Particulate Debris Released From Breast Implant Surfaces Is Highly Dependent on Implant Type

Abstract

Abstract Background Although breast implants (BIs) have never been safer, factors such as implant debris may influence complications such as chronic inflammation and illness such as ALCL (anaplastic large cell lymphoma). Do different types of BIs produce differential particulate debris? Objectives The aim of this study was to quantify, investigate, and characterize the size, amount, and material type of both loosely bound and adherent surface particles on 5 different surface types of commercial BIs. Methods Surface particles from BIs of 5 surface types (n = 5/group), Biocell, Microcell, Siltex, Smooth, SmoothSilk, and Traditional-Smooth, were: (1) removed by a rinsing procedure and (2) removed with ultrapure adhesive carbon tabs. Particles were characterized (ASTM 1877-16) by scanning electron microscopy and energy-dispersive X-ray chemical analysis. Results Particles rinsed from Biocell, Microcell and Siltex were <1 μm in diameter whereas SmoothSilk and Traditional-Smooth surfaces had median sizes >1 μm (range, 0.4-2.7 μm). The total mass of particles rinsed from the surfaces indicated Biocell had >5-fold more particulate compared with all other implants, and >30-fold more than SmoothSilk or Traditional-Smooth implants (>100-fold more for post-rinse adhesion analysis). Energy-dispersive X-ray analysis indicated that the particulate material for Biocell, Microcell, and Siltex was silicone (>50%), whereas particulates 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 released >10-fold fewer particles 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 are a likely key determinant of in vivo performance. Level of Evidence: 5