What Is “Off Label Use” Of Fillers & Is It Safe?
Millions of dermal filler injections are performed every year. However, each individual filler may only have FDA approval to treat one or two areas. Yet, most hyaluronic acid fillers are used around several areas of the face. This is known as “off label use”. Let’s learn more about, “What is ‘off label use’ of fillers and is it safe?”
First, let’s learn more about off label use. It essentially means that the FDA has not approved that specific drug or treatment for a specific ailment or body part. The drug or treatment is FDA approved for another area or ailment, however. Off label use does not refer to the use of drugs or treatments with absolutely no FDA approval. Off label use occurs in all medical specialties and is relatively common.
With fillers, an example of off label use would be using Restylane Defyne for the lips. While it is FDA approved for the nasolabial folds, marionette lines, and chin. It is widely accepted that any hyaluronic acid filler is safe to use off label in other common filler areas. However, most plastic surgeons are not going to recommend a random use of fillers such as in the legs or arms (unless to treat certain types of scarring).
Off label use is not illegal and often streamlines the studies and process for a new treatment to get final approval. It can take years to gain FDA approval, even if already approved elsewhere. As long as fillers are administered properly and under the proper guidance of a professional, off label use of filler is generally safe.