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FDA Issues Draft Guidance on Breast Implant Labeling

October 23, 2019

The FDA has released labeling recommendations for certain saline and silicone gel-filled breast implants in a new draft guidance.

A boxed warning should be included on physician and patient labeling materials for breast implants, the agency says. It should make clear that breast implants are not lifetime devices and that the chance of developing complications increases over time.

The agency is seeking feedback on all elements of the guidance, including the benefits and risks of smooth and textured breast implants.

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