FDA Requires Boxed Warning for Breast Implants, Restricts Sale, Distribution

WASHINGTON, D.C. — The Food and Drug Administration has ordered the manufacturers of breast implants to include a boxed warning in their labeling and has restricted the sale and distribution of the devices to only health care providers and facilities that provide a “Patient Decision Checklist.”

In an Oct. 27 announcement, the agency said it also approved new labeling that includes the boxed warning and patient checklist, updated silicone gel-filled breast implant rupture screening recommendations, a device description with a list of specific materials used in the device, and a patient device card.

In addition, the FDA released updated …


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