FDA Update 9/29/20 Breast Implants - Certain Labeling Recommendations to Improve Patient Communication Guidance for Industry and Food and Drug Administration Staff -Black Box Warning
FDA 8/20/20 - Medical Device Reports for Systemic Symptoms in Women with Breast Implants
FDA Update 8/20/20 - 7 Things You Should Know About Breast Implants
U.S. Food and Drug Administration
FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma | FDA August 20, 2020
FDA 8/20/20 - Medical Device Reports for Systemic Symptoms in Women with Breast Implants
FDA 5/18/20 Warning letter to Allergan and Ideal
FDA 5/18/20 Warning letter to Allergan
FDA 5/18/20 Warning letter to Ideal
FDA 5/14/20 - FDA issues warning letters to two breast implant manufacturers as part of ongoing efforts to protect patients
FDA 3/18/19 Warning Letter to Mentor and Sientra Manufacturers
FDA 3/18/19 Warning Letter to Mentor
FDA 3/18/19 Warning Letter to Sientra
FDA 3/25/19 - General and Plastic Devices Panel Meeting Day 1- 8:45 Hours
FDA 3/26/19 - General and Plastic Devices Panel Meeting Day 2- 8:50 Hours
10/5/19 - 1st World Consensus Conference on BIA-ALCL- 11:55 Hours-Dr. Clemens starts at 1 hr. 15 min.
NEWS ARTICLES
Impant Files
7/3/20 - The Danger of Hormone-mimicking Chemicals in Medical Devices and Meds
Meg Wilcox
6/1/20- Allergan Aesthetics Launches Dedicated Multi-Channel Campaign To Contact Patients Who May Not Be Aware Of The BIOCELL® Recall And To Improve Tracking Information For U.S. Breast Implant Patients
4/12/20 Do Some Surgical Implants Do More Harm Than Good?
Jerome Groopman
3/25/19 - FDA Kept Hundreds of Thousands of Breast Implant Incidents Hidden From Public
Sasha Chavkin
11/26/18 - Breast Implant Injuries Kept Hidden As New Health Threats Surface
Sasha Chavkin
PUBLICATIONS & STUDIES
5/29/20 - Bilateral breast implant-associated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): A case report
Patrick P. Bletsis, Laura E. Janssen, Otto Visser, Saskia R. Offerman, Michiel A. Tellier, Laurens Laterveer, and Peter Houptb
4/15/20 - Interleukin 17 and senescent cells regulate the foreign body response to synthetic material implants in mice and humans
Liam Chung, David R. Maestas Jr., Andriana Lebid, Ashlie Mageau, Gedge D. Rosson, Xinqun Wu1, Matthew T. Wolf, Ada J. Tam, Isabel Vanderzee, Xiaokun Wang, James I. Andorko, Hong Zhang, Radhika Narain, Kaitlyn Sadtler, Hongni Fan, Daniela Čiháková, Claude Jourdan Le Saux, Franck Housseau, Drew M. Pardoll, and ProfileJennifer H. Elisseeff
1/11/20 - 21-year-old silicone breast implants causing recurrent pneumonia, chest pain and coughing
9/13/18 - Largest-Ever Study Shows Silicone Breast Implants Associated with Rare Diseases
2017-2020 - 20 Publications with various topics involving breast implants
5/2017 - Autoinflammatory Syndrome Induced by Adjuvants (ASIA) Syndrome is Misguided
Arthur E. Brawer, M.D.
4/28/14 - Five-year Safety Data for Eurosilicone’s Round and Anatomical Silicone Gel Breast Implants
4/20/08 - FOREIGN BODY REACTION TO BIOMATERIALS
James M. Anderson, Analiza Rodriquez, David T. Chang
1996 - Laboratory Studies in Breast Implant Patients: ANA Positivity, Gammaglobulin Levels, and Other Autoantibodies
R. I. Lewy, E. Ezrailson
2/1/89 - Silicone in the liver: possible late effects.
J Hunt, M J Farthing, L R Baker, P R Crocker, D A Levison
Dr. Kappel and Dr. Dijkman
2/9/16 - Gel Bleed and Rupture of Silicone Breast Implants Investigated by Light-, Electron Microscopy and Energy Dispersive X-ray Analysis of Internal Organs and Nervous Tissue
R.M. Kappel, L.L. Boer, and H. Dijkman
Dr. Lu-Jean Feng
7/2020 - Understanding Breast Implant Illness, Before and After Explantation
Wee, Corinne E. MD; Younis, Joseph BS; Isbester, Kelsey BS; Smith, Arvin BS; Wangler, Brooke; Sarode, Anuja L. MPHb; Patil, Nirav MBBS, MPH; Grunzweig, Katherine MD; Boas, Samuel BS; Harvey, Donald J. MD; Kumar, Anand R. MD; Feng, Lu-Jean MD
VIDEOS AND MEDIA
3/25/19 FDA panel hears from women who say breast implants aren't safe
11/14/19 - Breast Implant Illness Awareness 4k Part 1
11/15/19 - Breast Implant Illness Awareness 4K Part 2