Today, the U.S. Food and Drug Administration is providing an update on adverse events reported to the Agency related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and systemic signs and symptoms referred to by patients as breast implant illness (BII), which some patients report after receiving breast implants. The FDA is also qualifying the BREAST-Q Reconstruction Module as a medical device development tool (MDDT) to aid in the assessment of certain medical devices such as breast implants. Qualification of the BREAST-Q Reconstruction Module MDDT included the Physical Well-being (Chest), Psychosocial Well-being, Sexual Well-being and Satisfaction with Breasts scales. An MDDT is scientifically validated and can be qualified for use in device evaluation and to support regulatory decision-making. Examples of MDDTs are clinical outcome assessments, assessments of biomarkers, and non-clinical assessment methods or models. The use of a qualified MDDT by a product sponsor is voluntary.

“The FDA has been diligently monitoring adverse events associated with breast implants for decades and has been working to better understand the quality of life and satisfaction a breast reconstruction patient may experience in order to refine our evaluation of breast implant benefits and risks. Our qualification of the BREAST-Q Reconstruction Module as a validated tool to assess outcomes of breast reconstruction surgery in terms of quality of life and satisfaction helps accomplish this,” said Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. “In addition, we continue to increase our scientific knowledge regarding BIA-ALCL and systemic symptoms referred to as BII, and remain committed to keeping the public informed.”

Medical Device Reports of BIA-ALCL

The FDA analysis of global medical device reports for BIA-ALCL covers reports received through January 5, 2020. It updates the FDA’s last public report with new information from July 7, 2019 to January 5, 2020. Today, the FDA updated the table on the agency’s BIA-ALCL webpage to include a total of 733 unique cases and 36 patient deaths globally, which reflect an increase of 160 new cases and 3 deaths since the early-July, 2019 update.

Specifically, 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.