Reference Information Section

Informed Consent

January 1, 2021 by Julio C. Novoa, M.D.

After reviewing a number of Informed Consent documents available online, including the draft Guidance for Industry and FDA Staff, we found that NONE meet the minimum standards for informing women of the risks of the ESSURE Permanent Birth Control Device.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?

PDF Novoa Medical Services' ESSURE Informed Consent Form

Letter to Colleagues - FDA Mandate

Notification of FDA MANDATE, ESSURE BLACK BOX WARNING (BBW)

Jama Article

January 23, 2018

Review of JAMA Article: Association of Hysteroscopic vs. Laparoscopic Sterilization With Procedural, Gynecological, and Medical Outcomes.

Doc Review of JAMA Article

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We understand that there are many questions that you may have about ESURE or of symptoms you may be having. We are gathering the most common questions and answers for the community to view. Go to Frequently asked Questions page

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