Hip Implant Complaints Flood FDA
The Food and Drug Administration has received more complaints about defective metal-on-metal hip implants in the last six months than in the total previous four years combined, according to a report in the New York Times.
The defect complaints mainly concern the DePuy (Johnson & Johnson) A.S.R. hip implant device but also include the Zimmer Durom cup.
Reader comments to the Times include many who raise these questions:
* Why is there no national registry of devices implanted in the human body, to make it easier to catch up with defect issues before they become widespread? Other countries have this.* Why does the FDA not mandate independent testing of permanent devices like hip implants before they are marketed? Why do the manufacturers control all the testing?
* Why couldn't the FDA foresee the issues with metal-on-metal hip implants which had been forecast in the medical literature for many years?
My take: Our system of regulating medical devices is badly flawed and in need of a big overhaul. This is the same conclusion reached recently by an independent panel of the Institute of Medicine.
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