Five Year Safety and Satisfaction With the Lightweight Breast Implant.

BACKGROUND The B-Lite® lightweight breast implant (LWBI), weighs ~ 30% less than traditional silicone implants, while maintaining an equivalent size, form and function. The LWBI thus places less stress on breast tissues, preserves tissue stability and integrity over time, reducing weight-related complications and reoperation rates. OBJECTIVES To assess the long-term (over 5 year) safety and performance of the LWBI in primary and revision augmentation procedures. METHODS Retrospective single-center, single surgeon analysis of prospectively collected data, was performed on 827 consecutive primary and revision augmentation patients operated between December 2013 and January 2019. 1653 implants (250-835 cc, mostly round, textured, extra high-profile) were implanted using standard surgical techniques. Direct physician-to-patient follow-up ranged from 6 to 67 months. Chart data on reoperations and overall complications as well as patient and surgeon satisfaction, were analyzed. RESULTS The 5 year Per Patient Kaplan-Meier reoperation free rate was very high (97.1%). Only 2 out of 5 total cases of capsular contracture grade III required reoperation (KM rate 0.2%, CI- 0.1-1.0). No cases of rupture or BIA-ALCL were recorded. 94.9% of patients rated the aesthetic outcome, and 95.5% of patients rated the natural look and feel of their breasts, at 4-5 (Satisfied-Very Satisfied). Similarly, the surgeon rated 4-5 on 95.4% of the patients' aesthetic outcomes. CONCLUSIONS The extremely favorable safety profile, high patient and surgeon satisfaction, and inherent benefits of reduced weight, in the largest known study of B-Lite® implant surgeries, should make the LWBI a strongly considered strategic alternative to traditional implants.