BACKGROUND: Breast augmentation is one of the most commonly performed aesthetic plastic surgical procedures, with over 250 thousand procedures in the United States in 2020 alone. However, the safety of breast implants should be closely researched and monitored, especially on the long-term.
OBJECTIVES: This study was undertaken to evaluate the long-term results of round micro-textured Eurosilicone (Eurosilicone S.A.S, Apt Cedex, France) Cristalline Paragel breast implants from a single centre, single surgeon experience, regarding both patient-reported outcome measures as well as revisions.
METHODS: A retrospective cohort study was undertaken of 84 patients who underwent primary breast augmentation with round micro-textured Eurosilicone Cristalline Paragel breast implants, either submuscular (dual-plane) or subglandular placed, in the period between 2001 and 2004. All patients were contacted for informed consent and after approval, the validated BREAST-Q questionnaire was sent and used to analyze patient satisfaction. In addition, objective data regarding revisions, including capsular contracture, rupture rate, pain and/or aesthetic causes needing revision surgery, were analyzed.
RESULTS: High BREAST-Q scores (67-100% for 0-100 scale variables and 66.0-77.3% of the patients scored "very satisfied" on categorical variables) were found without clinically significant differences between patients with dual-plane placed implants and subglandular placed implants. The overall revision rate was 29.8%, also with no significant differences between both groups (p=0.317).
CONCLUSIONS: This study showed high patient satisfaction and relatively low revision rates after 15-19 years follow-up of round micro-textured Eurosilicone Cristalline Paragel breast implants. No clinically relevant significant differences were found between dual-plane and subglandular placement of the implants.