In 2011, the Food and Drug Administration (FDA) issued a safety statement about the use of surgical mesh to treat pelvic organ prolapse (POP). The FDA asked for more studies of the material, especially when used for POP repair. POP can be a serious health problem in which some organs (such as your uterus or bladder) fall into your vagina. This can cause a vaginal bulge and often a sense of pressure or discomfort.
The Urology Care Foundation and the American Urological Association (AUA) are concerned that patients are confused about the use of mesh for prolapse repair versus its use in stress urinary incontinence (SUI) repair. Pelvic organ prolapse and SUI are different health conditions. Surgeries that use mesh to treat these conditions have their own unique risks and benefits.
Dr. J. Christian Winters is president of the Society of Urodynamics, Female Pelvic Medicine and Reconstructive Surgery. Dr. Winters answers patients’ questions on the safety of “vaginal mesh” in SUI repair.
Q: I have heard that vaginal mesh isn’t a safe treatment for stress urinary incontinence (SUI). What do women with SUI need to know about vaginal mesh?
A: Surgical mesh is used to treat a number of health problems, most commonly for hernia repair. In urology, this mesh is often used to treat SUI. SUI is a common health problem. People with SUI leak urine when coughing, sneezing, laughing, or doing other physical activities. One treatment for SUI is “sling” surgery. During this surgery, a sling is placed under the urethra, the tube that carries urine out of the body. The sling gives support to help stop urine leakage. Slings can be made from surgical mesh, one’s own tissue or donor tissue.
All surgeries carry a risk of side effects. The FDA found that long-lasting side effects from treating SUI with mesh seem to be rare.
Q: What does the American Urological Association (AUA) recommend to treat SUI?
A: There are many treatments for SUI, including pelvic floor muscle exercises, lifestyle changes, medical devices and absorbent pads. For some people, these options may not be enough, and they may choose to have surgery. You should talk to a urologist about what options are best for you.
For patients who choose to have surgery, mesh sling surgery is the most common procedure used. It is a less invasive surgery, and patients tend to recover quicker than with the alternative surgeries to correct SUI. (These alternatives are slings using patients’ own tissues and bladder suspension procedures.) The AUA’s guidelines list mid-urethral, mesh slings as a “standard” treatment for SUI. The AUA points to a large number of scientific studies that support the use of mesh slings to treat SUI. For more information on SUI and treatment choices, visit itstimetotalkaboutSUI.org.
Q: Has the FDA “recalled” vaginal mesh for SUI repair or found it to be “defective”?
A: No. The FDA has not “recalled” any mesh slings for SUI repair or asked doctors to stop using it. It is still available for doctors to use in appropriate patients because it has not been found to be “defective.”
To view the FDA’s “Information for Patients with SUI,” which includes a list of questions to ask your doctor, visit the FDA's website.
Q: What if I already have had surgery with mesh to treat my SUI? Should I have the mesh removed?
A: Surgical mesh is designed to be a permanent implant. If you are not having any side effects, there is no need to remove the mesh. When mesh is removed, side effects can occur. These can include injury to tissue near the mesh or repeat incontinence.
If you are thinking about sling surgery, or if you have undergone sling surgery for SUI and have concerns about the use of mesh, the Urology Care Foundation offers this advice:
Before surgery, talk with your urologist about which type of sling (mesh or human tissue) will be used. You should learn what results you can expect and why this surgery is being recommended for you.
Ask your doctor how often they have done this surgery, what training they have and what side effects their patients have seen.
It is important to recognize bad side effects early so they can be taken care of right away. Talk with your doctor about what symptoms (such as bleeding, pain or problems voiding) need immediate attention.
Many side effects of sling surgery for SUI may not be related to the mesh itself. Some problems can happen with non-mesh sling surgeries as well.
Mesh-related side effects from sling placement for SUI repair are usually easier to address than those related to POP repair.
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