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GPAC Mesh Resources

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

Mesh Patient Stories

 Mesh News 

Mesh Removal Information 

Reporting Adverse Events 

Mesh Studies

Dr. Alexander Galvin et al | Mar. 2020
Imaging and Treatment of Complications of Abdominal and Pelvic Mesh Repair

Dr. Galvin et al | 2020

Dr. Willem Cohen Tervaert | Dec. 2018
Autoinflammatory/Autoimmunity Syndrome Induced by Adjuvants (ASIA): A New Flame

Dr. Tervaert | 2018

World Journal of Gastrointestinal Surgery Study | April 2015
Mesh Implants: An Overview of Crucial Mesh Parameters

Lei-Ming Zhu et al | 2015

Regulatory Announcements

FDA September 2020 | Labeling Recommendations to Improve Patient Communication

FDA April 2019 | FDA Orders Mesh Manufacturers to Stop Selling Devices for Tansvaginal Repair of Pelvic Organ Prolapse
FDA Stops Use of TVT

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

FDA January 2016 - FDA Strengthens Requirements for Pelvic Mesh 
FDA Strengthens Requirements for Pelvic Mesh

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

UK MHRA 2014 - 7 Vaginal Mesh Implants: Summary of Benefits and Risks
UK Vaginal Mesh Implants

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

NHS England Mesh Working Group Report  - Mesh Oversight Report
UK Mesh Oversight Report

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

UK MHRA June 2022 | MHRA Future Regulation of Medical Devices in UK
UK Future Device Regulation

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

TGA November 2021 | Reclassification of Surgical Mesh Devices
TGA All Mesh Class 3 Devices

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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