July 2011 Archives

July 27, 2011

DePuy Hip Recall Makes Some Experts Question FDA Medical Device Review Process

A recently released medical device study concludes that the FDA should "abandon" its present system for approving U.S. medical devices such as the DePuy Hip because it fails to ensure patient safety.

Currently the FDA employs a streamlined approach to approve medical device applications such as those for the beleaguered DePuy knee and hip parts - a process that takes 10 months as opposed to several years.

However, this quick process is unreliable. As the result of a faulty or inadequate screening process, many patients with medical devices have found themselves harmed by medical devices, implanted with recalled items that require additional, painful and sometimes dangerous surgeries.

One patient who required revision surgery to fix a recalled DePuy Hip part states, "You put your faith in the doctor and the companies that make these products because they're the experts...It's just beyond me to think that things can get approved that don't really work" reports ABC News.

Unfortunately, faulty medical devices are placed in patients at an alarming rate. A study from the National Research Center for Women and families found that more than 437 million devices were recalled in 2010 due to fears that they might kill and permanently harm patients.

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