J&J metal hip trial stirs up renewed call for 510(k) reform

Metal-on-metal implant--courtesy of NIH

A San Francisco Chronicle story renews calls for the FDA to close loopholes that allow devices such as all-metal artificial hips to win 510(k) clearance, and avoid human testing before approval as a result. The argument comes in the context of thousands of lawsuits over ASR brand hips made by Johnson & Johnson ($JNJ)/DePuy, many of which released tiny metal fragments and led to patient health problems. An initial trial focused on the DePuy hip began recently in a Southern California court, the article notes, and thousands of lawsuits are pending. The idea is that closing the loophole that allowed all-metal hips to obtain 510(k) clearance without human trials would prevent similar problems in the future, and the story highlights hip implant patients who suffered without such a provision in place. Story

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