Study of Recalled Essure Implant Continues to Lose Participants, But FDA Reports Measures to Fix Data are Working
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Woman Dies During Essure Implant Procedure, FDA Investigates Complaints April 30, 2015 Irvin Jackson Add Your Comments An adverse event report suggests that a woman’s death may be linked to Essure birth control, indicating that she died while the controversial implant was being inserted. The report was submitted to the FDA’s Adverse Event Reporting System by Bayer, the manufacturer of Essure. The company reportedly received information about the potential Essure death from a doctor, and it is at least the fifth fatality associated with the complications from Essure birth control. 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 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. According to the adverse event report, a female patient died while the Essure was being inserted into her fallopian tube. The reason for her death is unknown, but she appears to have suffered a 5 mm puncture to her uterus. The puncture was found during the autopsy and it is unclear whether it occurred during the procedure or how it could be linked to her death. During the procedure, the surgeon noted having a problem finding the fallopian tube opening. “The operator gently pushed against the side of the uterus (described by the surgeon as probing) adjacent to the opening of the right fallopian tube with the tip of the essure catheter and advanced the catheter up to the black line,” the report indicates. “The patient suddenly coded. Prior to coding the patient was noted to be shaking a lot and experienced generalized seizure activity.” The company’s analysis noted that a link to the Essure placement procedure cannot be ruled out, though no definitive causal link could be made. “Preliminary autopsy results showed a perforation in the cornual region of the uterus near the right tube and 500 cc of blood in abdomen,” Bayer officials noted. “The reported uterine perforation was considered serious due to medical importance and is listed according to essure’s reference safety information.” The report was filed 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. Late last month, 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. Essure Complications Although the procedure has become increasingly popular, the FDA has received hundreds of adverse event reports over the past year involving side effects of Essure birth control, including instances where women had to undergo a hysterectomy due to complications that may have been experienced. Concerns over the birth control implant gained substantial media attention over the summer, 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. Tags: Bayer, Birth Control, 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 TermNameThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES Zantac Cancer Lawsuits Continue To Be Filed More Than 5 Years After Recall (Posted: yesterday) A man diagnosed with multiple forms of cancer has filed a Zantac lawsuit, blaming Boehringer Ingelheim for failing to adequately warn about the recalled heartburn drug’s health risks. 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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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Enfamil NEC Lawsuit Filed After Newborn Suffers ‘Nearly Total Bowel Necrosis’ (Posted: 2 days ago) Necrotizing enterocolitis caused by Enfamil resulted in a newborn suffering life-long bowel injuries, according to a lawsuit filed by his mother. MORE ABOUT: ENFAMIL AND SIMILAC BABY FORMULA LAWSUITReckitt Benckiser Faces Class Action Lawsuit Over Enfamil NEC Risks (06/12/2025)NEC Infant Formula Lawyers To Meet With MDL Judge Following Dismissal of First Bellwether Trial (05/29/2025)FDA To Investigate Whether Infant Formula Products Provide Enough Nutrition (05/16/2025)
Judge To Meet With Hair Dye Lawyers in Bladder Cancer Lawsuit for Initial Status Conference (Posted: 3 days ago) A California judge has ordered parties involved in a hair dye bladder cancer lawsuit filed against major cosmetic companies to meet for the first time this week to discuss the case. MORE ABOUT: HAIR DYE LAWSUITLawsuit Claims Paul Mitchell, Redken, Other Hair Dyes Led to Bladder Cancer Diagnosis for Hairdresser (05/09/2025)Salon Stylist Files Lawsuit Over Bladder Cancer From Hair Dye Products (05/02/2025)Hair Color Lawsuit Alleges Bladder Cancer Caused by Salon Dye (04/25/2025)