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Defenders: FDA calls for new boxed warnings on breast implants

The Food and Drug Administration is recommending so-called boxed warnings – the highest level warning the agency issues.

AUSTIN, Texas — The Food and Drug Administration is recommending all breast implants come with the highest level warning the agency issues, a big change in how they are being sold across the nation.

The so-called "boxed warnings" would require labels that read "breast implants are not considered lifetime devices" and "breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma."

The recommendation also includes making sure patients receive a booklet/brochure, patient decision checklist, this boxed warning and patient device card.

According to the FDA, “Specifically, FDA believes manufacturers should include a boxed warning and patient decision 200 checklist to help ensure patients receive and understand information about the benefits and risks 201 of breast implants.”


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The patient checklist would include these items:

  • Situations in which the device should not be used or implanted
  • Considerations for a successful breast implant candidate
  • Risks of undergoing breast implant surgery
  • Importance of appropriate physician education, training and experience
  • Risk of BIA-ALCL and systemic symptoms
  • Discussion of options other than breast implants
Credit: FDA
The FDA released this as an example of the boxed warnings it is recommending be added to breast implants.

The wording still needs final approval, but the hope is this will be a step toward making sure patients get information about the real risks of getting breast implants.

This is one of the stories the KVUE Defenders have been reporting on since the beginning of the year with our Medical Device Dangers series.

You can watch the full series here.

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