Abstract
Background
While Breast Implants (BIs) have never been safer, factors such as implant debris may influence complications such as chronic inflammation and illness such as ALCL. Do different types of BIs produce differential particulate debris?
Objectives
Our objective was to quantify, investigate and characterize the size, amount, and material-type of both loosely bound and adherent surface particles, using five different surface types of commercial BIs.
Methods
Surface particles from 5 surface types of BIs (n=5/group); Biocell, Microcell, Siltex, Smooth, SmoothSilk, and Traditional-Smooth were: 1) removed by a rinsing procedure and 2) removed using ultrapure-adhesive carbon-tabs. Particles were characterized (ASTM 1877-16) using Scanning-Electron-Microscopy and EDX-chemical analysis.
Results
Particles rinsed from Biocell, Microcell and Siltex were <1 micron in diameter while SmoothSilk and Traditional-Smooth surfaces had median sizes >1micron (range: 0.4-2.7microns). The total mass of particles rinsed from the surfaces indicated Biocell had >5 fold-more particulate compared to all other implants, and >30 fold-more than SmoothSilk or Traditional-Smooth implants (>100x more for post rinse adhesion analysis). EDX analysis indicated particulate material for Biocell, Microcell and Siltex was silicone (>50%), while particulate from SmoothSilk and Traditional-Smooth implants were predominantly carbon-based polymers, eg, polycarbonate-urethane, consistent with packaging (and were detected on all implant types). Generally, SmoothSilk and Traditional-Smooth implant groups had >10x fewer particles released than Biocell, Microcell and Siltex surfaces. Pilot ex-vivo tissue analysis supported these findings.
Conclusions
Particulate debris released from BIs are highly dependent on the type of implant surface and is a likely key determinant of in vivo performance.
Particulate Debris Released From Breast Implant Surfaces Are Highly Dependent on Implant Type
