title: Efficacy and safety of Macrolane(™) for breast enhancement: a 12-month follow-up study in Asian women.
abstract: The demand for breast enhancement has risen substantially over recent years. Stabilised hyaluronic acid of non-animal origin manufactured using NASHA(™) technology (Q-Med, Uppsala, Sweden) is an injectable gel, which has increasingly been used as a minimally invasive, non-permanent option for breast enhancement. The aim of this study was to investigate the 12-month efficacy and safety of NASHA gel, when used for breast enhancement in Asian women. Non-pregnant, non-breastfeeding women with small breasts (aged 20-50 years) were recruited into this open, prospective, non-comparative, single-centre study. Subjects received sub-glandular injections of NASHA gel. Efficacy and safety assessments were carried out at follow-up visits (1, 6, and 12 months). Physician and subject assessment of breast improvement was recorded using the Global Esthetic Improvement Scale (GEIS). Ninety-eight subjects of Asian ethnicity were enrolled; 65 subjects completed the 12-month follow-up period. Overall, a median volume of 200 mL (range 80-300 mL) NASHA gel was injected per subject. Following GEIS assessment, 79% of breasts were subject-assessed as improved, much improved, or very much improved 6 months after treatment; 48% of breasts were still considered improved after 12 months. Sub-glandular NASHA gel injection was well tolerated, eliciting no serious adverse events judged to be treatment-related. High rates of aesthetic improvement were observed for at least 6 months after NASHA gel breast enhancement. The minimally invasive injection of NASHA gel provided a treatment option, which was an attractive alternative to permanent breast implants for many women.
authors.affiliation: Nagumo Clinic, Tokyo, Japan. yamaguchi@nagumo.or.jp
authors.forename: Satoru
authors.initials: S
authors.lastname: Yamaguchi
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Nagumo
authors.forename: Koji
authors.initials: K
authors.lastname: Niwa
mesh_terms: D000328:Adult; D044466:Asian People; D003286:Contracture / Q000601:surgery; D004954:Esthetics; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D007267:Injections / Q000379:methods; D016462:Mammaplasty / Q000379:methods*; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D005782:Gels; D006820:Hyaluronic Acid