FDA Warns of Serious Complications Due to Transvaginal Mesh Procedures July 9, 2012

Women who have undergone transvaginal mesh procedures have reported an increasing number of complications and transvaginal mesh side effects, federal government statistics suggest. The United States Food and Drug Administration (FDA) reports having received 2,874 reports of problems associated with surgical mesh used to repair pelvic organ prolapse and stress urinary incontinence from 2008 through 2010.

Surgical mesh products are implanted to provide support for a woman’s organs in the pelvis, which drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. In extreme cases, the vagina can even fall to the point where it is pushedoutside of the body.

However, the FDA warns that serious complications could happenbecause of the this type of procedure. The FDA goes on to say “That serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.”

Also, according to the FDA, women may have several side effects associated with having transvaginal mesh surgery done. Here are some of the more common side effects reported by transvaginal mesh patients:

• Recurrence of POP
• Severe vaginal and pelvic pain
• Painful intercourse
• Irritation
• Infection
• Vaginal bleeding
• Vaginal Scarring
• Narrowing of the vaginal walls
• Urinary issues
• Incontinence

Since the FDA had received such a high amount of reports regarding transvaginal mesh injuries, a more thorough review of the overall safety profile of the mesh implants used from 1996 through 2011 was begun. The conclusion was that, although the mesh implants appeared to have few risks when used in other parts of the body, the use of the mesh in the pelvic region posed very specific threats to patients. Further, the FDA noted that there were few benefits to using the mesh implants over other more traditional surgical methods which do not use mesh. Many women affected have already begun to file a Vaginal Mesh Lawsuit against the manufacturers of the product.

References:

fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm
naturalhealthnews.blogspot.com/2009/03/transvaginal-mesh-and-womens-health.html