Background: The Breast Implant Follow-up Study is a large, ongoing observational study of women who received Natrelle round silicone-filled or saline-filled breast implants. This analysis describes patient-reported outcomes in the cohort who underwent breast augmentation.
Methods: Subjects prospectively completed two validated scales of the BREAST-Q (satisfaction with breasts and psychosocial well-being) preoperatively and at 1 and 4 years postoperatively. Effect size and z tests were used to compare differences between preoperative versus postoperative scores; multivariate mixed models were used to compare differences in scores between silicone-filled and saline-filled implants.
Results: Of 17,899 subjects completing the BREAST-Q preoperatively, 14,514 (81.1 percent) completed the postoperative questionnaire (12,726 received silicone-filled implants and 1788 received saline-filled implants). Overall, satisfaction with breasts and psychosocial well-being increased significantly at postoperative year 1 (p < 0.0001 for both), and the improvement was sustained at year 4 (p < 0.0001 for both). Large effect sizes were observed for 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). In the multivariate model, silicone-filled implants were associated with significantly greater improvement compared with saline-filled implants for satisfaction with breasts and psychosocial well-being at year 1 (p < 0.0001 for both) and year 4 (p < 0.0001 and p < 0.0019, respectively).
Conclusions: Breast implants are effective in improving women's quality of life. The authors found significant and sustained improvements in satisfaction and psychosocial well-being in women undergoing breast augmentation with Natrelle silicone-filled or saline-filled implants.
Clinical question/level of evidence: Therapeutic, IV.