From the Plastic and Reconstructive Service and Department of Surgery, Memorial Sloan-Kettering Cancer Center; Center for Devices and Radiological Health, U.S. Food and Drug Administration; Marina Plastic Surgery; American Society of Plastic Surgeons; Department of Surgery, Indiana University; Division of Plastic Surgery, Brigham and Women's Hospital; and Department of Plastic Surgery, University of Texas MD Anderson Cancer Center.
Plast Reconstr Surg. 2019 Mar;143(3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):65S-73S. doi: 10.1097/PRS.0000000000005571.
In January of 2011, the US Food and Drug Administration released a safety communication regarding the potential association between breast implants and anaplastic large cell lymphoma (ALCL). In August of 2012, the American Society of Plastic Surgeons, The Plastic Surgery Foundation, and the Food and Drug Administration signed a cooperative research and development agreement to develop a patient registry entitled the "Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology" (PROFILE).
The first report of the registry findings is presented here.
From August of 2012 to March of 2018, a total of 186 distinct cases of breast implant-associated ALCL (BIA-ALCL) in the United States were reported to PROFILE. At the time of this present analysis, complete detailed case report forms have been received for 89 (48%) cases. Median time from implantation of any device to BIA-ALCL diagnosis was 11.0 years (range = 2-44 years; n = 89). At the time of presentation, 96% of cases had local symptoms and 9% had concurrent systemic symptoms. The most common local symptom was a periprosthetic fluid collection seen in 86% of patients. All patients had a history of a textured device; there were no patients who had a smooth-only device history. At the time of initial case report submission, 3 deaths were reported.
The PROFILE Registry has shown to be an essential tool in unifying the collection of data pertaining to BIA-ALCL. These data have broadened our understanding of the disease and emphasize the critical importance of detailed tracking of BIA-ALCL cases.
2011 年 1 月，美国食品和药物管理局发布了一则安全通讯，涉及乳房植入物与间变性大细胞淋巴瘤（ALCL）之间的潜在关联。2012 年 8 月，美国整形外科学会、整形外科学基金会和食品和药物管理局签署了一项合作研发协议，开发了一个名为“乳房植入物和间变性大细胞淋巴瘤病因和流行病学患者注册”（PROFILE）的患者注册。
这里呈现了该注册的首次报告结果。
从 2012 年 8 月到 2018 年 3 月，美国共报告了 186 例明确的乳房植入物相关 ALCL（BIA-ALCL）病例。在本分析时，已收到 89 例（48%）病例的完整详细病例报告表。从植入任何装置到 BIA-ALCL 诊断的中位时间为 11.0 年（范围=2-44 年；n=89）。在就诊时，96%的病例有局部症状，9%的病例有同时出现的全身症状。最常见的局部症状是 86%患者出现的假体周围积液。所有患者均有纹理设备史，无仅使用光滑设备的患者。在初始病例报告提交时，报告了 3 例死亡。
PROFILE 注册已被证明是统一收集 BIA-ALCL 相关数据的重要工具。这些数据拓宽了我们对该疾病的认识，并强调了详细跟踪 BIA-ALCL 病例的至关重要性。
