Many women are experiencing a very sensitive, embarrassing problem, and are looking for ways to help it. Their incontinence is out of control, and they are seeking medical intervention. The only problem is that one of the treatment options, transvaginal mesh, may cause more harm than good.
So, if you are considering treatment options for a fallen bladder, uterus, or vagina, or bothersome stress urinary incontinence, you should gather as much up-to-date information as possible. Transvaginal mesh is often used as a treatment to hold up a fallen bladder to treat stress urinary incontinence, but it is important you know the risks involved with this procedure.
The Food and Drug Administration (FDA) issued a Medical Device Safety Alert about reports of complications associated with the placement of mesh through an incision made in the wall of the vagina. The FDA has received more than 1,000 reports from 9 manufacturers.
The most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the fallen bladder and/or incontinence.
Erosion and related vaginal scarring can led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh. Injuries to adjacent organs, such as the bowel, bladder, and blood vessels was also reported to FDA.
The FDA urges women to discuss with their physician the pros and cons of using mesh for their particular stress incontinence problem. It lists 9 areas that patients should definitely discuss with their surgeon before agreeing to surgery.
Tell your surgeon whether you have previously had a reaction to mesh or polypropylene materials.
Our Quick Question Guide
- Ask what the pros and cons of using surgical mesh in your case in particular if mesh is to be used.
- Ask your surgeon what’s been his or her experience with implanting this particular product–and what has been the experience of other patients that the surgeon has treated.
- Ask how your surgeon deals with complications that might arise.
- Ask what changes to expect after the surgery and how long to expect the results to last.
- Ask about any specific side effects that you should tell your surgeon about after the surgery.
- Find out what options you have, if for some reason, the mesh doesn’t resolve your problem.
- Find out what follow-up treatment would be done if you have complications related to the mesh–can the mesh be removed and what would the consequences be?
- If a mesh is to be used, ask for patient information that comes with the product.
The FDA is notifying healthcare professionals about potentially serious complications associated with the surgical mesh, such as vaginal mesh erosion, used to treat pelvic organ prolapse and stress urinary incontinence.
Doctors using transvaginal mesh for treatment of stress urinary incontinence and pelvic organ prolapse undergo training for each of the different placement techniques and should be aware of its risks. Physicians should also be attentive of potential complications resulting from the mesh implant. Some of the adverse issues that require special attention include erosion and infection. There are also serious problems that could result from the tools used during surgery, especially bowel, bladder and blood vessel perforations.
Patients should be adequately informed about the potential for serious complications that could impact their quality of life. These side-effects may include scarring or pain during sexual intercourse. Patients also need to be aware that surgical mesh is permanent and that some complications associated with the mesh may require revision surgery. Even after correctional surgery, the problem may not be solved.
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