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FDA Gives Unanimous Approval to a New Cheek Filler

FDA Approved Cheek Filler - Seattle Plastic SurgeryIn case you haven’t heard,  the US Food and Drug Administration (FDA) has approved Juvéderm Voluma XC (made by Allergan) to correct age-related volume deficits of the cheeks in adults aged 21 years and older.  Unfortunately, age can often cause a sagging effect underneath the eyes and above the cheek bones giving the face a more aged and tired appearance.

Juvéderm Voluma XC is a thick gel composed of cross-linked hyaluronic acid suspended in phosphate-buffered saline with 0.3% Lidocaine.  Other fillers such as Radiesse have been very successfully injected to augment the cheek area and to restore the “triangle of youth” for a long time. However, Voluma is the first dermal filler approved by the FDA specifically for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face.

The evidence presented to the FDA panel proved that the filler is effective and safe and that the benefits greatly outweigh the risks.  Many panel members even noted that the product fills an “unmet need.”

“As people age, the cheek area can lose volume, causing the cheeks to flatten out and the skin to droop and sag,” Derek H. Jones, MD, said in a news release announcing the approval. Dr. Jones is associate professor of dermatology at the University of California, Los Angeles; founder and medical director of Skin Care and Laser Physicians of Beverly Hills; and clinical investigator in the Juvéderm Voluma XC pivotal study.  Also, with Juvéderm Voluma XC, “physicians and patients were able to see instant and visible results, including correction of age-related volume loss in the cheek area and a more youthful appearance to the face,” according to Dr. Jones.

As far as side effects go, the most common adverse effects observed in the clinical trial included temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.  Thankfully, the adverse effects were predominantly described as mild to moderate (uncomfortable) in severity and lasted 2 to 4 weeks on average.

If you or someone you know is interested in Juvéderm Voluma XC and want to discuss the options we have available, contact our Bellevue office today and schedule a consultation with Dr. Jan Zemplenyi. He and the staff at the Bel-Red Center for Aesthetic Surgery can answer all of your questions, provide you with options and empower you to design a personal treatment plan!