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FDA Approves Restylane for Lip Augmentation

Restylane becomes first Hyaluronic Acid Filler approved for lips

Restylane Injectable Gel

Medicis, the makers of Restylane Injectable Gel, announced that the U.S. Food and Drug Administration has approved its application to expand the approved use of Restylane to include lip augmentation. Restylane’s approval for lip enhancement means that significant testing has been conducted, including a recent study where 80% of patients chose to be treated again after 6 months.

Already FDA-approved to treat moderate to severe facial wrinkles and folds, such as the lines from the nose to the corners of the mouth (nasolabial folds), Restylane is now the first and only hyaluronic acid dermal filler approved in the United States for lip augmentation, or adding volume to the lips.

Clinical study finds Restylane effective for Lip Augmentation

A recent clinical study by Medicis, with help from the FDA and a group of physicians, enrolled 180 patients to evaluate the safety and effectiveness of Restylane for lip augmentation in both the upper and lower lips. Restylane was found to be well tolerated and highly effective for lip augmentation for up to 6 months. An overwhelming majority of patients – 80% – were happy enough with their aesthetic results to choose retreatment after 6 months.

Though none were serious, adverse events were primarily pain, swelling, tenderness, bruising and erythema.

Restylane Hyaluronic Acid Dermal Filler

Restylane Injectable Gel is made of hyaluronic acid, a substance that is naturally present in the body. Restylane’s unique gel particle structure is designed for injection in the mid-to-deep dermis for structural support and lift, helping patients look younger by smoothing away moderate to severe facial wrinkles and folds, such as the nasolabial folds. Restylane may also be used to create fullness in the lips for patients over the age of 21.

Dermal Fillers at Hedden & Gunn Plastic Surgery

Show your face some love and call 205-980-1744 today to make your appointment for Injectable Dermal Fillers with the Cosmetic Surgeons at Hedden & Gunn Plastic Surgery. Restylane, Juvederm, Belotero Balance and more are available to soften facial wrinkles and restore youthful fullness and volume to the skin. To temporarily reduce wrinkles and frown lines, we offer Botulinum Toxin Type A products – Xeomin, Dysport and BOTOX Cosmetic – at our Birmingham, Alabama Cosmetic Center.

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