Study of Recalled Essure Implant Continues to Lose Participants, But FDA Reports Measures to Fix Data are Working
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Essure Implant Recall Urged By Lawmakers After Hearings October 26, 2015 Irvin Jackson Add Your Comments A number of lawmakers are calling for the FDA to force Bayer to issue a recall for the Essure birth control implant, calling for the agency to withdraw its original approval amid reports of complications and problems experienced by women. Representative Mike Fitzpatrick, a Republican from Pennsylvania, has said he intends to soon introduce the E-Free Act (PDF) in the U.S. House of Representatives. If approved, it would revoke the pre-market approval given by FDA to Essure’s original developer, Conceptus, in 2002. This would require Bayer, who currently owns and distributes the birth control implant, to remove Essure from the U.S. market. Fitzpatrick has support from Democrat Rosa DeLauro, a Connecticut Congresswoman who wrote a letter to the FDA (PDF) on October 9, also calling for an Essure implant recall. 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 Essure is form of long-acting birth control offered as an outpatient procedure by many medical facilities, where 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. The calls to recall Essure come on the heels of a September 24 meeting of the FDA’s Obstetrics and Gynecology Devices Panel, which was focused on the safety concerns surrounding the birth control implant and reports of Essure complications suffered by a number of women who received the device. The hearing was marked by a parade of women who gave passionate testimonies on the damage the Essure implants have allegedly done to their bodies and their lives. The FDA scheduled a meeting of their independent advisory committee to evaluate the safety of Essure, after noting that the agency received at least 5,093 adverse event reports involving the device between it’s approval in November 2002 and May 31, 2015. Most of those reports were voluntary from women who received the implants. The advisory committee suggested that better safety data is needed, including a patient registry and a new clinical study on safety and effectiveness. They also said Bayer should provide women with more detailed information about the risks of Essure before it is implanted, suggesting that women have review a checklist of possible complications and sign off on it before getting the procedure. According to the FDA adverse event reports, 3,353 of the incidents involved abdominal pain from Essure, 1,408 involved of menstrual irregularities, 1383 involved headaches, 966 were reports of fatigue, 936 were reports of weight fluctuation, and there were four reported deaths. “A citizen petition filed on behalf of hundreds of women injured by Essure asks FDA to remove the device from the market,” Rep. DeLauro noted in her letter. “FDA should take immediate action to do so.” DeLauro also asked the agency a number of pointed questions about how the hearing was conducted, seeking information on why a panel of women who had actually participated in the Essure clinical trials were not allowed to report to the panel. Had they been allowed, according to DeLauro, their public testimony would have indicated that Essure’s sponsors changed patient ages and information on the Essure complications they suffered when they submitted the data to the FDA for approval. DeLauro also noted that independent experts were not given sufficient time, and that the FDA has only posted 11 out of more than three thousand comments submitted to the docket of the citizen’s petition calling for an Essure recall. “Essure’s benefits do not outweigh its risks, and it should be withdrawn from the market,” DeLauro said. “If well-designed studies in the future indicate that the benefits outweigh the risks compared to alternative permanent or long-term contraception, the FDA can consider approving Essure at that time.” Tags: Bayer, Birth Control Device, 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 2 Comments Cherie October 27, 2015 That is great news but for the thousands of us lady’s that had to lose are Uterus and are woman hood who will replace that? My life had never been the same since and I’ll say there are many others the same way.there was no one in my family ever had to give up there uterus for any reason?So now I’ve lived in a empty shell thanks Bayer Sara October 27, 2015 I still have Essure. I go through pain on a daily basis. I have been suffering with this pain since july 2010. It has caused me agony. Doctors think im just trying to get pain pills when i go to the ER cause of the pain. I’m a 30 yo woman…i should not have to live my life around pain 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 Meningioma Diagnosis Information Required To Qualify for Lawsuit: Order (Posted: today) Women pursuing Depo-Provera meningioma lawsuits will have to provide documentary proof of their diagnosis and the versions of the birth control shot they received within 120 days of filing their case. MORE ABOUT: DEPO-PROVERA LAWSUITDepo-Provera Lawsuit Timeline for Preparing Pilot Trial Cases Outlined by MDL Judge (03/24/2025)Women Can File Depo-Provera Brain Tumor Lawsuits Directly in MDL: Court Order (03/18/2025)75 Lawyers in Depo-Provera Lawsuits Seek MDL Leadership Roles (03/10/2025) Cartiva SCI Lawsuit Alleges Toe Implant Worsened Pain, Decreased Range of Motion (Posted: yesterday) An Indiana woman has filed a Cartiva SCI implant lawsuit, indicating that the toe implant failed due to a defective design, resulting in the need for revision surgery and recommendations to permanently fuse her big toe. 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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 Meningioma Diagnosis Information Required To Qualify for Lawsuit: Order (Posted: today) Women pursuing Depo-Provera meningioma lawsuits will have to provide documentary proof of their diagnosis and the versions of the birth control shot they received within 120 days of filing their case. MORE ABOUT: DEPO-PROVERA LAWSUITDepo-Provera Lawsuit Timeline for Preparing Pilot Trial Cases Outlined by MDL Judge (03/24/2025)Women Can File Depo-Provera Brain Tumor Lawsuits Directly in MDL: Court Order (03/18/2025)75 Lawyers in Depo-Provera Lawsuits Seek MDL Leadership Roles (03/10/2025)
Cartiva SCI Lawsuit Alleges Toe Implant Worsened Pain, Decreased Range of Motion (Posted: yesterday) An Indiana woman has filed a Cartiva SCI implant lawsuit, indicating that the toe implant failed due to a defective design, resulting in the need for revision surgery and recommendations to permanently fuse her big toe. MORE ABOUT: CARTIVA IMPLANT LAWSUITCartiva Implant Injury Lawsuit Set for Trial in February 2026 (03/07/2025)Lawsuit Indicates Cartiva Implant Fails in 2 Out of 3 Patients, But Continued To Be Sold in U.S. (02/13/2025)Cartiva Toe Implant Lawsuit Filed Over Worsened Pain, Reduced Range of Motion and Need for Surgical Removal (02/07/2025)
Salon Professionals Claim Occupational Exposure to Hair Dye Products Caused Bladder Cancer: Lawsuits (Posted: 4 days ago) Two California hair stylists filed separate lawsuits, indicating that repeated occupational exposure to toxic chemicals in hair coloring dyes caused them to develop bladder cancer. MORE ABOUT: HAIR DYE LAWSUITHair Color Lawsuit Filed Over Salon Worker’s Bladder Cancer Diagnosis (03/20/2025)Brazilian Blowout Cancer Lawsuit Filed by Missouri Hair Stylists Over Exosure to Toxic Chemicals (03/11/2025)Initial Status Conference for Hair Dresser’s Bladder Cancer Lawsuit Set for May 5 (03/10/2025)