Bayer Issues Final Analysis Report on Essure Complications and Injury Reports

Following the decision to remove Essure birth control implants from the market amid reports of severe and debilitating complications, Bayer has submitted a final report to federal regulators, indicating it is aware of nearly 60,000 reports involving serious injuries, nearly 600 reports of Essure malfunctions and at least 115 deaths.

Bayer submitted its final analysis report (PDF) on Essure adverse event data on September 29, and the FDA issued a statement on the same day, announcing that the manufacturer has met the variance reporting requirements set by the agency when the birth control implant was pulled from the market.

Essure was marketed by Bayer for years as a safe and effective form of permanent birth control, involving flexible coils inserted into the Fallopian tubes during an outpatient procedure, which is intended to cause scar tissue to develop that blocks the tubes and prevents insemination. However, the device was removed from the market in 2018, following thousands of reports involving painful and debilitating Essure complications.

According to the FDA, the most commonly reported problems identified in data submitted by Bayer were pain, perforation of organs, parts of the Essure breaking off and being left behind in the body, pregnancies (including ectopic pregnancies which put the mother’s life at risk), and heavier periods.

The agency cautions that the reports do not necessarily involve unique cases, as Bayer gathers events identified in multiple locations, including comment threads from social media posts, which may include recurring reports by the same individual.

According to the final findings, Bayer has identified substantially more problems than were previously disclosed in a report issued in May, when the company was aware of 33,097 reportable events and 19 deaths. However, the medical device reports now include 57,099 serious injuries, 588 malfunctions and 115 deaths linked to Essure devices, which were derived from various social media reports and litigation.

Essure Recall Reporting Requirements

Although Essure was recalled from the market in most countries in 2017, Bayer continued to sell the device in the United States until the end of 2018. In the face of mounting pressure and publicity about the injuries women were experiencing from Essure, the company announced in July 2018 that it was removing Essure from the US. market on December 31, 2018.

Following that decision, the FDA confirmed Bayer would be required to extend a post-market surveillance study and take other measures to ensure long-term Essure oversight well after production and sales have ceased. The new data released by Bayer is part of those requirements.

Bayer also faced tens of thousands of Essure lawsuits filed by women who experienced. Several years of litigation, the company announced last year that it would pay $1.6 billion to settle about 90% of all Essure cases pending at that time. However, with approximately 750,000 women worldwide implanted with the device, and 70% of those Essure procedures occurring in the United States, it is expected that additional lawsuits will be filed in the coming years as women experience complications.

Image Credit: Image via 360b / Shutterstock.com

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