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 breast size (augmentation) or to rebuild breast tissue after mastectomy or other damage to the breast (reconstruction). 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).

The information provided on this website is designed to support, not replace, the relationship that exists between a patient and a physician. We have provided this information to: 

  • Help women make informed decisions about whether or not to get breast implants.
  • Explain the risks of breast implants and describe the surgical procedures used to implant them.
  • Provide information on saline-filled and silicone gel-filled breast implants, including data supporting a reasonable assurance of safety and effectiveness, approval letters, labeling and information on post-approval studies.
  • Provide information on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in women with breast implants.
  • Outline the regulatory history of breast implants in the United States.
  • Encourage reporting of adverse events associated with breast implants through our Medwatch Reporting System.

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Page Last Updated: 01/31/2019
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