecatory functions; and an overall reduction in their quality of life. Surgery to repair POP can be performed through the abdomen or transvaginally, through the vagina, using stitches, or with the addition of bladder slings or surgical mesh to reinforce the repair and correct the anatomy.
The FDA issued a safety communication in 2008 because of mounting adverse event reports associated with the transvaginal placement of the mesh. Since then, the number of adverse events has continued to climb.
Between 2008 and 2010, the FDA received 1,503 adverse event reports associated with the mesh used for POP repair, five times as many as the FDA had received between 2005 and 2007. The reports do not always differentiate between vaginal and abdominal procedures.
In July 2011, the FDA issued a Safety Communication saying the mesh was a continuous serious concern, with nearly 4,000 complaints since 2005, with the number more than doubling in the past two years.