ESSURE is advertised as a permanent form of birth control for women. This device is manufactured by Bayer. The intent of the device is to create an irreversible form of birth control for women who no longer wish to have children. According to the FDA, studies have shown that if the device is correctly implanted, the chance of pregnancy is less than (1) one percent. Bayer claims that about 750,000 women have received ESSURE since 2002.
Dr. Novoa is an advocate for women and their health care needs. He a major commentator for the ESSURE Problems forum on FaceBook representing over 43,000 women who have had problems following the placement of the ESSURE System. He has no financial conflicts of interest to declare regarding his assistance to these women nor has he been paid or is being paid by any person or organization for his assistance. He has volunteered his time and efforts in an attempt to provide as much assistance as possible regarding problems with the ESSURE.
Novoa Medical Services' goal is to provide women with information concerning the ESSURE device in order for them to make an educated decision regarding the use of this product for birth control.
After reviewing a number of Informed Consent documents available online, including the draft Guidance for Industry and FDA Staff, we found that NONE meet the minimum standards for informing women of the risks of the ESSURE Permanent Birth Control Device.
We created one that we felt met the minimum requirements based on the most recent information available. Please review the following ESSURE Informed Consent. After reading this, would you sign it and still get the ESSURE device placed?
Novoa Medical Services' ESSURE Informed Consent Form
Notification of FDA MANDATE, ESSURE BLACK BOX WARNING (BBW)
ESSURE - FDA Mandate PDF
ESSURE - FDA Mandate PDF - French Translation (Courtesy of Emilie Gillier)
ESSURE - FDA Mandate PDF - Italian Translation (Courtesy of Luca Veg Alghisi)
ESSURE - FDA Mandate PDF - Spanish Translation (Courtesy of Natalia G.H.)
Review of JAMA Article: Association of Hysteroscopic vs. Laparoscopic Sterilization With Procedural, Gynecological, and Medical Outcomes. (Publication Date: 01/23/18)
Review of JAMA Article
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