The U.S. Food and Drug Administration (FDA) said Wednesday it has taken new steps to strengthen breast implant risk communication.
The agency said it has taken such measures to help people considering implants make informed decisions.
Second, the agency said it approved new labeling for all legally marketed breast implants.
The FDA label includes box warnings, a patient device card, a device description with a list of special materials in the device, updated recommendations for screening for a silicone gel-filled breast implant, and a checklist for the patient’s decision to review with the patient. health care provider to ensure that the patient understands the risks, benefits, and other information about the device.
The checklist must be initialed and signed by the patient and signed by the physician implanting the device.
The FDA said it “expects manufacturers to post an updated device label on their websites in the next 30 days.”
Finally, the FDA said it released updated information on the status of breast implant manufacturer studies after approval.
These measures and the final guidelines issued in 2020 are coming, the agency wrote in va news release, which followed the Advisory Committee on General and Plastic Surgery in 2019 to publicly discuss the safety of breast implants and the long-term benefits and risks.
At the time, the commission recommended that the FDA revise the MRI review recommendations for silent cracks of silicone gel-filled breast implants, in addition to a warning in the box when labeling breast implants and a standardized checklist.
The new ordinance, the FDA said, restricts the sale and distribution of breast implants only to healthcare providers and institutions that provide patients with information using the patient brochure “Patient Decision Checklist.”
The restrictions are necessary based on the FDA’s finding that the available information “indicates that such restrictions are necessary to provide reasonable assurance about the safety and performance of the device.”
The FDA noted that the labeling of a medical device is intended to improve and does not replace a doctor-patient discussion about the risks and benefits that are different for individual patients.
Data from the study were also released on Wednesday, the agency said, further confirming the FDA’s commitment to a transparent understanding of the long-term effects of breast implants.
“By strengthening safety requirements for manufacturers, the FDA is working to fill information gaps for anyone who may be considering breast implant surgery,” said Dr. Health, it is written in the statement. “As the FDA continues to assess the overall effects of breast implants in patients, today’s measures help ensure that all patients receive the information they need to make well-informed decisions that affect their long-term personal health.”
Breast implants are classified as a Class III medical device that consists of devices that support or sustain human life, are essential in preventing damage to human health, or pose a potential, unreasonable risk of disease or injury.
The devices are implanted under the breast tissue or pectoral muscle to increase breast size or replace breast tissue that has been removed due to cancer or trauma or which did not develop due to a severe abnormality.
Breast implants are also used in revision operations aimed at correcting or improving the result or the original operation.
There are two types of breast implants approved for sale in the U.S., including saline and filled with silicone gel. While both types have a silicone outer shell, they differ in size, shell thickness, shape, and surface texture of the shell.