JUVÉDERM VOLBELLA® XC found to increase lip fullness and soften the appearance of lines around the mouth through one year.

Allergan, a leading global pharmaceutical company, recently announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market JUVÉDERM VOLBELLA® XC, for use in the lips for lip augmentation and for correction of perioral rhytids, commonly referred to as perioral lines, in adults over the age of 21. In clinical trials, JUVÉDERM VOLBELLA® XC was found to effectively increase lip fullness and soften the appearance of lines around the mouth in a majority of subjects through one year.

“Many of my patients are very bothered by the lines that can appear around the lips, known as perioral rhytids. Additionally, when seeking lip augmentation, patients want a smooth, result that is not drastic” said Dr. David E. Bank, clinical trial investigator and founder of The Center for Dermatology, Cosmetic & Laser Surgery. “JUVÉDERM VOLBELLA® XC adds fullness to the lips and softens the appearance of the lines around the lips.2 With JUVÉDERM VOLBELLA® XC I am able to subtly enhance my patients’ pout.”

“The FDA approval of JUVÉDERM VOLBELLA® XC further demonstrates Allergan’s commitment to developing advanced products and technologies that allow healthcare providers to better address evolving patient needs,” said Bill Meury, Chief Commercial Officer, Allergan. “Additionally, this approval brings to market a product unlike anything that is currently available in the United States. JUVÉDERM VOLBELLA® XC is formulated with VYCROSS®, a proprietary filler technology from Allergan, which yields smooth products that have been engineered to address specific patient concerns such as lip fullness, age-related volume loss in the cheek area, or perioral rhytids.”

APPROVED USES

JUVÉDERM VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21.

Are there any reasons why I should not receive JUVÉDERM VOLBELLA® XC injectable gel?

Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or Gram-positive bacterial proteins used in these products.

What are possible side effects?

The most common side effects include swelling, tenderness, bruising, firmness, lumps/bumps, redness, pain, discoloration, and itching.  Most side effects are mild or moderate and last 30 days or less.

One of the risks with using this product is unintentional injection into a blood vessel, and while rare, the complications can be serious and may be permanent.  These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring.

As with all skin injection procedures, there is a risk of infection.

For more information, visit the official Juvederm site.