To help patients who are considering breast implants make informed decisions, the FDA has added restrictions and approved new labeling for all approved breast implants.
The labeling requirements include, but are not limited to, black box warnings on breast implant packaging and a patient decision checklist, “which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device.” 1
Both the physician implanting the device and patient must sign the checklist.The FDA’s initial recommended elements for checklists are available on page 5 of this FDA guidance document. Manufacturers are expected to post updated device labeling to their websites within the next 30 days. Physicians should use the manufacturers’ forms and checklist when discussing and documenting informed consent.
The FDA is requiring these actions to “help ensure that all patients receive the information they need to make well-informed decisions affecting their long-term, personal health.” (1)
In addition to the black box warning, the revised product labeling will also include patient device cards; updated silicone gel-filled breast implant rupture screening recommendations; and a description of the materials used in breast implants and the chemicals that can be released from breast implants.
“A medical device’s labeling is intended to enhance, but not replace, the physician-patient discussion of the risks and benefits of breast implants that uniquely pertain to individual patients.” (1)
US Food and Drug Administration. FDA strengthens breast implant safety requirements and updates study results. October 27, 2021. Available at https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants . Accessed October 28, 2021.