Hidden Documents Over Essure's Complications Revealed

Hidden Documents Over Essure's Complications Revealed

Introduction

In an article published by the legal public watchdog group, Public Justice, on July 9, the group revealed hundreds of recently unsealed documents over the complications associated with Bayer’s birth control device, Essure, which is no longer available in the market.

In February, the group had filed a motion against Bayer to unseal many of the records, which the manufacturer had claimed confidential. Following the motion, hundreds of documents that were once kept hidden have been disclosed for public filing.

The documents indicate that the manufacturer was aware of the problems since it acquired Conceptus, the original creator of the Essure design, in 2013, and may have hidden the reports, which seem to confirm women’s claims about the complications, from the Food and Drug Administration's (FDA) for years.

The report unfolded a day after the FDA issued the preliminary results indicating that more than 20% of women implanted with the birth control device may be suffering from allergic or hypersensitivity reactions, which increase the risk of chronic abdominal pain, abnormal bleeding, and higher rates of gynecological surgical procedures.

It has been known that Bayer has been hiding various documents from the public related to the Essure implantation procedure, which has caused injury and death of many people. The document provided by the U.S. Food & Drug Administration gives a factual written account of important historical events. 

The Washington Post reports that Bayer failed to comply with obligations in their reporting, which led to FDA not reporting Essure’s warning.
In the year 2013, Bayer acquired Conceptus, the originator of Essure, and continued the wrong practice of keeping the content hidden which include detail of complaints made to the FDA. 

Essure forms scar tissue in the fallopian tubes nearly after three months of the implantation of the birth control device. This tissue formed serves as a barrier in the process of fertilization. This product is currently not in use in the United States for the last two years, however, women who have got it implanted continue to face struggle due to the defective quality of the product. 

There was a total of 15,083 reports related to Essure defectiveness registered to FDA in the year 2019. While in 2017 and 2018, 11,854 and 6,000 medical device reports were made, respectively. In the year 2020, 91% of the reports submitted to FDA cited litigation, while in 2018 95% of submitted reports filed legal suits followed by 73% of all submitted reports applying for a legal in the year 2017 and 2018. The litigation filed gave reference to the device report submitted to FDA previously. 

Bayer is currently facing 18,000 lawsuits nationwide, each claiming that the Essure birth control coils were dangerous and defectively designed and the women experienced painful and debilitating complications, including migration injuries, perforations, severe reactions, and other problems.