FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma

… update on adverse events reported to the Agency related to breast implants, including breast implant-associated anaplastic large cell lymphoma …

Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

… Q1. What does the FDA know about Breast Implant Associated Lymphoma? A1. The FDA first identified a possible association between breast implants and the development of ALCL in 2011. At that …

Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma

… of 1264 U.S. and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This total includes all breast implant related MDRs the FDA received with any mention …

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

… today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) … textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of …

Breast Implants

… FDA Strengthens Breast Implant Safety Requirements On October 27, 2021, the FDA took several actions to strengthen breast implant risk communication and help those who are …

What to Know About Breast Implants

… cell carcinoma (SCC) in the scar tissue (capsule) around breast implants. The March 2023 communication updates the … the same as the lymphomas described previously by FDA as Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). …

Types of Breast Implants

… On this page: Saline-Filled Breast Implants Silicone-Filled Breast Implants Summary Breast Implants Safety Information … Some are pre-filled and others are filled during the implant operation. Saline-filled implants come in different …

Breast Implant Surgery

… FDA Strengthens Breast Implant Safety Requirements and Updates Study Results On … 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are …

Breast Implants: Additional Resources

… On this page: Breast Implants Resource Groups Professional Society Webpages … Regulatory Agencies Manufacturers of Approved U.S. Breast Implants Registries/Postmarket Surveillance Breast … list is not intended to be an all-inclusive list of breast implant resource groups. This information is provided for …

FDA In Brief: FDA Warns About Differing Complication Rates for Acellular Dermal Matrix, a Type of Surgical Mesh, Used in Implant-Based Breast Reconstruction

… dermal matrix (ADM) products, a type of surgical mesh, in implant-based breast reconstruction. Over the past several years, the use … and is now commonly used off-label in implant-based breast reconstruction. We strongly encourage patients to …

Breast Implant Postmarket Safety Information

… On this page: The FDA’s Postmarket Evaluation of Breast Implants Warning Letters Issued to Breast Implant Manufacturers Ongoing Post-Approval Studies for …

FDA Issues Final Guidance for Certain Labeling Recommendations for Breast Implants

… Food and Drug Administration issued the final guidance, “ Breast Implants - Certain Labeling Recommendations to Improve … patients and health care professionals about the risks of breast implants. The draft guidance of this document was … we are recommending format and content changes to breast implant labeling so the information is presented in an easy …

Risks and Complications of Breast Implants

… 2023  The FDA has updated  the Risks and Complications of Breast Implants, clarifying information about Implant Removal and adding ultrasound as an acceptable … and Mesenchymal Tumors, including Sarcoma. FDA Strengthens Breast Implant Safety Requirements     On October 27, 2021, …

Study of Re-operations and Self-Reported Silicone-Gel Breast Implant Rupture (Interview Component)

… has recently completed a study on how often women who had breast implants had to go back to their surgeons for additional surgery on their breast(s). The study was presented at the Sixth World … Alabama, involved women who had their first breast implant before 1988. The majority of women in this study had …

Things to Consider Before Getting Breast Implants

… FDA Strengthens Breast Implant Safety Requirements and Updates Study Results On … 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are …

Breast Implant Resource Groups

… professional societies, and consumer groups involved in breast implant issues. This is not intended to be an all-inclusive list of breast implant resource groups. This document will be updated …

FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants

… Drug Administration took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. First, the agency …

Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders

… FDA Does Not Recommend Removal or Replacement of Textured Breast Implants in Asymptomatic Patients -- --Smooth and MICROCELL®Breast Implants and Tissue Expanders Not Impacted --   … information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) …

Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication

… of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication for the latest … lymphomas, in the scar tissue (capsule) that forms around breast implants. The various lymphomas reported are not the … described in previous FDA Communications as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). …

FDA Backgrounder on Platinum in Silicone Breast Implants

… manufacture of the shell and gel components of silicone breast implants. Because small amounts of platinum remain in … either by diffusing through the intact shell or through an implant rupture, and cause adverse effects. This backgrounder … key scientific studies on platinum in silicone gel-filled breast implants. STUDIES INCLUDED IN THE 2000 INSTITUTE OF …

Saline, Silicone Gel, and Alternative Breast Implants

… present in a premarket approval application (PMA) for a breast implant. This guidance document may also be useful in … device exemption (IDE). This document addresses breast implants filled with saline, silicone gel, or …

Medical Device Reports for Systemic Symptoms in Women with Breast Implants

… A number of patients and clinicians use the term "breast implant illness" or "BII" to describe a variety of systemic … some women following reconstruction or augmentation with breast implants. These symptoms include, but are not limited …

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s commitment to studying breast implant safety

… Choosing to obtain a breast implant, whether for augmentation or reconstruction, is a … personal choice, from the initial decision to undergo breast implant surgery to the size, material and surface …

Breast Implant Adverse Events During Mammography

… An FDA study on problems with mammography for women with breast implants was published in the Journal of Women’s … that mentioned problems with mammography for women with breast implants. The majority (62.1%) of problems reported were for breast implant rupture that was suspected to occur during …

Sientra’s Silicone Gel Breast Implants (Premarket application number: P070004) (Approved March 2012)

… and Detailed Information Links: Sientra’s Silicone Gel Breast Implants have a silicone outer shell that is filled … either smooth or textured shells. They are approved for breast augmentation in women age 22 or older and for breast … by enrolling more than 4,700 silicone gel-filled breast implant patients and following them for 10-years Case-Control …