U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Implants and Prosthetics
  5. Breast Implants
  1. Implants and Prosthetics

Breast Implants

Breast Implants - Certain Labeling Recommendations to Improve Patient Communication Draft Guidance

The draft guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication, provides recommendations for the form and content for certain labeling information for saline and silicone gel-filled breast implants, including:

  • Boxed warning
  • Patient decision checklist
  • Materials/device descriptions, including types and quantities of chemicals and heavy metals found in or released by breast implants
  • Silicone gel-filled breast implant rupture screening recommendations
  • Patient device card

When final, the recommendations in this guidance will supplement or, in some cases, replace recommendations in the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance, issued November 17, 2006.

Hands holding a pair of breast implants.Breast implants are medical devices implanted under the breast tissue or chest muscle to increase breast size (augmentation) or to replace breast tissue  that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality (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:


Related Links

Resources For You



Back to Top