Are face transplants still research, or regular care?

February 17, 2017 by Marilynn Marchione
In this Wednesday, Aug. 24, 2016 file photo, former Mississippi firefighter Patrick Hardison, 42, center, views a video showing progression of his face transplant, during a press conference marking one year after his surgery, at New York University Langone Medical Center in New York. Hardison was disfigured while trying to save people from a house fire in 2001. Is replacing a severely disfigured person's face with one from a dead donor ready to be called regular care, something insurers should cover? Mayo Clinic has raised that question by doing the first U.S. face transplant that's not part of research. (AP Photo/Bebeto Matthews)

Is replacing a severely disfigured person's face with one from a dead donor ready to be called regular care, something insurers should cover? Mayo Clinic has raised that question by doing the first U.S. face transplant that's not part of research.

Faces, hands, wombs and even a penis have been transplanted in recent years. Unlike liver or , these novel procedures are not life-saving but life-enhancing.

Who pays for care that can cost $700,000 or more is a growing concern. Ethics and liability issues also may arise when they're done without the oversight of an institutional review board, a hospital panel that ensures research participants' rights are protected.

The group that runs the nation's system, the United Network for Organ Sharing, plans a conference to help guide policy.

"It's time to come together and really ask the question, 'Is this going to become a standard of care?'" said Dr. Scott Levin, a University of Pennsylvania surgeon who heads the UNOS panel on this.

He has done several hand transplants and no longer considers them experimental, though insurers won't pay. Worldwide, about 100 hand, face or other, newer body-part transplants have been done, and "that's not a lot of cases" to judge safety and effectiveness for some types, he said.

Andy Sandness' operation last June was Mayo's first face transplant. Worldwide, roughly two dozen have been done, about half of them in the U.S. Four recipients have died.

At Mayo, "we wanted to do it as a clinical program" and felt there was no research question to be answered because the operation uses standard surgical techniques, said the plastic surgeon who led it, Dr. Samir Mardini. Without a transplant, Sandness would have needed 15 other reconstructive procedures and the cost would be 30 to 40 percent higher, Mardini said.

Hospital management and multiple committees reviewed the case, including an ethics panel, a social worker and transplant psychiatrist, to ensure Sandness knew the risks and was giving informed consent.

"It's critically important that he understand what he would be putting himself through," Mardini said.

Sandness' insurance company would not agree in advance to pay; so, a fund from a donor to start a hand and face transplant center at Mayo paid. Talks on paying for after-care are ongoing.

The long-term medical and psychological effects will be studied as part of formal research, even though the operation itself was not, Mardini said.

"I don't particularly agree with the argument that it's not research," said bioethicist Arthur Caplan, who advised New York University on its first , in 2015.

There's a higher bar to ensuring informed consent for research versus a new therapy, and "questions about competence, experience and even liability are different" when something is called regular care, Caplan said. "In my view it's still highly experimental."

Explore further: Penis operation highlights past, future of organ transplants

Related Stories

Penis operation highlights past, future of organ transplants

May 16, 2016
Add one remarkable case to the 30,000-plus organ transplants expected to be performed nationwide this year: A cancer patient who received a donor penis.

Cleveland Clinic does its second face transplant

November 18, 2014
Cleveland Clinic surgeons have replaced nearly the entire face of a middle-aged man severely disfigured in a car accident, the hospital announced Tuesday.

Womb transplant recipient grateful for chance at pregnancy (Update)

March 7, 2016
The recipient of the nation's first uterus transplant said Monday that she prayed for years to be able to bear a child, and is grateful to the deceased donor's family and surgeons who've given her that chance.

Frenchwoman who received first face transplant dies

September 6, 2016
The world's first face transplant recipient, Frenchwoman Isabelle Dinoire, died in April "after a long illness", a hospital said Tuesday.

Long-term benefits to the liver-kidney transplant

April 15, 2016
A new study from physicians at Mayo Clinic in Rochester, found there may be long-term benefits to simultaneous liver-kidney transplantation versus kidney transplantation alone. The study, "Decreased Chronic Cellular and Antibody-Mediated ...

Hand, face transplants regulated like other organs (Update)

December 26, 2013
The U.S. government is preparing to regulate the new field of hand and face transplants like it does standard organ transplants, giving more Americans who are disabled or disfigured by injury, illness or combat a chance at ...

Recommended for you

First major study comparing robotic to open surgery published in The Lancet

June 21, 2018
The first comprehensive study comparing the outcomes of robotic surgery to those of traditional open surgery in any organ has found that the surgeries are equally effective in treating bladder cancer. The seven-year study, ...

Antibodies may predict transplant rejection risk

June 19, 2018
The presence of certain antibodies in patients may suggest a higher risk of transplant rejection across multiple organ types, including the kidney, liver, heart and lungs, according to a new study published in PLOS Medicine.

First human test of robotic eye surgery a success

June 18, 2018
Researchers from the University of Oxford have completed the first successful trial of robot-assisted retinal surgery.

Surgical blood transfusions tied to clot risk

June 13, 2018
(HealthDay)—Blood transfusions around the time of surgery may raise your risk for dangerous blood clots, researchers say.

Tonsil and adenoid removal associated with respiratory, allergic and infectious disease

June 7, 2018
Tonsil and adenoid removal associated with long-term risks of respiratory, allergic and infectious diseases Removing tonsils and adenoids in childhood increases the long-term risk of respiratory, allergic and infectious diseases, ...

Clues found to early lung transplant failure

May 21, 2018
Among organ transplant patients, those receiving new lungs face a higher rate of organ failure and death compared with people undergoing heart, kidney and liver transplants. One of the culprits is inflammation that damages ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.