There have been a lot of media reports (as well as lawyer ads) lately about mesh implants used in gynecological surgery to treat pelvic organ prolapse. What is all the fuss about?
In 2008, the U.S. Food and Drug Administration (FDA) issued a warning about “mesh implants” and “slings” used to treat stress incontinence and pelvic organ prolapse in women. In 2011, the agency issued a stronger warning against the use of mesh implants placed vaginally to treat pelvic organ prolapse. To understand what this all means, it is important to know the history.
History of Mesh Implants and Slings
Conditions and Traditional Treatment
Stress incontinence occurs when women experience leakage of urine with coughing, laughing or physical activity. Pelvic organ prolapse refers to the sagging of pelvic organs, usually the bladder or bowel, through the vagina because of laxity in the vaginal walls.
Traditionally, both of these problems were fixed by repairing the patient’s own tissues or by placing a mesh implant on the back of the vagina through a large abdominal incision, resulting in multi-day hospital stays.
New Procedures
1. Stress Incontinence — In 1995, a “sling” made of synthetic material was introduced to treat stress incontinence. This new procedure offered a minimally invasive approach through the vagina that could be performed on an outpatient basis in about 30 minutes. Extensive studies showed it was as effective as the old approaches, with a much faster recovery time. Most surgeons treating stress incontinence quickly switched to some version of this sling procedure.
2. Pelvic Organ Prolapse — Following the success of the sling for stress incontinence, device manufacturers introduced a new minimally invasive option to treat pelvic organ prolapse, as well: a new synthetic mesh implant placed through an incision in the vagina.
This time, unfortunately, the solution was not so simple. “Erosions” of the new mesh implants became a big problem. Erosions occur when the mesh comes apart from the vaginal wall and then “peaks out” into the vagina, causing pain or bleeding. Studies showed problems with these new implants were occurring at rates as high as 25%, probably because the implant used to treat prolapse was much larger than the slings used for stress incontinence, and the incisions in the vagina were larger, too. Fortunately, most of the erosions could be fixed with simple office procedures, but there were patients who experienced more serious complications.
Making Sense of the FDA Warning
The FDA statements make an important distinction between slings used to treat stress incontinence and mesh implants used to treat pelvic organ prolapse, as well as a distinction between a mesh implant placed vaginally through an incision in the vagina and a one placed abdominally.
The bottom line: the FDA warning refers specifically to mesh implants placed through an incision in the vagina to treat pelvic organ prolapse. Slings to treat stress incontinence and mesh implants placed abdominally through an abdominal incision to treat pelvic organ prolapse are much safer procedures, with low rates of complications. There may still be some indications for the vaginal mesh procedure, but a long discussion with your surgeon should occur before this procedure is considered.
What If You Have Had a Vaginal Mesh Procedure?
Remember that even though the FDA issued a warning about these products, the agency has not taken them off the market. Even in the studies where 25% of women had erosions, 75% of the women did not, and many women have had no problems with these implants. If you are not having any issues, you do not need to do anything about the mesh. Removing it can be very difficult and is likely to damage the surrounding tissues, with no clear benefit. As always, you should discuss your individual case with your physician.
To find an excellent doctor who is right for you, please call our Physician Referral Service at 866.804.1007.