Piacquadio Daniel, Smith Stacy, Anderson Russell
Therapeutics Inc., San Diego, California, USA.
Dermatol Surg. 2008 Jun;34 Suppl 1:S48-52. doi: 10.1111/j.1524-4725.2008.34242.x.
BACKGROUND The rapid market expansion of filler treatment options requires physicians and health care providers to fully understand differences among comparable products. OBJECTIVE The objective was to compare commercially available polymethylmethacrylate (PMMA)-based soft tissue fillers to determine if there are meaningful variations in these products that could result in significantly different therapeutic profiles, especially with respect to safety. METHODS AND MATERIALS PMMA particles were evaluated for size and morphology using scanning electron microscopy (SEM) techniques. PMMA microsphere soft tissue filler products from the United States, Europe, Brazil, and Canada were compared with respect to size, homogeneity/irregularity, surface smoothness/roughness, and the presence or absence of sediment and particulate debris. RESULTS Marked differences with respect to PMMA particle morphology and related particle characteristics from a variety of products were found. Of note, some products demonstrated potentially concerning significant variability in particle size and irregular morphology. CONCLUSION It is anticipated that the variability detected in these products, based on the literature, could result in different therapeutic profiles, especially with respect to safety. Physicians and health care providers should be aware that "comparable" products that at a glance appear similar may not be equal.
背景 填充剂治疗选择的快速市场扩张要求医生和医疗保健提供者充分了解可比产品之间的差异。目的 目的是比较市售的基于聚甲基丙烯酸甲酯（PMMA）的软组织填充剂，以确定这些产品中是否存在有意义的差异，这些差异可能导致显著不同的治疗效果，特别是在安全性方面。方法和材料 使用扫描电子显微镜（SEM）技术评估PMMA颗粒的大小和形态。比较了来自美国、欧洲、巴西和加拿大的PMMA微球软组织填充剂产品在大小、均匀性/不规则性、表面光滑度/粗糙度以及是否存在沉淀物和颗粒碎片方面的情况。结果 发现各种产品在PMMA颗粒形态和相关颗粒特征方面存在显著差异。值得注意的是，一些产品在颗粒大小和不规则形态方面表现出潜在的显著变异性。结论 根据文献，预计在这些产品中检测到的变异性可能导致不同的治疗效果，特别是在安全性方面。医生和医疗保健提供者应意识到，乍一看相似的“可比”产品可能并不等同。
