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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Monday, February 11, 2013

Knowingly implant a failed medical device for profit.




New York Times     EDITORIAL
Published: February 10, 2013   FiDA Highlight
                                   
All-metal hip replacements have failed at a high rate and harmed many patients in recent years. Now there is evidence that a major manufacturer was aware of a serious problem with one of its models yet failed to alert patients or doctors and continued to market it aggressively.
The all-metal hips, in which a ball and a cup component are both made of metal, were thought to be superior in some respects to traditional hip replacements made of plastic and metal. Some 500,000 people in this country received all-metal devices over the past decade. They were not adequately tested because of regulatory loopholes the Food and Drug Administration is now moving to close, and began failing not long after implantation.
Thousands of patients have had to replace them in painful operations; hundreds more have suffered internal damage. Court documents now show that a major manufacturer, the DePuy Orthopaedics division of Johnson & Johnson, buried the bad news about a model known as the Articular Surface Replacement, the most failure-prone of the implants. The implants were recalled in 2010, but the documents show that as early as 2008 DePuy executives were told by a number of surgeons, including its own consultants, that the device appeared flawed. That was never disclosed to doctors who were putting the device into patients, nor were other unfavorable internal studies. By the time of the recall, the device had been implanted in about 93,000 patients around the world.
Surgeons have largely stopped using the device; even so, the company is facing more than 10,000 lawsuits in this country related to past implantations. Though the company says the evidence will ultimately show that it acted appropriately, it clearly has a lot of explaining t

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