FDA recommends warning for breast implants


(CNN) – The Food and Drug Administration is now recommending so-called “Boxed Warning” labeling materials for breast implants.

The FDA released the draft guidance on Wednesday.

Boxed warnings are the strongest FDA required warning for labeling. They notify consumers and health care providers about potential serious risks for certain drugs and devices.

One warning excerpt states, “breast implants are not considered lifetime devices.”

Another warns that implants have been associated with cancer and the immune system.

The FDA published the recommendations for public comment and review and they haven’t been finalized.

The move comes after breast cancer patients testified before the FDA in March about implant-associated illnesses and cancers.

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