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# Breast Implant Adverse Events Updated
- URL: https://www.fdaweb.com/breast-implant-adverse-events-updated/
- Published: 2020-08-20T12:00:00.000Z
- Updated: 2026-09-14T16:25:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147481

FDA has updated its alert on breast implant adverse events to include new reports received through 1/5\. An updated table on the agency’s breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) [Web page](https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma?ref=fdaweb.com) now includes a total of 733 unique cases and 36 patient deaths globally, which is an increase of 160 new cases and three deaths since a 7/2019 update.

“Specifically,” the alert says, “of the 733 total unique cases of BIA-ALCL reported to FDA, 620 cases were reported for Allergan implants, and 47 cases involved implants with an unknown manufacturer. With respect to implant surface for the 733 total unique cases of BIA-ALCL, 496 cases were reported to have textured implants, and 209 cases did not specify the implant surface. Of the 36 total patient deaths reported to FDA, 15 of the 16 patients for which the manufacturer of the implant is known, are reported to have had an Allergan breast implant at the time of their BIA-ALCL diagnosis. In terms of implant surface, of the 36 cases reported of patient deaths, 16 cases reported textured implants, and 19 cases did not contain information on the implant surface.”

FDA is also updating data on medical device reports received concerning systemic signs and symptoms referred to as “breast implant illness” (BII). A new table on the Web site summarizes unique BII medical device reports from the U.S. and worldwide that the agency has received from 11/2008 to 10/2019\. FDA says it received 2,497 medical device reports containing BII symptoms during this period. The agency says more patients and providers are reporting these conditions, likely due to increased awareness from press and social media. It notes that the top 10 most common symptoms reported to FDA’s medical device report database for patients with breast implants include fatigue (49%), brain fog (25%), joint pain (25%), anxiety (24%), hair loss (21%), depression (19%), rash (18%), autoimmune diseases (18%), inflammation (18%) and weight problems (18%).