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.]