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FDA September 2020 | Labeling Recommendations to Improve Patient Communication

Breast Implant Illness Symptoms
Breast Implant Ingredients

GPAC BREAST IMPLANT ILLNESS INFO

TRADUIT en FRANÇAIS

REPORTING ADVERSE EVENTS 

BREAST IMPLANT STUDIES

MDAnderson Study | September 2018

Largest-Ever Study Shows Silicone Breast Implants Associated with Rare Diseases

Dr. Brian Buinewicz, Danielle Valoras, and Robyn Towt | May 2023
Understanding Breast Implant Illness

Dr. Buinewicz, Valoras and Towt | 2023

Dr. Lu-Jean Feng Study | July 2020

Understanding Breast Implant Illness, Before and After Explantation A Patient-Reported Outcomes Study

Dr. Feng Study | 2020

Dr. Rita Kappel Study | April 2016

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

Dr. Kappel Study | 2016

Dr. Eduardo Fleury | January 2021

The Breast Tumor Microenvironment: Could Silicone Breast Implant Elicit Breast Carcinoma

Dr. Fleury Study | 2021

Dr. Arthur Brawer | 2019

The Clever Deception by Silicone Gel-filled Breast Implant Manufacturers Regarding the Phenomenon of GelBleed

Dr. Brawer Study | 2019

Dr. Brian Buinewicz | September 2021
Outcomes of Implant Removal and Capsulectomy for Breast Implant Illness in 248 Patients

Dr. Buinewicz Study | 2021

Dr. Lu-Jean Feng | September 1999
Analysis of Risk Factors Associated with Rupture of Silicone Gel Breast Implants
 

Dr. Feng Study | 1999

Dr. Lu-Jean Feng | April 2005
Pathology of Lymph Nodes From Patients with Breast Implants

Dr. Feng Study | 2005

FDA BREAST IMPLANT SAFETY ANNOUNCEMENTS

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

FDA September 2020 | Breast Implants - Certain Labeling Recommendations to Improve Patient Communication
FDA Black Box Warning

FDA September 2020 | Medical Device Reports for Systemic Symptoms in Women with Breast Implants

FDA September 2020 - Medical Device Reports for Systemic Symptoms in Women with Breast Implants 
FDA Systemic Symptoms

FDA September 2020 | 7 Things You Should Know About Breast Implants

FDA September 2020 - 7 Things You Should Know About Breast Implants
7 Things You Should Know

FDA August 2020 | FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant Associated Lymphoma 

FDA August 2020 - FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant Associated Lymphoma
FDA Update | August 2020

FDA August 2020 | FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant Associated Lymphoma 

FDA March 2021 | FDA Warns About Differing Complication Rates for Acellular Dermal Matrix, as Type of Surgical Mesh, Used in Implant Based Breast Reconstruction
FDA Mesh Warning

FDA August 2020 | FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant Associated Lymphoma 

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

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

FDA Breast Implant SSED - Summary of Safety and Effectiveness Data
FDA Breast Implant Labeling

GLOBAL REGULATORY AGENCIES

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

FDA Food and Drug Administration (United States)
FDA (United States)

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

Health Canada (Canada) 
Health Canada

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

MHRA Medicines and Heathcare products Regulatory Agency (United Kingdom)
MHRA (United Kingdom)

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

TGA Therapeutic Goods Administration (Australia)
TGA (Australia)

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

BfArM Federal Institute for Drugs and Medical Devices (Germany)
BfArM (Germany)
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