Gradient

Resources

GPAC / ASPS Checklist and Model Legislation

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

GPAC Breast Implant Illness Info

Reporting Adverse Events 

Studies

MDAnderson Study | September 2018

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

Dr. Lu-Jean Feng Study | July 2020

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

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. Eduardo Fleury | January 2021

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

Dr. Arthur Brawer | 2019

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

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

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

 

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

FDA Announcements

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

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

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 September 2020 | 7 Things You Should Know About Breast Implants

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

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 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 Resources

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

FDA Breast Implant SSED - Summary of Safety and Effectiveness Data

Regulatory Agencies

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

FDA Food and Drug Administration (United States)

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

Health Canada (Canada) 

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

MHRA Medicines and Heathcare products Regulatory Agency (United Kingdom)

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

TGA Therapeutic Goods Administration (Australia)

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

BfArM Federal Institute for Drugs and Medical Devices (Germany)