Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia: A Longitudinal Study of Implant and Other Related Risk Factors

Abstract

AbstractBackgroundBreast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an emerging cancer that has been linked to the use of textured devices. The recent increase in number and frequency of cases has led to worldwide regulatory action.ObjectivesThe authors aimed to longitudinally study BIA-ALCL in Australia since the index case was first reported in 2007.MethodsConfirmed historical cases were collected and then prospectively analyzed from October 2015 to May 2019. Clinical and implant exposure data were determined and compared with company sales data for 4 devices to generate implant-specific risk.ResultsA total 104 cases of BIA-ALCL were diagnosed in Australia with exposure to 149 unique breast implants. The mean age of patients was 48.2 years (range, 22.4-78.5 years). They had an average time from implantation to diagnosis of 6.8 years. A total 51.7% of implants utilized in this cohort were Allergan Biocell devices. The indication for implant usage was for primary cosmetic augmentation in 70%, post-breast cancer reconstruction in 23%, and following weight loss/pregnancy in 7%. The majority of women presented with early (stage 1) disease (87.5%). The risk for developing BIA-ALCL ranged from 1 in 1947 sales (95% confidence interval = 1199-3406) for Silimed Polyurethane devices to 1 in 36,730 (95% confidence interval = 12,568-178,107) for Siltex imprinted textured devices.ConclusionsImplants with higher surface area/texture seem to be more associated with BIA-ALCL in Australia. Recent regulatory action to suspend, cancel, or recall some of these higher risk devices is supported by these findings.Level of Evidence: 2