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Breast Implants – Certain Labeling Recommendations to Improve Patient Communication (Final Guidance)

U.S. Food and Drug Administration

Published Sep 1, 2020accessed Sep 18, 2026Updated Sep 19, 2026
Original source

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breast-implants-certain-labeling-recommendations-improve-patient-communication

fda.gov

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FactBreast Implant: US labeling guidance = Final FDA guidance issued September 2020 (docket FDA-2019-D-4467) on patient labeling content and format, including a boxed warning