Sculptra has been FDA approved in the US since 2004 as treatment for facial fat loss in HIV patients (facial lipo-dystrophy). However, Sculptra has been used by physicians for non-FDA indications such as cosmetic treatment of facial wrinkles or volume loss in non- HIV patients. This is known as an off-label use of the drug. There are many other instances of off-label use of drugs, such as injection of Cosmetic Botox into crow's feet area. (Cosmetic Botox is only FDA approved for use in the mid-forhead lines near the nose) The company has requested approval for additional indications for use from the FDA. Although there is rumors of pending approval of Sculptra for use as a facial filler in general population, the approval has not been issued yet.
As most physicians who picked up Sculptra early, we have been using it off label in cosmetic patients since it originally was approved.It is a great product for properly selected patients who are not in a hurry to see their results. It is a "stimulatory" filler so that the built up develops slowly and usually takes several sessions. However it has the longest durability of any "non-permanent" filler.
