American Society of Plastic Surgeons
For Consumers

FDA issues new labeling and informed-consent requirements for breast implants

The U.S. Food and Drug Administration today issued new requirements designed to improve communication to patients who are considering breast implants.

What ASPS members need to know

1. The sale and distribution of breast implants will now be restricted only to health care providers and facilities that utilize a "Patient Decision Checklist."

  • The surgeon must review the checklist with the prospective patient to help ensure the patient understands the risks, benefits and other information about the breast implant device.
  • The patient must be given the opportunity to initial and sign the patient decision checklist.
  • The implanting physician must sign the patient decision checklist; ASPS advises members that although a resident or advanced practice provider may be involved in a patient education/informed consent discussion, the patient decision checklist must be signed by the physician implanting the device.

2. The FDA approved new labeling for all legally marketed breast implants, which must include:

  • Boxed warning
  • Patient decision checklist
  • Updated silicone gel-filled breast implant rupture screening recommendations
  • Device description with a list of specific materials used in the device
  • Patient device card

3. The FDA released post-approval study data so patients can transparently understand the long-term effects of breast implants and make more informed decisions about their health.

How is ASPS supporting members?

ASPS today approved a new breast implant patient decision checklist that will be made available to ASPS members. This collaboratively developed checklist may be used by members to compliantly meet these new FDA requirements and will be shared with members next week. Additionally, it will be made available to members and the public on with updated safety information.

"The American Society of Plastic Surgeons supports all efforts to help educate patients, ensure they are informed of the risks of any procedure or device and foster shared-decision making," says ASPS President Joseph Losee, MD. "ASPS has endorsed a patient-information checklist, which was generated through a consensus process between ASPS leaders and patient advocates."

More information is available on the FDA website.

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