FDA Labelled Essure's Birth Control Study As "Inadequate"

FDA Labelled Essure's Birth Control Study As "Inadequate"

Introduction

Following hundreds of complaints of difficulties among women who had the coils implanted, the US Food and Drug Administration (FDA) compelled Bayer to perform a post-marketing study on the negative effects of Essure birth control implants.

However, due to a high incidence of dropouts among participants, the FDA recently labelled the study's progress as "inadequate." For years, Bayer advertised Essure as a safe and effective method of permanent birth control that involved flexible coils implanted into the Fallopian tubes during an outpatient surgery. Its purpose is to create scar tissue to form, which will obstruct the tubes and impede insemination. However, the device was withdrawn off the market in 2018 as a result of hundreds of claims of painful and severe Essure problems.

Following the device's recall, Bayer was instructed to do post-marketing monitoring on women who had received the implant in order to gain a better understanding of the birth control device's potential harmful health consequences.

In the most recent FDA Essure update, issued on October 6, the agency announced that the post-marketing surveillance study's status has been changed to "Progress Inadequate" due to declining follow-up rates among subjects who either received Essure implants or underwent laparoscopic tubal sterilisation (LTS), the group used as a comparison to determine Essure complication and efficacy rates.

Patients included in the trial were expected to return at 36-month, 48-month, and 60-month intervals. However, too many recruited patients in both groups are stopping, resulting in poor quality follow-up data, according to a report on the FDA's Postmarket Surveillance Studies Database.

The FDA discovered that 47.4% of Essure patients, or 161 out of 340, had dropped out of the research, with 29%, or 100 patients, dropping out due to missed follow-up. 43.6% of the LTS patients, or 344 out of 790 recruited in the trial, have dropped out, with one-third due to missed follow-up.

According to the report, the FDA downgraded the research status to 'progress insufficient' due to a rise in interim loss to follow-up rates in both groups after the previous database lock in 2021. 'Inadequate Progress' denotes that the research's progress is not in accordance with the study design.

According to the FDA, the COVID-19 pandemic may have contributed to some of the drop in follow-up rates in both groups. The FDA has warned Bayer that further initiatives to increase follow-up rates must be developed and implemented.

The data will be analysed again once all patients have completed three years of follow-up, and a final analysis will be performed when all patients have completed five years of follow-up. However, if the number of patients who discontinue treatment is not handled in some way, the results may be incorrect.

In a March update on Essure adverse event and product problem complaints, the FDA stated that it had received a total of 67,643 medical device reports related to the Essure implant. While the majority of reports received between 2013 and 2015 were voluntary submissions from women who got Essure implants, Bayer submitted 98% of the 3,701 reports received by the FDA last year. According to the FDA, 85% of those were connected to device removal, and the majority were related to litigation.

Tens of thousands of Essure lawsuits were brought against Bayer by women who reported negative health consequences when implanted with the birth control device.

Following several years of litigation, the firm stated in 2020 that it would pay $1.6 billion to resolve almost 90% of all Essure lawsuits that were ongoing at the time. However, with over 750,000 women implanted with the device globally, and 70% of those Essure surgeries taking place in the United States, it is likely that more cases will be brought in the future years as women continue to have difficulties.