Crossing new frontier: Paving the way to make face transplantation reality
Much is unknown about outcomes for subjects
Even before doctors in France performed a thus-far successful transplant of a partial face in November 2005, experts in the United States had the expertise and knowledge to transplant a face. What they have lacked is the right person to receive the graft.
Katrina Bramstedt, PhD, faculty bioethicist and director, research subject advocate program at the Cleveland Clinic, knows the first American face transplant could take place at her institution tomorrow. Or it could be a year or more away. Her job is to screen potential participants for what is still very much an experimental procedure. And she hopes that just because partial face transplants have been performed in France and, more recently, in China, the public doesn't assume that the procedure has become standard.
"From my perspective, a lot of things get done quicker in Europe, and that includes things like drug studies, than they do here," says Bramstedt. "That simply reflects the regulatory atmosphere, and hopefully [partial transplants in other countries] are not making people think it's a procedure that is ready to do in all cases."
Clinic received approval in 2004
In November 2004, the Cleveland Clinic became the first medical center in the United States to be approved by its institutional review board (IRB) to perform a full face transplant. But the time since has been spent screening potential candidates for the procedure and addressing how to go about finding a donor.
Doctors in France transplanted a chin, lips, and nose onto a woman who'd been bitten by her dog while unconscious from taking an overdose of sleeping pills. In April 2006, surgeons in China grafted a nose, cheeks, and upper lip onto a man who was mauled by a bear several years ago. The Cleveland Clinic team is seeking someone who needs a full face transplant, and has created a procedure it hopes will permit the team to successfully transplant the entire face, ears, and scalp of a brain dead donor onto someone whose trauma or disfigurement has left them with no other option.
Surgeons say it will be some time — perhaps years — before it is known whether the partial transplants in France and China are successful. Skin grafts are more susceptible to rejection than many organ or other tissue transplants and carry a life-threatening — and life-altering — risk. In the event that a face transplant was rejected, Bramstedt points out, the results would be impossible to hide, and the patient could be left in worse condition that he or she was in before.
On the upside, Cleveland Clinic surgeons hope that transplanting an entire face carries benefits, allowing nerves and circulatory vessels to remain intact, compared to partial face transplants that have partial nerves and blood vessels.
If the transplant is successful, it comes with a price. Many ethicists opposed to the idea of face transplants ask if it is appropriate to take a healthy person who is grossly disfigured and turn him or her into someone with an improved appearance but who is rendered chronically ill by the toxic regimen of immunosuppressants that must be taken for life.
Such opposition has led the United Kingdom's Royal College of Surgeons to place a moratorium on the procedure pending further discussion of the risks and ethical issues involved. The 2004 Working Party Report from the Royal College of Surgeons concluded that there were too many unanswered questions regarding facial transplantation to warrant clinical trials at the present time; and that position has not, as yet, been rescinded. The American Society of Plastic Surgeons and American Society of Reconstructive Microsurgery jointly have created a list of guiding principles for surgeons contemplating performing face transplant research. (See table.)
Right subject hard to find
Bramstedt says the perfect candidate for the surgery would have exhausted all other options.
There is, unfortunately, no shortage of people whose disfigurements are extensive enough that a new face would seem a godsend.
"It is amazing what can happen in car and truck accidents; the disfigurement is almost unbelievable," she says.
It is her job to find someone whose life has been ruined by their disfigurement, but yet is psychologically fit enough to recognize the risks and not be blinded by the very uncertain chance of a benefit.
A facial disfigurement is different from any other condition that causes a person to consider a transplant.
"The face is a social organ. Your whole concept of a first impression comes from what you see when you view a person, and you don't have the same reaction when you see someone with a disfigured hand," Bramstedt says.
Assessing a potential subject for a face transplant is different from assessing a potential organ recipient.
"The outcomes are measured differently," Bramstedt continues. "If the labs are off when you have a kidney transplant, you might not notice that, but if your nose is off-center, you'll notice."
Mental health issues become very important when evaluating a potential subject, as body image is a critical factor for the person before and after surgery.
"How have they been affected by their disfigurement? Are they shunned? What kind of support system do they have?" Bramstedt asks.
"This is still very much an experimental procedure. We don't know how it will work; so it's a huge step, and we have to be sure, as much as we can, that the candidate realizes what they are trading in and what the risks are related to the outcome."
The subject's expectations of how he or she will look afterward are explored in detail, with Bramstedt interested in how realistic or unrealistic those expectations are. "Do they misunderstand that this research is standard therapy and we do it all the time?"
One drawback to the worldwide media attention — and reported movie and book advances — surrounding the French woman who received a partial face transplant in 2005 is that Bramstedt occasionally encounters candidates who are interested in the media exposure that would come to the first American transplant recipient.
"If people are interested in being the first, that raises a lot of red flags on their motivation and goals," she says.
Ethicists say candidates for face transplants must understand that they are participating in research for the benefit of science, like participants in clinical trials, and are not receiving traditional medical care.
"I have had discussions with people who are trying to get into the studies for health care; but this is research. We're trying to learn about plastic surgery," Bramstedt says.
Donor faces: New frontier in transplantation
Receiving tissue transplants from deceased donors often has emotional and psychological repercussions for both the recipient and the donor families, though the procedures are common enough that they rarely gain attention outside the immediate circle of friends and family involved.
Face transplants, like the still-new hand transplant, carry additional baggage, experts agree.
Because the face is so closely tied to a person's idea of self, the recipient may have concerns that he or she will look like the donor; the donor's family may either hope or fear that their loved one's face will be recognizable on the recipient.
Researchers say the outcome is likely to be something in between.
"We educate [potential subjects] that their facial structure now will determine how they would look afterward," says Bramstedt. "They won't look like the donor."
Bramstedt explains that while it is not considered unethical to take tissues or organs from a consenting donor, some people question whether it is ethical to take a face.
"We talk with research subjects about how they feel about it — about how they would feel about receiving so much tissue, and tissue from the face," she says.
For example, some hand transplant recipients refuse to look at or touch their new appendage. The same could be true of face transplant recipients, Bramstedt says.
"We want the person [receiving the graft] to look at that face, and be able to emotionally do it," she points out.
Doctors are also concerned that the recipient understands the heavy responsibility that comes with the procedure. In addition to the lifelong commitment to taking immunosuppressants to help ward off rejection, the recipient would have other lifestyle changes to consider.
Experts everywhere — including the physicians who worked on the woman in France — were dismayed when the first face transplant patient resumed smoking before she even left the hospital, threatening the oxygen supply to the graft. Bramstedt says it's no different than making sure a potential liver recipient, whose own liver was damaged by alcohol abuse, abstains from drinking when he or she has a new liver.
Delving into a potential candidate's lifestyle and mental health are crucial not only for the success of the operation, but also to help increase the chances the patient will survive. Researchers are aware that if early attempts at the procedure fail, and the results are that recipients die or are even more disfigured than before, support for further attempts would plummet.
Seeking donors for partial or full face transplant is another unexplored area. U.S. tissue and organ transplant protocols do not address taking donors' faces. Families and potential donors who might have no problem with donating corneas, organs, and other tissues that would not noticeably disfigure a corpse know that removal of the face would inevitably result in a disfigured body and require a closed casket.
Some experts are concerned that potential organ donors might fear that if they sign an organ donor card, they will be automatically donating their faces upon death, and that those fears might cause people to avoid signing donor cards or to tear up donor cards they already have.
The United Network for Organ Sharing, which administers the nation's only organ procurement and transplant network, has no specific provisions for matching facial tissue donors and recipients. The McLean, VA-based American Association of Tissue Banks, the accrediting body for tissue banks in the United States, does not specifically address donation of facial tissues in its universal donor card, but does include space for donors to specify limitations or special wishes, which could be used to specifically donate or opt out of donating facial tissues.
Bramstedt points out that key to the debate over the risks and rewards of this research is that it "is not lifesaving surgery."
"If you need a liver, you need a liver to live," she says. "This is not surgery to preserve life or health."
The Chicago-based American Society for Reconstructive Microsurgery (ASRM) agrees. In its position paper on the ethics of facial transplantation, ASRM urges that "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."
"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 ASRM paper continues. "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."
Even before doctors in France performed a thus-far successful transplant of a partial face in November 2005, experts in the United States had the expertise and knowledge to transplant a face. What they have lacked is the right person to receive the graft.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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