Silicone particles in breast implant capsules: A retrospective single-center study evaluating silicone bleeding

Breast implants consist of a silicone elastomer shell filled with either silicone gel or saline solution. As per the Food and Drug Administration (FDA), breast implants offer safety and efficacy but pose short and long-term risks, including capsular contractures, silicone leakage, and discoveries of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Breast Implant Illness (BII).

This study aims to estimate the amount of silicone particles that leak from breast implants and deposit in the peri-prosthetic capsules of implants used in Belgium and investigate the various factors that may affect the magnitude of silicone leakage.

From a monocentric registry from the plastic and reconstructive surgery department of University Hospital Brugmann, thirty-nine capsules' slides were analyzed retrospectively using NDPView2 software. Silicone particles were counted and measured based on their largest diameter. The capsule surface area and its thickness were measured to calculate particle's density and total number of particles in each capsule.

Silicone particles were detected in 32 (82%) out of 39 capsules, with significant higher densities observed in silicone implants compared to saline implants (P=0.027). Overall average density was 66 particle/mm³. The density of silicone particles increased significantly with prolonged implantation duration (P<0.001). Particle's density tended to differ between different implants' textures and brands.

Silicone particles were found in capsules of both saline and silicone implants. Silicone generates primarily from the silicone gel. Implants texture, brand, and duration of implantation are factors that influence silicone bleeding. Addressing silicone leakage is crucial for enhancing implant safety and patient well-being.