FDA Strengthens Breast Implant Safety Requirements and Updates Study Results
On October 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions.
First, the FDA issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions.
Second, the FDA approved new labeling for all legally marketed breast implants that includes:
- Boxed warning.
- Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device.
- Updated silicone gel-filled breast implant rupture screening recommendations.
- Device description with a list of specific materials in the device.
- Patient device card.
The breast implant manufacturers have posted the updated device labeling to their websites.
Lastly, the FDA released updated information on the status of breast implant manufacturer post-approval studies.
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
FDA Guidances on Breast Implants
- Breast Implants - Certain Labeling Recommendations to Improve Patient Communication (2020): 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.
If you wish to submit an electronic comment on the final guidance, you may visit the docket page on Regulations.gov. Of the three tabs under the title, select "Browse Documents." Click on the title of the fourth document listed (labeled "OTHER"), "Breast Implants - Certain Labeling Recommendations to Improve Patient Communication Guidance for Industry and Food and Drug Administration Staff." IMPORTANT: make sure the posted date is listed as "Sep 29, 2020" because there may be more than one document with this title listed there. Enter your comments by clicking on the blue "Comment" button under the title.
- Saline, Silicone Gel, and Alternative Breast Implants (2006)
Restrictions on Sale and Distribution of Breast Implants
The restrictions on sale and distribution are included in the Post-Market Approval (PMA) Supplement Approval letter for these implants.
- Allergan Natrelle Silicone Gel-Filled Breast Implants
- IDEAL Implant Structured Breast Implants
- Mentor MemoryShape Silicone-Filled Breast Implants
- Mentor MemoryGel Silicone-Filled Breast Implants
- Mentor Saline-Filled and Spectrum Breast Implants
- Allergan Natrelle Saline Filled Breast Implants
- Sientra OPUS Silicone Gel Breast Implants
Safety Communications on Breast Implants
- Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates: FDA Safety Communication (3/31/21)
- 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)
Press Releases and Statements on Breast Implants
- FDA News Release: FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants (10/27/21)
- FDA News Release: 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)
- FDA News Release: 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: (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
Reports on Silicone Gel-Filled Breast Implants
- 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
- Consumer Update: What to Know About Breast Implants
- 2021 Meeting Materials of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Announcement
- 2019 Meeting Materials of the General and Plastic Surgery Devices Panel: Breast Implant Special Topics
- Report a Problem with Breast Implants