Global Adverse Event Reports of Breast Implant-Associated ALCL: An International Review of 40 Government Authority Databases.

Background: An estimated 200 patients have been reported with breast implant associated anaplastic large cell lymphoma (BI-ALCL), a rare T-cell lymphoma developing around breast prostheses. The purpose of this study was to review federal database submissions relating to BI-ALCL in 37 countries representing the majority of breast implant markets worldwide with available adverse event reporting. Methods: Database queries were performed for Australia, Brazil, Canada, China, Columbia, Japan, Mexico, National Competent Authorities of the European Member States, New Zealand, South Korea, and United States. Demographics, device characteristics, pathology, treatment modalities, and outcomes were assessed when available. Results: The United States MAUDE database included 459 entries in total for the search terms "Anaplastic" and "ALCL" as of September 2015. Excluding for duplicate entries, the MAUDE database had 258 unique cases of BI-ALCL of which 130 had pathologic markers performed. Implant surface was textured significantly more than smooth (50% vs. 4.2%, p=0.0001). Treatment, when reported (n=136), included explantation (n=125, 91.9%), chemotherapy (n=42, 30.8%), radiation (n=25, 18.4%), and/or stem cell transplant (n=9, 6.6%) and 5 deaths were reported. For the 40 countries queried, 340 unique cases were reported for lymphoma associated with breast implants. Conclusions: Worldwide federal reporting of BI-ALCL has significant limitations in providing data regarding clinical history, treatment, and oncologic follow up. Country-specific total implant and textured implant sales data is needed in order to determine critical incidence and prevalence analysis. Detailed BI-ALCL patient registries such as American Society of Plastic Surgeon's PROFILE and centralized tissue banking are necessary in acquiring accurate complete data for sound decision making. (C)2017American Society of Plastic Surgeons

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