But It’s Approved by the FDA!?!

We have all heard it.  “This FDA Approved treatment….”  But what does “FDA Approved” really mean? Are all FDA Approvals the same or is there a difference between them?

First, there are big differences amongst the types of FDA Approvals.  There are really two types of FDA Approvals for medical devices.  There is the 501(k) approval and there is the more stringent PMA Approval.  It is really important to understand the differences between these types of approvals when selecting a procedure that uses some form of medical device or medical technology that required a FDA Approval.

Most medical devices are 501(k) approved devices meaning that they are “substantially equivalent” to another already approved device.  It is the “substantially equivalent” that is the tricky part since this really is a grey area that leaves lots of room for interpretation.  There are medical devices that have been approved for one type of treatment that maybe are modified or not modified and then approved for a completely different medical application.  The FDA only requires that the device be safe and effective in its new application.   The problem is what and who decides if the device is really effective?  It is the role of the FDA to make that determination but in many situations, the FDA seems mostly concerned that the 501(k) devices are mainly safe and the effectiveness part takes a back seat in the process.  Every plastic surgeon can list a long line of devices that had received 501(k) approval but really were not effective for the application they were being marketed.  Most commonly these devices are used for skin tightening or fat removal but also cellulite treatment, hair removal, etc. and countless other applications can be listed.  The companies that manufacture and market these medical devices push the “FDA Approved” status loud and clear and not just to the public but also to medical professionals including doctors.  Too often the doctors react in a “knee-jerk” manner, worried that if they don’t have the latest medical devices in their office, patients will go elsewhere.  It is a fact that the medical device manufactures know and count on when they market and sell their devices.  “If you don’t have our Device X in your office, you won’t have any patients.”  Once the device is bought, it is like the hammer and the whole world becomes the nail.  Patients are going to be pushed to using the device even if there may be little or no proof that the device is really effective or if it is the best choice for treating the condition they are concerned about.  This is not to say that all 501(k) devices are bad or ineffective.  In fact, most are very effective and do achieve the results they are designed for but sadly, in the world of cosmetic medicine with all the “want-a-be” doctors and manufacturers, there are far too many medical devices and treatments that do not meet that threshold of quality.

The PMA Approval process is a much more rigorous and difficult process.  The PMA process requires much more scientific data about the safety and effectiveness of the medical device or treatment before it can be approved.  This is a process that can take years to perform the required levels of study and collect the data before submitting for final approval.  It is much more costly for the manufacturers and the scientists and doctors.  The patient safety guidelines are far stricter and the oversight is very aggressive.  That being said, most devices that have been through the PMA Approval process are very safe and very effective.

So the next time you hear the words, “FDA Approved” when you see an ad for a medical device or treatment, remember there are different levels of approval and not all approvals are equal.  As always, do your homework and make sure your doctor does too.

Herluf Lund MD

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