FDA Approves Lasting Filler for Lip Augmentation

The FDA has approved Juviderm Ultra XC for lip augmentation in adults ages 21 or older.

The injectable gel is now the only dermal filler approved to last up to 1 year in the lips. It is indicated for injection into the lips and perioral area.

Juviderm Ultra XC is formulated with a modified form of hyaluronic acid, a naturally occurring sugar in the body that helps the skin retain its natural moisture and softness, as well as a small amount of lidocaine as a local anesthetic.

The FDA first approved Juviderm in 2006, and then Juvederm Voluma XC for age-related mid-face volume loss in 2013, and now Juvederm Ultra XC for lip augmentation.

"When discussing lip treatment with patients, they most often express concern over being able to achieve a natural-looking result,” stated board certified dermatologist Suzanne Kilmer in an Allergan press release. “…Now, physicians and their patients can achieve the natural-looking results they have come to know and expect with Juvederm Ultra XC."

In clinical trials, 79% of patients who received the dermal filler showed a meaningful improvement in lip fullness 3 months after treatment, and more than 78% reported an improvement in their overall satisfaction with the look and feel of their lips at 1 year.

The most common side effects of Juviderm XC injectable gels occur at the injection site and include redness, swelling, tenderness, pain, discoloration, and itching.

Patients who have received Juviderm Ultra XC typically experience these mild or moderate side effects for up to 14 days.

Those taking medications that can prolong bleeding—such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin—may experience increased bruising or bleeding at injection sites.

Health care professionals should discuss the potential risks of the injections with patients prior to treatment, and ensure that patients are aware of the signs and symptoms of potential complications.