Additional Relevant Details The safety and effectiveness of JUVÉDERM VOLBELLA® XC has been demonstrated in several clinical trials including the U.S. pivotal study where 168 subjects were treated with JUVÉDERM VOLBELLA® XC.  A 5-point scale was used to evaluate the effectiveness of the product for lip fullness and a 4-point scale to evaluate the effectiveness of the product for smoothing lines around the mouth.2 Approximately two-thirds of subjects treated with VOLBELLA XC showed improvement in lip fullness and perioral lines through 1 year. The safety of JUVÉDERM VOLBELLA® XC was observed to be similar to that of the control. The most common side effects were temporary responses at the treatment site such as swelling, tenderness, bruising, firmness lumps/bumps, rednesss, pain, discoloration, and itching. Most of these side effects resolved within 30 days.2