Bayer Reports Nearly 12,000 Serious Injuries from Essure Birth Control Implants, Including 9 Deaths
According to updated data submitted to federal regulators, Bayer’s defunct Essure birth control implant was linked to nearly 12,000 injury reports and at least nine deaths, as of November 2020.
As part of an ongoing analysis of serious injuries and problems linked to Essure, the FDA issued an update on March 15, which is the seventh spreadsheet of reportable adverse events provided by Bayer as part of an agreement with the agency.
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.
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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.
The Essure variance quarterly analysis report (PDF) for the period of September 2020 through November 2020 indicates Bayer is aware of a total of 11,884 reportable events linked to Essure. Of those, 11,830 were serious injury reports, 45 were malfunction reports and there were a total of nine death reports.
The FDA reports that since the device was first approved in November 2002 until December 31, 2020, the agency has received 63,942 medical device reports related to Essure, with most being received between 2013 and 2015. Through the entirety of 2020, there were a total of 16,086 medical device reports linked to Essure implants. That compares to 15,083 reported in 2019.
The FDA noted that most of the reports appear to be linked to ongoing Essure lawsuits filed by consumers against Bayer.
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 the company faced a number of approaching trial dates in the litigation, and 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.
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