Resources

National Center for Health Research
Your Guide to Breast Implants & Your Health

http://breastimplantinfo.org

What You Need to Know About Breast Implants

Diana Zuckerman, PHD; Elizabeth Naglin-Anderson, MA; and Elizabet Santoro, RN, MPH, National Center for Health Research

http://www.center4research.org/breast-implants/?fbclid=IwAR2NU9x49Czbl5pqtdZmvFU_f1_gY3Ul6Wbu6y5Qo9zk8QbkpjnRejK3bqE

Your Guide to Breast Implants and Your Health

Diana Zuckerman, PhD

http://breastimplantinfo.org/new-research-confirms-breast-implant-illness/?fbclid=IwAR1JCg4sUs8qcW87T86amrov4XRJHA38YDFy4rKO2ZGZTs7LkC779EYel1U

Breast Implant Health Summit

https://breastimplanthealthsummit.com

List of Support Groups for Breast Implant Illness in Alphabetical Order

https://docs.google.com/document/d/1Yh5Ru220fJh3pWFbtIIduc5gISJMnF2Kcr-y25pEKNY/mobilebasic?fbclid=IwAR0FEwTXlrCO2X_7yMwsFKgiscFxHcCCy7s1w5DCHItfAROIE-GOz6kZLvg

FDA

FDA Breast Implants

https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants

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

https://www.fda.gov/media/131885/download?fbclid=IwAR0h00BK_jJCGMLl7lcj9GxH_zyWgrtQ3Y2PskxIiuxnBCX_3Cn_u_jJhlI

FDA 8/20/20 - Medical Device Reports for Systemic Symptoms in Women with Breast Implants
https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-systemic-symptoms-women-breast-implants

FDA Update 8/20/20 - 7 Things You Should Know About Breast Implants
U.S. Food and Drug Administration

https://m.youtube.com/watch?feature=youtu.be&v=FxX4F5VByDw

FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma | FDA August 20, 2020
https://www.fda.gov/news-events/press-announcements/fda-updates-analysis-medical-device-reports-breast-implant-illness-and-breast-implant-associated

FDA 8/20/20 - Medical Device Reports for Systemic Symptoms in Women with Breast Implants
https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-systemic-symptoms-women-breast-implants

FDA 5/18/20 Warning letter to Allergan and Ideal
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/allergan-607690-05142020

FDA 5/18/20 Warning letter to Allergan

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/allergan-607690-05142020?fbclid=IwAR2om7yBlYbNRIRyacxNnOTDAYN6MZM47XcaJjBwXLXPiPoyByWqfOHPOgQ

FDA 5/18/20 Warning letter to Ideal

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ideal-implant-incorporated-606103-05142020?fbclid=IwAR3zAZr9pxdJWxU9rhWnaXloHHiq6zy660_XbRsLZbYcQL45fhtfmihFrI0

FDA 5/14/20 - FDA issues warning letters to two breast implant manufacturers as part of ongoing efforts to protect patients

https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-two-breast-implant-manufacturers-part-ongoing-efforts-protect-patients?utm_campaign=051420_PR_FDA%20issues%20warning%20letters%20to%20two%20breast%20implant%20manufacturers&utm_medium=email&utm_source=Eloqua&fbclid=IwAR3rMoyJDjin_SN-TFguIrSUVCGQF8NH8HdVgRysPFZ4R_9wuzMPTkksm_c

 

FDA 3/18/19 Warning Letter to Mentor and Sientra Manufacturers

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633890.htm

FDA 3/18/19 Warning Letter to Mentor

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mentor-worldwide-llc-acclarent-573520-03182019?fbclid=IwAR2yoiX0iFssPIQYPCuSBikABrkuHrV03jVRAQe0Pvi96gAXXQQwqVk3U4Q

FDA 3/18/19 Warning Letter to Sientra

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sientra-inc-573436-03182019?fbclid=IwAR25XGGmQF-kRy47ukvD0RsrqiJgyGjxBymhxvT7rBvvIpNmYvGQJG1IBIg


FDA 3/25/19 - General and Plastic Devices Panel Meeting Day 1- 8:45 Hours 

https://www.youtube.com/watch?v=PqZwCQ_aWpc&feature=youtu.be&fbclid=IwAR33gWzVM9pc4NOkj8L0-gQ6qAsiuvUNLUaEXcOdxUR5hjoDiQIAzjDH6cs

FDA 3/26/19 - General and Plastic Devices Panel Meeting Day 2- 8:50 Hours

https://www.youtube.com/watch?v=vLHotHKSIIc&feature=youtu.be&fbclid=IwAR15m1FXisUMJVsuS841h31Y54MSK2KeeW_jLR8PdGmTAsQO3rdeduv-1Hk  

 

TESTIMONIES

 

FDA 3/25/19 - Prof. J.W. Cohen Tervaert 

https://www.youtube.com/watch?v=3QwMOoHhPKw

 

​FDA March 2019 - Terri Diaz 

https://www.youtube.com/watch?v=zw-q8YqzSnk&t=5s

 

FDA March 2019 - Robyn Towt 

https://www.youtube.com/watch?v=toF4-qPnUco&feature=youtu.be&fbclid=IwAR3jneGb6JnOaryH0VRjlwcv1Gema_2DQQs5LxnmIKOcNmc8HTVNmy6llFk


BIA-ALCL 

BIA-ALCL Website

https://biaalcl.com

10/5/19 - 1st World Consensus Conference on BIA-ALCL- 11:55 Hours-Dr. Clemens starts at 1 hr. 15 min.

https://www.youtube.com/watch?v=YxPFayQsjUo&feature=youtu.be&fbclid=IwAR2Yfpz1aBt6k-n-Z79qAufC7rnvq3cjGVTPKbo-P_JObqy408FqFteWsDQ\

NEWS ARTICLES

 

Impant Files

https://www.icij.org/investigations/implant-files/

7/3/20 - The Danger of Hormone-mimicking Chemicals in Medical Devices and Meds

Meg Wilcox

https://www.ehn.org/endocrine-disruptors-in-medicine-2646307813.html?fbclid=IwAR0_pzdy3nf85qqUM0uOje3mSW4amJ6WfZKqvFuzHg_j4cFbRU2Yrigh-hU

 

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

https://news.abbvie.com/news/press-releases/allergan-aesthetics-launches-dedicated-multi-channel-campaign-to-contact-patients-who-may-not-be-aware-biocell-recall-and-to-improve-tracking-information-for-us-breast-implant-patients.htm?_ga=2.117128518.1111950371.1591018652-1147189212.1591018652

4/12/20 Do Some Surgical Implants Do More Harm Than Good?

Jerome Groopman

https://www.newyorker.com/magazine/2020/04/20/do-some-surgical-implants-do-more-harm-than-good/amp?fbclid=IwAR2-g0dIjgkBiZAmXFe7sfBrgB-RKwX4wsrQBq_7WMk9A2L2rayEm1pQFwc

3/25/19 - FDA Kept Hundreds of Thousands of Breast Implant Incidents Hidden From Public

Sasha Chavkin

https://www.icij.org/investigations/implant-files/fda-kept-hundreds-of-thousands-of-breast-implant-incidents-hidden-from-public/?fbclid=IwAR3JeiFOsbOf3A3txOmKTdM-zYuHMXtKffx3SH_4YwfLxGMDIynFEg93G6c

11/26/18 - Breast Implant Injuries Kept Hidden As New Health Threats Surface 

Sasha Chavkin

https://www.icij.org/investigations/implant-files/breast-implant-injuries-kept-hidden-as-new-health-threats-surface/?fbclid=IwAR0qvR4n3fcCA1dMRAtL6i_GNGuMWuCwDd_NE33dMNojF7unWAd2BdsYsZI

 

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

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267678/?fbclid=IwAR0jotgUVyOUAinrxetQ3qjdkJ_U70DSv-NyIOo38EvORwcG4oo4FbID8RI

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

https://pubmed.ncbi.nlm.nih.gov/32295900/

1/11/20 - 21-year-old silicone breast implants causing recurrent pneumonia, chest pain and coughing

https://www.sciencedirect.com/science/article/pii/S2213007120300150

9/13/18 - Largest-Ever Study Shows Silicone Breast Implants Associated with Rare Diseases

https://www.mdanderson.org/newsroom/largest-ever-study-shows-silicone-breast-implants-associated-with-rare-diseases.h00-159227301.html

2017-2020 - 20 Publications with various topics involving breast implants

https://www.researchgate.net/profile/Yara_Bachour

5/2017 - Autoinflammatory Syndrome Induced by Adjuvants (ASIA) Syndrome is Misguided

Arthur E. Brawer, M.D.

https://www.naturalmedicinejournal.com/journal/2017-05/autoinflammatory-syndrome-induced-adjuvants-asia-syndrome-misguided

4/28/14 - Five-year Safety Data for Eurosilicone’s Round and Anatomical Silicone Gel Breast Implants

https://www.researchgate.net/publication/266683098_Five-year_Safety_Data_for_Eurosilicone%27s_Round_and_Anatomical_Silicone_Gel_Breast_Implants

4/20/08 - FOREIGN BODY REACTION TO BIOMATERIALS

James M. Anderson,  Analiza Rodriquez, David T. Chang

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2327202/

1996 - Laboratory Studies in Breast Implant Patients: ANA Positivity, Gammaglobulin Levels, and Other Autoantibodies

R. I. Lewy, E. Ezrailson

https://link.springer.com/chapter/10.1007/978-3-642-85226-8_36

2/1/89 - Silicone in the liver: possible late effects.

J Hunt, M J Farthing, L R Baker, P R Crocker, D A Levison

https://gut.bmj.com/content/30/2/239

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

https://www.clinmedjournals.org/articles/cmrcr/clinical-medical-reviews-and-case-reports-cmrcr-3-087.pdf

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

https://journals.lww.com/annalsplasticsurgery/fulltext/2020/07001/understanding_breast_implant_illness,_before_and.19.aspx

VIDEOS AND MEDIA

3/25/19 FDA panel hears from women who say breast implants aren't safe

https://www.youtube.com/watch?v=ETNnC4sDskk

11/14/19 - Breast Implant Illness Awareness 4k Part 1

https://www.youtube.com/watch?v=BcrRw3s5Nf0&fbclid=IwAR3TJFhp4JrmoyYtFfUYycXX8hEIfRcVTAbnSv1BJYXZKoOX4yq3NdNrPXE&app=desktop

11/15/19 - Breast Implant Illness Awareness 4K Part 2

https://www.youtube.com/watch?v=VjODrqRzmZA

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