Macrolane for breast enhancement: 12-month follow-up.
BACKGROUND
Stabilized hyaluronic acid–based gel of nonanimal origin (NASHA-based gel) is well established for use in aesthetic facial procedures. A new formulation (Macrolane VRF30, Q-Med AB, Uppsala, Sweden) may be suitable for patients seeking breast enhancement. The aim of this study was to develop a reproducible technique for injecting NASHA-based gel posterior to the mammary gland (subglandular injection) and to assess treatment safety and efficacy. The feasibility of dual-plane submuscular injection was also explored.


METHODS
Nonpregnant, nonbreastfeeding women with small breasts were recruited for this open-label, noncomparative study. Patients were treated in groups of four to enable step-wise revision of the injection technique. Safety and efficacy assessments (12-month follow-up) included adverse event reporting and the Global Aesthetic Improvement Scale, respectively.


RESULTS
Twenty-four women (mean age, 37 years) were recruited, 20 of whom underwent subglandular injection. A reproducible injection technique was successfully developed that could be performed under local anesthesia. High subject improvement rates for breast appearance (38 of 46 breasts; 83 percent) were observed for at least 6 months after treatment. At 12 months, 69 percent of breasts were still considered improved. Similar trends were observed with patient satisfaction levels. NASHA-based gel was generally well tolerated, with no inflammatory reactions or serious adverse events. Capsular contracture was the most commonly reported adverse event.


CONCLUSIONS
NASHA-based gel is a new option for patients who desire aesthetic improvement of the breast but who do not want to undergo surgery. Further studies to confirm these findings in larger numbers of patients are warranted.
Stockholm, Sweden From the Akademikliniken; ProForma Clinic; and Department of Radiology, Sophiahemmet Hospital.
Per
P
Hedén
Michael
M
Olenius
Magnus
M
Tengvar
D000328:Adult; D001940:Breast; D003357:Cosmetic Techniques; D005260:Female; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000031:analogs & derivatives; D007267:Injections / Q000379:methods; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D017060:Patient Satisfaction; D019736:Prostheses and Implants
D005782:Gels; D006820:Hyaluronic Acid