Pa. company illegally tested bone cement on humans

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Pa. company illegally tested bone cement on humans

June 17th, 2009 joshua

Federal authorities allege a West Chester, Pa., medical device company, Norian Corp., with training surgeons to use its experimental bone cement during spinal surgeries.

At least three people died in the operating room when surgeons used this unapproved device on patients. The Food and Drug Administration does not allow medical device companies to conduct their own clinical trials without approval.

Norian Corp. trained surgeons to use its bone cement during spinal surgeries. This device led to the deaths of three patients when it was injected into patients. They experienced severely low blood pressure, or hypotension.

In previous studies Norian conducted, the bone cement was the source of blood clots in human patients, and in pigs, those clots moved to the lungs. However, Norian continued to experiment.

The feds are charging the company with 51 felonies.

Surgeons interviewed by authorities never ruled out the cement, Norian XR, regarding the patient deaths.

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