An FDA 'ambiguity' means patients get unapproved devices

A Chicago surgeon invented a silicone and metal ring to repair heart valves, and implanted them in 150 patients before his new device received FDA approval, The Wall Street Journal reports. The episode has fueled a feud between the surgeon, Dr. Patrick McCarthy, and a former collaborator who alleges he used those patients for "human experimentation." It's also exposed a potentially serious ambiguity in FDA regulations that allows device manufacturers to determine - without independent review - which of their new products require FDA approval and which don't.

Dr. McCarthy's ring, known as a Myxo ring, was similar enough to existing, approved products that its manufacturer didn't see a need to go back to the FDA. "There is no way to know how many medical devices may have followed a similar path to use in patients since 1997, when a guidance document allowing this flexibility was introduced. But both industry and regulators say this guidance may have saved the industry hundreds of millions of dollars during that time" (Mundy and Favole, 12/23).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.