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Boston - Any face transplant performed at Brigham and Women's Hospital, based here, will be the culmination of carefully designed consent procedures for both the recipient and the donor's family, says the project's leader.
In May 2006, the program earned IRB (Institutional Review Board) approval to perform partial face transplants on selected disfigured patients, and expects approval from the New England Organ Bank (NEOB) possibly by February's end, says Bohdan Pomahac, M.D., associate director of the hospital's burn unit.
After that, he says, "We're good to go. There will be no formal obstacles to moving forward," although the program was still searching for recipients.
When he and his team might perform such a procedure is "the big unknown - we could find a recipient in March, and a donor shortly after. But likely it will take months, if not longer," Dr. Pomahac tells Dermatology Times.
He says his decision to start the transplant program stemmed from frustration with the results of head and neck reconstructions.
Particularly, in the central part of the face, Dr. Pomahac says, "There does not appear to be adequate tissue to replace the missing parts. Therefore, the aesthetic and functional outcomes were not always achievable to the level I would like to see in my patients."
Due to technical and ethical complexities of face transplantation, the NEOB has designed a special consent form to protect donors and their families, he says.
"We understand that this is a clinical, but highly experimental, procedure," he says. "Therefore, one can't assume that everyone who agrees to become an organ donor would agree to donate their face."
However, he says, "There are certain families that are willing to go to the utmost limit of helping others."
The program will approach families only when there's a sense the family might agree to such a donation, and only when there's reasonable certainty of matching a recipient's age, gender and skin color, he says.
"In other words," Dr. Pomahac says, "we're not going to randomly approach a number of donor families in the very vulnerable time of losing their loved ones, just in case."
Recipient consent forms are more complex, because no one knows how any face transplant recipients have fared beyond 18 months, although Isabelle Dinoire's results have been "very encouraging in terms of the outcome, appearance and function of the facial graft," he says.
However, the deterioration of Ms. Dinoire's kidney function (see main story) demonstrates how toxic immunosuppressive medications are, he says.
But in 10 years, he says, "There may be better drugs and ways of inducing immune tolerance. And the patients who would have refused a face transplant now might regret it because the opportunity to obtain a donor might be a lot slimmer" in the future.
Accordingly, Dr. Pomahac says any face transplant patient will need to understand, "There's a chance that things could markedly improve, or that the chronic rejection will never be solved. And they could undergo chronic, slow fibrosis of their face and associated problems that are observed in chronic rejection patients."
Ultimately, Dr. Pomahac says, "It's always the patient who decides if they're willing to take the risk, and to what degree. Our goal is to provide them as much information as possible so they feel adequately informed."
Granted, severely disfigured patients are much more willing to accept risks than those with minor deformities, he says.
However, he says, "It's a trade-off that we don't quite know how to assess," which underscores the importance of proceeding cautiously.
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