Crimes of Essure and the FDA: Position paper by Dr. Vikki G. Hufnagel, MD

December 5, 2016

Crimes of Essure and the FDA

“Women need to be informed that with the use of Essure they will be at higher risk for hysterectomy, and of all the risks associated with hysterectomy.” ~ Dr. Vikki Hufnagel

Position Paper

Release Date August 23, 2015
Submitted to the FDA 08/23/15
Amended version (here) 08/31/15

Submitted publicly and directly to the FDA
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The CRIMES OF ESSURE

Dr. Vikki Hufnagel — Director Hufnagel Bioethics Institute
Woodland Hills, Ca DoctorVikki@gmail.com 323–210–3371

This POSITION PAPER is authored by Dr. Vikki Hufnagel.

This document was created for review and presentation for the September 24, 2015 public advisory committee of the Food and Drug Administration (FDA). The FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of the Essure System.

General Name of Committee: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee, Bayer HealthCare’s Essure System

Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues.

This POSITION PAPER includes advice and recommendations regarding:
• Essure
• Informed Consent
• Women’s Health rights
• Ethics in Medicine and FDA governance