Breast Implants: Additional Resources
On this page:
- Breast Implants Resource Groups
- Manufacturers of Approved U.S. Breast Implants
- Registries/Postmarket Surveillance
- Breast Implants Advisory Panel Meetings
- FDA Communications
- FDA Resources
- Additional Research on Breast Implants
Breast Implants Resource Groups
This list is not intended to be an all-inclusive list of breast implant resource groups. This information is provided for information purposes only and does not constitute an endorsement by the FDA of the information or recommendation that a group provides. The FDA is not responsible for the content of individual group webpages found at any of the links below.
Professional Society Webpages
- Institute of Medicine
- National Cancer Institute
- National Women's Health Information Center
- Office of Research on Women's Health at the National Institutes of Health (NIH)
- American Cancer Society
- American Society for Aesthetic Plastic Surgery (ASAPS)
- American Society of Plastic Surgeons (ASPS)
- National Breast Cancer Foundation, Inc.
- National Research Center for Women and Families
- National Organization for Women
- Susan G. Komen for the Cure
- Society for Women's Health Research
Alerts and Safety Communications from International Regulatory Agencies
- Medicines and Healthcare Products Regulatory Agency (MHRA) (United Kingdom)
- French National Agency for Medicines and Health Products Safety (France)
- Health Canada (Canada)
- Therapeutic Goods Administration (Australia)
Manufacturers of Approved U.S. Breast Implants
| Company Name | Contact Information |
|---|---|
| Allergan, Inc. (formerly Inamed) P.O. Box 19534 Irvine, CA 92623 |
Phone: 714-246-4500; 800-433-8871 Fax: 714-246-6987 Website: www.allergan.com |
| Ideal Implant Incorporated 5005 LBJ Freeway, Suite 900 Dallas, Texas 75244 |
Phone: 214-492-2500 Website: www.idealimplant.com |
| Mentor World Wide LLC 201 Mentor Drive Santa Barbara, CA 93111 |
Phone: 805-827-6000; 800-525-0245 Website: www.mentorwwllc.com |
| Sientra, Inc. P.O. Box 1490 Santa Barbara, CA 93116-1490 |
Phone: 888-708-0808 Website: www.sientra.com |
Registries/Postmarket Surveillance
- National Breast Implant Registry
- Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE Registry)
- FDA Medical Device Reporting (MDR) Database
Breast Implants Advisory Panel Meetings
- October 2021 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
- March 2019 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Breast Implant Special Topics
- April 2005 Advisory Panel for Silicone Gel Breast Implants
- October 2003 Advisory Panel for Silicone Gel Breast Implants
- July 2002 Panel for Saline Breast Implants (Postapproval Update)
- March 2000 Panel for Saline Breast Implants
FDA Communications
- UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication (3/8/2023)
- Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication (9/8/2022)
- FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants (10/27/2021)
- Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates: FDA Safety Communication (3/31/2021) (Archived)
- FDA Issues Final Guidance for Certain Labeling Recommendations for Breast Implants | FDA News Release (9/20/2020)
- 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)
- The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market: FDA Safety Communication (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 (5/2/2019)
- Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL) – Letter to Health Care Providers (2/6/2019) (Archived)
- FDA Press Statement: Binita Ashar, M.D., on agency's continuing efforts to educate patients on known risk of lymphoma from breast implants (2/6/2019)
- Medscape Interview with FDA staff on Breast Implants (July 2013)
- FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants (1/26/2011)
FDA Resources
- Regulatory History of Breast Implants in the U.S.
- FDA/CDRH Division of Industry and Consumer Education (DICE)
- Post Approval Studies Webpage (Search to view all related studies)
- Freedom of Information Requests
- Report a Problem with Breast Implants
Additional Research on Breast Implants
- Global Adverse Event Reports of Breast Implant-Associated ALCL: An International Review of 40 Government Authority Databases (Plastic and Reconstructive Surgery Journal, May 2017)
- Executive Summary: An Update on the Safety of Silicone Gel-Filled Breast Implants (June 2011)
- Update on the Safety of Silicone Gel-Filled Breast Implants: FDA White Paper (June 2011)
- Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses (January 2011)