Are All FDA Approved Devices Safe?

The U.S. Food and Drug Association is responsible for ensuring that new medical devices are safe enough to be put on the market. As a federal agency, the FDA controls regulation nationwide and within Illinois and Chicago. But what most consumers don’t know is that the process for approving these medical devices doesn’t always ensure that they are effective alternatives to already established medical treatments.

The majority of newly approved medical devices undergo a 501(k) review. Under this review process the manufacturer needs to prove that their device is substantially similar to another device that has already been approved for the market. Once they have done that, the manufacturer just needs to show that the device does what it claims. Yet in the field of medicine, just performing a function is different than guaranteeing the supposed outcome.

For example, let’s suppose that Elaine, an Illinois woman, was trying to decide between which type of radiation she should get to treat her breast cancer. Her options range from conventional radiation, which would irradiate her whole breast five times per week for a total of five weeks, to a newly-FDA approved radiation therapy method called MammoSite brachytherapy. This new method only requires radiation for five days and uses radioactive ‘seeds’ to treat the cancer.

All things being equal, the MammoSite option is much more appealing because it gets the job done in a fraction of the time and is Elaine’s first choice. Her doctor recommends it and she decides to go with the newer treatment option. However, what Elaine doesn’t know is that even though MammoSite is FDA-approved, the long-term effectiveness of the treatment is not yet proven. While early studies have come back with promising results, it will be years before there is enough data to determine whether it is as effective as conventional radiation. Yet many of the women undergoing this form of treatment are unaware that it is still in an experimental state and are trusting the FDA-approval and their doctors’ recommendation.

And while MammoSite could very well live up to its hype and prove to be a wonderful innovation in breast cancer medical devices, at this point it is to early tell. It could also join the ranks of several other FDA-approved devices that eventually had to be pulled from the market.

Some argue that the FDA review process for medical devices needs to be revamped and made more rigorous. For example, the process the FDA uses to review radically new technologies is very strict. But where’s the middle ground? Why is one review so strict and the other so lax? And what can we as consumers and medical patients do to ensure that the medical devices we’re using are safe and not likely to end up as a medical device liability claim?
Current efforts to determine what needs be done to change the FDA’s current review process are underway in Washington, D.C. A non-partisan group, the Government Accountability Office, is completing a study of how effective the current review process is. A report is expected to be released in the coming months.

Chicago’s Kreisman Law Offices has been practicing medical device liability in Cook County and Illinois for over 30 years, in such areas as Bridgeview, Forest Park, Niles, and Worth.