The toolkit is a lengthy document (AUGS Informed Consent Toolkit.)
AUGS issued this statement after the FDA, in July 2011, announced a five-fold increase in the number of reported adverse events (AE) after mesh was used in the treatment of prolapse repair. The 1,503 complications included erosions, pain, bleeding, infection, organ perforation, urinary problems as well as three deaths (two from bowel perforations and one from hemorrhage. The AE reports were made into the FDA’s MAUDE database (Manufacturer and User Device Experience) which is believe to represent a small percentage of real-life AE.
In 2010 there were an estimated 75,000 transvaginal mesh procedures. Surgical mesh continues to be used to today in the treatment of pelvic organ prolapse and for incontinence.
Another interesting read comes from The American College of Obstetricians and Gynecologists. The group’s publication Number 49 from August 2009 is entitled “Informed Consent” (here).
And among the goals outlined says “seeking informed consent expresses respect for the patient as a person.”
The goals are admirable. A surgeon is reminded that it is an “ethical requirement” to seek informed consent and that it should be seen as a process rather than a “signature on a form.”
At the annual meeting of the American Association of Gynecologic Laparoscopists (AAGL), two leading urogynecologists debated the use of pelvic mesh versus native tissue repair in surgery.
In this Mesh News Desk podcast, Dr. Donald Ostergard talks about how to find a doctor to do pure tissue repair rather than use polypropylene mesh, tests, and treatments for SUI.
Why have hernia surgeries with mesh become the most common repair for 95 percent of procedures? Dr. William Brown weighs in on this Hernia Mesh Insights podcast.