Study of Recalled Essure Implant Continues to Lose Participants, But FDA Reports Measures to Fix Data are Working
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Essure Lawsuit Filed After Birth Control Coil Missing In Woman’s Body March 15, 2017 Irvin Jackson Add Your Comments After Essure birth control coils went missing inside her body, a Georgia woman has filed a product liability lawsuit against Bayer, alleging that the manufacturer failed to warn about the risk of severe complications associated with their product. The complaint (PDF) was filed by Pamela Graves in the U.S. District Court for the Northern District of Georgia on March 2, claiming that Bayer sold a defective and unreasonably dangerous device. Essure is marketed as a safe and effective form of permanent birth control, involving coils implanted in the fallopian tubes, which cause scar tissue to form and prevent pregnancy. However, thousands of women have reported suffering painful and debilitating Essure complications, where the coils migrated out of position, caused severe allergic reactions or other problems. Learn More About Paragard Lawsuits Women have reported problems where Paragard IUD fractured or broken during removal, resulting in serious injury. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Learn More About Paragard Lawsuits Women have reported problems where Paragard IUD fractured or broken during removal, resulting in serious injury. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Graves indicates that she had Essure coils implanted in May 2009. However, she quickly gained about 80 pounds, and developed constant pelvic pain, heavy bleeding, pain during intercourse, headaches and other problems. She also reported being able to feel the device if she lay on her stomach. In April 2016, she underwent a hysterectomy to have the Essure coils removed, after she learned about problems with the device that matched her symptoms. However, doctors discovered that one of the coils had migrated out of position and they were unable to locate it. There is a large chance that the errant coil is migrating through her body, where it could do further damage to internal organs, according to the complaint. The case joins several thousand other Essure lawsuits pending nationwide, each raising similar allegations that Bayer knew about issues with their product for years, yet withheld information from consumers, doctors and federal regulators. In November 2016, the FDA announced new Essure warning label changes in the United States, which included a “black box” warning, as well as a patient checklist that must be given to women considering the permanent birth control, to ensure they understand the potential risk of complications. Approximately 750,000 women worldwide have been implanted with the device, and Bayer estimates that 70% of those have been implanted in women in the U.S. As Essure injury lawyers continue to review and file claims for women nationwide, it is expected that thousands of additional cases may be filed in the coming months and years for women who still have the birth control coils in their body. Written by: Irvin Jackson Senior Legal Journalist & Contributing Editor Irvin Jackson is a senior investigative reporter at AboutLawsuits.com with more than 30 years of experience covering mass tort litigation, environmental policy, and consumer safety. He previously served as Associate Editor at Inside the EPA and contributes original reporting on product liability lawsuits, regulatory failures, and nationwide litigation trends. Tags: Bayer, Birth Control, Essure Image Credit: | 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 1 Comments Pat March 25, 2017 I had this happen to me in 1970. The IUD perforated the uterus and got embedded in tissue near the bowels. Could have caused peritonitis and killed me, the surgeon said. Phew. 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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 Term Δ MORE TOP STORIES Dupixent Sales Surge Amid Growing CTCL Cancer Lawsuit Allegations (Posted: yesterday) Sanofi indicates Dupixent sales are growing stronger as the medication gathers more indications for use worldwide, despite recent cancer concerns. 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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
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