A Study of Belotero® Intense Lidocaine for Lip Augmentation

The purpose of this study is to demonstrate the safety and effectiveness of Belotero Intense Lidocaine (BIL) for lip augmentation in subjects with upper and/or lower lip deficit.

Inclusion Criteria: * Desires lip augmentation to correct volume and has very thin to medium upper and/or lower lip deficit Exclusion Criteria: * Any previous surgery, including plastic surgery or permanent implant or graft in the lower third part of the face * Any previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the face * Any treatment with porcine-based collagen fillers or with Juvéderm® Voluma XC, Restylane® Lyft Lidocaine, Calcium hydroxyapatite (CaHA) within the past 24 months and/or other dermal fillers within the past 12 months in the lips, in the lower third part of the face, and/or the nose * Any previous treatment with dermal therapies within the past 3 months in the lower third part of the face * Has undergone oral surgery in the past 30 days * Lip volume deficit due to medical conditions * Known history of allergic/anaphylactic reactions/hypersensitivity to lidocaine or any of the device components