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Meaning of Bellafill FDA approval

Posted: 9:19 a.m. Monday, Jan. 12, 2015

By Anita Mandal, M.D.
Question: A plastic surgeon advised Bellafill® for my under eye hollows. Is Bellafill® safe for my dark circles even if it’s only FDA approved for the nasolabial smile lines?

Answer: Bellafill®, like most injectable fillers, is FDA approved for use in specific facial areas only. However, treatment of other facial areas with Bellafill®, even if not FDA approved, is the norm when it’s a “common practice consistent with the high quality of standards set by the medical profession.”

Bellafill®’s limited FDA approval for injection in the smile line does not mean it cannot be injected in other facial areas. FDA approval is necessary for an injectable filler to be legally used in the U.S. Medical products not FDA approved for any use or area are not used in the U.S. Medical products that are FDA approved for a given area or problem can be used in other facial areas if treating other areas is consistent with “commonly accepted standards of practice.”

While Bellafill® is FDA approved for the nasolabial folds, it is commonly used for hollows in the cheeks, temples, forehead and under eyes, most facial areas and the hands. Treating these areas is consistent with “commonly accepted practice.”

Also, even though the FDA requires a skin allergy test prior to treatment, most high-volume Bellafill® injectors do not administer this test to most patients. Allergic reactions to Bellafill® are very rare, temporary, and a negative test doesn’t mean you won’t have an allergic reaction to treatment.


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