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乳房植入物的评估、并发症及监测:解读2022年美国食品药品监督管理局乳房植入物指南

Assessment, Complications, and Surveillance of Breast Implants: Making Sense of 2022 FDA Breast Implant Guidance.

作者信息

Le-Petross Huong T, Scoggins Marion E, Clemens Mark W

机构信息

The University of Texas MD Anderson Cancer Center, Department of Breast Imaging, Houston, TX, USA.

The University of Texas MD Anderson Cancer Center, Department of Plastic Surgery, Houston, TX, USA.

出版信息

J Breast Imaging. 2023 May 22;5(3):360-372. doi: 10.1093/jbi/wbad029.

Abstract

As more information about the potential risks and complications related to breast implants has become available, the United States Food and Drug Administration (FDA) has responded by implementing changes to improve patient education, recalling certain devices and updating the recommendations for screening for silicone implant rupture. In addition to staying up-to-date with FDA actions and guidance, radiologists need to maintain awareness about the types of implants they may see, breast reconstruction techniques including the use of acellular dermal matrix, and the multimodality imaging of implants and their complications. Radiologists should also be familiar with some key differences between the updated FDA guidelines for implant screening and the imaging recommendations from the American College of Radiology Appropriateness Criteria. The addition of US as an acceptable screening exam for silicone implant rupture by the FDA is one of the most notable changes that has potentially significant implications.

摘要

随着越来越多与乳房植入物相关的潜在风险和并发症信息得以公开,美国食品药品监督管理局(FDA)采取了应对措施,通过实施变革来加强患者教育、召回某些器械,并更新了硅胶植入物破裂筛查的建议。除了及时了解FDA的行动和指南外,放射科医生还需要知晓他们可能遇到的植入物类型、包括使用无细胞真皮基质在内的乳房重建技术,以及植入物及其并发症的多模态成像。放射科医生还应熟悉FDA更新的植入物筛查指南与美国放射学会适宜性标准的成像建议之间的一些关键差异。FDA将超声检查新增为硅胶植入物破裂的可接受筛查检查,这是最显著的变化之一,可能具有重大影响。

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