October 25, 2024 - Do Not Use BioZorb Marker
Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication

September 27, 2024 - FDA Approves Motiva Implants
FDA Approves Establishment Labs Motiva Breast Implants

April 2, 2024 -  Sientra Implants Bought by Tiger Aesthetics
Breast Implant Manufacturer Sientra Bankruptcy Update: New Ownership Tiger Aesthetics Medical, LLC , Warranty Commitments

Feb 28, 2024 - FDA Statement on Breast Implant Safety Commitment
FDA Statement: CDRH’s Continued Commitment to Breast Implant Safety

February 13, 2024 - Sientra Implants Files for Bankruptcy
Breast Implant Manufacturer Sientra Files for Chapter 11 bankruptcy, operations will continue

February 2, 2024 - BioZorb Marker Safety Concerns
BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication

September 10, 2023 - Mammography Communication Updated
FDA: Important Information: Final Rule to Amend the Mammography Quality Standards Act (MQSA)

June 30, 2023 - Updates of BIA-ALCL & Systemic Symptoms in Women with Breast Implants
FDA: Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma

FDA: Medical Device Reports for Systemic Symptoms in Women with Breast Implants

May 30, 2023 - Ideal Implants Goes Out of Business
IDEAL implant ended operations on May 30, 2023 citing financial reasons

March 9, 2023 - Required Communication of Dense Breasts
FDA Updates Mammography Regulations to Require Reporting of Breast Density Information and Enhance Facility Oversight

March 8, 2023 - Update of Breast Implant Cancers Squamous Cell Carcinoma (SCC)
UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication

September 8, 2022 - Reports of Breast Implant Cancers 
Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication

Oct 27, 2021 - Black Box Warning, New Labeling, Informed Consent Checklist, Screening Updates & More
FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants

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.

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.

Breast implant manufacturers have posted the updated device labeling to their websites and FDA released updated information on the status of breast implant manufacturer post-approval studies.

March 31, 2021 - Surgical Mesh and Breast Surgery
Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates: FDA Safety Communication

Surgical mesh is typically a flexible, thin flat sheet, usually made of nondegradable synthetic materials, biodegradable synthetic materials, or from animal- or human-derived tissues called acellular dermal matrices (ADM). Surgical mesh is a medical device, regulated by the FDA.

The FDA has not cleared or approved any surgical mesh for use with breast implants or in breast reconstruction, and thus has not reviewed potential benefits and risks for these uses. The FDA recommends that patients discuss the benefits and risks of mesh with their health care providers.

May 14, 2020 - Warning Letters Issued to Breast Implant Manufacturers
FDA issues warning letters to two breast implant manufacturers as part of ongoing efforts to protect patients

Allergan cited for failure to comply with post-approval study requirements; Ideal Implant Inc. cited for failures relating to quality system and medical device reporting regulations

August 20, 2020 - Breast Implant Illness & BIA-ALCL Updates
FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma

Sep 28, 2020 -  FDA Breast Implant Labeling Recommendations
FDA Issues Final Guidance for Certain Labeling Recommendations for Breast Implants

October 23, 2019 - Q & A on BIA-ALCL
FDA Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

July 24, 2019 - Breast Implant Recall - Allergan BIOCELL® Textured Breast Implants and Tissue Expanders
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

Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders

March 25-26, 2019  - FDA Breast Implant Safety Meeting
FDA: March 25-26, 2019: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

February 6, 2019  - Risk of Lymphoma from Breast Implants
Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants