Off Label Uses

    With only few exceptions the dermal fillers that have been approved by the FDA for use in the US were studied for use in the nasolabial folds (commonly known as smile lines, connecting the outer nostril with the corner of the mouth), and are approved only for use in that location. That being said most injectors will use the product in other areas which are referred to as “off label” use. An FDA consumer report is available at www.vidyya.com/11pdfs/wrinklefillers062608.pdf. This is a common and very well accepted practice. For example, using a hyaluronic acid filler such as Juvederm to augment the lips or fill marionette lines are not approved uses and are therefore considered “off-label”. What this means is that prior to the FDA’s approval there were no specifics evaluated about these “other” areas. Your injector should discuss the “off-label” use of the product and you will likely see a clause relating to “off-label” use within the consent that you are asked to sign.