Health Canada bans 'brain patch' linked to brain disease
Health Canada is banning the use of the "Tutoplast Dura" brain patch because of fears it may be linked to a brain wasting illness, Creutzfeldt-Jakob disease.
The patch been linked to at least one CJD death in the United States. This has prompted a review of the product in Canada.
Tutoplast Dura is made from the brain tissue of human corpses. Health Canada estimates it's used in about 200 surgeries every year.
Neurosurgeons use it to repair the brain's dura mater the fibre-like outermost membrane surrounding the brain and spinal cord. It is also used in other operations from shoulder surgery to bladder lifts.
Health Canada says Tutoplast Dura can no longer be sold or imported. Physicians are being asked to place any supplies they may have in a secure place.
Creutzfeldt-Jakob disease is a rare brain disorder in which the brain matter wastes away.
Symptoms include depression, confusion, personality changes and memory loss. The condition degenerates rapidly and the patient develops neurological problems affecting sight, co-ordination, speaking ability and movement.
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"We are talking about the pure version of CJD," says Ryan Baker of Health Canada. "Not the one connected to mad cow disease, variant CJD."
Lyodura had been used in Canada since the 1970's. Surgeons say thousands of those patches have been used in Canada.
In 1987, the death of a Connecticut woman from CJD she had the patch implanted two years earlier sparked a recall of a specific batch of Lyodura patches in North America.
This year, the Japanese distributor of Lyodura B.Braun Melsungen and Japan's health department agreed to compensate the families of Japanese CJD victims. Each family will get more than $600,000.