Hecker Andrzej, Giese Barbara, Pignet Anna-Lisa, Schellnegger Marlies, Kamolz Lars-Peter, Lumenta David Benjamin
Research Unit for Digital Surgery, Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz, 8036 Graz, Austria.
Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz, 8036 Graz, Austria.
J Pers Med. 2023 May 11;13(5):816. doi: 10.3390/jpm13050816.
Breast-Implant-Associated Anaplastic Large-Cell Lymphoma (BIA-ALCL) is a rare low-incidence type of T-cell non-Hodgkin lymphoma, arising in the capsule around breast implants, and predominantly associated with the use of macro-textured breast implants. The purpose of this study was to use an evidence-based approach to systematically identify clinical studies comparing smooth and textured breast implants in women with regard to the risk of developing BIA-ALCL.
A literature search in PubMed in April 2023 and the article reference list of the French National Agency of Medicine and Health Products decision from 2019 were screened for applicable studies. Only clinical studies where the Jones surface classification could be applied (required information: breast implant manufacturer) for comparison of smooth and textured breast implants were considered.
From a total of 224 studies, no articles were included due to the lack of fit to the strict inclusion criteria.
Based on the scanned and included literature, implant surface types in relation to the incidence of BIA-ALCL were not evaluated in clinical studies and data from evidence-based clinical sources plays a minor to no role in this context. An international database that combines breast implant-related data from (national, opt-out) medical device registries is, therefore, the best available option to obtain relevant long-term breast implant surveillance data on BIA-ALCL.
乳房植入物相关间变性大细胞淋巴瘤(BIA-ALCL)是一种罕见的低发病率T细胞非霍奇金淋巴瘤,发生于乳房植入物周围的包膜,主要与使用大纹理乳房植入物有关。本研究的目的是采用循证方法,系统识别比较光滑型和纹理型乳房植入物在女性中发生BIA-ALCL风险的临床研究。
检索2023年4月的PubMed以及2019年法国国家药品和健康产品局决定的文章参考文献列表,筛选适用研究。仅考虑可应用琼斯表面分类法(所需信息:乳房植入物制造商)来比较光滑型和纹理型乳房植入物的临床研究。
在总共224项研究中,由于不符合严格的纳入标准,未纳入任何文章。
基于检索和纳入的文献,临床研究未评估植入物表面类型与BIA-ALCL发病率的关系,在此背景下,循证临床来源的数据作用很小或无作用。因此,一个整合来自(国家、非选择退出)医疗器械注册机构的乳房植入物相关数据的国际数据库,是获取关于BIA-ALCL的相关长期乳房植入物监测数据的最佳可用选项。