Bayer Identified Another 7,332 Reports Involving Serious Injury from Essure in June thru August 2020

According to recently released post-marketing data required by federal regulators, Bayer indicates it has identified thousands of additional reports involving serious injury from Essure, including dozens of deaths linked to the birth control implant that was removed from the market several years ago.

In an update about Essure safety risks released on December 7, the FDA summarized data from Bayer’s analysis of reports identified between June 2020 and August 2020, which included 7,509 event reports, including 7,332 cases involving serious injury, 104 reports of malfunctions, and 73 death reports.

The data was included in the manufacturer’s first quarterly analysis report (PDF) required by federal regulators to track long-term reports of problems associated with the permanent implant.

Essure was sold for years by Bayer as a safe and effective sterilization device, involving flexible coils inserted into the Fallopian tubes during an outpatient procedure, which cause scar tissue to develop that blocks the tubes and prevents insemination. However, the device was removed from the market amid tens of thousands of reports involving painful and debilitating injuries from Essure.

According to the FDA, the most commonly reported problems identified in the 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.

“Based on the limited information in the event descriptions for the reports and the nature of the information, it is difficult to identify duplicate reports within the spreadsheet of events, as well as duplicate reports previously submitted to the FDA,” the agency stated. “The limited information prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the reported deaths or other events in the reports.”

Tracking of Essure Injuries Following Recall

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 the 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.

In August, Bayer officials announced they would pay $1.6 billion to settle about 90% of all Essure lawsuits filed by women who claimed they were left with devastating injuries. However, the settlement does not address future claims brought by women who are likely to continue to experience problems from the birth control implant.

The deal was reached as company faced a number of approaching trial dates in the litigation, coming as a series of reports were released that highlighted the problems with Essure, including interim results from a post-marketing study the FDA released in September, which found that more than 20% of women implanted with the device faced hypersensitivity reactions, chronic abdominal pain, and abnormal bleeding, and many had much higher rates of additional gynecological procedures.

Approximately 750,000 women worldwide implanted with the device, and about 70% of those procedures occurring in the United States. As Essure injury lawyers continue to review and file claims in the coming months and years, it is expected that Bayer will have to fund additional settlements or face future rounds of jury trials.