Much preparation is needed before going for a full face transplant and (below) Dr Alex Clarke busy in her office

Dr Alex Clarke has been interviewed more than 200 times by the media in a month. Hundreds of people have been telephoning her every day. Her diary has been packed and she’s had scant time for patients, whom she was busy attending to at the plastic and reconstructive surgery department.

If the plastic surgeon at London’s Royal Free Hospital is the focus of intense media interest, it’s because in October last year the hospital announced that it would conduct a total face transplant.

“The issue of a total face transplant has evoked tremendous interest, not simply in the medical community but among people who think they might qualify to get a transplant. We have to tell hundreds of callers every day that this is not just a cosmetic affair. Only severely deformed cases can be considered for a transplant,” she said at the outset. “Plastic surgery, you see, has this magic, mythical public perception.”

She and Dr Peter Butler, the brain behind the programme, have been planning the procedure over the last decade. But other teams in France and America were also toying with the idea of a full face transplant. Earlier this year, a French team did a partial face transplant on Isabelle Dinoire, who was severely mauled by her dog. So is a competition on to be the world’s first plastic surgeons to do a full face transplant'

“Butler has been working on the tolerance models and laboratory-based work for over 14 years. Certainly we are not at the stage where we would rush it all to jeopardise the hard work. The French helped us enormously by carrying out the partial face transplant. This has moved our programme along. In fact, I can almost guarantee that the Americans will do the first full face transplant ahead of us. We are not in a race. We just want to do it well.”

Dr Clarke and Dr Butler have begun looking for the first four patients. “All sorts of people call up and put queries on our website. Some of them have severe injuries. Some have appearance-related concerns that are not serious enough.”

Ask her when and how long will it take before the world sees the first fully transplanted face, and Clarke says, “The programme has just begun to take shape. It’s possible that we never find a patient. It is possible but rather unlikely that there is nobody to benefit from this. I would hope that over the next year we certainly do at least one case.” And that provides the team time enough to find and prepare the recipient for one of the most difficult cases in surgery.

Clarke says they know it’s not going to be a bed of roses. “We are prepared for glitches. Someone might be willing and by the end of the preparatory process might just say ‘no’. It could be very frustrating. But I do think within the next year, we will get started, provided we find the donor first.”

The Royal Free Hospital in London will be the venue of the innovative surgery

The announcement raised questions on ethics. The Royal College of Surgeons soon came out with a working party report urging caution. It laid out 15 minimal standards that the face transplant team must meet before even thinking of getting started. Prof. Sir Peter Morris, chairman of the working party, said, “The greatest risk is the rejection of the new face. There’s a 10 per cent risk of acute rejection within two or three months and up to 50 per cent chance of chronic rejection later. The skin is top of the league when it comes to tissue or organ rejection.”

Then there is the critical threat of the patient having to be on a lifetime of immuno-suppressant drugs or steroids to prevent rejection and failure of the grafted organ or tissue. This therapy has well known side effects — hypertension, renal toxicity, diabetes, viral infections and cancer, conditions that shorten life.

Working party member Nichola Rumsey also raised concern that the recipient might end up getting a “mask-like” face whereas humans have to make minute facial changes to express emotions. “And what happens in case of a rejection where the patient will be left with a raw face and has to undergo conventional reconstruction,” she asked.

Changing Faces, a charity that provides aid for people with disfigurement, has been extremely vocal about the issue. “It is the responsibility of the research ethics committee to maintain the highest ethical standards,” said James Patridge, CEO of the charity, who was himself severely disfigured in a car fire as an 18-year-old.

Changing Faces, in fact, had called on the Royal College of Surgeons in March 2003 to create a moratorium on media coverage when the media was trying to identify the possible recipient of the world’s first face transplant.

Peter A. Clark of Pennsylvania’s Saint Joseph’s University is closely watching another proposal for a face transplant submitted in May 2004 to the University of Louisville Medical Center in Kentucky. “Even thought the microsurgical skills are well established, a face transplant is more than a matter of technical achievement. The psychological impact on recipients and their families as also the long-term risks of a lifetime of immuno-suppressant drugs must be considered. Ethical analysis shows that more time is needed to perfect the surgery so that the rejection rate can be lowered and the patient’s immune system can be taught to permanently tolerate the transplanted face,” he says.

Clark feels that permitting this surgery now, when there are so many unknowns, would be medically irresponsible and ethically objectionable.

Dr Alex Clarke, who worked for Changing Faces earlier, says her team is undeterred by such presumptions. “We meet all the 15 standards set out by the Royal College. In fact, we exceed them in some. We don’t anticipate any problems with that. We don’t actually start taking people through an assessment process unless absolutely sure that we’ve dotted all the ‘i’s and crossed all the ‘t’s.”

Indeed, the team has a Plan B in case of a graft failure. “Reconstructive surgeons always work in terms of Plan A, Plan B, Plan C. Those who are criticising us just don’t understand how plastic surgeons work.”

To back this up, Clarke, Butler and Simon Brill co-authored a paper with David Veale of the Institute of Psychiatry at London’s Kings College in the March issue of the journal Body Image, discussing in detail the psychological management of facial transplant. “We have a robust plan ready… and we are not taking it lightly at all.”

As a clinical psychologist, Clarke set out with public engagement exercises to begin with. “The first question to answer was whether people are willing to donate facial tissue to somebody in their family. Another early concern was the idea of compromised identity.” The team found that it was unlikely that the identity of the recipient would be compromised in a way people perceived it to be. “They were taking the ‘face-off’ image from the Hollywood film and imagining that there would be a direct swap of faces.”

To allay such fears, Clarke and Butler produced some computer-generated images of their own faces and swapped them. And what they got was a third face. “When the French did the transplant, we made those images available… it was very clear at the outset that the new face would be somewhere in between those of the donor and the recipient. That was a real advance,” says Clarke.

The team then needed to think about candidates for surgery. “Paradoxically, people who are very severely disfigured and so very distressed may not be robust enough to actually manage the demands of the surgery. So we have to focus on people who have clear functional problems like eyelids that don’t close or missing features. The idea is not to look at solutions for just facial scarring but for facial injury and manageably good mental health.”

Donors too are coming forward after the French transplant since the phenomenon is better accepted and understood now.

Clarke says some of the work that the British team has done will help all the others. “We have been very transparent and have published all the work so that the debate is moved forward and people benefit from the evidence.”

The immediate concerns, however, are identifying the first patient and going through the much-brainstormed preparatory drill. “The four patients will be taken on one after the other.

Each will inform the next. Unless we get the first one over the acute stage, we won’t think of the next one. There are so many levels of matching involved, including basic skin tone matching,” Clarke says.

The recipients will be taken through the process and then followed up very closely for the rest of their natural lives to monitor the outcome. “We are planning to set up a unit that does this all the time and publishes the findings. So this is as much a research programme as a clinical advance,” she contends.