Study of Recalled Essure Implant Continues to Lose Participants, But FDA Reports Measures to Fix Data are Working
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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.
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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 Safety Review Continues At FDA, Details of Safety Study Released April 20, 2017 Irvin Jackson Add Your Comments Federal regulators indicate that they received more than 5,000 medical device reports involving problems with Essure birth control implants last year, and recently reported details for an ongoing study that is designed to better understand the risks associated with the controversial device. The FDA issued an update to its ongoing investigation of Bayer’s Essure implant on April 18, confirming that the agency is still receiving and reviewing complaints from women and doctors nationwide who have experienced complications linked to the coil-shaped birth control devices. According to the update, the FDA received 5,016 medical device reports involving the product in 2016, which is a decrease from the 6,176 reports received by the agency the year before. The FDA also noted that it has received 38 reports of deaths associated with Essure birth control, but noted that eight of those may were incorrectly coded, as there was no indication of death. 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 Among the remaining 30 deaths reported, there were six reports involving with four adult deaths, and 21 reports linked to 18 pregnancy loss incidents. The FDA also received two reports of infants dying after they were born, and one in which they are not sure if the newborn died before or after its birth. In September 2016, the FDA approved a plan for a postmarket surveillance study on Essure health risks and benefits. The update provides details on the Essure study, which seeks to be a prospective observational cohort study involving 2,800 women; half of whom will receive the Essure, and the other half of whom will undergo laparoscopic tubal sterilization. The study will look for instances of: Chronic lower abdominal or pelvic pain New or worsening abnormal uterine bleeding Allergic reactions and hypersensitivity, as well as autoimmune-like reactions The need for revision surgery or invasive gynecologic surgery linked to Essure devices Effectiveness Pregnancy rates Essure Health Concerns Essure is a medical device that is designed to provide women with permanent sterilization, involving coils that are placed in the fallopian tubes during an out-patient procedure. The Essure coils cause scar tissue to form and prevent pregnancy. In November 2016, the FDA added a black box warning label to Essure implants, which is the strongest that the FDA can require a medical device carry. The black box came after independent experts recommended that additional information be provided about the Essure procedure problems experienced by many women who received the coils, including perforation of the uterus and fallopian tubes, pain and allergic reactions. The new warnings also inform women that if Essure needs to be removed, it must be done through a surgical procedure. Women who undergo the birth control procedure will now be presented with a patient checklist, which is designed ensure that they are aware of the potential side effects of Essure coils. The warnings provide women with information about the permanent and possibly irreversible nature of the implant, the fact that there are alternative contraceptives available, the effectiveness of Essure coils and the risk of unintended and ectopic pregnancies, common adverse events, long-term risks, and what signs and symptoms they should look out for that may indicate a problem. Tags: Bayer, Birth Control, 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 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 TermEmailThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES Uber Faces Lawsuit Indicating Driver Raped Passenger After Using Wife’s Account (Posted: today) A lawsuit filed by a Florida woman says she was raped after an Uber driver’s husband showed up behind the wheel. 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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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