First full-face transplant for African-American patient in the books can anymore. So he declined. “I was glad that he did,” he adds. “We don’t want patients blindly grasping a facial transplantation; we went those who are thoughtful about the implications of the characteristics. It’s essentially a once-in-a-lifetime choice.”
By Jim Leonardo
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obert Chelsea, 68, entered the history books in July, as he became both the eldest full-face transplant recipient in the world and the first African-American recipient after a 16-hour procedure led by ASPS member Bohdan Pomahac, MD, at Brigham and Women’s Hospital in Boston. Although a patient of African descent had received a face transplant in 2007 in Paris, that procedure involved only partial facial transplantation. Chelsea suffered burns to more than 60 percent of his body after a drunk driver struck his stalled vehicle in 2013, according to news reports. A myriad of serious complications and more than 30 surgeries followed; he was finally listed for a face transplant in March 2018. Although every facial transplantation procedure is infused with risk and unconventionality, the fact that Chelsea is African-American made this a particularly unique situation, Dr. Pomahac tells PSN. “We didn’t really appreciate how hard it would be to find the perfect match,” he says. “All of our previous patients have been Caucasian – we had completed eight prior to this – and matches have been fairly easy to find. There’s very little skin-tone difference and the blending is remarkably good. We haven’t needed to rely on a Hispanic donor for a Caucasian patient – because in our region, the white donors represent 94 percent of the ‘pool,’ which is an overwhelming segment of the population to recover from. “What we now realize with African-American patients is that the ethnic shape of some of the features, as well as the skin-shade range, are incredibly specific,” Dr. Pomahac adds. A transplant nurse found the solution to the skin-tone match question after realizing that the color-match palettes used by prosthestists would work in a similar manner for transplant patients. “This skin-shade palette contains 18 shades – from white to completely black – which allows us to match as perfectly as possible the donor and recipient,” Dr. Pomahac says. Dr. Pomahac notes that he and other facial transplantation surgeons had been limited by donor organizations’ confidentiality limits
Further consideration
(Top) ASPS member Bohdan Pomahac, MD, and Robert Chelsea, the eldest full-face transplant recipient in the world and the first African-American recipient of a face transplant. The pictures below show Chelsea during the 16-hour procedure, leaving the O.R. and a post-op meeting with Dr. Pomahac. (Photos courtesy of Brigham and Women’s Hospital in Boston) that preclude photographing donor faces. In addition, photographing small patches of face that keep the donor unrecognized typically are not instructive enough for transplant purposes, he says. “There’s so much difference in pigmentation that we started to realize that we can’t really communicate accurate shades when we’re at different places, which is normally the case,” he notes. “We needed something for each of us to have. The palette solves many issues. It’s kept on small, silicone squares and numbered, and we kept one and Chelsea kept one. He told us
what colors were acceptable – and we knew we were each looking at the same color.” The palette may have cleared one hurdle, but another having to do with ethnicity remained. In 2018, the team thought it had a donor match based on color, but Chelsea decided against that donor tissue. “The patient was of Hispanic origin, and the skin tone was lighter but seemed reasonable,” Dr. Pomahac recalls. “However, the patient thought that having a Hispanic nose and slightly lighter color together would probably not leave him looking like an African-Ameri-
Society reviewing FDA draft guidance on implant labeling
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SPS is conducting a rigorous review of “Breast Implants – Certain Labeling Recommendations to Improve Patient Communication,” a draft guidance released in October by the FDA that centers on manufacturer information accompanying breast implants. Once ASPS completes its review of the multi-point guidance, the Society will submit comments to the FDA by the Dec. 23 response deadline. This guidance, which essentially serves as an adjunct to existing related guidance, is designed to ensure patients receive and understand the benefits and risks of breast implants – including the risk of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), as well as symptoms commonly referred to as breast-implant illness (BII). The FDA is recommending that manufacturers include the following with packaging for breast implants: • “Black box” warning
December 2019
• Patient-decision checklist • Device/materials descriptions, including types and quantities of chemicals and heavy metals that reside in, or are released by, breast implants • Silicone gel-filled breast implant rupture-screening recommendations • Updated patient device card “Since the FDA hearing this past March, ASPS has been working with numerous stakeholders to shape the content and intent of a patient-decision checklist and black box
warning that provides useful information to patients so they can make an informed decision,” says ASPS President Lynn Jeffers, MD, MBA. “Patient safety is always the top priority of the Society and our members.” ASPS leaders conducted a meeting with patient advocates as well as Binita Ashar, MD, director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health, during Plastic Surgery The Meeting 2019 in San Diego to identify areas in which all parties can work together to improve the flow of information to patients. “These discussions were tremendously valuable, and further collaboration is underway to improve patient safety,” Dr. Jeffers says. Public comment on the draft guidance can be delivered electronically at regulations.gov under docket number FDA-2019-D-4467. Those with questions about the draft guidance are advised to contact the Division of Industry and Consumer Education. PSN
Although face transplants obviously are the most visible example of ethnicity-matching for transplant patients, bilateral hand and arm transplants also carry that component – but according to Dr. Pomahac and L. Scott Levin, MD, chair of Orthopaedic Surgery and professor of plastic surgery at Penn Medicine and director of the Hand Transplantation Program at The Children’s Hospital of Philadelphia and University of Pennsylvania, skin-tone matching is of much less importance. “The face is obviously different from the hands,” says Dr. Levin, who led the team that completed a successful, bilateral hand transplant for 8-year-old Zion Harvey, an African-American child, in 2015. “You can’t tell the shape and topography of African-American hands from Caucasian hands. There aren’t ethnic features in the hands. “We approach each patient individually – and each will have their own cultural bias and opinion,” Dr. Levin adds. “But I don’t approach an African-American hand transplant patient differently than anyone else.” “There’s a little bit of forgiveness with arms,” Dr. Pomahac says. “The aesthetics of the face are more important than those of the hands and arms. In my opinion, it’s a little less of an issue.” A longer-term issue impacting facial transplantation is a shallow donor pool for minority patients. According to organ donation statistics furnished by the federal Health Resources and Services Administration, in 2018 Caucasian donors represented 65.4 percent of the donor pool; African-Americans, 16.1 percent; Hispanics, 14.1; Asian, 2.3; and other, 2.0. In 2017, the AMA adopted a policy during its November Interim Meeting that aimed to increase organ donation rates “particularly among minority populations with historically low donation rates,” according to the association’s website. Some cite African-American mistrust of the medical community for the low numbers, although research conducted by transplant surgeon Derek Dubay, MD, revealed that potential donors had an inaccurate perception of tissue use – many thought their organs “wouldn’t be usable due to high blood pressure, heart disease” and other health issues common in the African-American population. “We need to enhance education to let them know that a lot of times, these organs are acceptable for transplant,” Dr. Dubay told BBC News. Considering the dearth of organs available for minorities, Dr. Pomahac’s advice for transplant surgeons who are treating these patients is, therefore, to have patience. “Be ready for a long period to pass before finding a donor,” he says, adding that surgeons must also be aware of skin-tone blending. “If the patient is a candidate for a partial face transplant, know that it’s very hard to blend. You may need to consider a full-face transplant, which isn’t our first choice; if that fails in 10 years, treatment options are extremely limited.” PSN
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