Study of Recalled Essure Implant Continues to Lose Participants, But FDA Reports Measures to Fix Data are Working
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Essure Side Effects May Be Linked to FDA Death Report November 7, 2013 Irvin Jackson Add Your Comments With health experts and consumer watchdogs increasingly raising concerns about the risk of health problems from Essure birth control implants, a recent report submitted to the FDA raises questions about whether the contraceptive may have been linked to the death of a woman who suffered a severe infection. According to an adverse event report submitted to the FDA’s MAUDE (Manufacturer and User Facility Device Experience) Database, a woman went into renal failure and died in August 2013, after undergoing an Essure procedure. The cause of death was attributed to Necrotizing Group A Streptococcus infection, also known as streptococcal toxic shock syndrome or a flesh-eating disease. The infection killed the tissue in the woman’s cervix, fallopian tubes and uterus after the Essure birth control was implanted in her right and left fallopian tubes. 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 In the report submitted by Bayer Healthcare on September 18, the manufacturer added narrative indicates that the attending physician does not directly link the death to the Essure insert or procedure. However, the report adds to recent media coverage surrounding the potential Essure side effects women may face from the birth control coils. The Mayo Clinic and others list risk of infection as a leading complication following Essure procedures. A similar case was reported in the Journal of Women’s Health in 2011, indicating that a 24-year old woman contracted a a Group A Streptococcus infection after an Essure implant three years earlier. She too reported worsening abdominal pain and eventually required a total abdominal hysterectomy. Essure Complications Essure birth control is a transcervical sterilization procedure, which is marketed as a less expensive, easier and safer alternative to tubal ligation surgery. Approved by the FDA in 2002, Essure was originally designed and manufactured by Conceptus, before being acquired by the pharmaceutical giant Bayer. More than 750,000 women have undergone Essure birth control surgery, according to prior data released by Conceptus. The birth control implant is offered as an outpatient procedure by many medical facilities. 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. The FDA has logged more than 850 reports of adverse side effects since 2004, which suggests that thousands of problems have been experienced, since it is widely acknowledged that only about 1% to 10% of all adverse events are ever reported to the FDA. Among reports submitted to the federal regulatory agency are more than 150 Essure complications involving the device moving and puncturing fallopian tubes or the uterus, with nearly 100 women requiring hysterectomies to remove Essure birth control following severe complications. In addition, at least 150 reports have been filed involving doctors complaining of the device breaking during insertion and numerous other problems with allergic reactions and side effects. Tags: Bayer, Birth Control, Essure, Infection 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 12 Comments Amy May 21, 2021 I had to have a hysterectomy after having tubes removed and then having uterus perforated by a coil that migrated. Last year I was diagnosed with kidney cancer which doctor was astounded. It isn’t normal for my sex or age or even ethnicity. I believe Essure played a part. I have pains still daily, inflammation, a hernia from one of surgery. It has been a living nightmare! Kerry July 9, 2020 i just had an ovarian cancer with my essure in. i think they are linked too. im only 43yrs old and i took the dna test and i didnt inherit it. Julie May 9, 2020 Im here after googling essure and cancer. I had stomach cancer and essure causes an overactIVe immune system, and overactive immune systems can cause diseases such as cancer Rebeeca December 3, 2016 Debra I was just diagnosed last month with uterine cancer. I also believe it is from the Essure. No family history of cancer. The ct scan the cancer is in the uterus horns and pointing towards the Fallopian tubes. Rosalind February 6, 2016 I had multiple complications and in the end hysterectomy Debra May 9, 2015 6 years after implant ovarian cancer. No familia history Doctor was boggled on the why with no history. I personally think it was a result of the Essure device. Complete hysterectomy lymph nodes an messenteric along with six rounds of chemo. April April 3, 2015 I had the essure procure done. Since then I suffer from terrible pain all the time. My periods since then have been horrible I cry my eyes out n suffer the whole time. As well as I bleed off n on the whole month. Please help me what do I do. Worst choice ever made please help me M.E. February 11, 2015 The U.S. Army Medical Command (MEDCOM) Contracting Center North Atlantic, located at MCAA NA Bldg T20, 6900 Georgia Avenue NW, Washington, DC 20307-5000 has announced its plan to procure ‘ESSURE’ Permanent Birth Control devices, using Taxpayer money, to permanently sterilize Female Military Service-persons and their Spouses. It is announced under Solicitation Number: W91YTZ-15-T-0044 (https://www.fbo.gov/spg/USA/MEDCOM/DADA15/W91YTZ-15-T-0044/listing.html). Is this what we want our Tax-dollars spent on? Deanna January 28, 2015 My moods are completely off since having it down, my period only happens now when I take progesterone for 5 days in a row. My ovaries hurt all the time. Brittany H December 3, 2014 I had the essure done in August of 2013. Since I have had it done my life has turned into a nightmare. I hurt so bad I cry and I just hope women research this before they have it done. If I would have researched it more I would have never had this done to me. annamarie November 30, 2014 I have been having abdomen pain problems. Since a year after putting. In the coils Charmain June 23, 2014 Having problems with essure having them removed. I have multiple side effects 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 TermPhoneThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES Depo-Provera Hearing Loss Lawsuit Filed Over Brain Tumor Side Effects (Posted: today) A Florida woman’s Depo-Provera lawsuit indicates she developed hearing loss and tinnitus due to the birth control injection not being adequately tested. 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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 Hearing Loss Lawsuit Filed Over Brain Tumor Side Effects (Posted: today) A Florida woman’s Depo-Provera lawsuit indicates she developed hearing loss and tinnitus due to the birth control injection not being adequately tested. MORE ABOUT: DEPO-PROVERA LAWSUITDepo-Provera Use for Endometriosis Caused Stroke-Like Symptoms, Golf Ball-Sized Brain Tumor: Lawsuit (04/15/2025)Depo-Provera Lawsuit Case Management Conferences Scheduled Throughout 2025 (04/08/2025)Depo-Provera Meningioma Diagnosis Information Required To Qualify for Lawsuit: Order (04/01/2025)
Nurse Assist Lawsuit Alleges Infection Caused by Saline Solution Used To Clean Wounds (Posted: yesterday) A lawsuit filed over recalled Nurse Assist sterile water and saline products indicates the lack of sterility led to infections in leg wounds they were supposed to cleanse. MORE ABOUT: STERILE SALINE SOLUTION RECALL LAWSUITMcKesson Sterile Water Lawsuit Filed Against Amazon, Nurse Assist Over Bacterial Wound Infection (03/21/2025)SteriCare Sodium Chloride Lawsuit Claims Recalled Saline Solution Caused Infection, Wrongful Death (11/12/2024)Nurse Assist Sterile Water and Saline Recalled Following FDA “Do Not Use” Warning (11/07/2023)
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