Essure, a non-surgical sterilization method for women, has recently come under fire because of associated and alleged adverse events numbering in the thousands. Essure is made up of two coils that are inserted into the fallopian tubes that promote scarring and occlusion.

The occlusion, once it’s verified by a trained medical professional is supposed to prevent pregnancy.

Yet, because of nearly 26,000 complaints filed since its approval in 2002, the U.S. Food and Drug Administration (FDA) issued an Essure FDA warningin 2016. The Essure FDA warning is a ‘black box warning’ for the label—the strongest agency issued warning available for a medical device. The Essure FDA warning reads:

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device.
 
According to a recent Buzzfeed article, there is a Facebook support group of 36,000 people that say this Essure FDA warning on the label is not nearly enough action on the part of the drug and medical device oversight agency.

The members of this group are women who say they have had negative and even dangerous adverse reactions and events happen because of implantation with Essure coils.

According to Buzzfeed, five of these women recently met with the head of the FDA, Scott Gottlieb. Their desire was to convince him that the Essure FDA warning was inadequate in the face of the data they have collected. Their ultimate goal is to get the device pulled off the market.

These five leading women—themselves having suffered at the hands of Essure coils—brought graphic pictures of alleged uterine implantation and perforation, Fallopian tube destruction, all-over body rashes, dental issues, and even stillbirths.

In addition, the core group was able to share survey data from nearly 500 added Facebook group members since the Essure FDA warning was implemented.

The surveys indicated that, of that large new group, only eight of them had even heard of the black box warning. It had never been discussed with them by their physician prior to the implantation procedure.

The article indicated that Gottlieb intends to wait on acting until the results of a safety study requested of the Bayer Co. at the time of the label change become available. The study is supposed to have 2,800 enrollees and be completed by the year 2023. To date, Bayer has purportedly only signed up 136 patients.

Meanwhile, this device continues to be available on the U.S. domestic market while it has been banned and/or temporarily removed from the market in Australia, Brazil, and several European countries.

The Bayer Compny no longer sells Essure coils anywhere but in the U.S. and they claim this action relates to a difference in attitude regarding sterilization itself.