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Posted by Newsbytes

"Inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump. But the FDA did not penalize the company, and patients had the device implanted on their hearts without knowing the facts." Read Article

Opinion:  A patient should have easy access to accurate and timely information relating to the risks associated with the major decision about to be made; instead of blindly relying on a  "regulatory system which generally serves patients well" and believing that “most companies are well intentioned.” If nothing else, intentions are not facts. 

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