RADIESSE Injection in Perioral and Marionette Lines

Inclusion criteria

• At the time of consent, women between the ages of 18 and 80 years old;
• Patient requires lower face treatment (perioral/marionette region) with RADIESSE;
• Willingness to comply with study requirements;
• Provide written consent;
• Patient has a rating of 2 or 3 at Baseline on the Merz Marionette Grading Scale, as per the investigator;
• Accepted the obligation not to receive any other facial procedures through the follow-up;
• Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
• No previous facial fillers for a period of 12 months prior to this study;
• No previous facial fillers in the lower face for 18 months prior to this study.

Exclusion criteria

• Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
• Hypersensitivity to RADIESSE, calcium hydroxylpatite filler or local anesthetics;
• Patient has received any lower face treatment during the last 12 months, or neuromodulator in the last 6 months;
• Patient has received mentalis muscle injections of any kind (BoNT-A or fillers) in the last 6 months;
• Patients meeting any official RADIESSE contra-indications;
• Patients presenting with porphyria;
• Inability to comply with follow-up and abstain from facial injections during the study period;
• Heavy smokers, classified as smoking more than 12 cigarettes per day;
• History of severe or multiple allergies manifested by anaphylaxis;
• Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
• Previous surgery including aesthetic facial surgical therapy or liposuction, piercing, or tattoos in the treatment area;
• History or presence of any disease or lesion near or at the treatment area, including inflammation, active or chronic infection, including in the mouth, dentals, head and neck region;
• Facial psoriasis, eczema, acne, rosacea, perioral dermatitis and herpes zoster in the treatment area;
• Cancer or precancer in the treatment area, e.g. actinic keratosis;
• History of bleeding disorders or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment;
• Patients using immunosuppressants;
• Patients with a tendency to form hypertrophic scars or any other healing disorders;
• Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics (e.g., certain anti-arrhythmics);
• Patients administered dental block or topical administration of lidocaine;
• Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.