When Eduardo D. Rodriguez, MD, DDS, FACS, and his team of more than 100 health care professionals at New York University (NYU) Langone Medical Center, New York, successfully completed the most extensive facial transplant to date last August, they not only gave a patient a new lease on life, but also helped establish new standards of care in this emerging field.1
The patient, volunteer firefighter Patrick Hardison, 41, suffered disfiguring burns across his entire face—including the loss of his eyelids, ears, lips, most of his nose, and his entire scalp—when he entered a burning home in a rescue search in September 2001.2, 5 During the 26-hour operation, Dr. Rodriguez and his team were able to, among other important successes, transfer a donor’s eyelids and transplant the muscles that control blinking—a notable accomplishment, as the procedure had not been performed previously on a seeing patient.1
Despite achieving these surgical milestones, the process involved in providing Mr. Hardison with a new face had its challenges. These hurdles were overcome, according to Dr. Rodriguez, through highly orchestrated teamwork and innovative technology—specifically the use of three-dimensional (3-D) modeling to create a precise “snap-fit” of the skeleton.
Listing the patient
Before arriving at NYU Langone, Mr. Hardison had already endured more than 70 operations, including the transfer of skin grafts from his thigh to his face, but unfortunately, he was unable to return to the life he had before the accident.3 He was disfigured with “no semblance of normal anatomy,” according to Dr. Rodriguez, and eating and speaking caused Mr. Hardison significant pain due to the extensive scar contracture.4
“There were a couple of factors that led me to the decision to take on Mr. Hardison’s case,” said Dr. Rodriguez, who joined the faculty at NYU Langone in November 2013 as chair of the Hansjörg Wyss department of plastic surgery with the goal of developing a face transplant program. “When I considered Patrick’s personal story along with the inability to improve his current physical state, I thought he would be an ideal candidate to enlist in our program,” Dr. Rodriguez said. “Most importantly, his surgeons had been able to preserve his sight despite the scarred tissue around his eyelids.” Specifically, surgeons had sutured Mr. Hardison’s eyelids together, leaving tiny pinholes to preserve his sight.
“They were very good surgeons and there were no other improvements that they could provide,” said Dr. Rodriguez. “There was nothing [more] that I could do short of a face transplant.”
Dr. Rodriguez’s team began vetting Mr. Hardison in 2012, a process that included interviews with the Mississippi firefighter and his family and friends to assess his comprehension of risks—there was a baseline 50 percent chance of success for the operation—and to ensure that he and his caregivers would be able to comply with postoperative responsibilities, including being able to keep medical appointments and adhere to a daily medicine regimen.5
The next step was finding a donor who matched Mr. Hardison’s skin tone, hair color, blood type, and skeletal structure. NYU Langone partnered with LiveOnNY, the New York metropolitan organ procurement organization, to locate the donor, David P. Rodebaugh, a 26-year-old BMX cycling enthusiast and a registered organ donor. Mr. Rodebaugh’s face was the fourth offered to Mr. Hardison: one donor was a man who did not have a favorable crossmatch, one was a man whose family withdrew consent; the other was from a woman, which Mr. Hardison declined.3
Challenges in an emerging field
An overarching concern regarding Mr. Hardison’s case, according to Dr. Rodriguez, centered on the fact that the surgical team would need to “recreate the defect” in order to successfully perform the face transplant. “We had to make him worse in order to make him better,” said Dr. Rodriguez. “In other words, everything his previous surgeons had done to protect his vision, we would have to remove. Removing all the scar tissue around his scarred eyelids and face would basically expose the globes and the eye sockets, so this would have to work. If it didn’t work, it would leave him worse than he was beforehand.”
Additionally, Dr. Rodriguez pointed out, Mr. Hardison’s entire face and scalp had been resurfaced with split-thickness skin grafts taken from his thighs and neck and shoulder areas, and all that work that had been done would also have to be removed to re-drape his facial skeleton with a new face.
Some of these challenges, including the transplantation of the ears and ear canals, were unique to Mr. Hardison’s case, but others were more familiar to Dr. Rodriguez, who, in March 2012, performed the most extensive full-face transplant on record up to that point while at the University of Maryland Medical Center (UMMC), Baltimore.6 The patient in that case, Richard Lee Norris, who was 37 years old at the time of the surgery, was injured in a gun accident and suffered the loss of his lips, nose, and his jaws and had limited movement of his mouth. The 36-hour procedure involved a multidisciplinary team of faculty physicians and a team of more than 200 nurses and professional staff.6
Facial transplants are rare, with 37 patients worldwide having undergone the procedure.4 The first partial face transplant was performed in 2005 in France on Isabelle Dinoire, 38, who had been mauled by her dog.3 The first full-face transplant took place five years later in Spain on a man identified only as “Oscar.” The first face transplant in the U.S. was performed in 2008 on Connie Culp, 46, who had been shot by her husband four years earlier.3
The primary technical challenge in Mr. Hardison’s case, and in all of the face transplants that have occurred over the last decade, according to Dr. Rodriguez, is ensuring functional return.7 “When you look at someone’s face it’s not just the appearance of a face on a still photograph, but it’s the normal function and movement of a face that gives the person a sense of normalcy. If you don’t have that, it’s just like wearing a mask. We don’t want to create mask-like features. We want these transplants to animate and have normal movement, so that they can smile, blink, the lips pucker, and that they have the ability to speak, eat, and swallow normally,” explained Dr. Rodriguez, who is dually board-certified by the American Board of Oral and Maxillofacial Surgery and American Board of Plastic Surgery.
Dr. Rodriguez earned his bachelor of science in neurobiology from the University of Florida, Gainesville, in 1988, followed by a doctor of dental surgery degree from New York University, NY, in 1992.8 He then completed his residency in oral and maxillofacial surgery at Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY, in 1997 and received his medical degree from the Medical College of Virginia, Richmond, in 1999. In 2003, Dr. Rodriguez graduated from the combined plastic surgery program at Johns Hopkins Hospital/UMMC, Baltimore. He subsequently completed an international reconstructive microsurgery fellowship at Chang Gung Memorial Hospital in Taipei, Taiwan, in 2004.
Teamwork first, then technology
Developing a synchronous 100-plus member multidisciplinary team working between two operating rooms (ORs) provided an optimal environment for Mr. Hardison’s complex transplant procedure. All different levels of staff needed to communicate effectively and efficiently, including Dr. Rodriguez, other plastic and reconstructive surgeons, cardiologists, a transplant immunologist, a medical ethicist, a clinical psychiatrist, a clinical psychologist, nurses, social workers, and other health care professionals.
“I was fortunate enough to have performed a transplant in Baltimore before I was recruited to NYU Langone, so I had some experience putting together a team and organizing this complex surgical event,” said Dr. Rodriguez. “When I came to NYU Langone, I already had something of a ‘recipe’ for how to do it. But I had to recreate the team once again. I began at NYU Langone in November 2013, and from the first day I arrived, I started to work with our department administrator Leslie Bernstein, personally meeting with and interviewing every member who was going to be on this team, including the nursing staff, anesthesiologists, scrub technicians—all of the individuals who were going to be in the surgical event, as well as the core surgical team.”
Once the team was assembled, Dr. Rodriguez led a series of meetings in the surgeons’ lounge with all participants present to clearly define everyone’s specific role. “We described exactly how we would position the patient, which arm would be used for the IVs, where we would place all of the instrumentation, and how many personnel would be allowed in the room at one time. We went through every step…and we would actually practice them in our intraoperative cadaver simulations.” Following the simulations, the team met again in an open forum where every member was invited to offer insight for improving the timeline and flow and for enhancing best surgical practices, with the ultimate goal of ensuring maximal patient safety.
Fostering open communication among team members was important in all phases of Mr. Hardison’s procedure, but particularly with regard to ensuring complete cohesion in the maintenance of certain donor organs. “We knew the donor for the face transplant recipient would likely be a young male. Based on that fact, the likelihood of procuring other organs for a number of different recipient operations would be high,” said Dr. Rodriguez. “We had to ensure that the fluid management of the donor in the OR would not only maximize profusion to the kidneys, but also limit over-hydration of the lungs. That required direct communication with lung transplant surgeons, kidney surgeons, representatives from the organ procurement organizations, and finally the anesthesiologist who is responsible for the care and maintenance of that patient in the OR.”
CT scans and 3-D modeling
While enhanced communication and team-building are processes that function to improve care in this field, the application of innovative technology is another notable milestone in the continually evolving field of facial transplant surgery.
Because a facial transplant procedure involves two individuals, size discrepancies between the facial structure of the recipient and of the donor are inevitable. Computed tomography (CT) scans of both Mr. Hardison and Mr. Rodebaugh allowed Dr. Rodriguez and his team to precisely determine how they would approach the reconstruction.
According to Dr. Rodriguez, Mr. Hardison had significant segments of the facial skeleton, including the cheekbones, nasal bones, and the mandible, that needed to be replaced or augmented. “CT scans and 3-D technology allow us to fit the skeleton of a donor on a recipient in a way that is very similar to a puzzle,” said Dr. Rodriguez. “Planning what portions of the facial skeleton we are going to include allows us to design how we are going to make our access incisions to these portions of the skeleton, and it also allows us to define what portions of the skeleton we would like to replace or improve.”
In addition to planning the surgery on a computer screen by receiving a stereolithic graphic model of the recipient and donor, Dr. Rodriguez can actually make instruments or cutting guides that are patient-specific to the recipient and the donor via 3-D modeling.
“We already knew Patrick Hardison—he had been our patient for over a year—but the limiting factor was the donor, and the donor was only identified for facial procurement within 24 hours of the operation,” said Dr. Rodriguez. As soon as we had the CT scan of the donor, we worked with a company, and within 24 hours they generated a 3-D print of these specific cutting guides that were shipped to the OR. It’s amazing technology.”
In the final hours of surgery, signs of success became apparent, according to a press release issued by NYU Langone. Mr. Hardison’s new face, specifically his lips and ears, were “robust with color, indicating circulation had been restored.”1 He was able to use his new eyelids and blink on the third day of recovery, and he was sitting up in a chair within a week. Mr. Hardison continues to engage in extensive rehabilitative therapy and, as is the case with all transplant patients, will remain on anti-rejection medication for the rest of his life. However, it is important to note that nearly 180 days post-op, Mr. Hardison had yet to experience an anti-rejection episode, which, according to Dr. Rodriguez, typically occurs within the first 90 days after surgery in face transplant patients.
Cost of care
Financial support for Mr. Hardison’s care, estimated to cost between $850,000 and $1 million, was provided through a grant from NYU Langone and included the pre-surgical workup, the procedure, and the entire care of the surgical patient up to 90 days. “We felt it was important that this grant include the care of the patient at all these stages,” said Dr. Rodriguez. “We worked with Patrick’s third-party payor, who agreed to cover financial responsibilities beyond the 90 days, which in his case is primarily the cost of the immunosuppression medication.”
Dr. Rodriguez said NYU Langone is currently working with a number of third-party payors to help define how these procedures could ultimately become standard of care. “The [American College of Surgeons (ACS)] can help us define the criteria of this procedure for select patients as standard of care. I think there could be no stronger lobbying group [than the ACS] to make this happen, since they were pivotal in making liver transplants, cardiac transplants, [and] lung and kidney [transplants] part of standard medical practice.”
The first comprehensive study of all known facial transplants, published by Dr. Rodriguez in an April 2014 issue of The Lancet, concluded that the procedure is “relatively safe, increasingly feasible, and a clear life-changer that can and should be offered to far more carefully selected patients.”9,10 The study includes an analysis of medical journals and interviews with surgeons who had performed face transplant procedures up to that point.
The study also highlights the fact that face transplants continue to be experimental and pose lifelong risks associated with infection and reactions to toxic immunosuppressive drugs. Despite those risks, Dr. Rodriguez said, advances in immunomodulatory and immunosuppressive protocols, microsurgical techniques, and computer-aided surgical planning, such as 3-D modeling and CT scans, are key to establishing new standards of care for this field.9
Dr. Rodriguez compared the first decade of facial transplantation to the beginning stages of liver transplantation in the 1960s, when recipients lived less than one year. Today, he says, liver transplantation is performed at more than 100 medical centers in the U.S. alone, and the vast majority of patients, including children, survive beyond a year, with outcomes continuously improving despite liver transplantation’s frequent complications. “We are still very much in the early days of facial transplantation,” said Dr. Rodriguez. “So long as our patients need it—and they do—then it is our medical duty to continue to advance science and medicine, and improve how we perform the procedure so that it is more widely available to future generations of people whose severe disfigurements go beyond the means of conventional surgery.”9
- New York University Langone Medical Center. Surgeons at NYU Langone Medical Center perform the most extensive face transplant to date and first in New York state. Press release. November 16, 2015. Available at: http://nyulangone.org/press-releases/surgeons-at-nyu-langone-medical-center-perform-the-most-extensive-face-transplant-to-date-first-in-new-york-state. Accessed December 28, 2015.
- Fishman S. Biography of a face. New York. November 15, 2015. Available at: http://nymag.com/daily/intelligencer/2015/11/patrick-hardison-face-transplant.html. Accessed November 25, 2015.
- Pengelly M. New York plastic surgeon performs “most extensive” face transplant ever. The Guardian. November 15, 2015. Available at: www.theguardian.com/us-news/2015/nov/15/face-transplant-plastic-surgeon-firefighter-new-york-magazine. Accessed December 28, 2015.
- Cha AE. Groundbreaking face transplant: After a firefighter was injured on duty, a deceased 26-year-old cyclist gave him his life back. Washington Post. November 17, 2015. Available at: www.washingtonpost.com/news/to-your-health/wp/2015/11/16/nyu-surgeons-announce-most-comprehensive-face-transplant-to-date-on-volunteer-firefighter-photos/. Accessed December 28, 2015.
- Chang J. Face transplant surgery gives 41-year-old former firefighter a new 26-year-old face. ABC News. November 15, 2015. Available at: http://abcnews.go.com/Health/unprecedented-face-transplant-surgery-firefighter-hope-life/story?id=35218667. Accessed March 23, 2016.
- Gann C. Virginia man gets a new face. ABC News. March 27, 2012. Available at: http://abcnews.go.com/Health/doctors-perform-extensive-face-transplant/story?id=16013394. Accessed December 28, 2015.
- Caplan A. Face transplant doc: Challenges in repairing destroyed faces. Medscape. Mar 7, 2014. Available at: www.medscape.com/viewarticle/821517. Accessed December 28, 2015.
- New York University Langone Medical Center. Facial transplantation: Almost a decade out, surgeons prepare for burgeoning demand. April 18, 2014. Available at: http://nyulangone.org/press-releases/facial-transplantation-almost-a-decade-out-surgeons-prepare-for-burgeoning-demand. Accessed January 4, 2016.
- New York University Langone Medical Center. Eduardo D. Rodriguez, MD, DDS, named chair of department of plastic surgery at NYU Langone Medical Center. Press release. August 26, 2013. Available at: http://nyulangone.org/press-releases/eduardo-d-rodriguez-md-dds-named-chair-of-department-of-plastic-surgery-at-nyu-langone-medical-center. Accessed December 28, 2015.
- Khalifian S, Brazio PS, Mohan R. Facial transplantation: The first 9 years. Lancet. 2014;384(9960):2153-2163.