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FDA Mesh Alert

22 December, 2011

 

 

mesh eroded into bladder

The very last lecture at the recent CFA Conference in Melbourne was a sobering one from Assoc Prof Christopher Maher reporting on a recent Food and Drug  Administration Alert – the American equivalent of our Australian TGA (Therapeutic Goods Administration) – with regard to the use of vaginal mesh for prolapse. Chris very clearly set out the sequence of events with regard to the alert and also highlighted the importance of establishing a ‘mesh register’ in Australia. The alert was announced on 13th July 2011 in America and the FDA began the process by undertaking a systematic review of the scientific literature followed by public hearings on 9th to 11th September, 2011.

The figures show that 2874 adverse reports were received in the last 3 years (January 1, 2008, to December 31, 2010), and included 1503 reports associated with POP repairs and 1371 associated with SUI repairs. The number of reports associated with POP repairs increased by more than 5-fold compared with the number of reports received in the previous 3 years (January 1, 2005, to December 31, 2007), according to the FDA. (http://www.medscape.com/viewarticle/746285) The most significant findings were that 35% of adverse events related to erosion of the mesh; 31% had pain and dyspareunia in 7.2%. The FDA concluded that mesh placed abdominally had less complications compared to the use of mesh in treating prolapse via a vaginal approach.

Chris stated the responsibility of the surgeons was to ensure that comparative studies be undertaken looking at mesh operations and cautioned that in America litigation was already a reality. There are 38 devices on the market and these should be looked at more closely over the next 2 years to establish their safety and efficacy with patients.

And the relevence for all of us?

Many of my patients are aghast when I tell them that the strategies taught to them at the first consultation and enlarged upon in my book Pelvic Floor Recovery– pelvic floor muscle training, ‘bracing’ or engaging the muscles prior to an increase in intra-abdominal pressure – otherwise known as ‘the knack’ – bladder training techniques, postures for bladder voiding and bowel evacuation and good bladder and bowel habits are FOR LIFE! Some have been known to say I would prefer to just have a quick fix…surgery. There are patients who absolutely require surgery for significant prolapse – but we now have Level 1 evidence that these conservative measures should be the first line of treatment for pelvic organ prolapse and continue throughout a woman’s life. And furthermore now we have cautions regarding complications with some mesh surgery.

So my message is prevention, prevention, prevention. And if you are embarking on surgery be well prepared and well informed.

Finally Kari Bo quoted Albert Einstein in one of her lectures at the conference and I think it very apt to finish with:

Intellectuals solve problems, geniuses try and prevent them’.

So lets all be geniuses!!!

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2 Comments
  1. Mary Egan permalink

    Great post, Sue! Important for women to know that even if they have a mesh repair they have to avoid bearing down FOR LIFE! These repairs often don’t last very long if the woman continues to do things the way she did before. Recently I had a client whose TVT came undone 2 years post-op when she joined an exercise class and did lots of abdominal exercises with bad form- breath holding and abdominal bulging.

    • Hi Mary,
      Sorry- I don’t know how I missed replying to your comment. thank you for replying!
      I think more and more we will be seeing damage to surgery because women are so much more into exercise and fitness these days… But sometimes to their detriment. Getting the message out about avoiding certain exercises, engaging your muscles to counteract downward forces and strengthening pelvic floor muscles is our responsibility. I think with the challenges now with mesh surgery, it will become increasingly important to promote conservative measures.

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