Federal government seeks to regulate hand, face transplants

The federal agency that oversees organ transplants wants to start regulating face and hand transplants in same way it monitors kidneys, hearts and other internal organs.

A proposed rule would mean a national registry and waiting list instead of local versions.

In the fall, the University of Pennsylvania became the first hospital in the region to perform a bilateral hand transplant. Because there are currently no national standards or procedures for such surgeries, the team worked with Gift of Life and ethicists to develop a new program for donations. It includes new consent forms and a script to follow when asking next-of-kin if they would consider donating the organs.

“We’re very careful with the families … First we ask for solid organ donation, and then the families may be approached, based on their loved one, (and asked) ‘would you consider another type of transplant, such as arm or face?’ And that’s a different discussion,” said Dr. Scott Levin, director of the Penn Hand Transplant Program and chair of orthopaedic surgery.

Penn is one of only about a dozen hospitals nationwide that has performed a hand or face transplant. Levin believes those kind of surgeries soon will become more common. As they do, he said, the national registry will be necessary.

“There will be a lot of people waiting for arms and faces and the question becomes, who gets them first?” Levin said.

Many critics once believed transplants were too risky to perform in non life-saving situations, but consensus in the medical community seems to be shifting somewhat.

The head of plastic surgery at Johns Hopkins University, another of the hospitals to have performed a face or hand transplant, agrees.

“I think this really reflects the increasing acceptance of hand transplant and face transplant as a way to treat those patients, who I think really need a breakthrough in conventional treatment for their deformities,” said Dr. Andrew Lee.

The rules, proposed by the Health Resources and Services Administration, would regulate transplants of feet, ankles, legs, fingers, voice boxes and possibly even reproductive organs.

The federal agency will accept public comment until mid-February, and the rules are expected to take effect in about a year.