The fields of surgery and anesthesia have storied histories with advances in care fueled by innovation by creative individuals striving to take better care of their patients. Advances in surgical technique have led to surgeries considered commonplace today that would have been deemed impossible in the past. For instance, in the nineteenth and early twentieth century, it was considered taboo to even consider operating on the heart, and those that dared to do so were often met with disapproval, and often justifiably so. Of 10 reported cases of surgery attempted for mitral stenosis between 1923 and 1928, eight patients died. Of the two surviving patients, only one benefitted from the surgery [1]. Over two decades later, in 1948, Charles Bailey, having experimented with mitral valve operations on dogs, attempted mitral valve surgery on patients at different hospitals in Philadelphia [2]. His first success came on his fifth patient, after four mortalities, for which he received the nickname the “butcher of Hahnemann Hospital.” Bailey’s first success came while operating on a patient in the afternoon following the death of his fourth patient in the morning at a different hospital. Recounting those events, Bailey noted, “We…promptly drove to Episcopal Hospital to commence the other operation before the morning’s news could be effective in possibly having the Episcopal Hospital administration forbid us from doing the procedure” [3]. This is one of many stories of surgical innovation that provokes numerous ethical questions.

Thousands of patients annually now benefit from mitral valve surgery pioneered in part by surgeons like Dr. Bailey. Regardless, this achievement does not justify the loss of life of the patients Dr. Bailey treated before his surgical technique was successful. While informed consent, as we currently use the term, was not commonplace at that time, it would be interesting to know what information was shared with the patients and their families prior to their surgery. Were these procedures approved by the hospitals? Were the procedures and their implications discussed with the other physicians and healthcare providers involved in the care of these patients? Many of these issues have been addressed to different degrees since the time of Dr. Bailey’s first operations for mitral valve stenosis.

In the United States, patients must now give informed consent before undergoing any procedure, for instance. Yet, other questions remain largely unanswered with ongoing ethical challenges. The care of patients undergoing innovative surgical procedures requires more than the skills of the surgeon alone. Anesthesiologists must provide safe anesthesia for the surgical procedure and care for the patient in the postoperative setting, including sometimes in an intensive care setting. Nurses and other healthcare providers also care for the patient throughout this process. There are no set rules or any guidance on how a surgeon might engage these other crucial members of the surgical (and medical) team in carrying out an innovative surgical procedure. Furthermore, unlike pharmaceutical drugs or medical devices, which are regulated by the Food and Drug Administration, the introduction of new surgical techniques requires no formal oversight. Surgeons must self-regulate the introduction of new surgical techniques. In some instances, surgeons may develop a new procedure as part of a protocol overseen by an Institutional Review Board, but not always [4]. The ethical dilemma lies in determining how to allow surgical innovation to continue for the benefit of future patients while mitigating harm to patients and engaging all parties involved in the process of surgical innovation. This complex undertaking may be approached by considering ethical issues from the perspectives of the key stakeholders in the process of surgical innovation: the surgeon, the patient and the public, the anesthesiologist, the medical device industry, and other members of the healthcare team.