From the Department of Plastic and Reconstructive Surgery, Erasmus MC Cancer Institute, University Medical Center Rotterdam.
Dutch Institute for Clinical Auditing.
Plast Reconstr Surg. 2023 Aug 1;152(2):307-318. doi: 10.1097/PRS.0000000000010208. Epub 2023 Jul 27.
Growing awareness about breast implant-related adverse events has stimulated the demand for large, independent data resources. For this, data from breast implant registries could be combined. However, that has never been achieved yet.
Real-world data from four currently active national breast implant registries were used. All permanent breast implants from the Australian, Dutch, Swedish, and American registries were included. A subpopulation present across all registries between 2015 and 2018 was subsequently selected, including only permanent breast implants inserted during primary surgery for breast reconstruction or augmentation in patients without previous breast device surgery. Nationwide coverage, patient and implant characteristics, infection control measures, and revision incidences were analyzed.
A total of 207,189 breast implants were registered. Nationwide coverage varied between 3% and 98%. The subpopulation included 111,590 implants (7% reconstruction, 93% augmentation). Across the registries, mean patient age varied between 41 and 49 years ( P < 0.001) for reconstruction and 31 and 36 years ( P < 0.001) for augmentation. Variation was observed in implant preferences across the countries and over the years. Infection control measures were most frequently registered in Australia. Cumulative revision incidence at 2 years ranged from 6% to 16% after reconstruction and from 1% to 4% after augmentation.
For the first time, independent, national, registry-based data from four breast implant registries were combined. This is a powerful step forward in optimizing international breast implant monitoring, evidence-based decision-making, and patient safety.
人们对与乳房植入物相关的不良事件的认识不断提高，这激发了对大型独立数据资源的需求。为此，可以合并乳房植入物注册中心的数据。然而，这一目标尚未实现。
本研究使用了四个目前正在运行的国家乳房植入物注册中心的真实数据。纳入了澳大利亚、荷兰、瑞典和美国注册中心所有的永久性乳房植入物。随后选择了 2015 年至 2018 年期间所有注册中心都存在的亚人群，包括在原发性乳房重建或隆乳手术中仅植入的永久性乳房植入物，且患者既往无乳房器械手术史。分析了全国范围内的覆盖范围、患者和植入物特征、感染控制措施以及翻修发生率。
共登记了 207189 例乳房植入物。全国范围内的覆盖范围在 3%至 98%之间。亚人群包括 111590 例植入物（7%为重建，93%为隆乳）。在所有注册中心，重建患者的平均年龄在 41 至 49 岁之间（P<0.001），而隆乳患者的平均年龄在 31 至 36 岁之间（P<0.001）。不同国家和不同年份的植入物偏好存在差异。感染控制措施在澳大利亚最常被登记。重建后 2 年的累积翻修发生率为 6%至 16%，隆乳后为 1%至 4%。
这是首次合并了四个乳房植入物注册中心的独立、国家、基于注册的数据集。这是在优化国际乳房植入物监测、循证决策和患者安全方面向前迈出的有力一步。
