When a medical doctor recommends a procedure involving an implanted medical device, such as artificial valves, hip replacements or surgical mesh, you probably assume that the device has been rigorously tested by U.S. health regulators such as the Food and Drug Administration. However, two new studies published September 29 2014 in JAMA Internal Medicine reveal inadequate device testing due to lax oversight by the FDA. Diana Zuckerman, president of the National Center for Health Research and lead author in one of the studies stated the following:
“Let the buyer beware before getting an implant in their body, because there may be no evidence the implant is going to benefit them and no study done in case it might harm them.”
The study examined 50 new medical devices that were part of the 510(k) process. The FDA uses this process to fast-track approval of medical devices that are viewed as substantially the same as other types of devices already on the market. Out of the 50 medical devices reviewed, the study indicates that about 16 percent were, in fact, substantially equivalent to devices already on the market. But – and here’s the biggest problem – the FDA’s clearance of the devices for market was not supported by publicly available evidence in 97 percent of cases. Information that should be available to the public, physicians, surgeons and other medical professionals is missing or incomplete, leaving people without the information they need to evaluate surgical and medical options.
Another study, published in the same edition of JAMA Internal Medicine, reported on research studies surrounding certain medical devices. The FDA ordered 223 studies for 158 medical devices from 2005 to 2011. Out of all of the studies, only one study led to any substantial changes in a product. Some other studies led to label changes in devices, but no design changes.
The most recent Reuters post points back to reports from 2011 of a similar nature, and indicates that nothing has changed at the FDA. That report from 2011, also by Reuters, cites an Institute of Medicine report that the 510(k) process is fatally flawed and should be replaced. According to the latest Reuters article, the FDA disagrees with this assessment, even though the organization commissioned the study and sought out an objective opinion.
The net result from the two studies revealing lax oversight by the FDA is that patients should be prepared to do their own due diligence into medical devices prior to accepting a doctor or surgeon’s recommendation. If it’s too late to do any research because you’ve been harmed, then you should immediately seek the services an an experienced, competent personal injury lawyer. Contact Attorney Michael Pence and schedule a free consultation.