FDA to Restrict Sales of Breast Implants, Issues Warning

New labels with warnings on breast implants 0:35

(CNN) -

The U.S. Food and Drug Administration (FDA) announced Wednesday that it made several changes to the regulation of breast implants, including a new advisory that will inform women that it is not a lifelong medical device.

The FDA made the decision to restrict the sale of breast implants only to healthcare providers who offer a standardized checklist that explains the risks, after hearing testimonies in 2019 from women who claim that their doctors did not adequately warn them about the risks. possible health complications associated with breast implants.

• Women express concern about the safety of breast implants

The changes require that doctors explain these potential problems to their patients and that they sign the checklist to show that they were adequately informed about the risk to their health.

The older the implants, the more health risks they pose, and may require additional surgery.

The warning and checklist will mention the possible relationship between implants and a type of cancer known as anaplastic large cell lymphoma (BIA-ALCL) and will also explain the symptoms that some implant patients have experienced, such as fatigue, joint pain, tiredness, brain fog, and memory loss.

About 400,000 women a year get breast implants, according to a 2017 report from the American Society of Plastic Surgeons.

About 75% of them do it for aesthetic reasons.

The rest are put on after a breast cancer operation.

The FDA also updated the implant rupture detection recommendations and updated its guidance on what manufacturers will have to do with post-approval studies.

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"In recent years, the FDA has sought more ways to increase patient access to clear and understandable information about the benefits and risks of breast implants," said Dr. Binita Ashar, director of the Office. Surgical Devices and Infection Control Center of the FDA Center for Devices and Radiological Health.

"By strengthening safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery."

Breast implants