Study of Recalled Essure Implant Continues to Lose Participants, But FDA Reports Measures to Fix Data are Working
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Nitrous Oxide Lawsuit Individuals who suffered harm, or families who lost a loved one after using nitrous oxide products may be eligible for financial compensation through a nitrous oxide lawsuit.
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Depo-Provera Lawsuit Depo-Provera lawsuits are being investigated for women who developed meningioma brain tumors after receiving Depo-Provera birth control shots, claiming that Pfizer failed to adequately disclose side effects.
Ozempic Lawsuit Lawyers are pursuing Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits over gastroparesis or stomach paralysis, which can leave users with long-term gastrointestinal side effects
Suboxone Tooth Decay Lawsuit Lawsuits are being pursued by users of Suboxone who experienced tooth loss, broken teeth or required dental extractions. Settlement benefits may be available.
Change Healthcare Lawsuit Lawyers are reviewing Change Healthcare class action lawsuits for individuals who had their personal information stolen due to the data breach.
Bard PowerPort Lawsuit Serious and life-threatening injuries have been linked to problems with Bard PowerPort. Lawsuits are now being pursued by individuals who suffered injuries from the implantable port catheter fracturing or migrating.
AngioDynamics Port Catheter Lawsuit Serious and life-threatening injuries have been linked to problems with Bard PowerPort. Lawsuits are now being pursued by individuals who suffered injuries from the implantable port catheter fracturing or migrating.
Processed Food Lawsuit Lawsuits are being pursued against the food industry over their manufacturing and advertising of ultra-processed foods, which have caused a generation of children to face an increased risk of developing childhood diabetes and other chronic illnesses.
Essure Recall Urged By Injured Women At FDA Advisory Committee Hearing September 25, 2015 Irvin Jackson Add Your Comments Dozens of women attended an FDA advisory committee meeting on Thursday, with more than 20 testifying and urging federal drug regulators to issue a recall of the Essure birth control implant. Women described a litany of harmful Essure complications and ailments that they believe were caused by side effects of the controversial implant. The group applauded when members of the Obstetrics and Gynecology advisory committee expressed concern over the device or grilled Bayer executives on shortcomings in the Essure clinical trials during the hearing. While the former users of the birth control who attended called for an Essure recall, 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. 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 At this point, according to Bayer, more than 750,000 women in the U.S. have already undergone the procedure to have Essure implanted, and officials for the birth control maker stood by the safety and effectiveness of the birth control device. The advisory committee’s recommendations are not binding, however the FDA often heavily weighs those recommendations in its final decisions. 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. In June, 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. 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. While clinical trials done by Bayer showed Essure to be safe and effective, the number of adverse event reports, and growing protests by women who say they have been injured by the device, has the FDA concerned enough to call for this week’s hearing. An editorial published in the New England Journal of Medicine on Wednesday ahead of the hearing, points out that the Essure safety hearing comes 13 years after the device was allowed on the market. The concerns over the implant point to failings of the FDA’s premarketing and postmarketing evaluations, the writers said. “Although Essure is designed to remain in place for a woman’s lifetime, few women in the premarketing studies were followed for more than 1 year — a limitation that precludes conclusions about longer-term risks,” the editorial states. “Appropriately, FDA approval was conditional on two mandatory postaapproval studies to provide 5-year follow-up data on patients in the premarketing approval studies. However, these studies were not made well known: neither one was registered at ClinicalTrials.gov….and their results were not disseminated in a timely way.” The editorial notes that what data is available paints an uncertain picture of the device. They also said that the controversy surrounding Essure should be a lesson to shore up the requirements for approval for medical devices before they are exposed to the public. “Though Essure offers possible advantages to women seeking sterilization, the evidence suggests that it is neither as effective nor as safe as the premarketing-approval evaluation indicated,” the journal noted. “The problems of inadequately rigorous premarketing and postmarketing studies, unregistered clinical trials, and incomplete and delayed dissemination of results are not unique to Essure.” Tags: Bayer, Birth Control, 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 7 Comments Mayra March 28, 2016 I would not recommend essure to anyone. I had it done a year ago and I have had a period every other week. I have lower back and hip pain. Seems bleeding keeps getting heavier and heavier. So frustrating. Carrie March 5, 2016 I just had a total hysteractomy done on January 18 due to the essure procedure. The pain I endured for 2 years because of this was unbearable. It was constant and nothing could lessen it even for a moment. It affected my work, my sleep, my social life and my family life. I can’t explain the instant relief I felt almost instantly after the hysteractomy. I should have done my research but I was told it was safe and effective. I am only 33. I have 2 daughters and my only reason for wanting permanent birth control was because I had severe hyperemesis with both pregnancies as well as with a miscarriage. I almost died during all 3 and I couldn’t go through it again…in a sense I just walked into a new nightmare. These people should have their insides mutilated and be forced to live their lives in chronic pain. Only seems fair. ANEL February 18, 2016 I have a lot of pain and my ovaries every day And more I wish some one will help as to find the answer susanna January 8, 2016 I have had essure for 10 yrs and had breakthough bleeding for a week Does anyone know if breakthough bleeding normal ? Sondra January 5, 2016 I have it what do I need to do For 7 years lisa September 27, 2015 I’ve had this in me for 8 years. I’ve lost my hair, I have skin issues, I have elevated metal levels, UTI, incontinence, a bloated belly, the unexplained pain, the unexplained allergies, I’m about to have a FULL hysto in 6 weeks to have the poison removed from my body. EddieAnn September 25, 2015 I’m living this nightmare everyday. I’m 44 yrs old and i have to have a hysterectomy in October to remove the remaining metal inside my uterus. 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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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