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Current Policy Priority

FDA Issues New Breast Implant Labeling Recommendations to Improve Patient Communication

Device Safety & Drug Development

September 29, 2020 - The FDA released new guidance on breast implant labeling, patient communication and informed consent today. The updated guidelines recommend that implant manufacturers incorporate a boxed warning and a patient decision checklist into the patient brochure. It also provides updated implant rupture screening recommendations.

Boxed Warning
The FDA suggested a boxed warning be part of the physician and patient materials for breast implants. The agency believes a boxed warning would be useful in communicating breast implant risks that have been identified. A boxed warning generally informs patients that:

  • Breast implants are not considered lifetime devices;
  • The chance of developing complications increases over time;
  • Some complications require more surgery;
  • Textured breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL);
  • Breast implants have been associated with systemic symptoms in some women (known as breast implant illness or BII).

Patient Decision Checklist
The FDA believes that a patient decision checklist highlighting key information regarding potential risks should be included at the end of the patient information booklet/brochure. FDA recommends that the checklist covers the following:

  • Situations in which an implant should not be used;
  • Considerations for a successful breast implant patient;
  • Risks of undergoing breast implant surgery;
  • Importance of appropriate physician education, training and experience;
  • Risk of BIA-ALCL;
  • Risk of systemic symptoms (BII); and
  • Discussion of options other than breast implants, as appropriate.​​​

Rupture Screening Recommendations Update
The FDA recommends that the patient labeling for silicone gel-filled breast implants include specific, updated rupture screening recommendations:

"It is recommended that you have periodic imaging (e.g., MRI, ultrasound) of your silicone gel-filled breast implants to screen for implant rupture regardless of whether your implants are for cosmetic augmentation or reconstruction. These recommendations do not replace other additional imaging that may be required depending on your medical history or circumstances. Even if you have no symptoms, you should have your first ultrasound or MRI at 5-6 years after your initial implant surgery and then every 2-3 years thereafter. If you have symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended."

Previously, the FDA recommended screening silicone breast implants for a rupture with a breast MRI 3 years after the initial implant surgery and every 2 years after that. The new guidelines reflect research indicating that ruptures tend to increase when an implant is about 6 years of age. The additional option of breast ultrasound will serve to provide a less costly alternative to breast MRIs.

For more information on breast implant safety and related issues, please see our August 24, 2020 and December 23, 2019 updates.

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