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FDA Panel Wants Higher Bar for Medical Devices Aimed at Curbing Obesity

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"High-risk medical devices intended to help obese patients lose weight should result in more weight loss than lower-risk methods, an FDA advisory panel said last week."

Mass Device, Ingrid Mezo

An FDA advisory panel says riskier medical devices for treating obesity should deliver more weight loss than less-risky treatments to justify the federal watchdog agency's approval.

High-risk medical devices intended to help obese patients lose weight should result in more weight loss than lower-risk methods, an FDA advisory panel said last week.

"For a 1-and-done [a permanently implanted device], or a device equivalent to a gastric bypass, you should have higher expectations of the weight loss," said panelist Dr. Steven Schwaitzburg, of Harvard Medical School. "Whereas, if we have lower-risk devices and are able to establish other types of endpoints like bridge [to surgery], exercise, etc., then [a lower bar for excess weight loss would be acceptable]."

Treating obese patients has a high public health impact, but obesity treatments present difficult trade-offs, the FDA's gastroenterology and urology devices advisory panel underscored during the meeting May 10-11 in Gaithersburg, Md.

Obesity has reached epidemic proportions in the U.S., more than doubling since 1960. Some 36% of adults are categorized as obese, as are 18.1% of adolescents and 19.6% of children 6-11, according to the National Institutes of Health and the Journal of the American Medical Assn. . .View Full Article


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