Sunday, October 12
PURPOSE: A large, multicenter US study was conducted in 2006 as part of an FDA-mandated post-approval study of Natrelle® silicone-filled breast implants. Our purpose is to describe long-term patient-reported outcomes with primary breast augmentation, specifically to address changes in body image over time and by implant type: silicone gel versus saline-filled devices.
METHODS: Primary breast augmentation patients enrolled in the prospective, multicenter study received 2 previously validated BREAST-Q scales measuring body image (satisfaction with breasts and psychosocial well-being). The surveys were administered preoperatively and at postoperative years 1 and 4. Scores were transformed to a 100-point scale, where a higher score indicated a better outcome. Student t tests and effect size calculations were used to evaluate differences in preoperative and postoperative mean scores.
RESULTS: Of the baseline study population (N=17,899), 77.1% completed the preoperative questionnaire (12,061 silicone; 1,734 saline implants); the postoperative survey was completed by 71.1% of the sample at year 1 and by 46.2% at year 4 (data collection is still ongoing at year 4). Significant improvements are found in body image as measured by the 2 scales; satisfaction with breasts increased by a mean of 57.0 points (31.8 preoperatively to 88.2 at year 1, P<.00001), and psychosocial well-being increased by a mean of 30.2 points (59.6 preoperatively to 89.6 at year 1; P<.0001). Large effect sizes are noted for both satisfaction with breasts (2.0 at year 1; 1.8 at year 4) and psychosocial well-being (1.2 at year 1; 1.0 at year 4). The improvement in body image is largely stable over time (Figure 1). In comparing silicone implants with saline implants, mean scores of satisfaction with breasts and of psychosocial well-being are significantly higher at year 1 and at year 4.
CONCLUSIONS: Significant improvements in body image are found among women receiving breast augmentation with Natrelle silicone or saline-filled breast implants, and the results appear stable over time. Outcomes were better in those with silicone versus saline-filled devices; however, this may be of more statistical than clinical significance. These data support the effectiveness of these medical devices in improving women’s quality of life.