Medicines and Healthcare Products Regulatory Agency Representatives’ Response to: Breast Implant–Associated Anaplastic Large Cell Lymphoma (BIA-ALCL): Comparison of Manufacturers From UK National Data

We read with interest the letter to the editor, Breast Implant–Associated Anaplastic Large Cell Lymphoma (BIA-ALCL): Comparison of Manufacturers From UK National Data.1 The Medicines and Healthcare Products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the UK, operating the UK postmarket medical device vigilance system. As part of this vigilance, the MHRA closely monitors breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).2 The MHRA published data are a result of additional follow-up of each BIA-ALCL report made to the MHRA, to determine the specific devices involved, patient history, and certainty of the diagnosis. We would like to provide further details about the MHRA data set and draw the author's attention to limitations of the data they have based their analysis on, as well as share conclusions from assessment of the wider evidence at this time. Recently, an updated assessment was completed by the MHRA to address the question of whether a single manufacturer, product, or device type was associated with a greater risk of BIA-ALCL. Wider global literature, global regulatory data and actions, MHRA incident reporting, and manufacturer sales data were used to evaluate the association of BIA-ALCL risk by manufacturer and by surface texture/topography. Consideration was given to the application of global data in the context of local UK risk, due to global variation in regulatory requirements, reporting system and registry completeness, differences in population, and device use and availability.