{"id":353257,"date":"2016-05-25T13:01:56","date_gmt":"2016-05-25T18:01:56","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-law\/injury\/product-liability\/essure-birth-control-issues-and-faqs.html"},"modified":"2023-12-06T10:28:25","modified_gmt":"2023-12-06T15:28:25","slug":"essure-birth-control-issues-and-faqs","status":"publish","type":"page","link":"https:\/\/www.findlaw.com\/injury\/product-liability\/essure-birth-control-issues-and-faqs.html","title":{"rendered":"Essure Birth Control: Safety Issues and Legal Information"},"content":{"rendered":"\n<div class=\"wp-container-core-columns-is-layout-9d6595d7 fl-sectionWithSidebar fl-container fl-flex fl-flex-wrap fl-gap30\">\n<div class=\"fl-page-articles fl-section-main fl-section-main-full-width\"><h1 class=\"fl-no-margin-top\">Essure Birth Control: Safety Issues and Legal Information<\/h1>\n\n<section class=\"fl-gutenberg-byline\">\n    <div class=\"fl-gutenberg-byline-content\">\n                    By <a href=\"https:\/\/www.findlaw.com\/company\/our-team\/christie-nicholson-j-d\/\">Christie Nicholson, J.D.<\/a> | Legally reviewed by <a\n                href=\"https:\/\/www.findlaw.com\/company\/our-team\/oni-harton-j-d\/\">Oni Harton, J.D.<\/a>\n                | Last reviewed\n        <time>\n                            December 06, 2023\n                    <\/time>\n    <\/div>\n\n    \n    <details class=\"fl-gutenberg-byline-toggle fl-gutenberg-byline-legally-reviewed\">\n        <summary>\n            <i class=\"fl-gutenberg-byline-icon\" aria-hidden=\"true\"><\/i>\n            Legally Reviewed\n        <\/summary>\n\n        <div class=\"fl-gutenberg-byline-toggle-content\">\n            <p><em>This article has been written and reviewed for legal accuracy, clarity, and style by <a href=\"https:\/\/www.findlaw.com\/company\/our-team.html\">FindLaw\u2019s team of legal writers and attorneys<\/a> and in accordance with <a href=\"https:\/\/www.findlaw.com\/company\/company-history\/editorial-policy.html\">our editorial standards<\/a>.<\/em><\/p>\n\n        <\/div>\n    <\/details>\n\n    <details class=\"fl-gutenberg-byline-toggle fl-gutenberg-byline-fast-checked\">\n        <summary>\n            <i class=\"fl-gutenberg-byline-icon\" aria-hidden=\"true\"><\/i>\n            Fact-Checked\n        <\/summary>\n\n        <div class=\"fl-gutenberg-byline-toggle-content\">\n            <p><em>The last updated date refers to the last time this article was reviewed by FindLaw or one of our <a href=\"https:\/\/www.findlaw.com\/company\/our-team\/contributing-authors.html\">contributing authors<\/a>. We make every effort to keep our articles updated. For information regarding a specific legal issue affecting you, please <a href=\"https:\/\/lawyers.findlaw.com\/?fli=bylinelink\" target=\"_blank\" rel=\"noopener\">contact an attorney in your area<\/a>.<\/em><\/p>\n\n        <\/div>\n    <\/details>\n<\/section>\n\n\n    <div class=\"fl-callout-text article-blockquote\">\n        <div data-testid=\"loading-message\" data-fui-focus-visible=\"\">\n<div>\n<div id=\"chatMessageResponser76\" class=\"___1yop6mf f336tjw f9ijwd5 fz7g6wx fod5ikn f1s184ao\" aria-live=\"assertive\">\n<div class=\"___1j4t0a1 f1lmfglv f1abmfm4\" aria-hidden=\"false\" data-testid=\"markdown-reply\" data-message-type=\"Chat\">\n<div class=\"___stpibi0 f22iagw f1vx9l62 fk15e71 f1k953kz f137keqj f1rncccw f1stllg3 f1w4kmmc f1tric3v f10dk5ic fx8cdsv f16nlwsl f1eookvz fhjrts3 fqugt2f f10km5jb f18d18k8 f1v1vhmp f1hdmul3 f198vjnp f2dshw1 fjpjndq fnmj2pj ffrrb40 f1mon110 fhajzam fimndk6 fxv4dng fb1rn9k f59wlhv f1xmfh30 f18yf5o5 fmr6chf fw8qy2q ff161sd f1qr7t77 f1yyogn1 foogchg fp5872b f1tpb8gf f1hdgrc8 f1vatr43 frkxccd f9pdzkb f158oiaz ft5kggy f5l4ui7 f13j03li f18xdoka f8off4e f1go6zfc f128n2ra f1jpxw2j f1lwd9n0 fy0b8hm f1g2633v fx4kvgi fkvolse f1gxrt3a f1os76ua f1js9cnw f1g87ej0 freluf8 f1yggaq6 f2i3chp f1151osp florpoh f35kzfz ftp9m57 f1e288vi fz62hnz fixvuys f1nmofwh fc1c6mv f18a2er7 fhvkrdl fhxnn68 f1oce4bo fvhlfan f7tc0t0 f1ngf1n2 ffrzq6x f1yjiq2m f1aqdgql f1huvaf f10ij78l f1k94sa4 fkmfumq f1jvzkyl f1eu24ob f1xbfc1f fmf0lwf f107dsy8 f3w566c f4648sl f13zpkng f7unjfp f8p1rz fzu6h1w f1i1bi6h f1smo7hi f1sk1xod f1kgogdq f1gjktkp ft608jz f19dd9cz fg3xr24 fhd155k f1b8gl2e fg4b9ou flb4lo fdicbfk fgwcyh1 f1jbds0d f1fb9uea f1stuka4 fcrtu6g fwqh0xn f11w66yg f6e0e65 f1vvgu0 f1607507 f1m9bycv f1ntoah8 f1b694rt faql4r2 fpjuhzh fmavl6h\">\n<p>The Essure birth control device led to thousands of adverse health reports, including organ perforation, chronic pain, and even death. Bayer, which acquired the original manufacturer, faced over 39,000 lawsuits and ultimately settled most claims for $1.6 billion. Bayer voluntarily removed the product from the market in 2018.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n    <\/div>\n\n\n\n<p>The Essure Permanent Birth Control System is a permanent, non-surgical form of birth control for women. The U.S. Food and Drug Administration (FDA) approved Essure in 2002.\u00a0<a href=\"https:\/\/www.fda.gov\/medical-devices\/essure-permanent-birth-control\/fda-activities-related-essure\" target=\"_blank\" rel=\"noopener\">According to the FDA<\/a>, as of December 31, 2019, all unused Essure units should have been returned to Bayer and are no longer available for implantation.<\/p>\n<p>Since its 2002 approval, thousands of patients filed complaints about the device. Some of these complaints were for organ perforation. Others involved pelvic pain, unintended pregnancies, abnormal bleeding, and even death.<\/p>\n<p>Conceptus, Inc. was the original manufacturer of Essure. However, Bayer later acquired the medical device company.<\/p>\n<p>The device consists of flexible coils inserted through the vagina and cervix into the fallopian tubes. The device irritates the fallopian tube tissue and builds scar tissue around the coil. This creates a barrier that blocks sperm from reaching the egg.<\/p>\n<p>While the device worked for thousands of women, many others experienced Essure complications. So many women were injured while they had the Essure implant they filed a <a href=\"https:\/\/www.findlaw.com\/litigation\/filing-a-lawsuit\/how-to-file-a-class-action-lawsuit.html\">class action lawsuit<\/a>.<\/p>\n<p>This article discusses the health problems associated with the device, Essure birth control lawsuits, and theories of liability that affected patients are reporting. If you&#8217;ve been harmed by Essure or another pharmaceutical product, a <a href=\"https:\/\/lawyers.findlaw.com\/products-liability-law\/\" target=\"_blank\" rel=\"noopener\">product liability attorney<\/a> can provide advice targeted to your situation.<\/p>\n<h2>How Many Essure Patients Experience Problems?<\/h2>\n<p>According to\u00a0<a href=\"https:\/\/www.consumerreports.org\/women-s-health\/consumers-guide-to-essure-birth-control\/#:~:text=The%20device%20is%20popular%20among%20women%20and%20physicians,it%2C%20the%20majority%20of%20them%20in%20the%20U.S.\" target=\"_blank\" rel=\"noopener\">Consumer Reports<\/a>, close to 20,000 Essure patients had\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/defective-medical-devices.html\">problems with the device<\/a>. Of the more than 17,000 patients who reported adverse events, more than half of them had to get surgery to resolve complications. Sadly, many of the women who got sick after having the Essure implant needed a complete hysterectomy.<\/p>\n<p>Approximately 3-4% of Essure patients experienced severe side effects. Many of these patients relied on their doctors to correct the problem. Unfortunately, most doctors don&#8217;t know how to solve the issue other than implanting more devices. This creates a vicious cycle. The more devices a doctor implants, the higher the risk of the woman getting sick.<\/p>\n<h2>Essure Health Problems<\/h2>\n<p>Women who had the Essure system implanted reported device breakage. Thousands of affected women reported mild to severe medical complications related to Essure. Some of the reported side effects include:<\/p>\n<ul>\n<li>Chronic pelvic pain<\/li>\n<li>Perforation or tears to the pelvic organs<\/li>\n<li>Life-threatening ectopic pregnancy<\/li>\n<li>Abdominal pain<\/li>\n<li>Device migration<\/li>\n<li>Hysterectomy to remove device and repair damaged organs<\/li>\n<li>Autoimmune reactions<\/li>\n<li>Miscarriage<\/li>\n<li>Severe headaches<\/li>\n<li>Allergic reactions to the device<\/li>\n<\/ul>\n<h2>FDA Response to Essure Complications<\/h2>\n<p>The FDA never\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/drugs-and-medical-device-recalls.html\">issued a recall<\/a>\u00a0for Essure. However, it did convene a meeting with the\u00a0<a href=\"http:\/\/www.fda.gov\/MedicalDevices\/ProductsandMedicalProcedures\/ImplantsandProsthetics\/EssurePermanentBirthControl\/ucm452254.htm\" target=\"_blank\" rel=\"noopener\">Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee<\/a>\u00a0in 2015 to consider scientific and clinical opinions and patients&#8217; experiences.<\/p>\n<p>As a result, the FDA ordered additional clinical testing for Essure and required the company to add a\u00a0<a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm488313.htm\" target=\"_blank\" rel=\"noopener\">black box warning<\/a>\u00a0on the device. It also demanded that the drug manufacturer include a patient decision checklist that doctors must review with patients before prescribing the device.<\/p>\n<p>While the FDA did not recall Essure, Bayer voluntarily removed it from the market in 2018. The company cited declining sales of Essure as the reason. However, one must imagine that the lawsuits also had something to do with it.<\/p>\n<h2>Legal Trouble for Bayer<\/h2>\n<p>Conceptus originally designed and marketed Essure as a contraceptive device. In 2013, Bayer acquired the company, thereby assuming any legal issues surrounding the <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/defective-medical-devices.html\">defective device<\/a>. Bayer purchased the company despite patients&#8217; complaints about Essure&#8217;s side effects as early as 2009.<\/p>\n<p>Between 2002 and 2019, more than 47,000 patients notified the FDA of adverse event reports. It wasn&#8217;t long until victims decided to sue Bayer Healthcare.<\/p>\n<p>Many of the cases were filed or consolidated in California. The U.S. District Court for the Eastern District of Pennsylvania handled many others. Plaintiffs complained that Essure caused\u00a0<a href=\"https:\/\/www.consumersafety.org\/news\/essure-settlement\/\" target=\"_blank\" rel=\"noopener\">severe health problems<\/a>, including:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.mayoclinic.org\/diseases-conditions\/pregnancy-loss-miscarriage\/symptoms-causes\/syc-20354298?p=1\" target=\"_blank\" rel=\"noopener\">Miscarriage<\/a><\/li>\n<li>Unwanted pregnancies<\/li>\n<li>Incorrect placement of the device<\/li>\n<li>Device failure<\/li>\n<li>Chronic pain of the pelvis<\/li>\n<li>Rashes<\/li>\n<li>Cramping<\/li>\n<\/ul>\n<p>These represent some of the severe complications associated with Essure. Many plaintiffs had to undergo various surgical procedures to correct the problem. Some fared worse. According to the FDA, more than 70 people with the Essure implant died from complications associated with the medical device.<\/p>\n<h2>First Lawsuit Related to Essure Birth Control Device<\/h2>\n<p>Heather Walsh was the first person to\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/essure-birth-control-lawsuits.html\">sue Bayer for issues with its Essure<\/a>\u00a0birth control device. Her claim, filed in 2013, alleged that one of the metal coils became lodged in her colon. As a result, she underwent a\u00a0<a href=\"https:\/\/www.mayoclinic.org\/tests-procedures\/abdominal-hysterectomy\/about\/pac-20384559\" target=\"_blank\" rel=\"noopener\">hysterectomy<\/a>. She also had several additional surgical procedures to remove the coil from her colon.<\/p>\n<p>Walsh reported experiencing extreme and prolonged pain and autoimmune disorders after her doctor implanted the device. She argued that Bayer did not warn doctors or patients about possible complications.<\/p>\n<p>By 2020, more than 39,000 women had sued Bayer for damages. Personal injury attorneys for the plaintiffs demanded compensation for:<\/p>\n<ul>\n<li>Medical expenses<\/li>\n<li>Future medical care<\/li>\n<li>Lost wages<\/li>\n<li>Pain and suffering<\/li>\n<\/ul>\n<p>In 2020, Bayer negotiated a settlement of more than 90% of the claims for $1.6 billion. This was about $45,000 per plaintiff. There are few, if any, cases still pending against Bayer for Essure problems.<\/p>\n<h2>Product Liability Attorneys Can Help Essure Plaintiffs<\/h2>\n<p>If you or a loved one developed severe medical complications as a result of any birth control device or medication, legal help is available. An experienced attorney can discuss the strengths and weaknesses of your case and advise you on how best to proceed.<\/p>\n<p>FindLaw&#8217;s directory of <a href=\"https:\/\/lawyers.findlaw.com\/drugs-medical-devices\/?fli=dcta\" target=\"_blank\" rel=\"noopener\">drug and medical device attorneys<\/a> can get you started. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys\u2019 experience with dangerous drug cases.<\/p>\n\n\n<div class=\"was-this-helpful\">\n    <div\n            class=\"was-this-helpful__question-container\"\n            aria-labelledby=\"was-this-helpful__question\"\n            role=\"group\"\n    >\n        <span\n                id=\"was-this-helpful__question\"\n                class=\"was-this-helpful__question fl-text-lg-bold\"\n        >Was this helpful?<\/span>\n        <button\n                class=\"was-this-helpful__button fl-text-sm\"\n                aria-label=\"Yes\"\n                value=\"yes\"\n        >\n            <span class=\"was-this-helpful__button-text fl-text-bold\">Yes<\/span>\n            <i class=\"was-this-helpful__button-icon\">\n                <svg width=\"22\" height=\"22\" viewBox=\"0 0 22 22\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n                    <g id=\"thumbs-up\" 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          class=\"fl-radio-button-field-input\"\n                                type=\"radio\"\n                                name=\"negative-feedback\"\n                                value=\"Other\"\n                        >\n                        <label\n                                class=\"fl-radio-button-field-label fl-text-sm was-this-helpful__radio-label\"\n                                for=\"was-this-helpful__radio-button--negative-other\"\n                        >Other<\/label>\n                    <\/div>\n                <\/fieldset>\n            <\/div>\n            <div class=\"was-this-helpful__form-buttons-container\">\n                <button\n                    class=\"was-this-helpful__feedback-button was-this-helpful__feedback-button--positive at-feedback-submit fl-button secondary\"\n                    type=\"submit\"\n                >\n                    <span class=\"fl-button-content\">Submit<\/span>\n                    <i\n                        class=\"fa fa-angle-right medium\"\n                        aria-hidden=\"true\"\n                    ><\/i>\n                <\/button>\n                <button\n                    class=\"was-this-helpful__feedback-button was-this-helpful__feedback-button--cancel fl-button primary disabled\"\n                    type=\"reset\"\n                >\n                    <span class=\"fl-button-content\">Cancel<\/span>\n                    <i\n                        class=\"fa fa-times-circle medium\"\n                        aria-hidden=\"true\"\n                    ><\/i>\n                <\/button>\n            <\/div>\n        <\/form>\n    <\/div>\n    <div class=\"was-this-helpful__thank-you-message\" role=\"status\">\n        <i class=\"was-this-helpful__thank-you-message-icon fa fa-check\"><\/i>\n        <p class=\"was-this-helpful__thank-you-message-text\" aria-live=\"polite\"><\/p>\n    <\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"fl-section-sidebar\"><div class=\"fl-editors-summary\" data-testid=\"fl-editors-summary\">\n    \n    <div class=\"fl-editors-summary-content\" data-testid=\"fl-editors-summary-content\">\n                    <h2>Can I Solve This on My Own or Do I Need an Attorney?<\/h2>\n                <div class=\"fl-editors-summary-content-main\" data-testid=\"fl-editors-summary-content-main\">\n            \n        <\/div>\n        <ul class=\"fl-list-style-none\">\n                            <li data-testid=\"fl-editors-summary-content-item\">\n                    <i class=\"fa fa-check medium fl-editors-summary-content-item-icon\" aria-hidden=\"true\"><\/i>\n                    A lawyer can help seek fair compensation on your behalf\n\n                <\/li>\n                            <li data-testid=\"fl-editors-summary-content-item\">\n                    <i class=\"fa fa-check medium fl-editors-summary-content-item-icon\" aria-hidden=\"true\"><\/i>\n                    Drug manufacturers have teams of lawyers on their side to defend against lawsuits\n\n                <\/li>\n                            <li data-testid=\"fl-editors-summary-content-item\">\n                    <i class=\"fa fa-check medium fl-editors-summary-content-item-icon\" aria-hidden=\"true\"><\/i>\n                    An attorney can help gather evidence and documentation to support your claim\n\n                <\/li>\n                    <\/ul>\n                    <div class=\"fl-editors-summary-content-description\" data-testid=\"fl-editors-summary-content-description\">\n                <p>An experienced attorney can increase your chances of success with your case. 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