Hospital May Have Sidestepped Prior Rules for Face Transplant

April 10, 2009— -- A Boston hospital may have bent its own rules to offer a disfigured patient a facial transplant -- but doctors and ethicists say the move was likely justified.

The surgery, which took place Thursday at Brigham and Women's Hospital in Boston, is the second face transplant operation performed in the United States and the seventh in the world.

A team of seven plastic surgeons and one ear, nose and throat surgeon led by Dr. Bohdan Pomahac took 17 hours to complete the surgery, according to a hospital press release. The release further indicated that the nose, hard palate, upper lip, facial skin, muscles of facial animation and the nerves that power them and provide sensation were transferred to the recipient from a deceased donor.

The patient was a man who required facial reconstruction after injuries he suffered in a severe traumatic accident, Kevin Myron, manager of media relations for Brigham and Women's Hospital, said.

At a Friday press conference, Pomahac acknowledged that the patient had not undergone immunosuppressant therapy before the operation -- a deviation from the hospital's previously stated policy on facial transplantation.

Immunosuppressant therapy -- a course of medication designed to ratchet down a patient's immune response -- is necessary in such operations to prevent the patient's body from rejecting the organs or tissues of the donor. Such therapy is crucial to the patient's survival, but it also comes with serious side effects, including an increased risk of infections.

At Friday's press conference, Pomahac said that the hospital has obtained approval from an institutional review board -- a committee that reviews the ethics of medical procedures -- for performing the operation on patients not on immunosuppressants. He said that the hospital made the decision to liberalize the rule in order to help more patients in need.

"We felt it was a natural progression of the program to extend [the operation] to the patient who is not on immunosuppressants."

Still, immunosuppressant therapy is a significant commitment. Dr. Joseph McCarthy, director of the Institute of Reconstructive Plastic Surgery at New York University's Langone Medical Center, said that the side effects of immunosuppression may be an even weightier consideration than the surgery itself.

"You are really committing the patient to a lifetime of treatment to prevent rejection," he said. "You have to be absolutely convinced that no existing traditional surgery or techniques would give these patients the quality of life they need, and therefore you can justify starting a course of immunosuppressant medications."

Pomahac said that the patient is now on immunosuppressants, and likely will be for the forseeable future.

"The patient is now expected to take immunosuppressant medication for the rest of his life," he said. "There is nothing on the horizon, no major medical breakthrough that would suggest otherwise."

But he noted that the doses would likely be reduced as time progresses, which would likely come hand-in-hand with a reduction in side effects.

Implications of Immunosuppression After Face Transplant

The importance of such side effects was not lost on Brigham and Women's. A 2007 article in a hospital newsletter and a 2008 article in the journal Transplantation suggest that Brigham and Women's had a policy in place not to perform such a surgery on any patient who did not already have a suppressed immune system.

"The BWH team recognizes the ethical concerns and tailored BWH's programs to address them," reads the article in a 2007 issue of BWH Bulletin. "One concern is that transplant patients spend the rest of their lives taking immunosuppressant drugs to keep the body from rejecting the organ. BWH will only perform facial transplants on those who already are on these drugs, most likely from a previous transplant."

Pomahac is quoted in the article as saying that patients already on immunosuppressants "know what it's like to live on these drugs, which can have debilitating effects on the body."

And in the 2008 Transplantation article, Pomahac wrote:

"We currently share the concern that life-long immunosuppression associated with facial transplantation may not outweigh its benefits as compared to the alternative reconstructive methods. We asked ourselves the question of which patient population would risk less and overall benefit more from undergoing face transplantation, and identified those currently on immunosuppressive therapy the most suitable candidates."

The hospital newsletter article further suggested that Brigham and Women's would only perform partial face transplants, chiefly in response to critics' concerns over "the ethics of changing a person's identity."

Position Shift on Face Tranplant Ethically Justified

Still, surgeons and ethicists alike appear to agree that shifting away from a policy limiting the patient pool for face transplants may not be such a bad thing -- particularly considering the horrific injuries that candidates for this surgery possess.

"I don't think that it makes sense to try and limit face transplantation to those already on immunosuppression," said Art Caplan, head of the bioethics center at the University of Pennsylvania. "That might be preferable, other things being equal, but the number of persons who will fit that selection standard is tiny."

Rosamond Rhodes, director of bioethics education at Mount Sinai School of Medicine, agreed. "When the facial disfigurement is so severe as to merit the risks of transplantation, the extra burdens of immunosuppression hardly adds to the burden.

"In that light, the BWH policy seems designed to spare the surgeons and institution from guilt or public criticism, rather than to serve the interests of patients in need of a face transplant," she added.

Brigham and Women's is not the only institution to have such a policy, however. Dr. L. Scott Levin, chief of plastic, reconstructive, oral and maxillofacial surgery and a professor of orthopaedic and plastic surgery at Duke University Medical Center in Durham, N.C., said that Duke has been IRB approved to conduct a face transplant operation, and they, too, have a policy that would limit the patient pool to those already taking immunosuppressants.

But he added that if the opportunity arose to perform such an operation -- even on a patient who was not currently immunosuppressed -- he would jump at the chance.

"There is such a huge need in patients who have been burned, unusually disfigured or injured in war," Levin said. "I'd do it in a heartbeat."

And McCarthy said he has no doubt that Brigham and Women's fully weighed the risks and benefits of the surgery and lifelong immunosuppression before going forward.

"You're at a first-rate institution," he said. "These decisions are not going to be made casually."

Face Transplant Operations Go Global

McCarthy added that Frenchwoman Isabelle Dinoire, the world's first patient to have a face transplant, only went on immunosuppressants after her operation in her home country in 2005, and she appears to be doing well today.

After Dinoire became the first recipient of a partial face transplant in November 2005, similar surgeries in various countries have followed.

The first such surgery in the U.S., took place in December and repaired the face of a female patient using facial tissue from a dead female donor.

Most recently, on the weekend of April 4, a team of doctors at Henri Mondor hospital in Paris performed the world's first simultaneous partial-face and double-hand transplant on a 30-year-old burn victim.

Roger Sergel and Michelle Schlief contributed to this report.