Aug. 16, 2001 (Washington) -- Warning of the risks of a fatal condition related to "mad cow" disease, a national consumer group is petitioning the FDA to ban the surgical transplant of tissue that surrounds the human brain.
But if the donor had Creutzfeldt-Jakob Disease, or CJD, a deadly brain-wasting illness, the disease could spread to the recipient.
CJD is rare, striking about one in a million people. Nevertheless, according to Public Citizen, dura mater transplants have caused at least 114 cases of CJD worldwide, including three in the U.S.
Great Britain and Japan have banned the use of dura mater, but the FDA permits the use of the transplant tissue in the U.S. In 1997, an agency advisory panel voted to recommend that doctors not use the material but left the final decision to neurosurgeons.
"Leaving this critical decision in the hands of neurosurgeons is a woefully inadequate step in protecting patients," said Sidney Wolfe, MD, director of Public Citizen's Health Research Group.
John Jane, MD, editor of the Journal of Neurosurgery, also signed the petition.
But Chicago neurosurgeon Richard Fessler, MD, a spokesman for the American Academy of Neurological Surgeons, tells WebMD that regulation is not needed.
Banning the tissue would be overkill, he says, because the disease is so rare and current information shows the risk of spreading it in this way is tiny.
Fessler adds, "I'm not saying dismiss it, but in the realm of ranges of risk, it's a really small risk."
Public Citizen's petition argues that neurosurgeons have several options instead of using dura mater. The group cites animal tissues, various synthetic graft materials that are approved for U.S. marketing, and taking tissue from a patient's leg or face.
Fessler gives a rough estimate that about 10,000 brain surgery procedures per year involve the transplant of dura mater or the use of other grafts. That's about 15% to 20% of all brain surgeries.
But Fessler says that doctors should have the full range of options available.
"If you have a reasonable substitute, it's fine to use something else," he tells WebMD. "Something from the patient's own body is probably the ideal, except for potential complications you can get."
These complications, he says, can include pain. Fessler adds that synthetic grafts are improving but can cause problems such as not being able to heal as well as real tissue. "They are not as good a substitute as using regular tissue."
Peter Lurie, MD, deputy director of Public Citizen's Health Research Group, tells WebMD, "There is no reason not to take dura mater off the market altogether. The number of cases of CJD has continued to mount, and there are more alternatives coming on the market."
The FDA did not return a call for comment on the petition.