Posts Tagged ‘ medical device approval ’

Metal Hip Device Implant Sold in EU After Rejected in U.S.

Feb 15th, 2012 | By
Metal Hip Device Implant Sold in EU After Rejected in U.S.

February 15, 2012 ~ Barry Meier of the New York Times reports that Johnson & Johnson’s DePuy division continued to sell a defective artificial hip overseas even after it was rejected for sale in the U.S. Two related versions of the metal-on-metal hip, DePuy ASR were implanted in about 93,000 patients worldwide with about one-third
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Study of Medical Device Rules Is Attacked, Unseen, New York Times, July 27, 2011

Aug 14th, 2011 | By

Allies of the medical device industry criticized an Institute of Medicine report, to be released July 29, that says the approval process for a wide range of medical devices such as hip implants, hospital pumps, surgical mesh and external heart defibrillators is deeply flawed, is injuring patients and causing numerous injuries, reports the New York
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.