患者登记和隆胸假体和大细胞淋巴瘤病因流行病学结果( PROFILE ): 2012 - 2020 年更新报告。
Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE): Updated Report 2012 - 2020.
发表日期:2023 Mar 30
作者:
Colleen M McCarthy, John Roberts, Erin Mullen, Nilsa Loyo-Berrios, Mark W Clemens, Sung W Yoon, Howard Levinson, Katie Sommers, Keith Hume, Logan Carr
来源:
PLASTIC AND RECONSTRUCTIVE SURGERY
摘要:
2011年1月,美国食品药品监督管理局(FDA)发布了一份安全通讯,涉及乳房植入物和间变性大细胞淋巴瘤(BIA-ALCL)之间的潜在联系。2012年,美国整形外科医师协会、整形外科基金会和FDA签署了一个合作的研究和开发协议,开发了一个名为“乳房植入物和间变性大细胞淋巴瘤病因流行病学患者登记表和病例结果登记表”或“PROFILE”登记表。这是关于登记发现的最新报告。从2012年8月至2020年8月,美国的PROFILE报告了330个独特、疑似或经确认的BIA-ALCL病例。其中包括自2018年以来新报告的144个病例。任何一种植入设备到BIA-ALCL诊断的中位时间为11年(范围为2-44年)。在报告时,91%的病例有局部症状,9%的病例有系统症状。最常见的局部症状是积液,占79%的患者。所有患者都有嵌入了有纹理的植入物的历史,没有患者有确认的光滑设备历史。大约11%的病例被诊断为1A期疾病(TNM分期分类)。PROFILE登记表仍然是集合关于BIA-ALCL的细致数据的关键工具。这些数据强调了仔细跟踪BIA-ALCL病例的重要性,并将对我们理解乳房植入物和ALCL之间的关系做出重要贡献。美国整形外科医师协会(ASPS)版权所有,2023年.
In January 2011, the FDA released a safety communication regarding the potential association between breast implants and anaplastic large cell lymphoma (BIA-ALCL). In 2012, the American Society of Plastic Surgeons, The Plastic Surgery Foundation, and the FDA signed a cooperative research and development agreement to develop a patient registry entitled the " Patient Registry and Outcomes F or breast Implants and anaplastic large cell Lymphoma etiology and Epidemiology" or "PROFILE" Registry.This is an updated report of registry findings.From August 2012 to August 2020, 330 unique, suspected or confirmed cases of BIA-ALCL in the US were reported to PROFILE. This includes 144 cases newly reported since the 2018 publication. Median time from implantation of any device to BIA-ALCL diagnosis was 11 years (range 2 - 44 years). At the time of presentation, 91% of cases had local symptoms and 9% had concurrent systemic symptoms. The most common local symptom was seroma seen in 79% of patients. All patients had a history of a textured device; there were no patients who had a confirmed smooth-only device history. Approximately, 11% of the reported cases were diagnosed with Stage 1A disease (TNM Staging Classification).The PROFILE Registry continues to be an essential tool in unifying the collection of granular level data pertaining to BIA-ALCL. This data emphasizes the critical importance of detailed tracking of BIA-ALCL cases and will contribute significantly to our understanding of the relationship between breast implants and ALCL.Copyright © 2023 by the American Society of Plastic Surgeons.