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FDA: Serious Complications of Transvaginal Mesh For Fallen Bladder, Stress Urinary Incontinence

By November 6, 2009

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:

  1. Tell your surgeon whether you have previously had a reaction to mesh or polypropylene materials.
  2. Ask what the pros and cons of using surgical mesh in your case in particular
  3. 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.
  4. Ask how your surgeon deals with complications that might arise.
  5. Ask what changes to expect after the surgery and how long to expect the results to last.
  6. Ask about any specific side effects that you should tell your surgeon about after the surgery.
  7. Find out what options you have, if for some reason, the mesh doesn't resolve your problem.
  8. 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?
  9. 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:

Related Resources

Video on Stress Urinary Incontinence.

Comments
November 6, 2009 at 7:43 pm
(1) Lisa says:

What are polypropylene materials? (sp?) Are they in the vinyl/polymer category? Do we want them in our mouths or on our hands, much less in our nether parts?

I love your questions to ask of your doctor or surgeon. But in my experience it can be difficult to ask questions to the back of the head of a physician leaving the examining room, and like pulling hens’ teeth to get a post operative report on what actually occurred during surgery.

But rah rah, do more of these.! We (women) are supposed to be so stoic and passive.

November 7, 2009 at 12:36 am
(2) Nancy says:

As I age, I greatly fear a prolapsed bladder. When my mother was in her nineties, this was a huge problem and surgery was too risky at her age. I’m committed to fixing the problem as soon as I develop symptoms, so I can avoid the situation she found herself in. For those reasons, I found this article very interesting.

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