Psychosocial considerations in facial transplantation.

The human face and facial transplantation have long captured the interest and imagination of scientists, the media and the lay public. The face is central to our identity, and our communication with the outside world. It is this great importance we attach to our face that makes facial disfigurement such a devastating condition. Facial transplantation could provide an excellent alternative to current treatments for facial disfigurement caused by burns, trauma, cancer extirpation or congenital birth defects. Herein we discuss some of the principal psychosocial considerations which have preceded the clinical introduction of facial transplantation, and which continue today after cases have been performed world-wide.

Clinical considerations in face transplantation.

Severe facial burns cause significant deformities that are technically challenging to treat. Conventional treatments almost always result in poor aesthetic and functional outcomes. This is due to the fact that current treatments cover or replace the delicate anatomical facial tissues with autologus grafts and flaps from remote sites. The recent introduction of clinical composite tissue allotransplantation (CTA) that uses healthy facial tissue transplanted from donors to reconstruct the damaged or non-existing facial tissues with original tissues makes it possible to achieve the best possible functional and aesthetic outcomes in these challenging injuries. The techniques required to perform this procedure, while technically challenging, have been developed over many years and are used routinely in reconstructive surgery. The immunosuppressive regimens necessary to prevent transplanted facial tissue from rejecting (tacrolimus/mycophenolate mofetil/steroid) were developed for and have been used successfully in solid organ transplants for many years. The psychosocial and ethical issues associated with this new treatment have some nuances but generally have many similarities with solid organ and more recently hand transplantation, both of which have been performed clinically for 40 and 10+ years respectively. Herein, we will discuss the technical and immunological aspects of facial tissue transplantation. The psychosocial and ethical issues will be discussed separately in another article in this issue.

Patient expectations in facial transplantation.

Meeting patients' expectations is essential for successful outcomes in reconstructive surgery. In the case of new procedures like facial transplantation that carry with them many unknowns and real, or potential, risk of toxic side effects this becomes especially important. In this study we assessed patient expectations in facial transplantation by surveying individuals with facial disfigurement (n = 34), reconstructive surgeons (n = 45), and controls from the general population (n = 148). Questions focused on quality of life improvement, esthetic and functional outcomes. Student t test was used to compare means of the 3 study groups. All groups projected low quality of life for nontreated disfigured persons, controls responding the most negatively (M = 1.91), followed by disfigured persons (M = 2.91; t = 2.14, P

Plastic surgeon's risk acceptance in facial transplantation.

BACKGROUND: A great deal of ethical debate has accompanied the introduction of facial tissue allotransplantation into the clinical arena. Critics contend that the risks of lifelong immunosuppression do not justify the benefits of this new non-life-saving reconstructive procedure, whereas proponents argue that they do. Absent from this debate are the opinions of individuals with real-life experiences with the risks and benefits associated with this new treatment. METHODS: In this study, the authors question facially disfigured individuals (n = 33) and the reconstructive surgeons who treat them (n = 45), organ transplant recipients (n = 42) and the professionals who manage their immunosuppression medication (n = 37), and healthy volunteer controls (n = 148) to determine the amount of risk they are willing to accept to receive facial tissue allotransplantation. A survey with psychometrically reliable and validated questions was administered to the above five groups, and appropriate statistical analysis was used to analyze and compare the data within and between groups. RESULTS: Of the five groups studied, reconstructive surgeons would accept the least amount of risk for a facial tissue allotransplant, followed by transplant specialists, then kidney transplant recipients, then facially disfigured individuals, and finally healthy control volunteers, who would accept the most amount of risk. CONCLUSIONS: The authors' data indicate that reconstructive surgeons are the least tolerant of risks compared with the other groups studied concerning facial tissue allotransplantation. This is particularly important because they are the primary caregivers to facially disfigured patients and, as such, will be the ones to lead the effort to move this new reconstructive treatment into the clinical arena.

Composite tissue allotransplantation: a review of relevant immunological issues for plastic surgeons.

BACKGROUND: Composite tissue allotransplantation of hand, facial and other tissues is now a clinical reality. The terminology, treatment principles, drug combinations, dosage schedules and mechanisms of the immunosuppression medications on which contemporary transplant surgery is based are unfamiliar to plastic surgeons and most healthcare providers outside the field of transplantation medicine. With this in mind, the purpose of this manuscript is to provide plastic surgeons with a comprehensive and understandable review of key immunological principles relevant to composite tissue allotransplantation. METHODS: We present an overview of the immunological basis of composite tissue allotransplantation aimed at the plastic surgery readership, based on our own experience plus manuscripts sourced from MEDLINE, EMBASE, text books, ancient manuscripts and illustrations. RESULTS: In this manuscript we provide the reader with a brief history of composite tissue allotransplantation (CTA), a concise description of the immunological terminology, treatment approaches, risks associated with immunosuppressive therapy, risk acceptance, and current research avenues relating to contemporary CTA. CONCLUSION: Today, as transplant and reconstructive surgeons join forces to move hand and facial tissue allotransplantation into the clinical arena, it is important that plastic surgeons have an understanding of the major immunological principles upon which this new treatment is based.

Ethical considerations in human facial tissue allotransplantation.

BACKGROUND: Human facial tissue allotransplantation is now a clinical reality. Proponents of this new treatment contend that the benefits outweigh the risks, while the critics argue they do not. This debate has been presented in great detail in the bioethics literature but has not been brought to the attention of the plastic surgery community. METHODS: The purpose of this paper is to provide a synopsis of the key issues being debated in facial transplantation by presenting to the plastic surgery community a synopsis of an ethical debate published in the 2004 summer issue of the American Journal of Bioethics. RESULTS: Presented is a set of ethical guidelines for facial transplantation in the form of a "target article." Alongside this are written commentaries from 15 experts in related fields, along with responses to these commentaries. Together, this discussion makes up a landmark exercise in open display and public and professional discussion and evaluation and serves as a comprehensive list of the major ethical issues being debated today in the field of facial tissue allotransplantation. CONCLUSIONS: Plastic surgeons play a central role in the care of facially disfigured patients and will therefore lead the introduction of facial tissue allotransplantation into the clinical arena. Consequently, it is important that they be aware of, and indeed that they play a key role in forming, the debate surrounding this new treatment. It is with this in mind that we present this synopsis to the plastic surgery readership.

Ethical considerations in face transplantation.

Human face transplantation is now a clinical reality. The surgical techniques necessary to perform these procedures have been used routinely in reconstructive microsurgery for many years. From an immunological standpoint since face and hand contain mostly the same tissues it is reasonable to assume that the same immunosuppressive regimen found to be effective in human hand transplants should also work in face transplantation. It is the ethical issues associated with the risks and benefits of performing facial transplantation that have posed the greatest challenges leading up to performing this new procedure. In this editorial, we will review some of the main events that have led to the recently performed human face transplants, specifically focusing on the key ethical issues at the center of this debate. We will discuss how the research and clinical experience in human hand transplantation laid the foundation for performing face transplantation and describe the research and the ethical guidelines upon which a team at the University of Louisville based their position "to move ahead" in spite of much criticism. Finally we will outline some of the key arguments against face transplantation, and conclude with a discussion on what comes next now that the first human face transplants have been performed.

Risk assessment of immunosuppressive therapy in facial transplantation.

BACKGROUND: Immunosuppression-related risks are foremost among ethical concerns regarding facial transplantation. However, previous risk estimates are inaccurate and misleading, because they are based on data from studies using different immunosuppression regimens, health status of the transplant recipients, tissue composition, and antigenicity. This review provides a comprehensive risk assessment for facial transplantation based on comparable data of immunosuppression, recipient health status, and composition and antigenicity of the transplanted tissue. METHODS: The risk estimates for face transplantation presented here are based on data reported in clinical kidney (10-year experience) and hand transplantation (5-year experience) studies using tacrolimus/mycophenolate mofetil/corticosteroid therapy. Mitigating factors including ease of rejection diagnosis, rejection reversibility, infection prophylaxis, patient selection, and viral serologic status are taken into account. RESULTS: Estimated risks include acute rejection (10 to 70 percent incidence), acute rejection reversibility (approximating 100 percent with corticosteroid therapy alone), chronic rejection (<10 percent over 5 years), cytomegalovirus disease (1 to 15 percent), diabetes (5 to 15 percent), hypertension (5 to 10 percent), and renal failure (<5 percent). CONCLUSIONS: A review of these data indicates that previously reported estimates of immunosuppression-related risks are outdated and therefore should no longer be used. These updated risk estimates should be used by facial transplant teams, institutional review boards, and potential recipients when considering the immunologic risks associated with facial transplantation.

Psychosocial implications of disfigurement and the future of human face transplantation.

Although the first face transplants have been attempted, the social and psychological debates concerning the ethics and desirability of the procedure continue. Critics contend that these issues have not yet been sufficiently addressed. With this in mind, the present article seeks to elaborate on key psychological and social factors that will be central for addressing the ethical and psychosocial challenges necessary to move face transplantation into mainstream medicine. The goals of this article are to (1) discuss the psychosocial sequelae of facial disfiguration and how face transplantation may relieve those problems, and (2) delineate inclusion and exclusion criteria for the selection of research subjects for face transplantation. The article uses concepts from symbolic interaction theory in sociology to articulate a theoretically coherent scheme for comprehending the psychosocial difficulties of facial disfiguration and the advantages offered by facial transplantation. The authors conclude that the psychosocial implications of disfigurement warrant surgical intervention and that research in the area of face transplantation should continue.

Research and events leading to facial transplantation.

Facial transplantation has long captured the interest and imagination of scientists, the media, and the lay public. Facial transplantation could provide an excellent alternative to current treatments for facial disfigurement caused by burns, trauma, cancer extirpation, or congenital birth defects. This article discusses the major technical, immunologic, psychosocial and ethical hurdles that have been overcome to bring facial transplantation from an idea to a clinical reality by providing the reader with a chronologic overview of the research and events that have led this exciting new treatment into the clinical arena.

Abdominal Wall Reconstruction in a Trauma Setting.

According to the World Health Organization "Global burden of disease study", future demographics of trauma are expected to show an increase in morbidity and mortality. In the past few decades, the field of trauma surgery has evolved to provide global and comprehensive care of the injured. While the modern day trauma surgeon is well trained to deal with multitrauma patients with injuries involving several systems, the ever-increasing nature and variety of multitrauma has left lacuna in certain areas. One such area is the management of abdominal wall injuries, which has been the domain of both plastic and reconstructive and general surgeons. The trauma surgeon is adept at treating the contents of the abdomen but not always the container. If not managed properly complications associated with abdominal wall injuries can lead to increased morbidity and mortality. In considering reconstruction of the abdominal wall in multitrauma patients proper evaluation, scrupulous planning, appropriate, and meticulous technique improve the chances for success with minimal complications. In the present article, we provide a brief description of the most commonly used procedures, and more importantly we outline the principles and guidelines applied to abdominal wall reconstruction in order to inform the trauma surgeon of different available treatment options. In doing so, we hope that this review will assist trauma surgeons in their overall care of patients that present with abdominal injuries.

Microvascular Reconstruction of the Upper Extremity.

BACKGROUND: Upper extremity composite tissue defects may result from trauma, tumor resection, infection, or congenital malformations. When reconstructing these defects the ultimate objectives are to provide adequate soft tissue protection of vital structures, and to provide optimal functional and esthetic outcomes. The development of clinical microsurgery has added a large number of treatment options to the trauma surgeon's armamentarium - primarily replantation of amputated tissues and transplantation of vascularized tissues from distant donor sites. Since the early 1970s, considerable refinement in microsurgical tools and techniques together with a better understanding of the anatomy and physiology of microcirculatory tissue perfusion led to the introduction of a variety of thin, pliable and versatile-free flap designs. METHODS: Sources for this manuscript include a comprehensive literature search using the PUBMED and EMBASE databases along with relevant text books, Selected Readings in Plastic Surgery(®), and personal experiences of upper extremity reconstruction and microsurgery. RESULTS: In this manuscript, we describe the primary microsurgical techniques used to reconstruct upper extremity tissue defects and discuss the basis for selecting one technique over another. CONCLUSION: Where possible, the best results may be achieved by reattaching the amputated original tissues (microsurgical replantation). In noninfected, uncontaminated traumatic injuries resulting in composite soft tissue defects, Early free flap reconstruction of the upper extremities has important advantages over delayed (72 h-3 months) or late wound closure (3 months-2 years). In recent years, thin, pliable, and versatile fasciocutaneous flaps such as the anterolateral thigh (ALT) and lateral arm (LA) free flaps have been increasingly used with great success to reconstruct the upper extremity. The use of "spare parts" and functional reconstructions using osteomyocutaneous free flaps or toe to thumb transfers complete the armamentarium of the upper limb reconstructive microsurgeon.

Composite tissue allotransplantation of the hand and face: a new frontier in transplant and reconstructive surgery.

Each year an estimated 7-million people in the USA need composite tissue reconstruction because of surgical excision of tumors, accidents and congenital malformations. Limb amputees alone comprise over 1.2 million of these. This figure is more than double the number of solid organs needed for transplantation. Composite tissue allotransplantation in the form of hand and facial tissue transplantation are now a clinical reality. The discovery, in the late 1990s, that the same immunotherapy used routinely in kidney transplantation was also effective in preventing skin rejection made this possible. While these new treatments seem like major advancements most of the surgical, immunological and ethical methods used are not new at all and have been around and routinely used in clinical practice for some time. In this review of composite tissue allotransplantation, we: (i) outline the limitations of conventional reconstructive methods for treating severe facial disfigurement, (ii) review the history of composite tissue allotransplantation, (iii) discuss the chronological scientific advances that have made it possible, (iv) focus on the two unique clinical scenarios of hand and face transplantation, and (v) reflect on the critical issues that must be addressed as we move this new frontier toward becoming a treatment in mainstream medicine.

Risk acceptance in laryngeal transplantation.

PURPOSE: Advancements in the fields of head and neck surgery and immunology have paved the way for new quality of life-improving procedures such as larynx transplantation. To quantitatively assess the risks versus benefits in larynx transplantation, we used a questionnaire-based survey (Louisville Instrument For Transplantation [LIFT]) to measure the degree of risk individuals are willing to accept to receive different types of transplantation procedures. METHODS: The LIFT contains 237 standardized questions incorporating standard gamble and time tradeoff outcome measures as well as questions assessing body image perception, depression, self-esteem, optimism, socially desirable responding, and demographics. Respondents were questioned on the extent to which they would trade off specific numbers of life-years, or sustain other costs, in exchange for receiving seven different types of transplant procedures. For this study, we questioned 243 individuals in three study populations with differing life experiences: healthy individuals, organ transplant recipients, and laryngectomees. RESULTS: All populations questioned perceived risks differently based on their varied life experiences and would accept differing degrees of risk for the different transplant procedures. Organ transplant recipients were the most risk-tolerant group, whereas laryngectomees were the least risk-tolerant. CONCLUSIONS: By questioning individuals with life experiences directly relevant to the risks and benefits associated with larynx transplantation, this study provides an empiric basis for assessing risk versus benefit in this new quality of life-improving procedure.

Investigation of risk acceptance in facial transplantation.

BACKGROUND: The surgical techniques necessary to transplant a human face are well established, and the early success of human hand transplants suggests that the immunological hurdles of transplanting human facial tissues have largely been overcome. Therefore, it is the ethical barriers that pose the greatest challenge to performing facial transplantation. At the center of the ethical debate is the question, "Do the risks posed by the life-long immunosuppression that a recipient would have to take justify the benefits of receiving a face transplant?" In this study, the authors answer this question by assessing the degree of risk individuals would be willing to accept to receive a face transplant. METHODS: To quantitatively assess risks versus benefits in facial transplantation, the authors developed the Louisville Instrument for Transplantation, or LIFT, which contains 237 standardized questions. Respondents in three study populations (healthy individuals, n = 150; organ transplant recipients, n = 42; and individuals with facial disfigurement, n = 34) were questioned about the extent to which they would trade off specific numbers of life-years, or sustain other costs, in exchange for receiving seven different transplant procedures. RESULTS: The authors found that the three populations would accept differing degrees of risk for the seven transplant procedures. Organ transplant recipients were the most risk-tolerant group, while facially disfigured individuals were the least risk tolerant. All groups questioned would accept the highest degree of risk to receive a face transplant compared with the six other procedures. CONCLUSIONS: This study presents an empirical basis for assessing risk versus benefit in facial transplantation. In doing so, it provides a more solid foundation upon which to introduce this exciting new reconstructive modality into the clinical arena.

Risk acceptance in composite-tissue allotransplantation reconstructive procedures.

Composite-tissue allotransplantation (CTA) is a new therapeutic modality to reconstruct major tissue defects of the face, larynx, and extremities. Unlike most life-saving organ-transplantation procedures, CTA is considered to improve quality of life. Therefore, the question arises, do the risks posed by the immunosuppression drugs that patients must take to prevent rejection justify the benefits of these procedures? The purpose of this study was to assess the relative risk that individuals are willing to accept in order to receive the benefits of CTA procedures. We used a psychometrically reliable and valid instrument to question two primary populations of individuals: those who live with the risks of immunosuppression, and healthy individuals. The level of risk acceptance for the seven transplant procedures tested (foot, single hand, double hand, larynx, kidney, hemiface, and full face) showed significant differences in research participants' risk acceptance for the different transplant procedures, but no significant differences between groups. Based on these findings, we conclude that certain CTA procedures convey benefits to recipients that are perceived by subjects, including individuals who live with the risks of immunosuppression, to warrant the risks of these procedures.

Investigation of risk acceptance in hand transplantation.

PURPOSE: Twenty-four hands have been transplanted in 18 individuals and clinicians continue to debate whether the risks justify the benefits in these procedures. To assess quantitatively the risks versus benefits in hand transplantation we used a validated instrument (Louisville Instrument for Transplantation) to measure the degree of risk individuals are willing to accept to receive different types of transplantation procedures. METHODS: The Louisville Instrument for Transplantation contains 237 standardized questions that incorporate modified standard gamble and time trade-off outcome measures and questions that assess body image perception, depression, self-esteem, optimism, socially desirable responding, and demographics. Respondents were questioned on the extent to which they would trade off specific numbers of life-years or sustain other costs in exchange for receiving 7 different transplantation procedures. For this study we questioned 227 individuals in 4 study populations with differing life experiences: healthy individuals, organ transplant recipients, upper-extremity amputee patients, and lower-extremity amputee patients. RESULTS: All populations questioned perceived risk similarly despite their differing life experiences and would accept differing degrees of risk for the different transplantation procedures. Organ transplant recipients were the most risk-tolerant group whereas upper-extremity amputee patients were the most risk adverse, even when considering a single hand transplant. All groups that were questioned would accept a higher degree of risk to receive a double versus a single hand transplant. CONCLUSIONS: By questioning individuals who have experienced directly the risks of immunosuppression and those who could benefit from hand transplantation, this study presents an empiric basis for assessing risk versus benefit in this procedure.

On the ethics of facial transplantation research.

Transplantation continues to push the frontiers of medicine into domains that summon forth troublesome ethical questions. Looming on the frontier today is human facial transplantation. We develop criteria that, we maintain, must be satisfied in order to ethically undertake this as-yet-untried transplant procedure. We draw on the criteria advanced by Dr. Francis Moore in the late 1980s for introducing innovative procedures in transplant surgery. In addition to these we also insist that human face transplantation must meet all the ethical requirements usually applied to health care research. We summarize the achievements of transplant surgery to date, focusing in particular on the safety and efficacy of immunosuppressive medications. We also emphasize the importance of risk/benefit assessments that take into account the physical, aesthetic, psychological, and social dimensions of facial disfiguration, reconstruction, and transplantation. Finally, we maintain that the time has come to move facial transplantation research into the clinical phase.