The US Food and Drug Administration (FDA) sent a letter to health care providers on Wednesday to raise awareness on additional cases of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL).
The letter addresses the last update on medical device reports (MDRs)—otherwise known as adverse event reports—submitted to FDA’s Center for Devices and Radiological Health (CDRH) regarding BIA-ALCL. The September 2018 update reported on a total of 660 MDRs of BIA-ALCL, up from the 414 of such MDRs that CDRH had received as of September 2017. The update amounts to 246 new cases since 2017.
As part of the agency’s additional data analysis, duplicates were removed to identify 457 unique MDRs for BIA-ALCL. These include nine patient deaths that were found to be likely attributable to BIA-ALCL.
Binita Ashar, a general surgeon and director of the Division of Surgical Devices at CDRH, explained that “the number of unique cases is lower than the total number of reports because the FDA’s medical device reporting system allows patients, providers and manufacturers to each file their own reports even if it’s about the same case, which can lead to duplicative reports of BIA-ALCL.”
Ashar argued that the spike in reported cases of BIA-ALCL had been anticipated given the agency’s ongoing efforts to increase awareness among health care providers and patients around the risk associated with breast implants. Yet challenges with analyzing the reported data remain. These relate to a lack of information in submitted MDRs, such as patient history on breast implant replacements…