There are interesting misperceptions about what it means when a medical device is approved by the FDA. Very often patients interpret this to mean that the new device works really well and even perhaps that it is better than older treatments. Companies often propagate this perception in their marketing. However, FDA approval means something very different than how clinically effective a device or treatment really is or how it stacks up to other treatments. Instead, FDA approval means that the treatment is shown to have some support of efficacy and that regulatory requirements for manufacturing, packaging and other factors have been met. FDA approval allows a company to market and sell the approved device. Depending on the type of device undergoing approval, the FDA process may be relatively streamlined or long and arduous for a company to navigate. For some devices the process is a 510k approval, which requires less testing and data. This makes sense when the new device is somewhat similar to older devices where there is a track record with which to compare. In other instances, the device must undergo the more rigorous Pre-Market Approval process which usually takes years to complete.
Having some interactions with FDA on various issues, I have been very impressed at how the professionals at FDA take their responsibility seriously to protect the public and to make devices and medicines available. We have to remember, however, that the FDA works within the framework of the laws and regulations that Congress has set for it. As a result, what the FDA is looking for when approving a device or medication may not be the same factors that you are wanting to know as a patient. For instance, although FDA approval means that there is some degree of efficacy, that does NOT necessarily mean that the device or treatment has a clinically significant effect or is better than – or even as good as – other treatments. For example, if a product is marketed to “tighten skin,” but the amount of resultant tightening is less than 5%, is that even visible? Does that make the treatment worth doing? Probably not – there may be a minor effect in some patients – but the treatment may be worthless in terms of results that you can see. And it is also important to remember that the medical studies that companies submit for FDA approval, and which they use in marketing, are generally company funded, so there is often a significant potential bias in how the study was done. Sometimes only the more favorable studies (from the company standpoint) are promoted.
So what does this mean for you as a patient? Well, for one thing it means the old rule of “buyer beware.” Just because a new device is “FDA approved” does not mean it works well, does not mean that it compares favorably to established treatments, and does not mean it will give you the results that you want. And in marketing, “Clinically Proven!” may only mean that there is some documented effect, even if this is so weak that it is meaningless to you. There are many closets in offices overflowing with old light treatment devices, lasers, and other devices that were FDA approved but were discarded because they just didn’t deliver the goods. So how do you know if a device makes sense for you? First, don’t rely on marketing – that serves to sell or promote the treatment. Instead, talk to a plastic surgeon who can offer you a variety of treatment options, and discuss with you whether newer treatments make sense, if they don’t really work, or maybe that we just don’t have enough data yet to know for sure. If the doctor can only offer you the new device – be cautious – there may be a big incentive for them to promote that device. Finally, although there are often many new and exciting treatments which emerge, remember that most new devices ultimately don’t hold up to the claims. For every product like Botulinum A Toxin (e.g., BotoxTM) that really works and changes patient options, there are a score of treatments or devices that fall by the wayside, leaving disappointed patients with thinner wallets.
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