Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation

Exclusion Criteria

• •Received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs \[oral/injectable corticosteroids or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)\], or other substances known to increase coagulation time from 10 days pre- to 3 days post injection \[Study device injections may be delayed as necessary to accommodate this 10-day wash-out period.\]
• •Have undergone facial plastic surgery (with the exception of rhinoplasty more than 2 years prior to enrollment), tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures at any time during the study
• •Have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study
• •Have begun use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the treatment area within 90 days prior to enrollment or be planning to begin use of such products at any time during the study.
• •Have very thin skin in the mid-facial region, tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads
• •Have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy, partial lipodystrophy, inherited disease, or HIV-related disease
• •Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the study
• •Have noticeable acne scarring, an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated