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, 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 reports of anaplastic large cell lymphoma (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.
Medscape Interview with FDA staff on Breast Implants (July 2013)
- News Release: FDA Approves New Silicone Gel-filled Breast Implant (June 2013)
- News Release: FDA Approves New Silicone Gel-filled Breast Implant (February 2013)
5 Things to Know About Breast Implants
- News Release: FDA Approves New Silicone Gel-filled Breast Implant (March 2012) [ARCHIVED]
- 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
- Silicone Gel-Filled Breast Implants: Updated Safety Information (Consumer Article)
- FDA Provides Updated Safety Data on Silicone Gel-Filled Breast Implants (Press Announcement) [ARCHIVED]
- Breast Implant Guidance for Industry (2006)
Post Approval Studies Webpage
- Freedom of Information Requests