Study of Recalled Essure Implant Continues to Lose Participants, But FDA Reports Measures to Fix Data are Working
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6,000 Essure Problems Reported to FDA Medical Device Monitoring System in 2018 May 16, 2019 Irvin Jackson Add Your Comments Years after concerns emerged about the risk of problems with Essure birth control implants, federal regulators indicate that they received more than 6,000 medical device reports involving complications associated with the device in 2018. The FDA issued a press release on May 15, to update the public about the status of the agency’s ongoing investigation into the safety of Bayer’s Essure implant, which was removed from the market in December. The agency reports noted that thousands of reports involving Essure problems were reported last year, although the number was about half of the 12,000 reports submitted in 2017. The FDA notes that most of the reports were submitted by Bayer itself, and are linked to a growing number of Essure injury lawsuits filed against the company by consumers who have experienced 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 Bayer currently faces more than 18,000 product liability complaints filed by women nationwide, each involving similar allegations that side effects of Essure coils caused women to experience painful and debilitating complications after receiving the birth control device. There is no multi-district litigation (MDL) established for Essure claims in the federal court system, meaning they are proceeding as individual claims. The FDA also notes that since the Essure implant was first approved in 2002, it has been linked to 49 reports of patient deaths. Of those, 23 of the reports were linked to pregnancy loss, five were linked to incidents of the death of an infant after live birth, 15 were linked to the deaths of adults, two were related to ectopic pregnancies and the rest are more vague, either not giving details about the death or related to reports of deaths posted in social media. “Even though this device is no longer sold, I want to reiterate the FDA’s commitment to regularly communicating with patients and health care professionals about Essure as more information is made available,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the press release. “Our work to continually monitor the long-term safety profile of Essure is part of our broader effort to assure device safety, which includes ongoing actions to enhance our post-market surveillance system to identify and address new safety concerns once a device is on the market and to encourage innovations that lead to safer medical devices.” The FDA also updated its Essure 522 study webpage, announcing that nearly 900 patients have been enrolled in the study, which was required by the agency when Bayer pulled the device from the market. 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 a half, 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 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. 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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 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)