The Japanese health ministry has belatedly decided to ban the import and use of dura mater grafts, almost ten years after similar action was taken by the US Food and Drug Administration (FDA). The decision highlights major deficiencies in the monitoring for safety of health-care products in Japan. The grafts, freeze-dried tissue from the outer skin of the human brain that is used in many neurosurgical procedures, are derived from human cadavers and have been linked to cases of Creutzfeldt-Jakob disease (CJD). Last week, an expert committee approved an earlier announcement by the Japanese government recommending that such grafts should be replaced by autogenic grafts or artificial substitutes.
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