Study of Recalled Essure Implant Continues to Lose Participants, But FDA Reports Measures to Fix Data are Working
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Essure Problems, Safety Concerns to be Reviewed by FDA Panel June 25, 2015 Austin Kirk Add Your Comments Amid continuing complaints involving problems with Essure, as well as concerns about the safety and effectiveness of the birth control implant, the FDA will hold public panel hearings to determine what, if any, regulatory actions may be necessary. The FDA has announced that it will convene a meeting of the Obstetrics and Gynecology Devices advisory panel on September 24, to examine the science and concerns around Bayer’s Essure implant, which has been linked to reports of severe complications among women throughout the U.S. Essure is an implant offered as an outpatient procedure by many medical facilities to provide long-term birth control. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination. 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 The FDA indicates that it has received 5,093 adverse event reports regarding potential Essure problems between the device’s approval in November 2002 approval date and May 31, 2015. Most of those reports were voluntary from women who received the implants. According to the FDA adverse event reports, 3,353 of the reports it received were of abdominal pain, 1,408 were of menstrual irregularities, 1383 involved headaches, 966 were reports of fatigue , and 936 were reports of weight fluctuation. Among the reports were at least four adult deaths on Essure. Two of those fatalities were directly attributable to the Essure implant and included a death due to uterine perforation and one due to an air embolism that occurred when the device was removed. A suicide and a post-operative Group A Strep infection were listed as causes for the other two fatalities. The uterine puncture death on Essure was reported by Bayer to the FDA in February, just after a citizen’s petition for an Essure recall was filed with the FDA, noting multiple reports of severe and debilitating problems associated with the implant, including extreme abdominal pain, excessive bleeding and internal organ injuries. In March, the FDA Center for Devices and Radiological Health rejected the petition, saying it was misfiled. However, the petition and its details were forwarded to the FDA’s Office of Compliance, which reportedly will conduct an investigation of the complaints. Concerns over the birth control implant gained substantial media attention in the summer of 2014, following Congressional testimony involving an Essure injury during a briefing by the National Center for Health Research that called for legislation to improve the FDA approval process. Bayer, which bought the original company that designed the Essure implant and now markets the device worldwide, has downplayed the complaints, maintaining that there are relatively few cases out of the Essure implants used worldwide. The results of the proposed advisory committee hearing, and any votes the committee takes, are non-binding on the FDA. However, the agency usually follows the recommendations made by its advisory committees. Tags: Bayer, Birth Control Device, 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. 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 TermPhoneThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES Depo-Provera Shots Triple Brain Tumor Risks Compared to Birth Control Pill: Study (Posted: yesterday) 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. 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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: yesterday) 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: 2 days ago) 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: 3 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)