The FDA has issued a draft guidance to propose labeling recommendations, including a boxed warning, to breast implant manufacturers in an effort to help patients understand the benefits and risks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
- 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.
- Breast Implants-Certain Labeling Recommendations to Improve Patient Communication: Draft Guidance for Industry and Food and Drug Administration Staff.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.
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