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A surgical procedure's risks, unmentioned

The New York Times, March 18, 2014

Many patients assume that, like prescription drugs, surgical procedures and instruments undergo extensive testing and must be government-approved. It's not necessarily so. Developers, of course, do test new instruments, and practitioners often train with an expert before using them unsupervised to treat patients. And the Food and Drug Administration must confirm an instrument's safety and effectiveness before it can be marketed — but only if the device is deemed significantly different from others already approved. Surgical techniques, however, are not subject to the stringent approval process that drugs go through.