The Food and Drug Administration (FDA) has taken additional steps to strengthen the safety requirements for breast implants.
The new FDA order restricts the sale and distribution of breast implants to health care providers and facilities that provide information to patients using the patient brochure “Patient Decision Checklist.” Health care providers are required to review the checklist with the prospective patient to communicate the risks, benefits, and other information associated with the breast implant device. Moreover, patients must be given the opportunity to initial and sign the checklist, which will then be signed by the physician implanting the device.
Along with the patient brochure, the FDA has approved additional labeling requirements for all legally marketed breast implants. A Boxed Warning will be required to inform patients that:
- Breast implants are not lifetime devices.
- The risk of developing complications increases over time, with some complications requiring more surgery.
- Breast implants have been associated with the development of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
- BIA-ALCL occurs more commonly in patients with textured breast implants than smooth implants, and deaths have occurred from BIA-ALCL.
- Breast implants have been associated with systemic symptoms.
The new labeling will also include revised screening recommendations to detect rupture in patients who receive silicone gel-filled breast implants, a device description with a list of specific materials used in the device, and a patient device card.
The FDA expects manufacturers to post updated device labeling within the next 30 days. Updated information on the status of breast implant manufacturer post-approval studies has also been released.
“In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants,” said Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. “By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.”
- FDA strengthens safety requirements and updates study results for breast implants. News release. US Food and Drug Administration. Accessed October 27, 2021. https://www.prnewswire.com/news-releases/fda-strengthens-safety-requirements-and-updates-study-results-for-breast-implants-301410216.html.
- Breast Implants. US Food and Drug Administration. Accessed October 27, 2021. https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants.