Textured Breast Implants: A Closer Look at the Surface Debris Under the Microscope
Textured Breast Implants: A Closer Look at the Surface Debris Under the Microscope
复制标题
带纹理的乳房植入物：在显微镜下仔细观察表面碎片
作者：
Leland H Webb;Victoria L Aimé;A. Do;Kenneth Mossman;R. Mahabir
背景：乳房植入物的纹理化是为了降低相关并发症的风险。每个制造商使用独特的，有时专有的技术来纹理表面的植入物。人们对这种表面结构纹理的完整性或表面脱落颗粒物质的倾向知之甚少。本研究旨在确定美国食品和药物管理局（FDA）批准的三种纹理植入物的表面颗粒脱落程度，这三种植入物由Allergan、Mentor和Sientra生产。方法：采用扫描电子显微镜（SEM）对3种假体进行对照成像。然后将液体粘合剂醋酸乙烯（EVA）共聚物涂在植入物的外壳上，冷却后从表面剥离。利用扫描电镜对EVA共聚物进行了成像，定性分析了表面颗粒碎片的位移。重复植入物的扫描电镜成像，与对照图像进行定性比较。结果：3种种植体的脱皮共聚物均出现表面脱落。三种乳房植入物的比较表明，爱力根植入物的脱落程度最大。结论：本研究突出了3种fda批准的乳房植入物的动态表面材料特性。从种植体表面脱落的颗粒物质可以通过适度的粘附沉淀。我们对SEM结果的定性检查显示，艾尔建乳房植入物比Mentor或Sientra植入物脱落的碎片更多。
Background: Texturing of breast implants is done to decrease the risk of associated complications. Each manufacturer utilizes unique and at times proprietary techniques to texture the surface of their implants. Little is known about the integrity of this surface structure texturing or the propensity for the surfaces to shed particulate matter. This study aimed to determine the extent of surface particulate shedding from 3 textured implants approved by the US Food and Drug Administration (FDA), which are manufactured by Allergan, Mentor, and Sientra. Methods: Control images of each of the 3 textured breast implants were obtained with scanning electron microscopy (SEM). A liquid adhesive, ethylene vinyl acetate (EVA) copolymer was then applied to the external shell of the implants, allowed to cool, and peeled from the surface. Images of the EVA copolymer were taken with SEM to qualitatively analyze displacement of surface particulate debris. Scanning electron microscopy imaging of the implants was repeated for qualitative comparisons with the control images. Results: The peeled copolymer of the 3 implants exhibited surface shedding. Comparison of the 3 breast implants showed the shedding to be greatest for the Allergan implant. Conclusions: This study highlights the dynamic surface material properties of the 3 FDA-approved breast implants. Shedding of particulate matter from the implant surfaces can be precipitated by moderate adhesion. Our qualitative examination of SEM findings showed more debris shed from the Allergan breast implants than from the Mentor or Sientra implants.