Study of Recalled Essure Implant Continues to Lose Participants, But FDA Reports Measures to Fix Data are Working
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Bayer Issues Final Analysis Report on Essure Complications and Injury Reports October 1, 2021 Irvin Jackson Add Your Comments 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. Learn More About Essure Implant Lawsuit Problems with Essure birth control implant may cause painful complications. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Learn More About Essure Implant Lawsuit Problems with Essure birth control implant may cause painful complications. Learn More SEE IF YOU QUALIFY FOR COMPENSATION 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. Tags: Bayer, Birth Control, Essure Image Credit: Image via <a href="http://www.shutterstock.com/gallery-320989p1.html?cr=00&pl=edit-00">360b</a> / <a href="http://www.shutterstock.com/editorial?cr=00&pl=edit-00">Shutterstock.com</a> More Essure Lawsuit Stories Study of Recalled Essure Implant Continues to Lose Participants, But FDA Reports Measures to Fix Data are Working November 1, 2023 Progress of Essure Birth Control Implant Post-Marketing Study “Inadequate,” FDA Warns Bayer October 11, 2022 85% of Bayer Essure Adverse Event Reports Submitted Last Year Linked to Device Removal: FDA March 16, 2022 0 Comments Share Your CommentsFirst Name*Last NameEmail* Shared Comments*This field is hidden when viewing the formI authorize the above comments be posted on this page Yes No Post Comment I authorize the above comments be posted on this page Weekly Digest Opt-In Yes, send me a weekly email with the latest lawsuits, recalls and warnings. 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Study of Recalled Essure Implant Continues to Lose Participants, But FDA Reports Measures to Fix Data are Working November 1, 2023
Progress of Essure Birth Control Implant Post-Marketing Study “Inadequate,” FDA Warns Bayer October 11, 2022
85% of Bayer Essure Adverse Event Reports Submitted Last Year Linked to Device Removal: FDA March 16, 2022
Depo-Provera Shots Triple Brain Tumor Risks Compared to Birth Control Pill: Study (Posted: today) Canadian researchers say receiving Depo-Provera injections for more than a year triples the risk of brain tumors compared to women who take birth control pills. MORE ABOUT: DEPO-PROVERA LAWSUITDepo-Provera Lawsuit Pre-Settlement Funding and Loans Must Be Disclosed Under Court Order (07/09/2025)Depo-Provera Wrongful Death Lawsuit Blames Injections for Fatal Brain Tumor (07/02/2025)Lawsuit Alleges Depo-Provera DMPA Injection Increases Brain Tumor Risks (06/20/2025)
Uber Faces Lawsuit Indicating Driver Raped Passenger After Using Wife’s Account (Posted: yesterday) A lawsuit filed by a Florida woman says she was raped after an Uber driver’s husband showed up behind the wheel. MORE ABOUT: UBER SEXUAL ASSAULT LAWSUITUber Driver Background Check Materials Must Be Produced in Sexual Assault Lawsuits: Court (06/17/2025)MDL Judge Updated on Uber Driver Sex Assault Lawsuit Status as Claims Top 2,800 (06/06/2025)Uber Seeks To Transfer MDL Sexual Assault Lawsuits to Districts Where Attacks Occurred for Trial (05/23/2025)
Depo-Provera Lawsuit Pre-Settlement Funding and Loans Must Be Disclosed Under Court Order (Posted: 2 days ago) A U.S. District Judge has ordered women involved in Depo-Provera lawsuits to inform him of any third-party pre-settlement loans they take out, as predatory interest rates may force them to reject settlement offers. MORE ABOUT: DEPO-PROVERA LAWSUITDepo-Provera Shots Triple Brain Tumor Risks Compared to Birth Control Pill: Study (07/11/2025)Depo-Provera Wrongful Death Lawsuit Blames Injections for Fatal Brain Tumor (07/02/2025)Lawsuit Alleges Depo-Provera DMPA Injection Increases Brain Tumor Risks (06/20/2025)