Last week, I wrote about the tragic case of a young girl in
California who was declared brain-dead after what most media sources called a
tonsillectomy. In fact, the patient had a much more extensive procedure for
treatment of obstructive sleep apnea. In addition to having her tonsils
removed, she underwent a uvulopalatopharyngoplasty
(UPPP) and resection (removal) of her inferior nasal turbinate bones.
As I stated before, I will not speculate on whether the
surgery was indicated or why the patient died because none of the facts about
those two aspects of the case have been disclosed.
Questions have arisen about the informed consent discussion
that may have been held with the patient's mother. We obviously do not know
exactly what was said. However, some have wondered whether the possibility of
death after this procedure was part of the consent process.
The mortality rates for a simple tonsillectomy range from
about 1 in 10,000 to 1 in 35,000. For UPPP, the mortality rate for adults is
generally quoted at 0.2% or 1 in 500. I was unable to find any information
about the mortality rate for that operation in the pediatric age group.
The issue then is—must a surgeon mention death as a possible
outcome after this type of surgery?
According to a medico-legal encyclopedia,
the disclosure of risk depends on two general elements.
Would other doctors have
disclosed the risk of death and would the patient (or family) have made a
different decision if the risk of death had been discussed?
A paper
from Duke University states the following: "In fact, there is no dictum
that death must be included among the risks of every surgical procedure; when
the risk of death is so low as to be unexpected and highly improbable,
including it may actually be misleading." What they mean is that patients
could be unnecessarily dissuaded from agreeing to a procedure they really
needed.
The authors of the Duke paper go
on to say that the question of how high of a risk requires disclosure is
debatable, "but it may range from any chance of death to about
0.1% risk as a reasonable threshold for inclusion." Keep in mind that this
is merely an opinion by three surgeons and a medical oncologist.
An informed consent guideline
from Harvard says, "The type and the number of risks to be disclosed
should depend on the significance the doctor's patient would attach to such risks
in deciding whether to consent to the procedure or treatment. (The court
recognizes that such disclosure does not apply to all 'remotely possibly risks
of proposed treatment' which may be 'almost without limit.')"
The website
of Dr. Erik J. Kezirian, a prominent expert in sleep apnea surgery, has information pertinent to this issue. The surgeon lists a number of complications related to UPPP
including bleeding, infection, difficulty swallowing, tooth injury, and
continued snoring. Notably absent is any mention of death.
I had always heard that adverse
outcomes occurring less than 1% of the time need not be part of an informed
consent discussion. Again, this is only an opinion. There is no agreed upon
standard.
If a malpractice suit is filed, I doubt it will hinge on informed consent, but it is useful to discuss the topic.
What do you think about informed consent and the risk of death?
[Disclaimer: I am not a lawyer and
this is not legal advice.]
