Policy Archive

FDA Issues New Breast Implant Labeling Recommendations to Improve Patient Communication

October 27, 2021 - The FDA released new guidance on breast implant labeling, patient communication and informed consent today. The updated guidelines recommend that implant manufacturers incorporate a 'black box warning' and a decision checklist into the patient brochure. It also provides updated implant rupture screening recommendations.

• Boxed Warning
• Patient Decision Checklist
• Rupture Screening Recommendations
• Patient Device Card
   

Boxed Warning
The FDA is requiring that a boxed warning be part of the physician and patient materials for breast implants. The agency believes a 'black box warning' will be useful in communicating breast implant risks that have been identified. The boxed warning will inform 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 is requiring implant manufacturers to include a patient decision checklist highlighting key information regarding potential risks at the end of the patient information booklet/brochure. Surgeons must review this checklist with their patients to help ensure that they understand the risks, benefits and other information about breast implants. The checklist covers:

• 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; 
• Risk of systemic symptoms; and 
• Discussion of options other than breast implants, as appropriate.
   

Rupture Screening Recommendations
The FDA is updating the silicone gel-filled breast implants rupture screening guidelines:

"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.
 

Patient Device Card
Patient device cards provide patients with specific information about their breast implants. Patients should receive this card immediately following surgery. The device card should include the following information:

• Device’s serial or lot number;
• Device’s style and size;
• Unique Device Identifier (UDI);
• Web link to access most current patient decision checklist, boxed warning, and labeling for the specific implant that the patient received;
• A statement that “There is a boxed warning for breast implants, see web link;” and
• Toll-free phone number to the breast implant manufacturer.

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