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

Doctor Answers (9)

Using Juvederm off-label

+1

Juvederm filler is an excellent hyaluronic acid filler with many years of clinical safety and efficacy data behind it. It is formally approved for the nasolabial folds, although it has been widely used by physicians for off-label uses such as the lips, jawline, cheeks, hands, and more. Dr. Benjamin Barankin, Toronto Dermatology Centre.


Toronto Dermatologic Surgeon
5.0 out of 5 stars 21 reviews

FDA Approval

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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.

Kris M. Reddy, MD, FACS
West Palm Beach Plastic Surgeon
4.5 out of 5 stars 16 reviews

Juvederm FDA Approved Uses

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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.

Steven H. Williams, MD
San Francisco Plastic Surgeon
4.5 out of 5 stars 23 reviews

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Juvederm injections in the face

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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.

Scott Trimas, MD
Jacksonville Facial Plastic Surgeon
5.0 out of 5 stars 8 reviews

Using Juvederm in the face

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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 deep wrinkles because these additional areas rely on the same principles as the correction of the nasolabial folds.
 

Pat Pazmino, MD
Miami Plastic Surgeon
4.5 out of 5 stars 65 reviews

Off label use of juvederm

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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.

Steven Wallach, MD
Manhattan Plastic Surgeon
4.5 out of 5 stars 17 reviews

Off Label and Standard of Practice for Juvederm

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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 better option than manual extraction. Giving advice like this over the phone without seeing you is not prudent or effective.

Harold J. Kaplan, MD
Los Angeles Facial Plastic Surgeon
5.0 out of 5 stars 6 reviews

Juvederm safe anywhere in the face except under eyes.

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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.

George J. Beraka, MD (retired)
Manhattan Plastic Surgeon
5.0 out of 5 stars 9 reviews

Juvederm off label indications

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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.

Edward Buckingham, MD
Austin Facial Plastic Surgeon
5.0 out of 5 stars 31 reviews

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.