Federal rule would ease access for face, hand transplants

The proposal calls for putting them under the same regulatory authority as organ transplants.

By Carolyne Krupa — Posted Jan. 23, 2012

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Plastic surgeon Dr. Maria Siemionow, PhD, asks one to imagine what it's like to live without a face, with no nose, lips or eyelids.

"You cannot speak, you cannot close your eyes, you cannot breathe [normally]. You can't eat because you don't have a palate, and you can't drink because you have no lips," said Dr. Siemionow, head of plastic surgery at Cleveland Clinic. "Is that quality of life?"

Until recently, patients with these and certain other devastating injuries had few options. But recent advancements in immunosuppressive therapies and surgical skills led to the first face and hand transplants, said Dr. Siemionow, who led the country's first successful face transplant in 2008.

Such transplants are expected to become more common, especially in the treatment of veterans wounded in the wars in Iraq and Afghanistan, federal officials and surgeons say.

The federal government is preparing for future demand with a proposed rule that would make it easier to match donors with recipients and ensure that needed tissues are allocated fairly and safely for all patients, said Jim Bowman, MD, medical director of the Health Resources and Services Administration Division of Transplantation. Under the rule, prospective transplant patients would be put on a national waiting list, as is done with transplants involving hearts, kidneys and other organs.

"It's going to improve access for patients who are looking for hand and face transplants," Dr. Bowman said. "It's also going to give physicians confidence that everyone is playing on the same playing field and no one is going to be given an unfair advantage."

The proposed rule

The rule would place vascularized composite allografts under the purview of the Organ Procurement and Transplantation Network. VCAs cover a variety of composite tissues -- such as faces, hands, fingers, toes, larynges and abdominal walls -- that must be transplanted quickly and can be damaged or die from a lack of blood supply. Such tissues are now under the regulatory authority of the Food and Drug Administration.

"Currently, the number of patients is very small, so the allocation is being performed through regional appeals," said Dr. Linda Cendales, assistant professor and director of vascularized composite allotransplantation at Emory University School of Medicine in Atlanta.

Dr. Cendales has helped perform three hand transplants, including participating in the first two performed in the U.S. in Louisville, Ky., in 1999 and 2001. The transplants help patients regain the ability to perform daily tasks with their hands and improve quality of life, she said.

For example, in 2011, Dr. Cendales performed a hand transplant on a 21-year-old patient who had lost her left hand and both legs to an inflammatory disease as an infant. The surgery "has affected her own body image, how she perceives her body image and the confidence this has provided her," Dr. Cendales said.

The proposed rule would mean that VCAs are performed under common safety standards that are consistent with organ transplants, she said. Placing VCAs under the transplant network also would help with the collection of valuable data for research to help advance the field, Dr. Bowman said. The Dept. of Health and Human Services is taking public comments on the proposal through Feb. 14.

Anticipating demands for transplants

There are 10 hand, two face and one abdominal wall transplant programs in the U.S., but more centers are expected to begin doing these types of surgeries soon, according to the Federal Register report on the proposed rule.

Though advancements in body armor have saved the lives of many troops injured in Iraq and Afghanistan, more veterans are living with injuries to their arms, legs, head or neck, Dr. Cendales said.

More than 1,000 troops have lost an arm or leg in the conflicts, and 20% of those have lost two or more limbs, the report said. As of mid-2010, an estimated 200 wounded troops were potentially eligible for face transplants and about 50 for hand or forearm transplants.

But William Gunnar, MD, national director of surgery for the Dept. of Veterans Affairs, said it's impossible to predict future demand for the transplants.

The surgeries are still experimental. Patients and physicians must carefully weigh the risks against the potential benefits, as well as other options such as prosthetics, Dr. Gunnar said. The surgeries require patients to be on immunosuppressants the rest of their lives to prevent rejection of the transplant. "The issue is the complexity of the risk-benefit analysis associated with lifelong immunosuppression," he said.

Warren Breidenbach III, MD, MSc, who led the first successful hand transplant in the U.S., said he would have liked more discussion about the potential implications of the proposed rule before now.

He foresees medical advances that could make it possible to use composite tissues in reconstructive surgery without the need for immediate vascularization, blurring the regulatory lines between the FDA and the transplant network.

Specialty bias also could pose problems for the advancement of the field, said Dr. Breidenbach, professor and chief of the division of reconstructive and plastic surgery at the University of Arizona College of Medicine.

"Every specialty develops an attitude which accidentally can influence another specialty when the two mix, causing problems," Dr. Breidenbach said. "We as a group should consider discussing some of these issues in anticipation of setting an agenda that would help the field grow. There will be unintended consequences that I don't think we as a society have thought through."

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External links

Organ Procurement and Transplantation Network proposed rule, Federal Register, Dec. 16, 2011 (link)

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