The U.S. FDA’s Center for Devices and Radiological Health (CDRH) announced it will study how patients assess the benefits and risks of using smooth or textured breast implants. The study will focus on how patients interact with the risk of developing Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), the agency announced June 13th.
BIA-ALCL is a specific type of T-cell lymphoma that is associated with textured breast implants, according to the FDA. The agency first identified the connection between textured breast implants and BIA-ALCL in 2011. In 2016, the World Health Organization (WHO) determined that BIA-ALCL was a potential complication of receiving breast implants, but the difficulty in identifying and studying this type of cancer made determining exact causes, case numbers, and symptoms impossible. According to the FDA, BIA-ALCL can be deadly but is both rare and largely treatable with surgery and chemotherapy.
The CDRH’s study is focusing on patients’ understanding of the risks of BIA-ALCL as part of an effort to assess whether patients are more influenced by the risk of developing BIA-ALCL or the potential benefits of receiving textured breast implants. The CDRH stated in the announcement that these patient preferences will be used to help guide regulatory decision-making.
Preparations for this study began in 2020 when the CDRH contracted the Research Triangle Institute (RTI) International, a North Carolina nonprofit research institute, to conduct the study. RTI International and the CDRH collaborated on designing the survey tools needed to prioritize the collection of information about the needs and experiences of breast implant patients.
During the design process, both RTI International and the CDRH consulted with focus groups made up of patients who were either considering breast reconstruction or augmentation or had already undergone the augmentation or reconstruction procedure in order to gain insight into both current and potential patient perspectives. Both organizations also consulted health care providers for input on the study’s design.
According to the CDRH, the results of this new study should be appearing by the end of the year in a peer-reviewed journal.