Maria Siemionow, MD, PhD, DSc—who is gearing up for the first full facial-skin transplant—speaks with PSP

If all goes as hoped, 2006 could well be the year that Maria Siemionow, MD, PhD, DSc, at long last gowns up, dons a pair of surgical gloves, strides confidently into the operating room, and earns her place in history by performing the world’s first successful facial resurfacing of a disfigured patient, using skin donated from another human being.

Siemionow will take this bold step in transplantation science at The Cleveland Clinic, where she is director of plastic surgery research. The clinic green-lighted the surgery more than a year ago, after Siemionow and her team convinced the renowned institution that facial-skin transplantation was more than theoretically feasible.

Facial-skin transplantation entails harvesting, as one single flap, all of the skin above the clavicle—along with fat layers, nerve tissues, and blood vessels—from a donor cadaver, then attaching the flap to the recipient’s face (after the damaged skin has been removed) and revascularizing it. Siemionow hopes that the procedure will eventually supersede the current method of rectifying severe facial disfigurement caused by burns and other forms of trauma, which is to resurface the patient’s face with skin culled from an undamaged part of the patient’s own body. This approach, unfortunately, often yields a less-than-satisfactory aesthetic result, and an even poorer one with respect to functionality.

Polish-born Siemionow graduated from the medical school in her hometown of Poznan in 1974 and subsequently pursued hand-surgery training in Finland and the United States. She has been preoccupied with the possibility of transplanting facial skin since the earliest days of her reconstruction-focused career.

Naturally, what Siemionow is proposing has provoked an intense ethics debate: Some surgeons and ethicists, for instance, contend that transplantation in general should be a procedure undertaken only when it would save a patient’s life—and that, in this instance, the “only” thing to be gained is the enhancement of that life, not its rescue from the jaws of death.

Siemionow was kind enough to sit for an interview with Plastic Surgery Products. She talked about the development of her facial-skin transplantation procedure and offered a defense to its critics.

Plastic Surgery Products: Where do things currently stand with your plans to conduct the procedure for the first time?

Siemionow: We are still in the process of identifying and interviewing patient candidates. We have not yet made the final selection.

PSP: How are you finding these prospects?

Siemionow: This has not been a situation in which we are soliciting candidates. Since the announcement of our plans for this new surgery, several people have come forward and approached us about being considered as the first patient. They have sent us their medical records, and we have been evaluating those.

PSP: When do you expect to make a decision and set a date for the first surgery?

Siemionow: There is no timetable for this process.

PSP: What are the criteria on which you’ll be basing your decision to select that initial patient?

Siemionow: The inclusion–exclusion criteria are part of our proprietary protocol, which I am not at liberty to discuss at this time. However, I can say that the candidates are individuals—such as burn victims—who have previously gone through as many as 30 to 50 reconstructive procedures of the face, none of which has resulted in restoration resembling anything close to what we would recognize as a normal face.

Not a “Face Transplant”

PSP: We’ve been using the nomenclature of facial-skin transplantation in talking about your new procedure, but in the consumer press it’s being called a “face transplant.” What’s the proper terminology?

Siemionow: “Face transplant” gives a false impression of this procedure. It makes it sound as though we are taking one person’s physical identity and giving it to someone else. That’s not what this is.

PSP: Let’s set the record straight then.

Siemionow: The more appropriate nomenclature is to call this a “facial resurfacing,” because what we contemplate is the resurfacing of the facial deformity with a skin envelope.

PSP: That said, what brought you to this momentous innovation? What led you to even consider attempting it?

Siemionow: For more than 20 years, my work has dealt with tissue allografting in experimental scenarios to help patients with severe trauma injuries. So this is not something that came about overnight. I first wrote about the possibility of using these techniques on a larger scale for facial resurfacing 5 years ago.

PSP: How easy or difficult was it to persuade The Cleveland Clinic to support this endeavor, given its controversial nature?

Siemionow: Because the procedure is one that has never before been performed, it was looked at very closely by The Cleve­land Clinic’s Institutional Re­view Board. Naturally, there were a lot of questions about it—about the science—and a great deal of debate. Ultimate-ly, the board agreed that the procedure had clear merit, could be performed safely, and therefore should be attempted.

PSP: At the American Society of Plastic Surgeons meeting last September, you said that you were unable to perform as many animal studies as you might have liked for want of funding. Can you elaborate?

Siemionow: This type of groundbreaking work requires a lot of research in the form of collaborative studies, which becomes very expensive very quickly. Because of these costs, it can be difficult to secure all the support needed from funding agencies, and that is what I was addressing. How­ever, enough funding was provided to allow me to produce sufficient evidence of the procedure’s potential viability and to develop the necessary protocols.

PSP: One of the things that has been made known about this new procedure is your intention to use minimum levels of immunosuppression drugs. Discuss that, if you will.

Siemionow: I’m very concerned about the patient’s need to take immune-system-suppressing drugs for the rest of his or her life to prevent rejection of the donated skin envelope. It is our goal to introduce new protocols that will be safer for patients and will require using the lowest possible amounts of those drugs. I have developed a tolerance-inducing protocol for composite-tissue allograft transplants, and we are introducing it currently in a clinical trial of solid-organ transplants.

Life Expectancy

PSP: What is your sense of the life expectancy of a successfully performed facial-skin transplant?

Siemionow: We can only base our expectations on the experiences with composite grafts of the human hand, which, in bilateral hand transplants, is a skin component almost as large as that of the face. The first of these hand procedures was performed in 1998; since then, there have been 24 additional cases. To date, there has been only one case in which the patient’s body rejected the transplanted skin, and that was because he stopped taking the immunosuppression drugs.

PSP: How likely is it that the patient will regain facial animation following surgery using this new approach?

Siemionow: That’s going to depend on how much animation of the face the patient has to start with. Bear in mind that the candidates for this procedure are patients who have already received multiple skin grafts over the years, and it is those grafts that now preclude much of the animation. The skin grafts are stuck to the muscles, and that’s why those muscles are not working as they should.

PSP: Does your procedure entail transplantation of donor muscle in addition to skin?

Siemionow: No. Only the skin and subcuteaneous tissues will be transplanted. Removal of the recipient’s facial muscle to make way for replacement with donor muscle is not a part of our protocol.

PSP: How do you plan to harvest the facial skin and then revascularize it?

Siemionow: The basics of the procedure are the same as for any microsurgery. We take the flap vessels and nerves, then reconnect them. But I don’t want to oversimplify this—facial resurfacing promises to be a very challenging form of microsurgery that will require innovative dissection techniques and very precise bleeding control. We’ve tested these to some extent on cadaver specimens and feel that we have a very good sense of how these techniques can best be employed.

PSP: How long do you expect to spend in the operating room when you perform this procedure?

Siemionow: About 15 hours.

PSP: Do you have any concern about ischemia, given that amount of operating-room time?

Siemionow: No. We will be using standard preservation techniques, and those should be more than adequate. If we were also harvesting and transplanting muscle, that length of time might be problematic, but we’re not, so it isn’t an issue.

PSP: What is your recourse in the event that the flap fails acutely while the patient is still on the table?

Siemionow: We have a rescue plan at the ready. Should the flap fail, we will cover the patient with skin grafts in the same way he or she was covered before.

Realistic Expectations

PSP: The patient who receives this historic first facial-skin transplant will have certain expectations about the outcome. But because the procedure has never been done before, you obviously can’t show the individual any photos to provide a sense of how the face will look. What are you doing to manage expectations and prevent them from becoming unrealistic?

Siemionow: That has long been part of the process, beginning with the evaluation of candidates. Importantly, we have taken a multidisciplinary approach, bringing in specialists from other fields—including psychology—and involving the candidates and their families with support groups. However, even though this marks the first time the patient will undergo this form of skin resurfacing, it will not be the first facial-reconstructive procedure he or she has received, but possibly the 50th.

In other words, we are not talking about a patient who was just injured yesterday. He or she will have been through reconstructive surgery enough times to know what to expect. Accordingly, I don’t believe that we will have any problem with unrealistic expectations.

PSP: Is there a role for stem cells in the facial-resurfacing process?

Siemionow: I don’t think so. But who knows? Maybe in the future there could be.

PSP: Do you envision this procedure someday becoming covered by insurance?

Siemionow: Perhaps. That is something we are working on even now. The idea is that this one transplant procedure would replace the need for the multiple skin-grafting procedures that are now common. Insurance companies may find this more economical in the long run, even if the patient has to take expensive immunosuppression medications for life. There could also be lower overall costs for insurance companies, employers, and taxpayers if the procedure proves successful in moving the patient off of the disabled worker rolls and back into a productive life.

PSP: You’ve told us what you could about the criteria for choosing your patients, but what about the donors? What can you share about the criteria for their selection?

Siemionow: We’ll be using procedures for identifying donors very similar to those long used for identifying donors for organ transplants and other types of transplantation cases.

PSP: Assuming that all this works as projected, could there one day be waiting lists of patients who want to receive facial-skin transplants, much as there are waiting lists now for kidneys and other transplantable organs?

Siemionow: I’m sure there will be, and for the same reasons. But it would be nice if the waiting list for facial-skin donations is only a short one.

PSP: This is a reconstructive procedure. Do you see it ever having application in aesthetic plastic surgery?

Siemionow: I don’t think so. Just the fact that the patient will require a lifelong regimen of immunosuppression drugs would make it wholly unsuitable for use by aesthetic practices.

PSP: Your planned new procedure has come under fire because of the ethics of performing it; that is, the use of transplantation to enhance quality of life rather than to save life. What is your response to the critics?

Siemionow: First, let me say that there is nothing wrong with giving these facially deformed patients a better quality of life. These are people who live as recluses, afraid of venturing out in public because of the reactions that their deformity will engender. This procedure also is challenged because of the potential for rejection of the transplanted tissue, as well as for the patient to suffer side effects from the immunosuppression drugs.

My response to that is to ask the critics how this is materially any different from the situation with a patient who receives a kidney transplant. A new kidney similarly enhances a patient’s quality of life by discontinuing dialysis—therein too is the risk of organ rejection as well as the risk of medication side effects.

I believe that, when all is said and done, we should allow the patient to be the one to decide whether this is right for him or her. I believe that is the most ethical way to proceed. PSP

Rich Smith is a contributing writer for Plastic Surgery Products.

One Surgeon’s Perspective

by V. Leroy Young, MD, FACS

Many medical advances are accompanied by controversy. Those of a certain age remember the furor that surrounded the first human heart transplant, performed by Christiaan Barnard, MD, in 1967. Now a widely accepted surgical procedure backed by decades of success, early heart transplants were viewed by many as a form of sacrilege: The heart was not simply a pump; rather, it was the source of human emotions and even the seat of the soul.

Facial transplantation, more accurately termed “facial resurfacing” by Maria Siemionow, MD, PhD, DSc, is raising questions of personal identity not unlike the emotion-filled heart transplant of nearly 40years ago.

The debate surrounding facial resurfacing correctly encompasses the risks inherent in taking immunosuppressive drugs for life when the transplantation is not a life-saving procedure. Plastic surgeons are keenly aware that most people with severe facial disfigurement suffer greatly; and reconstruction to correct profound facial deformities can restore quality of life, which matters considerably.

In this interview, Siemionow outlines some of the protocols put in place at The Cleveland Clinic in anticipation of the first full-facial-resurfacing procedure ever performed. Obtaining informed consent for a new experimental procedure is tricky, but she and her multidisciplinary team of colleagues seem to have given this matter long and deep thought. Patient selection will be guided by many factors, including whether current reconstructive techniques would work just as well, whether these techniques can achieve a relatively normal appearance and improved functionality, and whether the patient’s psychological state can handle the challenges ahead.

The most serious risks involved in facial-skin transplantation are rejection and the long-term use of immunosuppressive drugs, which may shorten the patient’s life. As Siemionow says, the patients are the ones who must decide whether these risks are worth the benefits.

When Barnard performed the first heart-transplant surgery, he did not inform the hospital administration in advance, let alone ask for permission or review. Now that the first facial-skin transplant has been performed in France, the genie cannot be put back in the bottle. Fortunately, Siemionow’s team seems to have developed multiple layers of patient-safety measures and thoughtful protocols before they choose their first patient for facial-skin transplantation.

V. Leroy Young, MD, FACS, is a prominent aesthetic and reconstructive plastic surgeon in St Louis. He is affiliated with Barnes-Jewish West County Hospital. He chairs or serves on numerous committees of the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery. He can be reached at (314) 628-8200.