FDA may Issue Regulation Against Artificial Hip Implants That Fail Early

The US Food and Drug Administration revealed that it is considering a proposal under which manufacturers will be stopped from selling artificial hip implants that fail early.

According to the agency, the manufacturers will have to prove that their device is completely safe and effective before they are allowed to sell their existing models or obtain approval for new models.

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Hip joint replacement has been instrumental in transforming the lives of many who had been disabled owing to severe pain in the hip joint.

The proposal will close a loophole present in the 1976 federal law under which companies have to only show that their device resembles the ones currently in the market without any need to conduct clinical studies.

The agency has expressed concerns over a large number of all-metal hip implants failing very soon after being implanted, forcing patients to undergo expensive and painful surgeries to replace in implants and also increasing health risks as tiny metallic debris released by the implants often cause bone and tissue damage.

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Source-Medindia

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