Results from the Multicenter Nonrandomized BREAST-II Trial for Total Breast Reconstruction Solely Using Autologous Fat Transfer: 1-Year Follow-Up.

Abstract

Background: Autologous fat transfer (AFT) has emerged as a promising technique for total breast reconstruction after mastectomy, particularly in cases unsuitable for other reconstruction methods. Evaluation of its efficacy, safety, and impact on quality of life (QoL) is essential. The authors assessed efficacy and safety outcomes of AFT as postmastectomy total breast reconstruction based on 12-month follow-up data from the BREAST-II trial.

Methods: This multicenter nonrandomized clinical trial included women 18 years of age or older with a history of or planned mastectomy across 8 Dutch hospitals. Participants underwent multiple AFT sessions combined with external expansion using the Evebra device, with a maximum of 5 sessions over 12 months. The primary outcome was QoL measured by BREAST-Q and BODY-Q. Secondary outcomes included safety (eg, serious adverse events), operating time, hospital stay, and number of sessions.

Results: A total of 229 women were included. At 12 months after AFT, significant improvements were observed in Psychosocial Well-Being (+5.72 ± 16.79), Sexual Well-Being (+8.05 ± 19.61), Physical Well-Being: Chest (+5.97 ± 20.44), and Satisfaction with Chest (+17.22 ± 27.27) (all P < 0.001). BODY-Q scores showed significant increases in satisfaction with the abdomen, back, body, hips/outer thighs, inner thighs, and scars (all P < 0.001). Among 805 AFT sessions, 52 adverse events occurred (6.46% complication rate). Hospital stays were less than 1 day per session.

Conclusions: AFT is an effective and safe total breast reconstruction technique after mastectomy, significantly improving QoL with low complication rates. These findings support AFT as a valuable addition to breast reconstruction options.