Royal College Issues Revised Guidelines for Face Transplantation

In the light of new information on facial transplantation—including the psychological and ethical aspects of the controversial procedure—a Working Party of the Royal College of Surgeons of England now endorses moving cautiously forward in performing further face transplants, according to a report published in the Jan. 27 issue of Transplantation.

In its initial report in 2003, the Working Party concluded that facial transplantation should not be attempted until further research was done to define the risks. The new report cites several new developments since then—most significantly, the encouraging results of a partial face transplant procedure performed by a French surgical team. The panel also notes progress in experimental studies of facial transplantation and more follow-up information on patients undergoing hand transplantation and other types of "composite" transplant procedures.

The past few years have also seen "a deepening understanding of the potential psychological problems of facial transplantation as well as a very considerable debate on the ethical aspects of the procedure." The new report states, "[T]he working party now accepts its inevitability but endorses the urgency of establishing sound ethical principles" for performing face transplants.

As in 2003, the technical skill to perform face transplantation is not at issue. Rather, the obstacle is the high risk that the recipient's immune system will reject the transplanted tissues. Recipients require lifelong immunosuppressive drug treatment to prevent rejection. Updated experience with hand transplants, as well as the French face transplant recipient, suggests that close monitoring and treatment adjustments can head off problems with acute rejection. However, the risks of chronic (long-term) rejection remains unknown—based on experience with other types of transplants, a 30 to 50 percent risk seems "a reasonable estimate."

The report cites the many psychological issues that face transplant recipients must confront, including unrealistic expectations, the risk of devastating transplant failure, and the reactions of others to their altered appearance. Face transplantation also entails a host of social issues—including "invasive press interest and publicity," as demonstrated by the French case.

The panel reiterate their concerns about the ethical aspects of face transplantation, including the difficulty of obtaining valid patient consent when the risks of the operation are simply unknown—the "Catch-22" of needing to proceed with research in order properly to establish the risk of an experimental procedure.

To address these concerns and provide protections for patients, the report lists recommended standards for any surgical team contemplating a facial transplant procedure. Of course, the surgeons and hospital must have the skill and ability to provide optimal surgical and medical care. There must be set procedures for patient selection, as well as for presenting the risks in a way that allows patients to make a true informed decision.

Expert psychological care must be provided for patients before and after transplantation—including arrangements for long-term psychological support, whether the procedure is a success or failure. The guidelines also call for care and support for family members of both the transplant donor and recipient.

Adequate long-term funding for all aspects of care must be provided, without compromising care for other patients in need. The recommendations also address concerns about the availability of independent experts, who should be included on the review committees that will consider applications for facial transplant procedures. "If all of these requirements are met, review committees might reasonably take the view that individual patients may proceed with facial transplantation in an appropriately regulated research setting," the Working Panel concludes.

We hope that the second edition of our report, including the minimal requirements we define, will allow face transplantation to progress in a rational way that protects the interests of vulnerable patients," comments Sir Peter Morris of the Royal College of Surgeons of England and the Centre for Evidence in Transplantation, London School of Hygiene and Tropical Medicine. "Face transplantation raises a number of complex medical, ethical, and psychological issues, and we encourage others both inside and particularly outside the transplant community to review and comment on our review and recommendations."

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SRM