The U.S. Food and Drug Administration (FDA) announced Wednesday that it had taken new actions to strengthen breast implant risk communication.
The agency said it had taken such action in order to aid people who are considering getting the implants to make informed decisions.
Secondly, the agency said that it had approved new labeling for all legally marketed breast implants.
The FDA labeling includes boxed warnings, a patient device card, a device description with a list of specific materials in the device, updated silicone gel-filled breast implant rupture screening recommendations and a patient decision checklist that must be reviewed with the patient by the health care provider to make certain that the patient understands the risks, benefits and other information about the device.
The checklist must be initialed and signed by the patient, as well as signed by the physician implanting the device.
The FDA said that it “expects manufacturers to post the updated device labeling to their websites within the next 30 days.”
Lastly, the FDA said it had released updated information on the status of breast implant manufacturer post-approval studies.
These actions and final guidance issued in 2020 come, the agency said in a news release, following a 2019 General and Plastic Surgery Devices advisory panel to publicly discuss breast implant safety and long-term benefits and risks.
At the time, the panel recommended that the FDA revise the MRI screening recommendations for silent ruptures of silicone gel-filled breast implants in addition to the boxed warning in breast implant labeling and the standardized checklist.
The new order, the FDA said, restricts the sale and distribution of breast implants to only health care providers and facilities that provide information to patients utilizing the patient brochure “Patient Decision Checklist.”
The restrictions are required based on the FDA’s finding that the available information “indicates such restrictions are necessary to provide a reasonable assurance of the device’s safety and effectiveness.”
The FDA noted that a medical device’s labeling is intended to enhance and not replace physician-patient discussion of risks and benefits that are different for individual patients.
Study data also released Wednesday, the agency said, further’s the FDA’s commitment to transparently understanding the long-term effects of breast implants.
“By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery,” Dr. Binita Ashar, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in a statement. “As the FDA continues to evaluate the overall effects of breast implants in patients, today’s actions help ensure that all patients receive the information they need to make well-informed decisions affecting their long-term, personal health.”
Breast implants are designated a Class III medical device, which is comprised of devices that support or sustain human life, are of substantial importance in the prevention of the impairment of human health or present a potential, unreasonable risk of illness or injury.
The devices are implanted under the breast tissue or chest muscle to augment breast size or to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop due to a severe abnormality.
Breast implants are also used in revision surgeries, that aim to correct or improve the result or an original surgery.
There are two types of breast implants approved for sale in the U.S., including saline-filled and silicone gel-filled. While both types have a silicone outer shell, they vary in size, shell thickness, shape and shell surface texture.