In a sweeping move, the Food and Drug Administration announced stronger safety requirements for all breast implants that will include new warning labels and sales restrictions.
The new labeling will include a boxed warning, one of the strongest of its kind because of its visibility, informing patients of the significant risks of breast implants, including rupture and the potential for systemic illnesses and a type of cancer.
“This is a big step,” said Dr. Binita Ashar, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health. “Placing a restriction on medical devices is a very big step and we are committed to ensure the safety of these products.”
The new requirements come more than two years after a 2019 advisory committee meeting to discuss long-term risks and benefits of implants.
The FDA is also requiring all patients to review a safety checklist to ensure they are aware of not just the risks of implants, but also when they should and shouldn’t be used, as well as surgical alternatives, especially for mastectomy patients. The hope is that the checklist will provide valuable safety information that patients may never see on the implants’ box, since it’s something that’s opened in the operating room and then thrown away.
“This is intended to encourage greater conversations between patients and physicians about the risks and benefits of breast implants,” Ashar said.
The agency will also restrict sales and distribution of implants to only doctors and medical facilities that provide patients with specific safety information.
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“This is all about educating patients and making sure they have the correct information in front of them to make a decision,” said Dr. Elisabeth Potter, a plastic surgeon in Austin, Texas.
“I’m elated at the announcement,” said Raylene Hollrah, 48, a breast cancer survivor, who developed the lymphoma, called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. “Patients will still have a choice when choosing implants, but it will be an informed one. We have been advocating for everything that was announced today.”
While the new requirements are a significant step for women who are about to receive implants, there’s concern that the millions who already have them may not be aware of the risks already inside their bodies.
“For women seeking a breast augmentation and reconstruction as of now, her experience will be better informed,” Potter said. “This does not fix the problems of women who haven’t been counseled or not presented all of their options. That’s been the challenge.”