FDA Adds Boxed Warning to Breast Implants

Posted By American Med Spa Association, Tuesday, November 2, 2021

The US Food and Drug Administration announced Wednesday that it made several changes to breast implant regulations, including new labeling that includes a boxed warning and a patient checklist that will inform people that implants are not a medical device that will last a lifetime.

After hearing testimony in 2019 from women who said their doctors did not adequately warn them about the potential health complications of breast implants, the FDA said it decided to restrict the sale of breast implants to only health care providers who offer patients a standardized checklist that explains the risks. The changes require doctors to walk patients through these potential problems and to give the patient an opportunity to sign off on the checklist to show they were properly informed about the risks to their health.

The older the implants are, the more health risks they pose, and those risks could require additional surgery.

The warning and the checklist will explain symptoms that some patients with implants have experienced, including fatigue, joint pain, tiredness, brain fog, and memory loss. It will also explain the possible link between implants and a rare type of cancer of the immune system known as anaplastic large cell lymphoma (BIA-ALCL). The cancer occurs more commonly in patients with textured breast implants than those who have the smooth implants. Many of the documented cases were tied to textured implants produced by Allergan that the company voluntarily recalled in 2019.

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