Particulate Debris Released From Breast Implant Surfaces Is Highly Dependent on Implant Type
Particulate Debris Released From Breast Implant Surfaces Is Highly Dependent on Implant Type
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DOI：
10.1093/asj/sjab051
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发表时间：
2021-02-09
影响因子：
2.9
通讯作者：
Hammond, Dennis
中科院分区：
文献类型：
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作者：
Hallab, Nadim James;Samelko, Lauryn;Hammond, Dennis
背景资料：尽管乳房植入体（BI）从未如此安全，但植入体碎片等因素可能会影响慢性炎症和ALCL（间变性大细胞淋巴瘤）等疾病等并发症。不同类型的BI是否会产生不同的微粒碎屑？目的：本研究的目的是定量、调查和表征5种不同表面类型的商业BI上松散结合和粘附的表面颗粒的大小、数量和材料类型。（n = 5/组），Biocell、Microcell、Siltex、Smooth、SmoothSilk和Ammonal-Smooth：（1）通过冲洗程序除去，和（2）用超纯粘合剂碳片除去。颗粒的特点（ASTM 1877-16），通过扫描电子显微镜和能量色散X射线化学analysis.Results：从Biocell，Microcell和Siltex冲洗的颗粒为1 μ m（范围，0.4-2.7 μ m）。从表面冲洗的颗粒的总质量表明，与所有其他植入物相比，Biocell具有>5倍的颗粒，并且比SmoothSilk或预防性Smooth植入物多>30倍（对于冲洗后粘附分析，多>100倍）。能量色散X射线分析表明，Biocell、Microcell和Siltex的颗粒材料为硅胶（>50%），而SmoothSilk和Prostional-Smooth植入体的颗粒主要为碳基聚合物，例如聚碳酸酯-氨基甲酸乙酯，与包装一致（在所有植入体类型上均检测到）。通常，SmoothSilk和预防性Smooth植入物组释放的颗粒比Biocell、Microcell和Siltex表面少10倍以上。试点离体组织分析支持这些findings.Conclusions：从生物指示剂释放的颗粒碎片是高度依赖于植入物表面的类型，并在体内性能的一个可能的关键决定因素。
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 mu m (range, 0.4-2.7 mu m). 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.