For Face Transplant Patients, Selection Criteria Could Stiffen in Future Selection criteria for face transplant patients may tighten up in the future.

May 22, 2009 -- It's a procedure so rare that only a handful of surgeons worldwide have any experience with it. Patients are rarer still.

But as the number of successful face transplant surgeries inches ever higher, medical ethicists already are discussing how to make decisions on if and when patients should be eligible for the costly and complex procedure that some say represents the ultimate gift from a deceased donor's family.

The issue of face transplantation garnered renewed interest on Thursday, when James Maki, 59, the country's second-ever face transplant recipient, appeared before reporters and cameras gathered at Brigham and Women's Hospital in Boston.

In 2005, Maki lost much of his face to burns when he fell on the electrified third rail of a Boston subway track. While the surgeries prior to the face transplant restored some function, he still was missing a nose and otherwise grossly disfigured.

Maki's first order of business in his first public appearance following the operation was to thank the widow of Joseph Helfgot, the deceased donor of his new face. Helfgot died last month after a heart transplant procedure.

"I want to say thank you to Susan and her husband Joseph for the gift they have given me. I will be forever grateful," Maki said. "I also want to thank the doctors and nurses who have given me a new chance to live my life. ... I now see this chance as a way to start fresh."

A month after the surgery, Maki's face still has not healed completely. Deep purple furrows run from the top of his newly replaced nose to the base of his reconstructed cheeks. He still has some trouble speaking, and he has yet to gain feeling in much of the new face. Still, he noted that he was pleased with the result of the surgery.

"My nose looks the same as my old nose," he told reporters.

The press conference took place shortly after Maki had met Susan Whitman-Helfgot for the very first time.

"Joseph's life ended too soon, but it is my great joy to meet Jim," Whitman-Helfgot said. "It is a miracle and a blessing."

When Is Face Transplant the Proper Choice?

But even now, as the world's total number of face transplant recipients stands at six, it is clear that there are differences when it comes to determining whether a patient is a viable candidate for a new face, as opposed to a liver, heart or other organ.

The United Network of Organ Sharing (UNOS) has no hard-and-fast rules when it comes to the lifestyle behaviors of those on the organ transplant waiting list, noted UNOS spokeswoman Mandy Claggett. However, the hospitals that put these patients on the waiting list often will create strict criteria on alcohol use, substance abuse or any factors that would suggest the patient would have difficulty adhering to the stringent regimen of anti-rejection drugs they would have to take for the rest of their lives.

"Most programs do exclude patients who are non-compliant or not adherent with medical therapy, and most exclude patients who continue to engage in the same behaviors that resulted in end-organ damage -- intravenous drug abuse, continued alcoholism, et cetera," said Dr. David Cronin, director of liver transplantation at Froedtert Memorial Lutheran Hospital in Milwaukee. "On the issue of face transplantation, I suspect that many of the candidates incurred their 'end-organ failure' from an accident or war-related injury."

So while there are standard exclusion criteria for some forms of organ transplant -- for example, a patient in need of a liver may be denied a spot on the UNOS waiting list if he cannot abstain from alcohol for six months before surgery -- there are currently no such restrictions for face transplant candidates.

This makes is difficult to determine whether Maki, who has a past history of drug abuse, would normally fit the bill of an ideal organ recipient. By the same token, the world's first face transplant patient, Frenchwoman Isabelle Dinoire, in a much-publicized story, continued her smoking habit as her grafted tissue healed.

Face Transplants Only Option for Some Patients

Rather, facial transplant patients are largely selected by a process of elimination -- those patients for whom other surgeries have not worked.

"In my mind, facial transplants have to occur when traditional methods fail," said lead surgeon Dr. Bohdan Pomahac of Brigham and Women's Hospital in Boston at the Thursday press conference.

The extent of Maki's injuries, Pomahac said, certainly fulfilled this criterion. Pomahac was the burn surgeon on duty when Maki arrived in the Brigham and Women's Hospital emergency department after the accident that destroyed his face.

"He burned off his face, including nose, upper lip, roof of the mouth, et cetera," Pomahac said.

Indeed, Maki's injuries were so profound that there are hints that Brigham and Women's Hospital may have bent its previous rules on who could be considered a viable patient for the procedure.

As late as last year, Brigham and Women's had publicly stated that it would not perform this kind of transplant because of ethics guidelines that it created when face transplants first became a viable option. Citing the rigors and side effects of immunosuppressant therapy to prevent organ rejection, the hospital's old rules, now changed, would only allow a patient to receive a face transplant procedure if he or she already was using these drugs after a procedure such as a heart or kidney transplant.

However, doctors and ethicists have subsequently agreed the move was likely justified.

"It is hard for us to imagine how difficult it was for Jim. He feared going outside," Pomahac said. "I feel that we are here on a mission, using cutting-edge technology to restore patients' lives."

Future May Hold Stricter Face Transplant Guidelines

While finding a family who is willing to donate the face of their deceased loved on is still a challenging prerequisite for face transplant surgery, the number of patients involved in these surgeries is still small enough that large-scale selection criteria probably do not come into play.

Face Transplant Criteria Could Become More Stringent

While face transplant recipient candidates remain scarce, as of Thursday afternoon there were 102,137 Americans on the UNOS organ transplant waiting list. The number of available organs is far fewer, and many patients die before an organ becomes available.

"Solid organs for transplantation are extraordinarily scarce resources," said Rosamond Rhodes, director of Bioethics Education at the Mount Sinai School of Medicine in New York City.

"When one person is allocated an organ, someone else may die for lack of an organ. Consequently, it is critical to allocate the short supply justly," she said. "Because face transplantation is so new, the just allocation issue is not yet critical."

But while today's face transplant recipients may face fewer selection criteria than those who need a liver, heart or kidney, Rhodes said this may not be the case in the future.

"As more face transplants are completed successfully, the demand for the treatment will increase and the available facial tissue will become a scarce resource," she said. "Then, principles of justice should be used to govern the allocation."

Cronin agreed.

"I would predict that as facial transplantation becomes more popular, the selection criteria will evolve to insure the appropriate care and success of the composite tissue transplant," he said. "Although the face may not be a scarce or life-saving 'organ' in the same sense that solid organs are, the expense and investment in the procedure will require a similar selection process with the possible requirement of additional increased psychological scrutiny."

Meanwhile, Maki said that though he was aware the story has been the subject of much media attention, he wished to live quietly and privately.

"I now see this chance as a way to start fresh," he said. "I just appreciate that I have the chance to start a new life, because the first part of my life was nothing but trouble."