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Restylane FDA Approved For Lip Augmentation


A facial filler already FDA approved for lines and wrinkles around the nose and mouth, Restylane is now FDA approved to add volume to the lips as well.

While many practitioners have been using facial fillers to add volume to the lips, many of those dermal fillers are actually only FDA approved to treat facial lines and wrinkles. For example, Restylane was FDA approved in 2003 to smooth wrinkles and folds, particularly the nasolabial folds or Marionette Lines but has been widely used off-label to volumize the lips. It was only recently that Restylane has received FDA approval for lip augmentation or adding volume to the lips.

restylane fda approval for lip augmentation
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In the past, FDA approvals for facial fillers have mainly been focused on addressing lines and wrinkles. Which makes the FDA approval of Restylane for lip augmentation the first in it's class and allows Medicis, the manufacturer to actually market the product as something that was only previously used off-label.

Similar to Juvederm, Restylane is a facial filler comprised of transparent hyaluronic acid gel, which the human body naturally produces. Just one of the many fillers available to practitioners to add volume to the face, Restylane and Juvederm have been used off-label by many as an option to define and plump up the lips. However, FDA approval for Restylane means significant testing has proven the safety and effectiveness for lip augmentation.

According to Dr. Heidi Waldorf, Director of Laser and Cosmetic Dermatology at Mount Sinai Medical Center in New York, New York, "As a physician, I can use a product off-label in other areas other than where it was originally FDA approved for. However, manufacturers can't discuss their products being used for any other purpose other than what it is indicated for."

Once a product has been FDA approved for another indication, in this case Restylane for lip augmentation, patients can expect to see more direct-to-consumer marketing to promote the product's new FDA approval.

Dr. Waldorf stresses the importance of considering facial balance when it comes to augmenting the lips with any facial filler, including Restylane with it's recent FDA approval. "More doctors will begin to offer Restylane for lip augmentation due to potential increased patient demand," predicts Dr. Waldorf, "Nevertheless, both the patient and doctor have to be aware of the importance of balance and shape of the face, including the lips. You don't want to just treat the lips or the results can be very unnatural and overdone looking."

Dr. Waldorf says treatment should be holistic and not based only one part of the face that the patient is concerned about. "In my practice, I tend to treat the face as a whole unit rather than the lips per say," describes Dr. Waldorf, "Very often, just getting stability to the skin around the lips to lift and give some support under the nose for example, results in nicer, fuller and more uplifted lips without actually putting anything in the lip."

Amongst Dr. Waldorf's patients, her goal is to offer them a way to look the best they can - not to look contrived or overdone. "My patient population doesn't want anybody to know they had "something" done, they just want to get compliments. They want to feel good about themselves when they look in the mirror and get that positive reinforcement for themselves."