If you are considering treatment options for a fallen bladder, uterus, or vagina, or bothersome stress 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 or stress urinary incontinence.
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 has sometimes 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.
- 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 if for patient information that comes with the product
Reporting Complications to the FDA
Keep this on file:
You can report any problems to the FDA's MedWatch Adverse Event Reporting program either online, by mail, or fax:
- Complete online MedWatch Voluntary Reporting Form 3500
- Mail: MedWatch Forms to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
- FAX: 1-800-FDA-0178
- Phone: 1-800-FDA-1088