{"id":353253,"date":"2016-04-04T10:46:44","date_gmt":"2016-04-04T15:46:44","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-law\/injury\/product-liability\/drug-coated-stents-faq.html"},"modified":"2023-11-29T09:56:06","modified_gmt":"2023-11-29T14:56:06","slug":"drug-coated-stents-faq","status":"publish","type":"page","link":"https:\/\/www.findlaw.com\/injury\/product-liability\/drug-coated-stents-faq.html","title":{"rendered":"Drug-Coated Stents: Legal Info and FAQ"},"content":{"rendered":"\n<div class=\"wp-container-core-columns-is-layout-8f761849 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\">Drug-Coated Stents: Legal Info and FAQ<\/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 updated\n        <time>\n                            November 29, 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-key-takeaways fl-mb30\" data-testid=\"fl-key-takeaways\">\n    <div class=\"fl-card-content\">\n        <div class=\"fl-card-body fl-card-bg-teal fl-flex fl-flex-column\">\n                            <h2 class=\"fl-card-title fl-h2 fl-no-margin\">Key Takeaways<\/h2>\n                        <p>Drug-coated stents come with serious risks like blood clots, infection, and allergic reactions. While they can improve outcomes for some heart patients, not everyone is a safe candidate for these devices. Ongoing FDA monitoring and legal claims highlight concerns about their safety and long-term effects.<\/p>\n\n        <\/div>\n    <\/div>\n<\/div>\n\n\n<p>A stent is a small, lattice-shaped tube, made of metal or plastic, that doctors insert permanently into an artery or blood vessel. Doctors typically use them to treat\u00a0<a href=\"https:\/\/www.mayoclinic.org\/diseases-conditions\/coronary-artery-disease\/symptoms-causes\/syc-20350613\" target=\"_blank\" rel=\"noopener\">coronary artery disease<\/a>. They also use them in conjunction with a balloon catheter.<\/p>\n<p>A\u00a0<a href=\"http:\/\/www.nhlbi.nih.gov\/health\/health-topics\/topics\/stents\/\" target=\"_blank\" rel=\"noopener\">stent<\/a>\u00a0opens an artery that has become too narrow due to atherosclerosis. This is a condition where plaque builds up on the artery&#8217;s inner walls, blocking blood flow. Surgeons typically place stents inside a coronary artery after a balloon angioplasty procedure. It helps prevent\u00a0<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK545139\/\" target=\"_blank\" rel=\"noopener\">restenosis<\/a>.\u00a0Restenosis is the re-closing or re-blocking of the artery.<\/p>\n<p>This article answers common questions about drug-coated stents and how they can be dangerous for patients. You&#8217;ll also find information on lawsuits and legal options if you&#8217;ve been injured by a stent.<\/p>\n<p>You can also talk to a <a href=\"https:\/\/lawyers.findlaw.com\/products-liability-law\/\" target=\"_blank\" rel=\"noopener\">product liability attorney<\/a> near you for targeted legal advice. An attorney can determine if you have a valid legal claim. If so, they will advocate for you throughout the process and fight for fair compensation.<\/p>\n<h2>What is a drug-coated stent?<\/h2>\n<p>A drug-coated\u00a0stent\u00a0is a regular bare-metal stent that slowly releases drugs into your body. These drugs help prevent arterial scarring. They also reduce the possibility of restenosis.<\/p>\n<p>The Food and Drug Administration (FDA) has approved two leading brands of drug-coated stents, among others. These include:<\/p>\n<ul>\n<li>The\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf2\/P020026b.pdf\" target=\"_blank\" rel=\"noopener\">Cypher Sirolimus-Eluting Coronary Stent,<\/a>\u00a0manufactured by\u00a0Cordis Corporation<\/li>\n<li>The\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf3\/P030025c.pdf\" target=\"_blank\" rel=\"noopener\">Taxus Express Paclitaxel-Eluting Coronary Stent System<\/a>, manufactured by\u00a0Boston Scientific Corporation<\/li>\n<\/ul>\n<p>The FDA lists\u00a0<a href=\"http:\/\/www.fda.gov\/MedicalDevices\/ProductsandMedicalProcedures\/DeviceApprovalsandClearances\/Recently-ApprovedDevices\/default.htm\" target=\"_blank\" rel=\"noopener\">recently approved medical devices<\/a>\u00a0on its website with links to consumer information.<\/p>\n<h2>What types of stents do cardiologists use?<\/h2>\n<p>Cardiologists and other healthcare professionals use different types of stents. It depends on the nature of your medical issues and desired clinical outcomes. Cardiologists often use stent implantation to address various cardiovascular diseases and problems.<\/p>\n<p>Some of the\u00a0<a href=\"https:\/\/www.mayoclinic.org\/tests-procedures\/coronary-angioplasty\/about\/pac-20384761\" target=\"_blank\" rel=\"noopener\">health issues<\/a>\u00a0stents address include:<\/p>\n<ul>\n<li>Angina<\/li>\n<li>Heart attack<\/li>\n<li>Atherosclerosis<\/li>\n<li>Stroke<\/li>\n<li>Coronary artery disease<\/li>\n<li>Inflammation or infection of\u00a0<a href=\"https:\/\/my.clevelandclinic.org\/health\/body\/23471-endothelium\" target=\"_blank\" rel=\"noopener\">endothelial<\/a>\u00a0(vessel walls)<\/li>\n<li>Acute myocardial infarction<\/li>\n<li>Acute coronary syndrome<\/li>\n<li>Coronary lesions<\/li>\n<li><a href=\"https:\/\/www.mayoclinic.org\/tests-procedures\/coronary-angioplasty\/about\/pac-20384761\" target=\"_blank\" rel=\"noopener\">Coronary angioplasty<\/a><\/li>\n<li><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK499893\/\" target=\"_blank\" rel=\"noopener\">Neointimal hyperplasia<\/a><\/li>\n<\/ul>\n<p>Doctors treat these health issues in various ways. Surgeons, doctors, and cardiologists perform numerous procedures to help patients live longer and avoid future cardiovascular problems.<\/p>\n<p>The different types of stents available to cardiologists include the following:<\/p>\n<ul>\n<li>Polymer-coated<\/li>\n<li><a href=\"https:\/\/www.sciencedirect.com\/topics\/nursing-and-health-professions\/bare-metal-stent\" target=\"_blank\" rel=\"noopener\">Bare metal stents (BMS)<\/a><\/li>\n<li>Stainless steel stents<\/li>\n<li>Sirolimus-eluting stents<\/li>\n<li>Everolimus-eluting stents<\/li>\n<li><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK507788\/\" target=\"_blank\" rel=\"noopener\">Intracoronary stents<\/a><\/li>\n<li>Coronary artery stents<\/li>\n<li>Durable polymer stents<\/li>\n<li>Paclitaxel-eluting stents<\/li>\n<\/ul>\n<p>If your doctor uses a stent and you get sick, you <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/get-legal-help-with-a-defective-product-injury.html\">may have a legal claim<\/a>. It depends on whether the surgeon was negligent and the medical device was defective. The drug-eluting stent compounds (DES) could also be an issue. If the stents contain an infection, you may develop a severe illness.<\/p>\n<h2>What procedures require drug-coated stents?<\/h2>\n<p>Medical professionals use stents to improve long-term outcomes for cardiac patients. Whether they proceed with a procedure depends on a patient&#8217;s risk factors and whether they can handle the potential side effects of a stent implantation.<\/p>\n<p>Some of the procedures that require the use of drug-coated stents include:<\/p>\n<ul>\n<li>Target vessel revascularization<\/li>\n<li><a href=\"https:\/\/my.clevelandclinic.org\/health\/treatments\/22066-percutaneous-coronary-intervention\" target=\"_blank\" rel=\"noopener\">Percutaneous coronary intervention (PCI)<\/a><\/li>\n<li>Coronary artery bypass<\/li>\n<li>Cardiovascular surgery<\/li>\n<li>Vascular surgery<\/li>\n<li>Interventional cardiology<\/li>\n<li>Bypass surgery<\/li>\n<li>Dual antiplatelet therapy<\/li>\n<\/ul>\n<p>These procedures and therapies often require the use of cardiac medications. For example, some stents contain\u00a0<a href=\"https:\/\/www.mayoclinic.org\/drugs-supplements\/clopidogrel-oral-route\/description\/drg-20063146\" target=\"_blank\" rel=\"noopener\">clopidogrel<\/a>\u00a0or\u00a0<a href=\"https:\/\/www.fda.gov\/medical-devices\/recently-approved-devices\/resolute-onyx-zotarolimus-eluting-coronary-stent-system-onyx-frontier-zotarolimus-eluting-coronary\" target=\"_blank\" rel=\"noopener\">zotarolimus<\/a>, an immunosuppressant.<\/p>\n<p>Some of the other drugs that doctors administer using heart stents include:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.mdpi.com\/2077-0383\/12\/3\/1238#:~:text=The%20anti-proliferative%20drug%20released%20from%20the%20polymer%20or,the%20growth%20of%20neointimal%20tissue%20inside%20the%20stent.\" target=\"_blank\" rel=\"noopener\">Proliferation<\/a>\u00a0medications<\/li>\n<li>Antiproliferative drugs<\/li>\n<li><a href=\"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCULATIONAHA.120.046308\" target=\"_blank\" rel=\"noopener\">Monotherapy inhibitors<\/a><\/li>\n<\/ul>\n<p>Before the FDA approves certain drugs and drug-coated stents, they review the results of randomized controlled trials. They need to confirm the benefits of these surgical interventions outweigh any risks.<\/p>\n<p>If you undergo a cardiac procedure using a drug-coated stent and develop health issues, contact your cardiologist immediately. You may also want to get a <a href=\"https:\/\/lawyers.findlaw.com\/personal-injury-plaintiff\/\" target=\"_blank\" rel=\"noopener\">personal injury lawyer<\/a>. There&#8217;s a chance you have a legal claim.<\/p>\n<h2>Is the FDA investigating drug-coated\u00a0stents?<\/h2>\n<p>In 2006, the FDA announced that it was\u00a0<a href=\"http:\/\/www.bmj.com\/content\/333\/7581\/1235.2\" target=\"_blank\" rel=\"noopener\">closely monitoring drug-coated stents<\/a>\u00a0and had been since the devices entered the U.S. market in 2003 and 2004. Reports showed a small but significant risk of stent thrombosis. Stent thrombosis is when blood clots in the stent. However, the FDA lacked sufficient information to decide the severity of the risk.<\/p>\n<p>According to the\u00a0<a href=\"https:\/\/www.mayoclinic.org\/diseases-conditions\/coronary-artery-disease\/in-depth\/drug-eluting-stents\/art-20044911#:~:text=Today%2C%20new%20and%20improved%20versions%20of%20drug-eluting%20stents,likely%20to%20cause%20restenosis%20than%20are%20bare-metal%20stents.\" target=\"_blank\" rel=\"noopener\">Mayo Clinic<\/a>, the FDA believes these stents are safe and effective if doctors use them properly. However, the FDA continues to monitor new designs of these devices to ensure they remain safe.<\/p>\n<h2>What are the risks of drug-coated stents?<\/h2>\n<p>The FDA was initially concerned with the risks of stents and stent placement. Even if appropriately implanted, patients still face certain risks.<\/p>\n<p>Some of the risks of\u00a0<a href=\"https:\/\/www.healthline.com\/health\/heart-disease\/drug-eluting-stent\" target=\"_blank\" rel=\"noopener\">drug-eluting stents<\/a>\u00a0include:<\/p>\n<ul>\n<li>Infection<\/li>\n<li>Blood clot<\/li>\n<li>Late stent thrombosis<\/li>\n<li>Bleeding<\/li>\n<li>Rupture of the duct or vessel when the surgeon inserts the stent<\/li>\n<li>Stent migration<\/li>\n<li>Allergic reaction to the drug used in a drug-coated stent<\/li>\n<li>In-stent restenosis, when the inside of the stent becomes clogged, and the risk is higher in those with non-drug-coated stents<\/li>\n<\/ul>\n<p>Other rare complications of coronary stents include chest pain, heart attack, or tearing of the blood vessel.<\/p>\n<p>Drug-coated stents may have additional risks. Ask your healthcare professional about the risks associated with stents and drug-coated stents.<\/p>\n<h2>When should people avoid drug-coated stents?<\/h2>\n<p>Drug-coated stents can be dangerous for patients who have had recent heart surgery. They can also be harmful to women who are nursing or pregnant. Patients who receive a drug-coated stent may need antiplatelet drugs for at least several months.<\/p>\n<p>Patients who can&#8217;t tolerate <a href=\"https:\/\/my.clevelandclinic.org\/health\/treatments\/22060-angioplasty\" target=\"_blank\" rel=\"noopener\">angioplasty<\/a> or are allergic to the stent materials should avoid these procedures. Doctors shouldn&#8217;t use these devices in patients who can&#8217;t take blood-thinning (antiplatelet) medication.<\/p>\n<p>Clinical trials haven&#8217;t studied the safety and effectiveness of a drug-coated stent in the following patients:<\/p>\n<ul>\n<li>People with a blockage in a heart bypass graft<\/li>\n<li>Individuals who are having a heart attack<\/li>\n<li>Those patients who previously underwent intravascular radiation treatment<\/li>\n<\/ul>\n<p>Drug-coated stents have additional restrictions. Your healthcare professional can tell you more about whether you&#8217;re an appropriate candidate for this technology.<\/p>\n<h2>Get Legal Help With a Stent Injury<\/h2>\n<p>Medical device manufacturers must make their products as safe as possible. They must also inform the medical community and the public of any known risks associated with their products.<\/p>\n<p>If a device manufacturer fails to do this, they may be legally responsible for patients&#8217; injuries. This is the case when plaintiffs&#8217; injuries result from inadequate warnings or the unreasonably dangerous nature of the\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/defective-medical-devices.html\">medical device<\/a>.<\/p>\n<p>These cases fall under product liability law. If you or a loved one had a drug-coated stent implanted and are experiencing unusual health problems, contact your doctor immediately. You may also wish to meet with an attorney to discuss your options.\u00a0<\/p>\n<p>FindLaw&#8217;s directory of <a href=\"https:\/\/lawyers.findlaw.com\/products-liability-law\/\" target=\"_blank\" rel=\"noopener\">product liability 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 cases involving defective medical devices.<\/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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