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Is the Use of Juvaderm in Areas Other Than the Naso-labial Folds Considered off Label?

asked 3 years ago by lia in Bend, OR 97701
Latest answer by Kris M. Reddy, MD, FACS
Question viewed 888 times
Tags: nasolabial folds, injection site, placement

8 answers to Is the Use of Juvaderm in Areas Other Than the Naso-labial Folds Considered off Label?

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FDA Approval

Allergan has received FDA approval for physicians to utilize juvederm to provide patients with enhanced comfort during treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds (or "parentheses") that appear around the nose and mouth. Beyond that it is is considered off label use, but many other areas can and are being done safely.
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Juvederm FDA Approved Uses

Thank you for your question. Since 2008 Juvederm has been FDA approved for "moderate to severe facial wrinkles and folds (such as the nasolabial folds)". In our San Francisco Bay Area practice we regularly use Juvederm for correction of many undesired facial wrinkles and folds in addition to common off-label uses including lip enhancements and correction of acne scarring. I hope this helps.
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Juvederm injections in the face

Juvederm and the other hyaluronic acid filler like restylane are indicated for treatment of nasolabial folds and similar areas. So technically it depends how far away from the perioral or mouth region you go then it may be considered off-label. However, it is very safe and effective in other facial areas but you would be correct in that assumption. I hope this information helps.
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Using Juvederm in the face

Juvederm is an excellent hyaluronic acid based injectable that can be used effectively for facial contouring. Juvederm is commonly used around the lips, the smile lines, the marionette lines, under deep wrinkles, under deep scars, and even under the area of the eye. Like all medications, Juvederm may be used in off label indications by a physician with good judgment and experience. Although Juvederm was initially approved for the nasolabial folds, is used throughout the face and... more
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Off label use of juvederm

Off-label means that the FDA approved it for a different area. Alot of times companies do not want to bother getting approval for all areas because it is too expensive. But, it is pretty safe in most areas of the face.
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Off Label and Standard of Practice for Juvederm

It's unfortunate that you were unable to have the doctor or one of his staff members perform a quick evaluation to address your concern. Being that the product is not able to migrate into a different position after 3 days, it's not clear why this was suggested to you. Because you may actually be seeing swelling vs. product, massaging may exacerbate the situation. If you and your doctor agree that the product is not in the intended area, dissolving it with hyaluronidase would be a much... more
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Juvederm safe anywhere in the face except under eyes.

Hi. Off label does not mean much.  It's up to the discretion of an experienced doctor.  Juvederm is off label for creating fuller upper cheeks, and yet it is very safe and effective for this purpose.
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Juvederm off label indications

Juvederm is approved for use in facial lines and fold. This would include naso-labial folds, marionette lines and even perioral lip lines. Injection into the lips or other locations would be considered off-label. However off-label uses of medications is common practice and as is filler use and is perfectily acceptable. In fact many of the most useful practices in medicine are off-label. It just isn't cost effective in this country to get FDA approval for any conceivable use.... more

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