FDA warning fuels debate: Mesh use in vaginal prolapse surgery


Pelvic organ prolapse is a common problem that I see daily in my office.

I start my management by counselling my patient about all her available options. This usually includes a discussion about conservative management, behaviour modification, pessary trial and surgical options.

For surgery, there has been a debate between “mesh-supporters” and “mesh-avoiders”, as I like to call them. In a nutshell, using mesh increases complications and avoiding mesh increases failure.

In my opinion, the core of the discussion should always remain: what is the right option for the patient that will maximize benefits and minimizes risks? The question is easy to formulate, the answer remains more complicated.

During my training, I only learned the traditional mesh-free surgery. I also learned the arguments for and against mesh surgery.

In June 2011, I was invited to a workshop in Halifax on the application of Elevate® Anterior and Posterior Prolapse Repair Systems by American Medical Systems (AMS). This is one of many available mesh systems.

In July 2011, still before I book my first patient for the procedure, the U.S. Food and Drug Administration (FDA) released a Safety Notification regarding the use of vaginal mesh for the repair of prolapse identifying this as an area of “continuing serious concern.” Since then, the debate has fueled.

This is the second time FDA tackles mesh. In Oct. 2008, the FDA released a Public Health Notification regarding the use of mesh for the treatment of prolapse and incontinence. The report was criticized by mesh-supporters for reasons that I find valid.

The new report focuses only on prolapse treatment and states that:

  1. Mesh use is not proven to provide improved outcomes when compared with native tissue repairs
  2. Serious complications with mesh use are not rare

The American College of Obstetricians ad Gynecologists (The College) responded by advising all its fellows to read the 2011 FDA Safety Notification. The College notes that “given the limited data and frequent changes in the marketed products for vaginal surgery for prolapse repair (particularly with regard to type of mesh material itself, which is associated with several of the postoperative risks, especially mesh erosion), patients should consent to surgery with an understanding of the postoperative risks and complications and lack of long-term outcomes data.”

I like what Dr. Rebecca Rogers said in her Green Journal editorial published ahead-of-print (October 2011):

As surgeons, we want to be neither dinosaurs who are out of date with current therapies, nor cowboys, jumping on the bandwagon of new therapies the minute they become available, particularly when clinical data do not exist to inform our decisions.

At this time, we should offer our patients a detailed discussion of the risks, benefits and alternatives to the best of our knowledge with current available data. The patient will then be able to make a well informed and educated decision.



Categories: Health

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