Importance Breast implants are among the most commonly used medical devices. Since 2008, the number of women with breast implants diagnosed with anaplastic large-cell lymphoma in the breast (breast-ALCL) has increased, and several reports have suggested an association between breast implants and risk of breast-ALCL. However, relative and absolute risks of breast-ALCL in women with implants are still unknown, precluding evidence-based counseling about implants.

Objective To determine relative and absolute risks of breast-ALCL in women with breast implants.

Design, Setting, and Participants Through the population-based nationwide Dutch pathology registry we identified all patients diagnosed with primary non-Hodgkin lymphoma in the breast between 1990 and 2016 and retrieved clinical data, including breast implant status, from the treating physicians. We estimated the odds ratio (OR) of ALCL associated with breast implants in a case-control design, comparing implant prevalence between women with breast-ALCL and women with other types of breast lymphoma. Cumulative risk of breast-ALCL was derived from the age-specific prevalence of breast implants in Dutch women, estimated from an examination of 3000 chest x-rays and time trends from implant sales.

Main Outcomes and Measures Relative and absolute risks of breast-ALCL in women with breast implants.

Results Among 43 patients with breast-ALCL (median age, 59 years), 32 had ipsilateral breast implants, compared with 1 among 146 women with other primary breast lymphomas (OR, 421.8; 95% CI, 52.6-3385.2). Implants among breast-ALCL cases were more often macrotextured (23 macrotextured of 28 total implants of known type, 82%) than expected (49 193 sold macrotextured implants of total sold 109 449 between 2010 and 2015, 45%) based on sales data (P < .001). The estimated prevalence of breast implants in women aged 20 to 70 years was 3.3%. Cumulative risks of breast-ALCL in women with implants were 29 per million at 50 years and 82 per million at 70 years. The number of women with implants needed to cause 1 breast-ALCL case before age 75 years was 6920.

Conclusions and Relevance Breast implants are associated with increased risk of breast-ALCL, but the absolute risk remains small. Our results emphasize the need for increased awareness among the public, medical professionals, and regulatory bodies, promotion of alternative cosmetic procedures, and alertness to signs and symptoms of breast-ALCL in women with implants.

重要性 乳房植入物是最常用的医疗器械之一。自 2008 年以来，乳房植入物被诊断为乳房间变性大细胞淋巴瘤 (breast-ALCL) 的女性人数有所增加，一些报告表明乳房植入物与乳房 ALCL 风险之间存在关联。然而，植入物女性的乳房 ALCL 的相对和绝对风险仍然未知，排除了有关植入物的循证咨询。

目的 确定乳房植入物女性乳房 ALCL 的相对和绝对风险。

设计、设置和参与者 通过基于人群的荷兰全国病理学登记，我们确定了 1990 年至 2016 年期间诊断为乳房原发性非霍奇金淋巴瘤的所有患者，并从治疗医生那里检索了临床数据，包括乳房植入物状态。我们在病例对照设计中估计了与乳房植入物相关的 ALCL 的优势比 (OR)，比较了乳房 ALCL 女性和其他类型乳房淋巴瘤女性之间的植入率。乳房 ALCL 的累积风险来自荷兰女性乳房植入物的年龄特异性患病率，根据对 3000 次胸部 X 光检查和植入物销售的时间趋势进行估计。

主要结果和措施 乳房植入物女性乳房 ALCL 的相对和绝对风险。

结果 在 43 名乳腺 ALCL 患者（中位年龄 59 岁）中，32 名进行了同侧乳房植入物，而 146 名患有其他原发性乳房淋巴瘤的女性中有 1 名（OR，421.8；95% CI，52.6-3385.2）。根据销售数据（2010 年至 2015 年期间，共售出 109449 枚中的 49193 枚，占 45%），乳腺 ALCL 病例中的植入物更常见（28 枚已知类型的植入体中的 23 枚，占 82%）。P  < .001)。在 20 至 70 岁的女性中，乳房植入物的估计患病率为 3.3%。在 50 岁和 70 岁的女性中，乳房 ALCL 的累积风险分别为 29/百万和 82/百万。在 75 岁之前需要植入物导致 1 例乳房 ALCL 病例的女性人数为 6920。

结论和相关性 乳房植入物与乳房 ALCL 风险增加有关，但绝对风险仍然很小。我们的研究结果强调需要提高公众、医疗专业人员和监管机构的认识，推广替代整容程序，并提高对植入女性乳房 ALCL 体征和症状的警觉性。