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QUOTED. 25 October 2019. Amy Abernethy & Jeff Shuren.

Executive Summary

The US FDA is recommending additional warnings to be added to breast implant labeling in the wake of information linking the implants to systemic health issues. See what FDA deputy commissioner Amy Abernethy and FDA device center head Jeff Shuren said about it here.

“We believe women should have thoughtful and balanced discussions with their health-care providers about both the benefits and risks of breast implants based on clear and current information. This draft guidance is an important step in making that happen." – Amy Abernethy, deputy commissioner, FDA and Jeff Shuren, device center head, FDA

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