LINK HERE: DePuy business decision to market failed DePuy hip
Barry Meier, reporter for the New York Times reports that Johnson & Johnson DePuy executives discussed the FDA refusal to clear the metal on metal hip one year before the recall. Aware that the hips were performing worse than the control group and patients were experiencing painful revision surgeries, executives did not stop sales nor did they inform clinicians and their patients.
This is why patient advocates are demanding "Give us our damned data." Our government pays for these failed products and the failures will be identified in real time if each product is followed post-market. Medicare pays for a large portion of these implanted devices and there should be a transparent mechanism for the data to be shared with patients in a meaningful way. We can evaluate new cars and new appliances. It should be mandated for all implanted medical devices. A minimum warranty is a useful feedback mechanism to the producer of the implanted medical device! Now there is no accountability. Patients are in medical and legal purgatory when a device fails. Legal justice may offer 5 cents on the dollar compensation, but no one can restore health and trust.
Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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