The United States position: position paper of the American Society for Reconstructive Microsurgery on facial transplantation.

Composite tissue allotransplantation (CTA) has been performed on a limited basis clinically since 1992. Transplants of nerve, tendon, joint, larynx, tongue, hand, and, most recently, abdominal wall have been reported on just a few cases. The functional and aesthetic outcomes of these transplants have exhibited variable degrees of success. The greatest experience in CTA has been in the hand, with over 18 cases reported worldwide. The outcomes of hand transplantation have been found to be similar to replantation at equivalent levels.

Common to most cases of CTA is the need for ongoing immunosuppression with the attendant adverse consequences of systemic drug toxicity on lung, kidney, hematopoetic, immunologic, and endocrine systems with increased risks for neoplastic disease, metabolic disorders, and opportunistic infection. Despite recent novel approaches in immune suppression, tissues that undergo CTA exhibit chronic rejection with progressive degradation which is most visibly apparent in the integument and vascular systems. The effects of chronic rejection on long term CTA function and survival have not yet been determined.

Recent experiences in CTA have prompted the proposal of facial transplantation as an alternative approach to treating the facially disfigured. Several centers in the US and abroad have established institutional protocols for facial transplantation. The technical issues surrounding facial transplantation are generally touted as being solved although very little data exist to support this conclusion. If one examines the results of the three reported cases of facial replantation, which provide our best means for objective comparison, the functional and aesthetic results are quite mixed. Anatomic and vascular injection studies suggest that a donor transplant should include the skin, subcutaneous tissue, and SMAS facial musculature system with at least two adjacent vascular choke territories to supply the total facial transplant. This is at variance with proposed facial transplant models that call for skin and subcutaneous tissue only in the transplant, and would accordingly result in an inanimate facial mask. Restoration of animation in the transplant has not been addressed from a functional perspective. Should the transplant be animated using the recipient's facial nerve? If not, will the patient's intrinsic facial musculature be sufficient to animate the composite transplant? The answers to these questions are highly pertinent and as of yet, unknown.

Public debate has given rise to meaningful concerns regarding the known issues of chronic immunosuppression and rejection of the facial transplant. How might the facial transplant change under conditions of chronic immunosuppression and rejection? What would be the consequence of a transplant failure? Is failure acceptable? Can a patient, under these circumstances, engage in informed consent? The answers to these questions are unknown.

The ethics of facial transplantation go beyond the life and death issues common to most transplants and engage other topics that heretofore have not influenced medical decision processes. The face represents the most identifiable aspect of an individual's physical being and is central to communication. One might expect that a facially deformed patient is markedly impaired, but most studies confirm that the severity of deformity does not necessarily correlate with distress. Most patients with facial deformity adapt quite well and accept their physical appearance as "self." The psychology of acquiring another person's identity is very complex; the psychology of losing that newly acquired identity can only be imagined. Similarly, the psychologic repercussions of a facial transplant on family and friends of both donor and recipient cannot be underestimated. The ethics of inflicting an untried, and potentially fatal or deforming remedy for the purposes of advancing science must be carefully weighed against the Hippocratic credo of doing no harm. Those against facial transplantation argue that the desperation of disability never justifies the infliction of a hopeless remedy. Proponents of facial transplantation argue that selected patients who seek improvement in their quality of life in certain circumstances are prepared to assume risks to achieve it. Answers to these ethical issues can be easily manipulated to comport with most viewpoints. In the final analysis, however, ethics must be regarded as a means for discussing the issues of facial transplantation and not, necessarily, for resolving them.

The 2004 Working Party Report from the Royal College of Surgeons in England concluded that there were too many unanswered questions regarding facial transplantation to warrant clinical trials at the present time. Clearly, facial transplantation is a procedure that has considerable potential for improving the lives of the facially disfigured. Given the current limitations, however, proceeding with a full-scale clinical effort poses great risk for stifling meaningful progress. At the least, further research and progress in CTA transplant immunology is warranted to address the outstanding issues of chronic rejection and patient safety.

In summary, facial transplantation is a procedure that carries unknown risks and benefits. Presently, there are insufficient data available upon which to estimate risks and obtain informed consent regarding physical and psychologic safety of the procedure. It is appropriate, therefore, that those involved in this important work move forward in incremental steps with particular emphasis in improving transplant immunology and critically analyzing the long-term results of CTA from a functional, aesthetic and psychosocial perspective.

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Made public January 25, 2006.