FDA announces new restrictions on breast implants, orders stricter warnings

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The United States Food and Drug Administration (FDA) said on Wednesday it had taken further steps to strengthen communication about the risks of breast implants.

The agency said it has taken such steps in order to help people considering implantation make informed decisions.

First, the FDA wrote that it has issued orders restricting the sale and distribution of breast implants to help ensure that patients considering them receive adequate information about the risks.

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Second, the agency said it had approved new labeling for all legally marketed breast implants.

FDA labeling includes boxed warnings, a patient device card, a description of the device with a list of specific materials in the device, updated recommendations for screening for rupture of silicone gel-filled breast implants, and a Patient decision checklist that should be reviewed with the patient by the health service. provider to ensure the patient understands the risks, benefits, and other information about the device.

The checklist should be initialed and signed by the patient, as well as signed by the physician implanting the device.

The FDA said it “expects manufacturers to post updated labeling for the device on their websites within the next 30 days.”

A nurse prepares an implant for surgery
(iStock)

Finally, the FDA said it has released updated information on the status of post-approval studies from breast implant manufacturers.

These actions and the final guidance released in 2020 come, the agency said in a press release, following a 2019 general and plastic surgery device advisory committee to publicly discuss the safety of breast implants and long-term benefits and risks.

At the time, the panel recommended that the FDA revise the MRI screening recommendations for silent tears of silicone gel-filled breast implants in addition to the boxed warning in breast implant labeling and listing. standardized control.

The new ordinance, the FDA said, restricts the sale and distribution of breast implants to only health care providers and facilities that provide information to patients using the patient pamphlet “Checklist of breast implants. patient decisions ”.

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The restrictions are required based on the FDA’s conclusion that the available information “indicates that such restrictions are necessary to provide reasonable assurance of the safety and efficacy of the device.”

The FDA has noted that the labeling of a medical device is intended to improve, not replace the doctor-patient discussion of the risks and benefits that are different for each patient.

According to the agency, data from the study also released on Wednesday confirms the FDA’s commitment to transparently understanding the long-term effects of breast implants.

“By strengthening safety requirements for manufacturers, the FDA is working to fill the information gap for anyone considering breast implant surgery,” Dr. Binita Ashar, director of the Bureau of Surgical Devices and infection control at the Center for Devices and Radiological Health, said in a statement. “As the FDA continues to assess the overall effects of breast implants on female patients, today’s actions are helping to ensure that all patients receive the information they need to make informed decisions affecting their personal health. long term. “

Breast implants are designated as a Class III medical device, which includes devices that support or maintain human life, are of substantial importance in preventing impairment of human health, or pose an unreasonable potential risk of disease. or injury.

The devices are implanted under breast tissue or chest muscle to increase breast size or to replace breast tissue that has been removed due to cancer or trauma or that has not grown due to breast cancer. ‘a serious anomaly.

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Breast implants are also used in revision surgeries, which aim to correct or improve the outcome or original surgery.

There are two types of breast implants that are approved for sale in the United States, including implants filled with saline solution and those filled with silicone gel. Although both types have a silicone outer shell, they vary in shell size, shell thickness, shape, and shell surface texture.


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