Medical Devices

Breast Implants

On March 25-26, 2019, the FDA plans to convene a meeting of the General and Plastic Surgery Devices Panel at the FDA’s Headquarters in Silver Spring, Maryland, to discuss a range of topics concerning the benefit-risk profile of breast implants. The FDA plans to publish a Federal Register notice and agenda on the FDA’s Advisory Committee Calendar webpage 15 days in advance of the meeting. You can also sign up to receive email updates about all FDA advisory committee meetings.

Hands holding a pair of breast implants.Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase (augment) breast size or to rebuild (reconstruct) breast tissue after mastectomy or other damage to the breast. They are also used in revision surgeries, which correct or improve the result of an original surgery.

There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled. Both types have a silicone outer shell. They vary in size, shell thickness, shell surface texture, and shape (contour).

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Page Last Updated: 03/22/2019
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