Background: Before performing the first face transplant in the United States, the authors addressed several ethical considerations: subject selection, adequacy of informed consent, and risk-to-benefit analysis. Methods: Destruction of the patient's midface, including its bony architecture, had impaired the ability of the authors' patient to speak, eat, smell, and socialize. These functional impairments and the inability of conventional reconstruction to reconstruct this deformity justified considering this patient for face transplantation. The patient's resilience in adapting to her injury, her conscientious self-care following her initial injury, and her ability to understand the risks and uncertainties of the proposed procedure were important factors in selecting her as a candidate for this innovation. To enhance our patient's understanding of this largely untried procedure, the informed consent process occurred over multiple encounters involving both information disclosure and assessment of comprehension of what the procedure involved, including its potential benefits and risks. The patient demonstrated not only understanding of the procedure, including its innovative nature and concomitant uncertainties, but also that its goals were consistent with her values. Results: Research risk-to-benefit analysis involved balancing societal and subject benefits against subject risks. The potential benefit to society and increased knowledge of the role of face transplantation in facial reconstruction were substantial. The subject's benefits had been maximized and harms minimized through subject selection, team expertise, and preparation. This produced a risk-to-benefit profile in which we considered that the benefits sufficiently outweighed the risks to proceed with transplantation in this patient. Conclusion: Ethical considerations were important determinants in the decision to proceed with facial transplantation in this woman.
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