Mid- to Long-term Outcomes Following Primary Augmentation With B-Lite Lightweight Breast Implants: A Prospective Multicenter Postmarketing Clinical Follow-up Study.

Abstract

Lightweight breast implants (B-Lite) integrate air-filled microspheres into silicone gel to reduce implant weight by up to 30% while maintaining volume and mechanical properties. Long-term prospective data in primary augmentation remain limited. To evaluate clinical performance, safety, satisfaction, and quality of life (QoL) outcomes following primary augmentation with B-Lite implants. This multicenter, prospective, single-arm manufacturer-sponsored postmarketing clinical follow-up (PMCF) study enrolled genetically female patients (18-60 years) undergoing bilateral primary breast augmentation. Implants (round or anatomical; POLYsmoooth, POLYtxt, MESMO, or Microthane; 200-755 cc) were placed through inframammary incisions using a standardized technique. The primary endpoint was ≥1 bra-cup increase at 12 months; secondary endpoints included QoL (Body Esteem, Rosenberg, shortened Tennessee, RAND SF-36), satisfaction, and adverse events (AEs) such as capsular contracture (Baker III-IV), rupture, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and reoperation. In all, 101 patients (mean age 32.7 ± 8.0 years; BMI 20.9 ± 1.8) underwent augmentation. At 12 months, ≥1-cup increase occurred in 92% (95% CI, 84%-97%). No Baker III/IV contracture, rupture, or BIA-ALCL occurred. The most frequent AE was transient sensory change (8.9%); others were infrequent and mainly procedure related. Kaplan-Meier reoperation risk was 6.9% at 1 year and 9.9% at 5 years. Patient satisfaction averaged 98.6% with 0% regret; surgeons were satisfied or very satisfied at 97% to 100%. QoL showed durable gains in Body Esteem-sexual attractiveness and Rosenberg; SF-36 composites remained stable. Lightweight B-Lite implants showed high effectiveness, very high satisfaction, and a favorable safety profile through 3 to 5 years.