FiDA Failed Implant Device Alliance: Monumental regulatory fail: metal on metal hips

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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Thursday, January 17, 2013

Monumental regulatory fail: metal on metal hips

http://www.nytimes.com/2013/01/17/business/fda-to-tighten-regulation-of-all-metal-hip-implants.html?emc=tnt&tntemail1=y

F.D.A. Seeks to Tighten Regulation of All-MetalHip Implants – Full Article

By BARRY MEIER

After an estimated 500,000 patients in the United States have received a type of artificial hip that is failing early in many cases, the Food and Drug Administration is proposing rules that could stop manufacturers from selling such implants.

Under the proposal, which the agency is expected to announce on Thursday, makers of artificial hips with all-metal components would have to prove the devices were safe and effective before they could continue selling existing ones or obtain approval for new all-metal designs.

Joshua Borough for The New York Times

Some all-metal hip implants have failed prematurely, forcing thousands of patients to undergo operations to replace them.

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Thursday, January 17, 2013

Monumental regulatory fail: metal on metal hips

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