The FDA’s recent Safety Alert on the surgical mesh used in pelvic organ prolapse repair surgery has angered surgeons and patients alike.  The report amends an earlier FDA Safety Alert, which stated that vaginal mesh problems were rare.  Now the FDA reports these complications are in fact not rare, and many are severe, life-altering, and in some cases, permanent.  What has patients and surgeons up in arms is that this medical product was never tested for safety in this particular application.  Because it had been tested for use in abdominal muscle repair surgeries, the agency deemed it was safe by association for pelvic muscle repair.  Now that hundreds of thousands, if not millions, of women have been implanted with pelvic mesh, the FDA finally has put data together to show its dangers – and has gone as far as to advise against its use.  Pre-market clinical tests would have prevented the onset of significant health problems from the use of this medical product. More information can be found at www.meshproblems.com.

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This entry was posted on Friday, January 27th, 2012 at 8:04 pm and is filed under . You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.