Highlights from AUGS Informed Consent Toolkit
Some Highlights from the AUGS Informed Consent Toolkit, September 8-9, 2011
- “At this time, AUGS does not support the routine use of transvaginal mesh for the repair of POP.”
- “Given the potential risks, AUGS suggest future placement of transvaginal mesh for POP repair should be judicious and be performed only by surgeons with appropriate training, including extensive training in pelvic surgery, and who are in practices with high volumes of these procedures and are able to track short-and long-term outcomes – both objective and subjective.”
- “A complete and comprehensive informed consent process which clearly identifies the risks and benefits of all available treatment options, including a detailed consent form, is necessary. AUGS recommends a consent process that informs patients of non-surgical treatments, alternative native tissue surgical repairs, and abdominal repairs. If transvaginal mesh is deemed necessary, the surgeon must review possible adverse outcomes associated specifically with the use of mesh for the vaginal repair of prolapse as part of the informed consent process.”
- “AUGS recommends that FDA invoke its power under section 552 of the Act to require post-marketing surveillance for existing and future transvaginal mesh devices for POP repair.”
- “Mesh procedures are subject to unique complications that are not seen with non-mesh procedures.”
- “AUGS supports mandatory premarket clinical trains for transvaginal mesh for POP.”
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.”