In a report by the Associated Press (AP), Norian and its parent company Synthes Inc, are described as having conducted tests of the bone cement between 2002 and 2004 on about 200 patients, three of whom died. The tests were stopped after the third death.
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The bone cement was developed to fill bone defects and is currently used in the arm. However it is not approved for use in the load-bearing spine. Notably, the surgeries cited by authorities frequently involved older patients with compression fractures.
AP reports that according to the June 2009 indictment, pilot studies of the bone cement showed that it produces blot clots in humans, while animal data suggest that the clots could migrate to the lungs. The patients who died were found to have suffered severe low blood pressure after receiving injections of the bone cement. None of the surgeons could rule out the bone cement as a factor in the deaths, an FDA investigator has said.