New JAMA Studies Critical of FDA Medical Device Clearance Process

Two studies published recently in the prestigious medical journal JAMA Internal Medicine say that many of the medical devices approved by the Food and Drug Administration (FDA) lack evidence verifying their safety and effectiveness.

One study, led by Dr. Diana Zuckerman, president of the National Center for Health Research, looked at moderate to high-risk medical devices cleared through the FDA’s controversial 510(K) medical device clearance process, which allows for fast-track approval of devices that are shown by scientific evidence to be “substantially equivalent” to a device already on the market (known as a “predicate device”). Under the 510(K) process, evidence of substantial equivalence to a predicate device takes the place of testing in human patients.

According to Zuckerman and colleagues, approximately 400 moderate to high-risk implanted medical devices receive 510(K) approval by the FDA each year. They used FDA databases to assess 50 devices cleared between 2008 and 2012 as well as the 1,105 predicates listed by the manufacturers for the devices. Public evidence of substantial equivalence was found for just 16% of the new devices and 3% of the predicates.

“If wonderful studies are being done, there is no evidence of this, and there’s no way for the public to see it,” said Zuckerman per a Wall Street Journal report. “It’s shocking how little information is available despite an FDA leadership that talks about transparency.”

The FDA responded that it “reviews a significant amount of data—far more than what is publicly available.” \

Another JAMA-published studyAnother JAMA-published study, this one led by Ian S. Reynolds of the PEW Charitable Trusts, looked at post-approval surveillance (described by the study authors as “critical to evaluating the safety and effectiveness of medical devices) of FDA-approved high-risk medical devices. The study looked at 223 studies on 158 devices ordered by the FDA between January 1, 2005 and December 11, 2011. During that period the FDA only once ordered an action other than achange despite frequent study delays. It never issued a warning letter or penalty due to study delays or other PAS issues.

The authors took issue with the studies’ sample sizes, protocol and availability of findings, writing that, “Improved completion and accessibility of PASs could help answer important questions of safety and effectiveness about medical devices.”

Andrus Wagstaff Protects Medical Device Recipients When Regulators Fail To Do So
Commentary accompanying the two new JAMA studies calls the FDA’s premarket and postmarket device review processes as a “work in progress.” The Denver personal injury attorneys at Andrus Wagstaff believe that regulators and manufacturers should be doing more right now to protect device recipients, and we’re prepared to hold legally responsible device makers who fail to ensure the safety and efficacy of their products.

DePuy metal hips and surgical mesh were both approved through the FDA’s 510(K) process; both have proven to be anything but safe and effective, in many cases leaving patients with new harm and more medical bills.
If you were implanted with a metal hip, transvaginal mesh or another medical device that caused injury, schedule an initial consultation with our team to discuss your case free of charge.