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Medical devices don’t receive rigorous scrutiny

medical device labWhen a doctor or surgeon recommends a particular medical device, such as a hip replacement, you probably assume that the device has been tested thoroughly, that it is safe and proven to be an effective treatment for your ailment. But recent studies have shown that this really isn’t the case, and that patients should be prepared to do their own research into medical devices prior to accepting a doctor or surgeon’s recommendation.

News stories and medical studies since 2011 have indicated there are problems with the process the Federal Drug Administration (FDA) uses to review and approve medical devices. The most recent news stories indicate that the data the FDA says it requires is often missing.

The latest story is a report from international news agency Reuters by reporter Andrew Seaman. The story was published on September 29, 2014. That article says that two new studies both indicate that medical devices are not tested thoroughly enough before being approved for implantation in the human body. The two most recent studies were published in JAMA Internal Medicine. You can read one of the studies here.

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. A summary of the article is available here (requires subscription to read the full article).

The most recent Reuters story 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.

A myriad of lawsuits, particularly surrounding the design of hip replacements, indicate that patients are being harmed by these medical devices. A trial is underway in Dallas now that is considered a bellwether case, meaning the result will be used as a guide to help determine how much companies that manufactured the devices, including Johnson & Johnson, will have to pay in settlements with patients injured by the devices.

Many metal-on-metal hip replacements have been recalled, including the DePuy Orthopaedics ASR™ XL Acetabular Hip System and the DePuy ASR™ Hip Resurfacing System. Stryker Rejuvenate and Stryker ABG II Modular-Neck Hip Stems are other examples of defective metal-on-metal hip components. Both were recalled by Stryker in 2012. Another problem hip implant component is the Zimmer Durom Acetabular Cup, which Zimmer stopped distributing in 2008.

Contact a qualified attorney if you have any of these hip implants. You can reach the experienced attorneys of English, Lucas, Priest & Owsley at (270) 781-6500 or contact us through our web site here.