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).
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.
- Encourage patients to report adverse events associated with breast implants through the FDA's Medwatch
- Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants
- 5 Things to Know About Breast Implants
- 2019 Meeting Materials of the General and Plastic Surgery Devices Panel: Breast Implant Special Topics
- Update on the Safety of Silicone Gel-Filled Breast Implants (2011) (PDF - 1.5MB)
- Update on the Safety of Silicone Gel-Filled Breast Implants (2011) - Executive Summary
- Freedom of Information Requests