FDA said it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths.
The agency identified those unique cases from a total of 660 adverse event reports in the U.S. from 2010 through September 2018, including 246 new adverse event reports since 2017.
FDA began reporting on cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma and a known risk from breast implants, in 2011. The new total of reports is larger than the number of unique cases because patients, providers, and manufacturers may all report an incident, resulting in duplicative reports.
