A Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks

Inclusion criteria

• ≥ 20 years old
• willing to undergo augmentation therapy of the buttocks where a maximum total injected volume of 400 ml of the study product is judged by the Investigator to be enough to achieve full correction
• understand and comply with the requirements of the study
• be willing to understand and comply with the requirements of the study
• be willing to abstain from esthetic surgery and esthetical augmentation procedures (other than the study treatment) between the umbilicus and the knees.
• be a male or non-pregnant, non breast-feeding female.
• give written informed consent to participate in the study

Exclusion criteria

• Active skin disease, inflammation or related conditions Tumors or pre-malign tissue disorder near or on the area to be treated
• scar tissue in the area to be treated
• subjects seeking corrections for other body parts then the buttocks anywhere between the umbilicus and the knees
• subjects with human immunodeficiency virus (HIV) associated lipodystrophy
• subjects having undergone liposuction within 6 months prior to inclusion
• BMI <20 or expected instable weight
• insufficient tissue cover in the area to be treated
• excessive skin laxity in the area to be treated
• other injectable implant or permanent implant near or in the area to be treated
• previous radiation therapy of tumors near or in the area to be treated
• concomitant anticoagulant therapy, anti-platelet therapy or a history of bleeding disorders.
• a presence or history of connective tissue diseases
• ongoing immunosuppressive therapy
• known allergies or hypersensitivity reactions towards anesthetics
• previous inflammatory or hypersensitivity reactions towards products containing Hyaluronic acid
• any condition which in the opinion of the investigator makes the subject unsuitable for inclusion use of any investigational drugs or devices within 30 days prior to inclusion.