High-Risk Medical Device Approval Based on Few Studies

August 13, 2015 — High-risk medical devices are often approved by the FDA based on just one study proving they are safe and effective, according to new research published by the Journal of the American Medical Association.

Class III (“high-risk”) devices must be approved with a premarket approval application (PMA) for the FDA to evaluate safety and effectiveness

Using public data from ClinicalTrials.gov, researchers looked at studies on 28 high-risk devices that were approved in 2010 and 2011. They found 286 clinical trials, but there was wide variation in pre-market and post-market studies.

On average, the FDA relied on one study per device to decide on its approval. The FDA ordered 33 post-market studies for 28 devices, but only six of those studies were completed by October 2014.

Furthermore, five devices had no post-market studies, 13 devices had three or fewer post-market studies, and half of the studies did not compare the new device to an existing device.

The authors warned:

“Most devices have been or will be evaluated through only a few studies, which often focus on surrogate markers of disease in small numbers of patients followed up over short periods of time and study indications that differ from the original FDA-approved indication.”

The problem is that many devices are only classified as “high-risk” after they cause thousands of serious injuries. For example, the FDA approved vaginal mesh without requiring safety studies because it was “similar” to hernia mesh, which is used for an entirely different purpose.

In 2011, the FDA warned that vaginal mesh complications were “not rare.” However, it was not until April 2014 that the agency proposed reclassifying vaginal mesh as a high-risk device. By that time, tens of thousands of women had already been injured and filed lawsuits.

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