Plastic and Reconstructive Surgery Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.
Division of Plastic and Reconstructive Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA.
Ann Surg. 2020 Sep 1;272(3):403-409. doi: 10.1097/SLA.0000000000004179.
This study sought to estimate the incidence and incidence rate of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) at a high-volume single institution, which enables vigorous long-term follow-up and implant tracking for more accurate estimates.
The reported incidence of BIA-ALCL is highly variable, ranging from 1 in 355 to 1 in 30,000 patients, demonstrating a need for more accurate estimates.
All patients who underwent implant-based breast reconstruction from 1991 to 2017 were retrospectively identified. The incidence and incidence rate of BIA-ALCL were estimated per patient and per implant. A time-to-event analysis was performed using the Kaplan-Meier estimator and life table.
During the 26-year study period, 9373 patients underwent reconstruction with 16,065 implants, of which 9589 (59.7%) were textured. Eleven patients were diagnosed with BIA-ALCL, all of whom had a history of textured implants. The overall incidence of BIA-ALCL was 1.79 per 1000 patients (1 in 559) with textured implants and 1.15 per 1000 textured implants (1 in 871), with a median time to diagnosis of 10.3 years (range, 6.4-15.5 yrs). Time-to-event analysis demonstrated a BIA-ALCL cumulative incidence of 0 at up to 6 years, increasing to 4.4 per 1000 patients at 10 to 12 years and 9.4 per 1000 patients at 14 to 16 years, although a sensitivity analysis showed loss to follow-up may have skewed these estimates.
BIA-ALCL incidence and incidence rates may be higher than previous epidemiological estimates, with incidence increasing over time, particularly in patients exposed to textured implants for longer than 10 years.
本研究旨在估计一家高容量单机构中乳房植入物相关间变性大细胞淋巴瘤（BIA-ALCL）的发病率和发病率，这使得能够进行强有力的长期随访和植入物跟踪，以获得更准确的估计。
BIA-ALCL 的报告发病率差异很大，范围从每 355 例患者中 1 例到每 30,000 例患者中 1 例，表明需要更准确的估计。
回顾性确定了 1991 年至 2017 年期间接受植入物乳房重建的所有患者。每例患者和每例植入物估计 BIA-ALCL 的发病率和发病率。使用 Kaplan-Meier 估计器和寿命表进行时间事件分析。
在 26 年的研究期间，9373 名患者接受了重建，共使用了 16065 个植入物，其中 9589 个（59.7%）为纹理。11 名患者被诊断为 BIA-ALCL，他们都有纹理植入物的病史。BIA-ALCL 的总发病率为每 1000 名患者中有 1.79 例（1 例每 559 例），每 1000 个纹理植入物中有 1.15 例（1 例每 871 例），中位诊断时间为 10.3 年（范围，6.4-15.5 岁）。时间事件分析表明，BIA-ALCL 的累积发病率在 6 年内为 0，在 10 至 12 年内增加到每 1000 名患者 4.4 例，在 14 至 16 年内增加到每 1000 名患者 9.4 例，尽管敏感性分析表明随访失访可能会使这些估计值产生偏差。
BIA-ALCL 的发病率和发病率可能高于以前的流行病学估计，发病率随时间增加，特别是在暴露于纹理植入物超过 10 年的患者中。
