Brigham and Women's Hospital has given a surgical team permission to perform partial face transplants on certain disfigured patients, making it the second US hospital that has gone public with plans to do this rare and hotly debated procedure.
Only three partial face transplants have been announced worldwide -- two in France and one in China -- and the first one, done a year and a half ago on a woman who was mauled by her dog, created an international sensation. Critics said it was unethical to expose patients to the risks of a transplant for a non-lifesaving procedure, but the surgeons involved said face transplants have the potential to transform the lives of people so severely disfigured that they don't work or socialize.
A major ethical concern is that recipients must take powerful drugs to keep their immune systems from rejecting the donor tissue, exposing them to dangerous infections and an elevated risk of cancer. To address this, Brigham doctors said they will perform face transplants only on patients already taking immunosuppressant drugs, most likely people who have had organ transplants. Some might have developed cancer on their faces as a side effect of anti-rejection drugs, while others may have suffered burns or another type of trauma. Pomahac said he has seen four patients in the past several years who potentially qualify.
Dr. John Barker, a surgeon at the University of Louisville in Kentucky who has done extensive research on face transplants, called the Brigham approach "beautiful," saying that the hospital's plan solves a major ethical problem by providing transplants only to patients already on anti-rejection drugs. Physicians, he added, may learn more about face transplants as a result, while helping a small group of patients.
The other US site, the Cleveland Clinic, has 15 potential patients waiting for full-face transplants. Dr. Bohdan Pomahac, a 36-year-old plastic surgeon who heads the Brigham program, said he believes partial face transplants raise fewer concerns, in part because they do not alter a person's identity as much as a transplant of the entire face.
During a partial transplant, surgeons remove part of a deceased donor's face -- the nose, upper lip and part of a cheek, for example -- and painstakingly attach the tissue, blood vessels, and nerves to the disfigured patient.
Pomahac -- who is associate director of the hospital's burn unit and attended medical school in the Czech Republic before training at Brigham and Women's -- said he was driven to establish the program despite international debate surrounding face transplants, partly because of the "helplessness I feel when I have a very difficult case."
He has performed dozens of surgeries on some burn and cancer patients, trying to reconstruct their faces with tissue grafted from elsewhere on their body, and they still look disfigured, he said.
Pomahac has not yet discussed a transplant with any of his patients who would potentially qualify. Over the next several months, he will meet with doctors in Massachusetts who might have appropriate patients, so he can start a waiting list. Any interested patients would undergo extensive medical and psychiatric screening, including an evaluation by a psychiatrist from Massachusetts General Hospital who is not connected with the Brigham program and would act as a patient advocate. Pomahac said he expects insurers to pay for the procedure, which will cost many thousands of dollars.
Finding donors might prove even more difficult than identifying patients, delaying a transplant by months or even years.
Doctors at Brigham and Women's have met with the New England Organ Bank, which is creating a special consent process and form for families of potential face transplant donors. Spokesman Sean Fitzpatrick said that Massachusetts residents who sign up as organ donors when they get their driver's licenses will not automatically be considered face donors, because the procedure is outside the normal expectations for organ donation. Instead, the organ bank will seek permission from families when the deceased already is donating other organs.
"Because it's new, everyone has to make sure they're taking extra steps to be cautious," Fitzpatrick said. Organ bank staff will ask the board to give final approval to the program in the fall.
Dr. Maria Siemionow, head of the Cleveland Clinic's face transplant program, said finding donors will be a major challenge. With other organ transplants, the donor and recipient must have the same blood type. But for many face transplants, their race, gender, and general age also must match to ensure the donor skin does not look out of place on the recipient's face. On top of those limitations, families may say no because they are planning an open-casket wake, or simply because they consider removing a face, or part of one, macabre.
Since the first partial face transplant in France, in November 2005, doctors, researchers, and ethicists have debated whether face transplants are safe and ethical.
Aside from having concerns about exposing patients to immunosuppressant drugs when their lives are not at stake, critics worry that it is not possible to fully inform patients about the procedure's risks because patients cannot know how they would react to having a different face.
Carson Strong, a professor of human values and ethics at the University of Tennessee College of Medicine, said he is opposed to face transplants generally, partly because of the risk that the patient's immune system could reject the donor tissue. This would require more surgery to remove the rejected tissue and close the new wound, and could leave patients more scarred than before the transplant, he said.
"Such a setback would no doubt be very upsetting," Strong wrote in an e-mail.
The patients at Brigham and Women's would take on other risks as well. They might have to take higher doses of anti-rejection drugs or additional drugs, exposing them to an increased risk of infection and cancer.
Doctors also do not know what effect a face transplant would have on the original transplant, so doctors will begin with kidney and pancreas transplant patients -- who could go on dialysis or take medications, respectively, to replace the function of a damaged organ. For heart, liver, or lung transplant patients, the loss of the organ could be fatal.
Aside from medical concerns, patient groups are divided about face transplants for other reasons.
Debbie Oliver, executive director of AboutFace, an advocacy organization for people with facial disfigurement, said: "It's very tough for the community to come to grips with this. We're teaching people to love themselves and put themselves out there. We're promoting acceptance. This goes against every grain of everything we're fighting for."
Mike Paganelli, 50, of Westford, who was burned in a truck accident in 2004, said he has thought about having a face transplant -- he would love to look like he once did and "have a nice smooth face and nice round lips." But he is leaning against it because of all he has gone through -- 33 surgeries -- and the risks of the new procedure, said Paganelli, who is a patient of Pomahac's but would not qualify for the Brigham program, unless doctors later expand to patients not on anti-rejection drugs.
"I was a handsome man. . . . I have pictures of me here in the house and I kind of look at them sometimes," he said. "I would love to look like that again. . . . But as time goes on and we accept ourselves, we don't look at those pictures as much anymore."
Still, it is clear from the Cleveland Clinic's experience that some patients want this option. Some of the people on its waiting list are so disfigured they wear masks.
In an interview this month with the French newspaper Le Monde, the original face transplant recipient, Isabelle Dinoire, said that her operation was successful -- two instances of near rejection were overcome with additional drugs -- but that she still feels the loss of her original face. "I have returned to the planet of human beings -- those with a face, a smile, facial expressions that let them communicate," she told the newspaper.
Pomahac showed photos of Dinoire to the human research committee at Brigham and Women's that approved the face transplants after extensive review this spring.
The group "found that the risks to subjects were minimized as best possible, and were reasonable in relation to the possible benefits to subjects" and the knowledge likely to be gained, Dr. Elizabeth Hohmann, the committee's physician director, wrote in an e-mail.
Barker, the University of Louisville surgeon, said transplants are far superior to reconstruction in terms of function and appearance, though his university decided against proceeding with face transplants because of the risks.
"We have some patients with 120 [reconstructive] operations and you still look at them and it's hard to sit in front of them," Barker said. "Think of exchanging that for one major surgery and maybe two or three others, and you look in the mirror and you look like a human being."