The US Food and Drug Administration (FDA) is responsible for approving drugs for medical uses, and the agency has developed a set of expectations for using results from randomized clinical studies to determine (with varying degrees of success) whether a drug is safe and effective. But advances in materials science and miniaturization have led to an explosion in the use of medical implants, which do everything from acting as a replacement for balky knees to restarting arrhythmic hearts. Two new evaluations of the clinical studies used during the implant approval process suggests that the approval process for implants isn’t nearly as rigorous as it might be.
The significance of the FDA’s approval is made clear by the authors of one of the evaluations, which was published yesterday by the Journal of the American Medical Association. As is the case with drugs, many physicians view the FDA’s acceptance as an indication that a device is safe and effective, as do many insurance companies. The makers of the implants, for their part, often view approval as a sign that it’s safe to begin a direct-to-consumer advertising campaign for their product.
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