Studies Question Lack of FDA Medical Implant Testing

medical implant

The safety of new implant devices may slide under the FDA's radar

Studies on the safety of medical implants show that new technology may not always be the best, and you may not always know about it right away.

Published in the current issue of JAMA Internal Medicine, the reviews assessed FDA-approved implants for the presence of safety data in both the application and post-approval stages. Not only did researchers find that safety information was not present in the applications of the majority of their sample, but also that the FDA did not follow up with testing high-risk devices until at least six months after they were approved and potentially in-use.

A Lack of Safety Data in Approval Process

The first study took a sample of 50 new implants – including hip replacements and surgical mesh – and reviewed their manufacturers' applications for evidence of safety tests from 2008 to 2012. Because the implants were modified versions of existing devices, they were not required to be clinically tested, according to federal law. However, in this case, manufacturers are still responsible for proving the modified devices are safe, comparable, and just as effective as their previous versions.

Despite this requirement, only eight of the 50 applications included the safety data. This led researchers to call for the FDA's attentiveness to the law in order to best protect the public health.

A Slow Response in Post-Approval Reviews

An oversight on the presence of safety data in the application process could make matters worse after the FDA officially approves a device. Normally, the FDA issues these studies because they have a few concerns about a high-risk implant, such as a heart stent or a defibrillator that is meant to be in the body for a long time.

The second study found there are delays of six months or more in finalizing the protocol for post-approval studies, according to Pew Charitable Trusts. This makes it difficult for doctors and the public to be aware of potential problems with implants as soon as they are approved.

Pew also suggests that the follow-ups themselves are inefficient. From 2005 to 2011, the FDA issued 223 post-approval studies for 158 high-risk implants. After review, only one device was taken off the market and 31 devices required labeling changes.

"Given our findings...we encourage the agency to work together with all stakeholders to evaluate how these studies can more effectively be used to improve the public health," the authors wrote.

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“Studies, Commentary, Viewpoint on the FDA, Medical Devices.” JAMA Internal Medicine. Sept. 29, 2014.
“Two more studies say FDA bad at regulating medical devices.” Philly News. Sept. 30, 2014.