Five-year Patient-reported Outcomes Following Primary Breast Augmentation With Polyurethane-coated Implants: Development and Preliminary Validation of a Device-specific Instrument

Abstract Background Long-term patient-reported outcomes after primary aesthetic breast augmentation remain incompletely characterized, particularly in cohorts receiving polyurethane-coated implants. Although validated generic instruments are widely used, device-specific patient perception may not be fully captured by broader outcome measures. Objectives To evaluate five-year patient-reported outcomes following primary breast augmentation with polyurethane-coated implants and to develop and preliminarily validate a device-specific patient-reported outcome instrument. Methods A retrospective cohort study was conducted including 110 consecutive patients who underwent primary aesthetic breast augmentation with polyurethane-coated implants. At a mean follow-up of 5.2 ± 0.8 years, patients completed a 15-item polyurethane implant–specific patient-reported outcome instrument (PU-PRO) assessing Perception, Aesthetic Satisfaction, and Postoperative Experience. Psychometric evaluation included content validity assessment, internal consistency analysis, exploratory factor analysis, and test–retest reliability over an 8-month interval using intraclass correlation coefficients (ICC). Results Ninety-nine patients (90%) completed the 5-year assessment, and 87 (88%) completed the 8-month reassessment. Mean scores (0–100 scale) were 81.3 ± 12.8 for Perception, 84.5 ± 11.9 for Satisfaction, and 78.2 ± 14.3 for Experience. One patient (1%) reported clinically evident rippling, and no revision surgeries occurred during follow-up. Cronbach’s alpha ranged from 0.84 to 0.91 across domains. Exploratory factor analysis supported a three-factor structure explaining 68% of total variance. ICC values ranged from 0.88 to 0.93, demonstrating high temporal stability. Conclusions Primary breast augmentation with polyurethane-coated implants demonstrated sustained high levels of patient-reported satisfaction at five-year follow-up in this cohort. The PU-PRO instrument showed preliminary evidence of reliability and construct validity. Further prospective studies incorporating validated comparative instruments are warranted.