Story at a glance
- The Food and Drug Administration enacted stronger warnings for breast implants on Wednesday.
- The FDA’s requirements largely affect manufacturers of the implants.
- The updates come following years of investigations into health issues being linked to breast implants.
The Food and Drug Administration (FDA) enacted stronger warnings for breast implants on Wednesday.
“On October 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions,” the FDA said in a news release.
The FDA’s requirements largely affect manufacturers of the implants, including restricting the sale and distribution of the implants to “ensure that patients considering breast implants are provided with adequate risk information,” requiring new labelling on the risks — including a boxed warning — and updating the manufacturers’ post-approval studies.
The updates come following years of investigations into health issues being linked to breast implants. In 2019, the FDA requested a recall of Allergan textured breast implants and tissue expanders due to their connection with a rare form of cancer.
In recent years, the FDA has also investigated the connection between certain health issues and breast implants, including connective tissue diseases, chronic fatigue and muscle pain, among others.
Roughly 400,000 people get breast implants each year, 100,000 of whom do so as reconstructive surgery following cancer, according to the American Society of Plastic Surgeons.
The FDA’s new rules will take effect in 30 days.
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