U.S. proposes regulating face, hand transplants

[Clark]

http://seattletimes.nwsource.com/text/2017170968.html

U.S. proposes regulating face, hand transplants
By MARILYNN MARCHIONE


The government wants to start regulating face and hand transplants just as it does with kidneys, hearts and other organs, with waiting lists, a nationwide system to match and distribute body parts and donor testing to prevent deadly infections.

It's a big step toward expanding access to these operations, especially for wounded troops returning home. A dozen U.S. hospitals do face or hand transplants and more are preparing to offer the operations. More than 1,000 troops have lost an arm or leg in Afghanistan or Iraq, and the government estimates that 200 troops might be eligible for face transplants.

"These body parts are starting to become more mainstream, if you will, than they were five or 10 years ago," said Dr. James Bowman, medical director of the Health Resources Services Administration, the government agency that regulates organ transplants.

The agency has proposed new rules that expand the regulation of transplants to include faces, hands and other body parts. Waiting lists for these body parts are informal and local now. The new rule would make such transplants part of the nationwide matching system run by the United Network for Organ Sharing, or UNOS.

The rules would regulate transplants of feet, ankles, legs, fingers, windpipes, voice boxes, the abdominal wall and possibly even a uterus or a penis, operations tried at least once in other countries.

"When you think about the human body, there is really nothing that could not be replaced by transplantation. Almost nothing," said Dr. Bohdan Pomahac, who has done four face transplants at Brigham and Women's Hospital in Boston.

At least 18 face transplants have been done around the world, starting in 2005 with a French woman mauled by her dog. The Cleveland Clinic did the first face transplant in the U.S. in 2008.

The Department of Defense is providing money for more of these surgeries in Cleveland and Boston in hopes of helping soldiers disfigured in battle. The University of Pittsburgh, the University of California, Los Angeles, and other medical centers plan to offer face or hand transplants soon.

The first successful hand transplant in the United States was performed in 1999, and more than three dozen have been done worldwide.

The proposal to treat these like organ transplants "is terrific" and is supported by leading transplant-surgery groups, Pomahac said.

The federal agency will accept public comments on the rules until Feb. 14 before making a decision. The rules are expected to take effect this year or early next year.

The change would not affect regulation of heart valves, bone and other tissue implants or transplants, which are overseen by the Food and Drug Administration. Instead, it would cover transplants of complex tissues such as a combination of bone and muscle involving blood vessels, such as a hand or face.

[Clark]

http://www.therepublic.com/view/story/b85d121437044d02ac15dc822b4584f3/VA--Transplant-Oversight

Richmond-based United Network for Organ Sharing to oversee US face, hand transplants
By TAMMIE SMITH

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Under new federal transplant policy, faces and hands and other body parts classified as vascularized composite allografts — VCAs for short — will fall under the National Organ Transplant Act.

That means face and hand transplant programs will have to meet the same strict regulations and standards as heart and liver programs, for instance — which could have been the case before but there wasn't the formal oversight from the United Network for Organ Sharing, the Richmond-based organization that has a federal contract to oversee and manage the nation's transplant system.

It means the supply of faces and hands for transplant might increase exponentially, and will require sorting through delicate issues such as whether signing an organ donor card covers consent for donating one's face or hands.

"For most people when they sign on to their state registry or they check off the box on their license, they really are not thinking they are signing on to donate a hand or a face," said Dr. Suzanne V. McDiarmid, chairwoman of a new UNOS committee that is developing transplant policy for faces, hands and other VCAs.

"I think that we would not assume consent for hand and face transplantation at this stage of the journey," said McDiarmid, medical director of the hand transplantation program at UCLA Health. "So even though in many states signing on to your registry is legally binding, and in theory your family cannot override your decision, the sensitivity of donation for hand and face, I think we would be very cautious."

That is just one of the issues before the new committee, which met for the first time by conference call Nov. 22 and will have an in-person meeting in Chicago in coming weeks.

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