Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Final Guidance
The final guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication, provides recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants, including:
- Boxed warning (page 4 of the guidance)
- Patient decision checklist (page 5 of the guidance)
- 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
The recommendations in this guidance supplement the recommendations in the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance, issued September 29, 2020 superseding the prior version dated November 17, 2006
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 seek to 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 discussion 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
- Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates: FDA Safety Communication (3/31/21)
- FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma (8/20/20)
- FDA News Release: FDA issues warning letters to two breast implant manufacturers as part of ongoing efforts to protect patients (5/14/20)
- 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)