What is ESSURE?

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.

Our Stance

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.

Informed Consent

After reviewing a number of Informed Consent documents available online, including the draft Guidance for Industry and FDA Staff, we found that NONE meet the minimum standards for informing women of the risks of the ESSURE Permanent Birth Control Device.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

Letter to Colleagues - FDA Mandate

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.)

Jama Article

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

Recent Activity


FDA announcement on manufacturer to halt Essure sales in the U.S.

Jul 20 2018
The U.S. Food and Drug Administration was notified by Bayer that the Essure permanent birth control device will no longer be sold or distributed after December 31, 2018. FDA Announcement



International Interview with Spanish Journalist

Mar 15 2016
The following is the English translation of an email interview Dr. Novoa conducted with Miguel Jara, freelance reporter from Spain regarding his opinions of the ESSURE device. Blog page with Dr. Novoa interview - Spanish version

Miguel Jara interview - translated



Voiced Concerns to Department of Emergency Medicine

Nov 26 2015
Due to Dr. Novoa's continuing concerns over his experience with the ESSURE device, he contacted the Department of Emergency Medicine voicing his concerns regarding the device's effects on women.

Letter to Department of Emergency Medicine



Communication with Bayer

Nov 26 2015
Due to Dr. Novoa's continuing concerns over his experience with the ESSURE device, he contacted the Department of Emergency Medicine voicing his concerns regarding the device's effects on women.

Letter from Bayer
Response to Bayer from Dr. Novoa



Advocate Public Speaker

Sept 24 2015
Dr. Novoa spoke in opposition of the ESSURE device (distributed by Bayer Pharmaceuticals) before an FDA Committee Meeting in response to complaints and petitions demanding the product's removal from the market. Dr. Novoa was able to speak for 3 minutes while providing his professional opinion on the dangers of the device and pointing out Bayer's erroneous public ads declaring the device to be a "Non-Surgical" alternative to women sterilization.

Dr. Novoa's Unedited ESSURE Speech presented before the FDA

As a result of the day-long hearing, advocates against the device, like Dr. Novoa, were able to successfully persuade the FDA Advisory Committee to recommend that Bayer change their marketing strategy for the device.



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