Battling the Chimaera: How Much Disclosure of Rare Risks Is Necessary?

The authors debate how much information should be included in the informed consent, and they use the case of resistant Mycobacterium chimaera found in the LivaNova PLC Stockert 3T heater-cooler system as a case-in-point. The issue raised specifically by this case is whether institutions that use this specific heater-cooler system are obligated to inform the patient of the specific risks of infection with resistant M chimaera. The publication is very informative, and the scope of the debate focuses on the purpose of informed consent, the legal obligation, and how narrow or broad the consent need be. It should not be surprising to anyone that there are no straightforward answers.