Face transplant in France raises ethical concerns

U.S. experts have questions about consent, risk of immune rejection


A week after French doctors conducted the world's first partial face transplant, two U.S. bioethicists question whether the procedure may have been performed prematurely given its risks.

Carson Strong, a medical ethics professor at the University of Tennessee-Memphis, said the procedure is not safe because of the likelihood that donated skin will be rejected by the body's immune system.

Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said the surgeons should have assigned an independent advocate to advise the 38-year-old woman on the extraordinary risks involved in replacing her lips, nose and facial tissue.

In Baltimore, a facial transplantation team at the Johns Hopkins School of Medicine is researching ways to help the body better tolerate donor skin implants but does not expect them to become a clinical reality for five to 10 years. Dr. Eduardo Rodriguez, a senior surgeon on the team, which was formed in 2003 and now works with primates and other animals, said facial transplantation procedures are premature "for anybody at this point" until scientists better understand tolerance.

Laurent Lantieri, a French adviser to the surgeons at Edouard-Herriot Hospital in Lyon, France, who performed the operation Monday, came out against it shortly after the operation was completed because other techniques hadn't been tried.

But the French surgeons said common reconstructive procedures were unlikely to help the woman, who was deformed after being mauled by her dog in May.

Rodriguez, an assistant professor of plastic and reconstructive surgery at Hopkins, said he disagreed with that claim based on his experience operating on badly deformed patients.

"We deal with many dog bites at Johns Hopkins, and I don't think any of them would be good candidates for this procedure," he said.

Yet at two other U.S. medical centers, teams of doctors are preparing for facial transplants. Surgeons at the Cleveland Clinic Foundation have had the procedure cleared by an internal review panel and have begun screening potential recipients. The hospital is developing a complete face transplant -- from under the chin to the forehead, a spokeswoman said yesterday.

At the University of Louisville Health Sciences Center, a surgical team proposed the procedure in 2004 but a review panel has yet to approve it.

Facial transplantation comes with great risks. The body's immune system sometimes rejects an implanted heart or liver as foreign, but skin is even more likely to prompt such a rejection.

Even when a transplant operation succeeds, as appears to be the case with the French patient, a recipient would have to take medication for his or her whole life to suppress the immune system. The highly toxic regimen carries risks of cancer and heart failure, and other chronic health problems.

For crucial organ transplants, doctors have long deemed these risks acceptable. But for someone with a facial deformity, bioethicists say, doctors must be extremely selective because their patients are not on the verge of death.

Caplan criticized the French surgeons for failing to open their protocols to ensure that a patient was prepared for the risks. For this procedure, he said, prospective patients are not really capable of informed consent because of their desperation in facing possible years of isolation and dozens of reconstructive surgeries.

A solid peer review process and an independent advocate representing the patient is enough to offset problems with informed consent, he said. But in this case, neither happened.

"They didn't really circulate their protocol, and that's been criticized inside and outside the country," he said.

Strong's criticism centered on the risks, which he believes outweigh the potential benefits. In a 2004 paper in the American Journal of Bioethics, he wrote that one in five recipients could be expected to experience rejection within three years and that after that, rates of loss are even higher after facial graft procedures.

"A lot of people are concerned that it's just too early to be doing these," he said yesterday. "Given the current state of our science in immunosuppression, the risks are very significant compared to the potential benefits."

Strong pointed to similar problems with hand transplants. One of the French doctors on the partial face transplant team was also the first to perform a successful hand transplant. However, that patient stopped taking immunosuppression medication and the hand was eventually removed.

"It seems clear that there is a definite risk of rejection," Strong said. "And if the graft is rejected by a patient, the patient is in a worse situation.

Caplan said both U.S. teams have gone through a more thorough peer review process.

Dr. John Barker, director of plastic surgery research at the University of Louisville, who performed a hand transplant shortly after the French team, congratulated the French team in a written statement.

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