Loch-Wilkinson Anna, Beath Kenneth J, Knight Robert John William, Wessels William Louis Fick, Magnusson Mark, Papadopoulos Tim, Connell Tony, Lofts Julian, Locke Michelle, Hopper Ingrid, Cooter Rodney, Vickery Karen, Joshi Preeti Avinash, Prince H Miles, Deva Anand K
Sydney, New South Wales; and Melbourne, Victoria, Australia.
From the Faculty of Medical and Health Sciences, Macquarie University; the Joint Breast Implant-Associated ALCL Task Force, American Society of Plastic Surgeons/American Society for Aesthetic Plastic Surgery/New Zealand Association of Plastic Surgeons; the Integrated Specialist Healthcare Education and Research Foundation; the Australian Breast Device Registry, Department of Epidemiology and Preventative Medicine, Monash University; and the Peter MacCallum Cancer Center.
Plast Reconstr Surg. 2017 Oct;140(4):645-654. doi: 10.1097/PRS.0000000000003654.
BACKGROUND: The association between breast implants and breast implant-associated anaplastic large cell lymphoma (ALCL) has been confirmed. Implant-related risk has been difficult to estimate to date due to incomplete datasets. METHODS: All cases in Australia and New Zealand were identified and analyzed. Textured implants reported in this group were subjected to surface area analysis. Sales data from three leading breast implant manufacturers (i.e., Mentor, Allergan, and Silimed) dating back to 1999 were secured to estimate implant-specific risk. RESULTS: Fifty-five cases of breast implant-associated ALCL were diagnosed in Australia and New Zealand between 2007 and 2016. The mean age of patients was 47.1 years and the mean time of implant exposure was 7.46 years. There were four deaths in the series related to mass and/or metastatic presentation. All patients were exposed to textured implants. Surface area analysis confirmed that higher surface area was associated with 64 of the 75 implants used (85.3 percent). Biocell salt loss textured (Allergan, Inamed, and McGhan) implants accounted for 58.7 percent of the implants used in this series. Comparative analysis showed the risk of developing breast implant-associated ALCL to be 14.11 times higher with Biocell textured implants and 10.84 higher with polyurethane (Silimed) textured implants compared with Siltex textured implants. CONCLUSIONS: This study has calculated implant-specific risk of breast implant-associated ALCL. Higher-surface-area textured implants have been shown to significantly increase the risk of breast implant-associated ALCL in Australia and New Zealand. The authors present a unifying hypothesis to explain these observations.
背景：乳房植入物与乳房植入物相关间变性大细胞淋巴瘤（ALCL）之间的关联已得到证实。由于数据集不完整，迄今为止植入物相关风险难以估计。 方法：对澳大利亚和新西兰的所有病例进行识别和分析。对该组报告的带纹理植入物进行表面积分析。获取了三家主要乳房植入物制造商（即美敦力、艾尔建和西利美）可追溯至1999年的销售数据，以估计特定植入物的风险。 结果：2007年至2016年期间，澳大利亚和新西兰共诊断出55例乳房植入物相关ALCL。患者的平均年龄为47.1岁，植入物暴露的平均时间为7.46年。该系列中有4例因肿块和/或转移表现死亡。所有患者均接触过带纹理植入物。表面积分析证实，75个使用的植入物中有64个（85.3%）的表面积较大。生物细胞盐损失纹理（艾尔建、英格美和麦加恩）植入物占该系列使用植入物的58.7%。比较分析显示，与Siltex纹理植入物相比，使用Biocell纹理植入物发生乳房植入物相关ALCL的风险高14.11倍，使用聚氨酯（西利美）纹理植入物的风险高10.84倍。 结论：本研究计算了乳房植入物相关ALCL的特定植入物风险。在澳大利亚和新西兰，表面积较大的带纹理植入物已被证明会显著增加乳房植入物相关ALCL的风险。作者提出了一个统一的假设来解释这些观察结果。
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