FDA Recommends Boxed Warning For Breast Implants

(CNN) — The US Food and Drug Administration on Wednesday released draft guidance recommending a “boxed warning” on labeling materials for breast implants. Boxed warnings, which alert health care providers and consumers to serious risks associated with a drug or device, are the strongest form of warning required by the FDA for labeling.
An example of the boxed warning states that “breast implants are not considered lifetime devices” and “breast implants have be