News >

FDA Recommends Boxed Warning, Additional Labeling Measures for Breast Implants

Gina Columbus @ginacolumbusonc
Published: Wednesday, Oct 23, 2019

The FDA has issued a draft guidance to propose labeling recommendations, including a boxed warning, to breast implant manufacturers in an effort to help patients understand the benefits and risks of these devices, the agency announced in a statement.1

 

References

  1. Statement on the Agency’s Continued Efforts to Protect Women’s Health and Enhance Safety Information Available to Patients Considering Breast Implants. FDA. Published October 23, 2019. https://bit.ly/35WzONY. Accessed October 23, 2019.
  2. Breast Implants-Certain Labeling Recommendations to Improve Patient Communication: Draft Guidance for Industry and Food and Drug Administration Staff. FDA. Published October 23, 2019. https://bit.ly/33V42z1. Accessed October 23, 2019.

... to read the full story
To Read the Full Story

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Publication Bottom Border
Border Publication
x