Breast Implants - Certain Labeling Recommendations to Improve Patient Communication Draft Guidance
The draft guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication, provides recommendations for the form and content for certain labeling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.
This draft guidance will be open for public comments for 60 days, through December 23, 2019, at www.regulations.gov under docket number FDA-2019-D-4467.
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:
- 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
- The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication (7/24/2019)
- FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market: FDA News Release (7/24/2019)
- 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
- What 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
- FDA Guidance: Saline, Silicone Gel, and Alternative Breast Implants (2006)