Posted on 06/21/2006 9:09:43 PM PDT by TigerLikesRooster
TGA's stolen body part alert
June 22, 2006 - 12:28PM
Australia's drug regulator has warned health departments and selected doctors that Australians might have been implanted with a medical product made from stolen human body parts.
The Therapeutic Goods Administration (TGA) released a statement today, saying the skin graft product AlloDerm had been the subject of an international recall.
It follows reports in Fairfax newspapers that 46 Australians had been implanted with the product, which contained parts stolen from funeral homes in New York.
The bones, ligaments and skin - many of them aged and, due to the potential for infection, unsuitable for transplant - were traded to legitimate firms, which transformed them into products used to cure back pain, incontinence and other medical conditions.
The material might have been implanted into Australian patients under a scheme that allows patients, in consultation with their doctors or dentists, to obtain products not yet approved for use here.
In its statement today, the TGA said the product had been recalled because the manufacturer "was not satisfied with documentation relating to the selection and testing of the donor tissue".
"Implicated batches were manufactured from early 2004 to September 2005," it stated.
AlloDerm is manufactured by American company LifeCell, but a co-founder of the Australian branch of LifeCell, Stephen Livesey, today said that LifeCell had confirmed to him that none of the affected tissue had been sent to Australia.
"I have been in contact with LifeCell in the United States. They have traced the [tissue] grafts in question and they have informed me that absolutely no graft in question was sent to Australia and no graft was used in implantation into patients," he told Channel Nine today.
Dr Livesey, now the chief scientific officer with the Australian Stem Cell Centre in Melbourne, said Australian patients had nothing to fear.
"I think in terms of the rigour and the thoroughness that LifeCell conducted their investigations, they have traced the grafts and they can say no grafts were transplanted into Australia," he said.
The TGA said AlloDerm had not been approved for general marketing in Australia, but had been supplied on an individual patient basis through the Special Access Scheme (SAS).
"The TGA approved the use of AlloDerm under the SAS for only 46 patients," it said in the statement.
"The TGA has written to the 13 medical and dental practitioners who may have imported AlloDerm and advised them of the concerns regarding this product.
"The TGA has advised state and territory health departments of this issue and will keep them updated with progress of the investigation."
It recommended that patients who have been treated with AlloDerm consult their doctors.
The punishment for organleggers should be death and dismemberment. Not necessarily in that order.
"Organleggers?"
Bootleggers do not traffic in boots.
True, but it isn't exactly in common usage or in the dictionary, and I'd bet for the reason I gave above. And I LIKE Larry Niven's stuff, don't get me wrong. I just haven't read The Jigsaw Man.
Still, we don't have a term for the actor that does that act. As official representative of the English language, I decree that henceforth, organlegger will certainly do until something better comes along. 8^)
I believe Niven wrote the story to be distopic, but I thought the world he made would be utopic.
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