Five-Year Safety and Satisfaction With the Lightweight Breast Implant

Abstract

Background: The B-Lite lightweight breast implant (LWBI) weighs approximately 30% less than traditional silicone implants while maintaining an equivalent size, form, and function. The LWBI thus places less stress on breast tissues and preserves tissue stability and integrity over time, reducing weight-related complications and reoperation rates.

Objectives: The authors sought to assess the long-term (>5 years) safety and performance of the LWBI in primary and revision augmentation procedures.

Methods: A 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. A total 1653 implants (250-835 cc, mostly round, textured, extra high-profile) were implanted employing 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 of 5 total cases of capsular contracture (CC) grade III required reoperation (Kaplan-Meier rate = 0.2%, CI = 0.1-1.0). No cases of rupture or breast implant-associated anaplastic large cell lymphoma were recorded. A total 94.9% of patients rated the aesthetic outcome, and 95.5% of patients rated the natural look and feel of their breasts at 4 to 5 (satisfied-very satisfied). Similarly, the surgeon rated 4 to 5 on 95.4% of the patients' aesthetic outcomes.

Conclusions: The favorable safety profile, high patient and surgeon satisfaction, and inherent benefits of reduced weight should make the LWBI a strongly considered strategic alternative to traditional implants.

Figure 1.

Hooke’s law and breast tissue responses. The elastic tissue of the breast is symbolized by a spring with constant K. The displacement is described as ΔX = F/ K, where ΔX is the displacement, F is the force applied (weight, or m*g), and K is the spring constant (tissue stiffness). A heavier implant will result in increased forces and consequential stretch of the breast compared with a lighter implant. Therefore, when m < M, this results in F1 < F2 and ΔX1 <ΔX2. Reprinted with permission from G&G Biotechnology Ltd., Haifa, Israel.

Figure 2.

Follow-up periods of the patient cohort.

Figure 3.

Kaplan-Meier estimator of reoperation-free rate.

Figure 4.

(A) Patient satisfaction with aesthetic outcome. (B) Patient assessment of natural look and feel. (C) Investigator satisfaction with aesthetic outcome. (A) Patients rated their satisfaction with the surgical procedure on a scale of 1 to 5, where 1 = “most dissatisfied” and 5 = “most satisfied.” (B) Patients rated their breast appearance and naturalness/softness of how their breasts felt following surgery on a scale of 1 to 5, where 1 = “not at all” and 5 = “natural and soft.” (C) The surgeon rated his satisfaction with the operative results on a scale of 1 to 5, where 1 = “poor” and 5 = “excellent.”

Figure 5.

(A, C, E) This 33-year-old female presented for breast augmentation. (B, D, F) The same female 5 years following augmentation with B-Lite, Round 325cc, HP, bilateral, subglandular placement.

Figure 6.

(A, C, E) This 51-year-old female presented for breast augmentation. (B, D, F) The same female 5.5 years following augmentation with B-Lite, Round, 440cc, XHP, bilateral, subglandular placement.

Figure 7.

(A, C, E) This 27-year-old female presented for breast augmentation. (B,D,F) 4.5 years following augmentation with B-Lite, Round 345cc, XHP, bilateral, subglandular placement.