Affiliation:
1. Department of Plastic Surgery, Haaglanden Medical Centre (HMC), The Hague, the Netherlands
2. Department of Anesthesiology and Epidemiology, Leiden University Medical Centre (LUMC), Leiden, the Netherlands
3. Department of Plastic Surgery, Velthuis Clinics, Rotterdam, the Netherlands
4. University of Groningen and University Medical Centre Groningen (UMCG), Groningen, the Netherlands
Abstract
Abstract
Background
Breast augmentation is one of the most commonly performed aesthetic plastic surgical procedures, with over 250,000 procedures in the United States in 2020 alone. However, the safety of breast implants should be closely researched and monitored, especially in 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-center, single-surgeon experience regarding both patient-reported outcome measures and 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, between 2001 and 2004. All patients were contacted for informed consent, and after approval, the validated BREAST-Q questionnaire was sent and utilized 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 groups (P = 0.317).
Conclusions
This study showed high patient satisfaction and relatively low revision rates after 15 to 19 years of 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.
Level of Evidence: 4
Publisher
Oxford University Press (OUP)
Cited by
3 articles.
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