jueves, 20 de agosto de 2020

FDA Update on Breast Implants: Medical Device Reports, video and BREAST-Q tool


Breast Implants: FDA Provides Updates on Medical Device Reports, Releases Video and Qualifies BREAST-Q Reconstruction Module

To help patients and health care professionals have the most complete benefit and risk information available for breast implants, the FDA posted several updates to its website:
  • Updated information on Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Medical Device Reports (MDRs) received between July 7, 2019 to January 5, 2020.
  • The total number of Medical Device Reports related to systemic symptoms referred by some patients as Breast Implant Illness (BII) covering data the FDA received between January 1, 2008 to October 31, 2019.
  • Video: “7 Things to Know about Breast Implants” with content about risks,  complications, BIA-ALCL, and systemic symptoms.
  • Newly qualified tool: the BREAST-Q Reconstruction Module to better understand quality of life and satisfaction associated with breast construction surgery among patients.
These are examples of the FDA’s continued efforts to protect patients’ health and help ensure the safety of breast implants.

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