Study of Recalled Essure Implant Continues to Lose Participants, But FDA Reports Measures to Fix Data are Working
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Bayer Faces Essure Lawsuits From 18,000 Women Nationwide January 9, 2019 Austin Kirk Add Your Comments Bayer currently faces more than 18,000 Essure lawsuits filed by women nationwide, each involving similar allegations that the controversial birth control device left them with severe and devastating injuries. At the end of December, Bayer ceased sale and production of all Essure birth control implants in the United States, amid continuing questions about the safety and health risks associated with the device that has been placed in women worldwide for permanent sterilization. While the company has claimed that the halt in Essure sales was due to financial and business decisions, allegations raised in lawsuits filed nationwide allege that Bayer knew or should have known that the Essure device posed an unreasonable risk for women, yet failed to provide adequate warnings for consumers or the medical community. 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 In a third quarter investor report, Bayer indicated that it faced about 18,000 product liability lawsuits over Essure as of October 30, 2018. The claims involve women who suffered injuries such as hysterectomies, perforation, pain, bleeding, weight gain, allergic reactions to nickel, depression and unwanted pregnancies. In addition, the company warned investors that additional lawsuits were likely. Although Essure was recalled from the market in most countries in 2017, Bayer continued to sell the device in the United States. Amid 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 that 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. FDA officials have reported that the agency received about 12,000 adverse event reports related to the Essure birth control implant last year. In April, the FDA made changes to Essure’s premarket approval, requiring both doctors and patients to sign off on a checklist of potential Essure complications. In November 2016, following controversial hearings in the U.S., where testimony was heard from large numbers of women and medical experts, the FDA decided not to recall Essure in the United States. However, the agency did require Essure black box warnings, which are the strongest that the FDA can require a medical device carry. Approximately 750,000 women worldwide have been implanted with the device, and Bayer has previously estimated that 70% of those have been implanted in women in the U.S. The manufacturer has reportedly spent about $413 million defending the litigation over the last year, and may face substantially greater liability at trial if Essure settlements or another resolution for the cases is not reached. Tags: Bayer, Birth Control, Essure Image Credit: Image via <a href="http://www.shutterstock.com/gallery-3015638p1.html?cr=00&pl=edit-00">Lukassek</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. Want your comments reviewed by a lawyer?To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.Contact Phone #Alt Phone #Private CommentsNOTE: Providing information for review by an attorney does not form an attorney-client relationship.CAPTCHAGA SourceGA CampaignGA MediumGA ContentGA TermEmailThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES Depo-Provera Hearing Loss Lawsuit Filed Over Brain Tumor Side Effects (Posted: today) A Florida woman’s Depo-Provera lawsuit indicates she developed hearing loss and tinnitus due to the birth control injection not being adequately tested. MORE ABOUT: DEPO-PROVERA LAWSUITDepo-Provera Use for Endometriosis Caused Stroke-Like Symptoms, Golf Ball-Sized Brain Tumor: Lawsuit (04/15/2025)Depo-Provera Lawsuit Case Management Conferences Scheduled Throughout 2025 (04/08/2025)Depo-Provera Meningioma Diagnosis Information Required To Qualify for Lawsuit: Order (04/01/2025) Nurse Assist Lawsuit Alleges Infection Caused by Saline Solution Used To Clean Wounds (Posted: yesterday) A lawsuit filed over recalled Nurse Assist sterile water and saline products indicates the lack of sterility led to infections in leg wounds they were supposed to cleanse. MORE ABOUT: STERILE SALINE SOLUTION RECALL LAWSUITMcKesson Sterile Water Lawsuit Filed Against Amazon, Nurse Assist Over Bacterial Wound Infection (03/21/2025)SteriCare Sodium Chloride Lawsuit Claims Recalled Saline Solution Caused Infection, Wrongful Death (11/12/2024)Nurse Assist Sterile Water and Saline Recalled Following FDA “Do Not Use” Warning (11/07/2023) Ozempic Side Effects Caused Stomach Paralysis and Severe Abdominal Pain, Lawsuit Claims (Posted: 4 days ago) A product liability lawsuit filed against Novo Nordisk accuses the drug maker of failing to provide adequate warnings of Ozempic side effects, like stomach paralysis. MORE ABOUT: OZEMPIC LAWSUITOzempic Gastroparesis Lawsuit Filed Over Nausea, Severe Abdominal Pain (04/04/2025)Ozempic Delayed Gastric Emptying Led to Stomach Paralysis: Lawsuit (03/27/2025)Court Urged To Reject Motion To Dismiss Lawsuits Over Ozempic, Mounjaro Gastrointestinal Risks (03/21/2025)
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 Hearing Loss Lawsuit Filed Over Brain Tumor Side Effects (Posted: today) A Florida woman’s Depo-Provera lawsuit indicates she developed hearing loss and tinnitus due to the birth control injection not being adequately tested. MORE ABOUT: DEPO-PROVERA LAWSUITDepo-Provera Use for Endometriosis Caused Stroke-Like Symptoms, Golf Ball-Sized Brain Tumor: Lawsuit (04/15/2025)Depo-Provera Lawsuit Case Management Conferences Scheduled Throughout 2025 (04/08/2025)Depo-Provera Meningioma Diagnosis Information Required To Qualify for Lawsuit: Order (04/01/2025)
Nurse Assist Lawsuit Alleges Infection Caused by Saline Solution Used To Clean Wounds (Posted: yesterday) A lawsuit filed over recalled Nurse Assist sterile water and saline products indicates the lack of sterility led to infections in leg wounds they were supposed to cleanse. MORE ABOUT: STERILE SALINE SOLUTION RECALL LAWSUITMcKesson Sterile Water Lawsuit Filed Against Amazon, Nurse Assist Over Bacterial Wound Infection (03/21/2025)SteriCare Sodium Chloride Lawsuit Claims Recalled Saline Solution Caused Infection, Wrongful Death (11/12/2024)Nurse Assist Sterile Water and Saline Recalled Following FDA “Do Not Use” Warning (11/07/2023)
Ozempic Side Effects Caused Stomach Paralysis and Severe Abdominal Pain, Lawsuit Claims (Posted: 4 days ago) A product liability lawsuit filed against Novo Nordisk accuses the drug maker of failing to provide adequate warnings of Ozempic side effects, like stomach paralysis. MORE ABOUT: OZEMPIC LAWSUITOzempic Gastroparesis Lawsuit Filed Over Nausea, Severe Abdominal Pain (04/04/2025)Ozempic Delayed Gastric Emptying Led to Stomach Paralysis: Lawsuit (03/27/2025)Court Urged To Reject Motion To Dismiss Lawsuits Over Ozempic, Mounjaro Gastrointestinal Risks (03/21/2025)