The US Food and Drug Administration (FDA) has taken several steps to improve the communication of risks associated with breast implants to patients and to help those who are considering the procedure make an informed decision, according to a statement released by the agency.
To ensure that patients are informed about the risks associated with receiving breast implants, the FDA has restricted the sale and distribution of breast implants to health care providers who use the patient decision checklist.
“The agency has approved new labeling for all legally marketed breast implants that includes a boxed warning, a patient decision checklist, updated silicone gel-filled breast implant rupture screening recommendations, a device description with a list of specific materials used in the device, and a patient device card,” the FDA stated.
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Patient Decision Checklist
Core to new labeling is the development of the patient decision checklist. “The checklist 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. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device.”
The FDA also released updated information on the status of breast implant manufacturer postapproval studies. These actions were designed to help patients understand the risks and benefits of breast implants and make more informed decisions about their health, the agency explained.
To better understand patient perspective and address risks associated with breast implants, the convened the General and Plastic Surgery Devices Advisory Panel in 2019, which was open to the public, at which the long-term benefits and risks for breast augmentation and reconstruction surgery were discussed.
“The meeting covered a range of important topics on breast implant safety, including characterization of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) incidence and risk factors and methods for assessing systemic symptoms referred to by patients as breast implant illness,” the FDA stated.
The panel recommended box warnings in the implant labeling and a standardized checklist as a part of the consent process. The panel also called for revisions to the magnetic resonance imaging (MRI) screening recommendations for silent ruptures of silicone-filled implants and greater transparency about materials in breast implants. These recommendations were incorporated into the FDA’s final guidance for breast implants issued in September 2020.
The new labeling recommendations are a part of the supplemental approval applications submitted by manufacturers. Manufacturers are expected to update the labeling on their websites within the next 30 days.
“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,” the FDA said.
Reference
US Food and Drug Administration. FDA strengthens safety requirements and updates study results for breast implants. October 27, 2021. Accessed October 27, 2021. https://www.fda.gov/news-events/press-announcements/fda-strengthens-safety-requirements-and-updates-study-results-breast-implants?utm_campaign=FDA+Strengthens+Safety+Requirements+and+Updates+Study+Results+fo&utm_medium=email&utm_source=govdelivery
