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