Risk Factors Associated With BIA-ALCL Development: A Case Control Study

The World Consensus Conferences on Breast Implant–Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), held in 2019, 2020 and 2021, aimed to raise awareness of this cancer. So far etiology and risk factors associated to BIA-ALCL are only hypothesized. On February 28th 2024, Binita Ashar, Director of the Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality (OPEQ), released a statement on behalf of the Center for Devices and Radiological Health (CDRH) branch of the FDA, in regards to the publication of the AAPS Consensus paper. While underpinning that prophylactic removal of textured implants is not recommended by the FDA in asymptomatic patients, they agreed that individual patients should primarily discuss possible risks and benefits of preemptive implant removal with their healthcare providers to make an informed decision about their health. On the same day, the ASPS used an external methodologist to independently review the paper from Santanelli di Pompeo et al. and analyze the authors' risk reduction rationale. The relevance of the findings were undermined, due to the fact that no randomization and no control or comparison groups could be found (i.e. controls without BIA-ALCL). Center for Devices and Radiological Health (2024) CDRH’s continued commitment to breast implant safety, U.S. Food and Drug Administration.