2020 Breast Implant Health Summit

Our BIHS 2020 Health summit was a great success. We brought together some of the most experienced minds in the field to discuss the health-related issues of breast implant illness.

Our discussion was practitioner-driven and we shared experiences of what works and what has not worked to help people heal from implant-related illness. It was an open discussion. Our goal was to have an educational platform to provide practitioners with guidance to help people with breast implant illness and the breast implant health summit of 2020 did just that.

Practitioners and those with breast implant-related illnesses are welcome to view our On-Demand summit with the link below.

On-Demand Link

https://vimeo.com/ondemand/bihs

HOSTS

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Danielle Valoras

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Terri Diaz

PRESENTERS

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SCHEDULE

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2020 RESOURCES

FDA

FDA updated 11/16/21 - What You Need to Know About Breast Implants

https://www.fda.gov/consumers/consumer-updates/what-know-about-breast-implants

 

FDA 10/27/21 - FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants

https://www.fda.gov/news-events/press-announcements/fda-strengthens-safety-requirements-and-updates-study-results-breast-implants

 

FDA updated 6/14/21 - Labeling for Approved Breast Implants (SSED)

https://www.fda.gov/medical-devices/breast-implants/labeling-approved-breast-implants

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 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 Update 8/20/20 Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma | FDA 
https://www.fda.gov/news-events/press-announcements/fda-updates-analysis-medical-device-reports-breast-implant-illness-and-breast-implant-associated

 

FDA Update 6/29/20 Breast Implants - Certain Labeling Recommendations to Improve Patient Communication Guidance for Industry and Food and Drug Administration Staff

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

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 5/14/20 - 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 3/25/19 - 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 - Danielle Valoras 

https://www.youtube.com/watch?v=K8HjbrUEvvA&feature=share&fbclid=IwAR2P5fN-OefoUNW30yKyaURB3qMl9upGBkeh6YQAU4AsSUSLOL-r0Inj4Ao

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 

10/9/21 - 3rd  World Consensus Conference on BIA-ALCL

https://www.youtube.com/watch?v=YYHSUPUyUJs&t=22567s

11/6-7/20 - 2nd World Consensus Conference on BIA-ALCL

https://www.mdanderson.org/education-training/professional-education/cme-conference-management/conferences/world-consensus-conference-on-breast-implant-associated-anaplast.html

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

2/21/22 - She's the reason Arizona has a law requiring surgeons to warn patients about the dangers of breast implants

Bianca Buono, Katie Wilcox

https://www.12news.com/article/news/health/breast-implants-almost-killed-her-arizona-law-protect-people-like-her/75-a7c9d5fb-0ca4-4438-b133-f710759ce97a

2/1/22 - FDA wants women to understand the risks and benefits related to breast implants

Kelly Bilodeau, Executive Editor, Harvard Women's Health Watch

https://www.health.harvard.edu/womens-health/fda-wants-women-to-understand-the-risks-and-benefits-related-to-breast-implants

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

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

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

9/7/21 - Outcomes of Implant Removal and Capsulectomy for Breast Implant Illness in 248 Patients

Jacob Y KatsnelsonJoseph R SpaniolJoshua C BuinewiczFrederick V RamseyBrian R Buinewicz 

https://pubmed.ncbi.nlm.nih.gov/34513545/

 

3/21/21 - Autoimmune dysautonomia in women with silicone breast implants

Gilad Halpert, Abdulla Watad, Avishai M.Tsur, Arad Dotan, Hector Enrique Quiros-Lim, Harald Heidecke, Boris Gilburd, Josef Haik, Yair Levy, Miri Blank, Howard Amital, Yehuda Shoenfeld

https://www.sciencedirect.com/science/article/abs/pii/S0896841121000391?fbclid=IwAR3wGmmZDJTjzKSCYS68gsHp23DNXnSykvuH68KGT6KAbMvI1O9GxzFXzNA

5/29/20 - Bilateral breast implant-associated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): A case report

Patrick P. BletsisLaura E. JanssenOtto VisserSaskia R. OffermanMichiel A. TellierLaurens 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. Dijkman

9/20/21- Assessment of Silicone Particle Migration Among Women Undergoing Removal or Revision of Silicone Breast Implants in the Netherlands

Henry B. P. M. Dijkman, PhD1Inca Slaats, BSc1,2Peter Bult, PhD, MD2

https://pubmed.ncbi.nlm.nih.gov/34542618/

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

 

PODCASTS & LIVES

 

Wendy Myers

Dr. Kevin Kelly with Wendy Myers: Detect Breast Cancer Sooner than Mammograms with Sonocine with Dr. Kevin Kelly

https://myersdetox.com/152-detect-breast-cancer-sooner-than-mammograms-with-sonocine-with-dr-kevin-kelly/

 

Dr. Khan & Dr. Shafiq

4/28/20 - HIGH BLOOD PRESSURE - Cardiologist links to Breast Implant Illness - BII - Facebook Q/A

https://www.youtube.com/watch?v=fQTm8Xq2WOQ&feature=youtu.be&fbclid=IwAR1MlhOyjZSXxt4QWy1BvlepaHWJogFLE91zcmsfAX7ToTRy0Gc-aFxVZ0c

Prof. J.W. Cohen Tervaert's publications

12/2018 -

Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis

Abdulla WatadVered RosenbergShmuel TiosanoJan Willem Cohen TervaertYarden YavneYehuda ShoenfeldVarda ShalevGabriel ChodickHoward Amital

10/2018 - Autoinflammatory/autoimmunity syndrome induced by adjuvants (ASIA; Shoenfeld's syndrome): A new flame

Jan Willem Cohen Tervaert

 

8/2018 - Autoinflammatory/autoimmunity syndrome induced by adjuvants (Shoenfeld's syndrome) in patients after a polypropylene mesh implantation

Jan Willem Cohen Tervaert

7/2017 - Silicone breast implants and autoimmune rheumatic diseases: myth or reality

Jan Willem Cohen Tervaert, Maartje J ColarisRené R van der Hulst

3/2017 - Vitamin D deficiency as a risk factor for the development of autoantibodies in patients with ASIA and silicone breast implants: a cohort study and review of the literature

Maartje J L ColarisRene R van der HulstJan Willem Cohen Tervaert

2/2017 - Is explantation of silicone breast implants useful in patients with complaints?

M. de Boer, M. Colaris, R. R. W. J. vander Hulst, J. W. Cohen Tervaert

7/2016 - Two hundreds cases of ASIA syndrome following silicone implants: a comparative study of 30 years and a review of current literature

Maartje J. L. Colaris, Mintsje de Boer, Rene R. van der Hulst & Jan Willem Cohen Tervaert

7/2013 - Silicone implant incompatibility syndrome (SIIS): a frequent cause of ASIA (Shoenfeld's syndrome)

J W Cohen TervaertR M Kappel

Rita Kappel, MD, PhD and Ger Pruijn, PhD publications

6/2020 - Low molecular weight silicones induce cell death in cultured cells

Rita M Kappel, MD, PhD and Ger JM Pruijn, PhD

3/2020 - Explantation of Silicone Breast Implants Ameliorates Gel Bleed Related Health Complaints in Women with Breast Implant Illness

Rita M Kappel, MD, PhD and Ger JM Pruijn, PhD

 

Eduardo Fluery,  MD, PhD publications

8/2020 -  Silicone-induced granuloma of breast implant capsule (SIGBIC): similarities and differences with anaplastic large cell lymphoma (ALCL) and their differential diagnosis

Eduardo de Faria Castro Fleury, Milena Morais Rêgo, Luciana Costa Ramalho, Veronica Jorge Ayres, Rodrigo Oliveira Seleti, Carlos Alberto Pecci Ferreira, Decio Roveda Jr

 

 

6/2020 - Silicone Induced Granuloma of Breast Implant Capsule (SIGBIC) diagnosis Breast Magnetic Resonance (BMR) sensitivity to detect silicone bleeding

Eduardo Fluery MD, PhD

5/2020 - Synchronous breast implant associated anaplastic large cell lymphoma (BIA-ALCL) and silicone induced 

granuloma of breast implant capsule (SIGBIC): What to learn

Eduardo Fluery MD, PhD

5/2020 -  Synchronous silicone-induced granuloma (SIG) of breast implant capsule (BIC) and gluteal implant capsule (GIC): What to learn

Caio Castro MDDaniela Fernandes MD, Marina Mendonça MD, Décio Roveda Junior PhD, Gustavo Badan PhD, Eduardo F. C. Fleury PhD

2/2020 - Breast magnetic resonance imaging (BMRI) in the diagnosis of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL): Findings beyond late seroma

Eduardo Fluery MD, PhD

12/2019 - Clear to cloudy II: radiological perspective of silicone breast implants

Eduardo Fluery MD, PhD

12/2019 - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL): An Open Wound

Eduardo Fluery MD, PhD

10/2019 - Silicone‐induced granuloma of breast implant capsule mimicking anaplastic large cell lymphoma

Caio Castro MDDaniela Fernandes MD, Marina Mendonça MD, Décio Roveda Junior PhD, Gustavo Badan PhD, Eduardo F. C. Fleury PhD

 

11/2018 - When breast implants get alive

Eduardo Fluery MD, PhD

5/2018 - Additional Risk Factors for Breast Implant–Associated Anaplastic Large Cell Lymphoma

Eduardo Fluery MD, PhD

7/2017 -  Breast magnetic resonance imaging: tips for the diagnosis of silicone-induced granuloma of a breast

implant capsule (SIGBIC)

Eduardo de Faria Castro Fleury, Ana Claudia Gianini, Veronica Ayres, Luciana C. Ramalho, Rodrigo Oliveira Seleti

& Decio Roveda Jr.