Skip to main content
Sister Publication Links
  • ESG: THE NEW IMPERATIVE
Subscribe
  • My Account
  • Login
  • Subscribe
  • News
    • Current News
    • COVID-19
    • Providers
    • Insurance
    • Government
    • Finance
    • Technology
    • Safety & Quality
    • Transformation
    • People
    • Regional News
    • Digital Edition (Web Version)
    • Patients
    • Operations
    • Care Delivery
    • Payment
    • Midwest
    • Northeast
    • South
    • West
  • Digital Health
  • Insights
    • ACA 10 Years After
    • Best Practices
    • Special Reports
    • Innovations
  • Data/Lists
    • Rankings/Lists
    • Interactive Databases
    • Data Points
  • Op-Ed
    • Bold Moves
    • Breaking Bias
    • Commentaries
    • Letters
    • Vital Signs Blog
    • From the Editor
  • Awards
    • Nominate/Eligibility
    • 100 Most Influential People
    • 50 Most Influential Clinical Executives
    • Best Places to Work in Healthcare
    • Excellence in Governance
    • Health Care Hall of Fame
    • Healthcare Marketing Impact Awards
    • Top 25 Emerging Leaders
    • Top 25 Innovators
    • Diversity in Healthcare
    • Women in Healthcare
    • - Luminaries
    • - Top 25 Diversity Leaders
    • - Leaders to Watch
    • - Luminaries
    • - Top 25 Women Leaders
    • - Women to Watch
  • Events
    • Conferences
    • Galas
    • Virtual Briefings
    • Webinars
    • Custom Media Event: ESG Summit
    • Transformation Summit
    • Women Leaders in Healthcare Conference
    • Social Determinants of Health Symposium
    • Leadership Symposium
    • Health Care Hall of Fame Gala
    • Top 25 Women Leaders Gala
    • Best Places to Work Awards Gala
    • Top 25 Diversity Leaders Gala
    • - Hospital of the Future
    • - Value Based Care
    • - Supply Chain Revenue Cycle
    • - Hospital at Home
    • - Workplace of the Future
    • - Strategic Marketing
    • - Virtual Health
  • Listen
    • Podcast - Next Up
    • Podcast - Beyond the Byline
    • Sponsored Podcast - Healthcare Insider
    • Video Series - The Check Up
    • Sponsored Video Series - One on One
  • MORE +
    • Advertise
    • Media Kit
    • Newsletters
    • Jobs
    • People on the Move
    • Reprints & Licensing
MENU
Breadcrumb
  1. Home
  2. Technology
September 25, 2015 01:00 AM

Post-market surveillance must ramp up to flag adverse events

Sabriya Rice
  • Tweet
  • Share
  • Share
  • Email
  • More
    Reprints Print

    During a Food and Drug Administration hearing Thursday to scrutinize the safety and efficacy of the Essure female contraceptive, Essure's maker, Bayer, revealed it had received more than 17,000 adverse-event reports from women around the globe.

    That's over 11,000 more than the 5,093 reports captured by June of this year on the Manufacturer and User Facility Device Experience (MAUDE) database, an FDA website for patients and clinicians to submit complaints.

    The high number of events flagged on the MAUDE database may have prompted the FDA hearing, but health policy and quality and safety leaders argue the voluntary reporting system does not provide the rigorous post-market surveillance needed to capture adverse events before problems become widespread.

    It takes years of evidence collection before warnings are issued about treatments that may be harming patients. That concern was voiced by Lisa McGiffert, director of the Consumers Union Safe Patient Project, in a recent Q&A with Modern Healthcare. The problem is underscored by legislation like the 21st Century Cures Act which aims to speed the development and approval of new drugs and devices.

    Advocates for fast-track drug and device approval are basing their support on the theory that some kind of “magical post-market surveillance system” is going to track treatment issues, and as soon as problems are spotted, the treatment in question will be pulled from the market, McGiffert said, adding “It doesn't happen that way.”

    Essure has become somewhat of the poster child for such concerns because of its delayed scrutiny.

    Despite mounting criticism, Essure's manufacturer has vehemently supported the device, stating that side effects are possible with any new device or procedure, and that Essure is “supported by more than a decade of research and real-world experience.”

    But a panel of independent experts Thursday told the FDA they disagreed. Not enough research was conducted by Conceptus, the original manufacturer who sold the device to Bayer, prior to approval of the permanent female sterilization device 13 years ago. The device's use should be limited, the panelists urged.

    Federal officials did not provide a timeline on when action will be taken on Essure based on the suggestions offered, but said addressing its problems is a high priority, given the many complaints received.

    Voluntary reporting through the MAUDE database is a passive form of tracking that often underestimates the number of adverse events that actually occur in day-to-day practice, noted the authors of an editorial posted Thursday in the New England Journal of Medicine.

    With Essure, safety concerns might have been detected sooner or avoided altogether if there had been higher-quality pre- and post-marketing evaluations, and more timely and transparent dissemination of study results, wrote Yale researchers, Drs. Sanket Dhruva, Joseph Ross and Dr. Aileen Gariepy in the NEJM commentary.

    The FDA should reevaluate its process for the new device rollouts, using Essure and other therapies that have proved harmful as a cautionary context, Gariepy told Modern Healthcare. “Is it sufficient? Or can we do better for our patients?” she asked. “We really need better, more transparent data.”

    However, it's not just the government asking hard questions about medical evidence. Various specialty organizations and manufacturers have launched registries, big-data initiatives and other projects they hope will facilitate early detection of the problems associated with new and existing clinical therapies.

    For example, in June the American Society of Clinical Oncology announced the official rollout of CancerLinQ, a health information-technology platform initiative in which participating oncology groups share data from millions of electronic health records to provide real-time feedback on cancer trends and patient outcomes.

    Drug and device manufacturers have also been voluntarily participating in projects such as Yale University's Open Data Access Project and GlaxoSmithKline's Clinical Study Data Request initiative, which aim to facilitate access to clinical trial data.

    In 2014, Bayer became one of 11 other drug and device manufacturers to participate in the GSK initiative, but the project's website says that Bayer data is “coming soon.”

    Letter
    to the
    Editor

    Send us a letter

    Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.

    Recommended for You
    google_sized_getty_i.jpg
    Democrats ask Google to protect abortion-patient privacy
    Cue Health COVID test
    High-tech’s business model hasn’t worked for the Cue COVID test
    Sponsored Content
    Health IT Strategist (HITS) Newsletter: Sign up for the latest IT and medical technology news delivered 3 days a week (M, W, F).
     
    Get Newsletters

    Sign up for enewsletters and alerts to receive breaking news and in-depth coverage of healthcare events and trends, as they happen, right to your inbox.

    Subscribe Today
    MH Magazine Cover

    MH magazine offers content that sheds light on healthcare leaders’ complex choices and touch points—from strategy, governance, leadership development and finance to operations, clinical care, and marketing.

    Subscribe
    Connect with Us
    • LinkedIn
    • Twitter
    • Facebook
    • RSS

    Our Mission

    Modern Healthcare empowers industry leaders to succeed by providing unbiased reporting of the news, insights, analysis and data.

    Contact Us

    (877) 812-1581

    Email us

     

    Resources
    • Contact Us
    • Advertise with Us
    • Ad Choices Ad Choices
    • Sitemap
    Editorial Dept
    • Submission Guidelines
    • Code of Ethics
    • Awards
    • About Us
    Legal
    • Terms and Conditions
    • Privacy Policy
    • Privacy Request
    Modern Healthcare
    Copyright © 1996-2022. Crain Communications, Inc. All Rights Reserved.
    • News
      • Current News
      • COVID-19
      • Providers
      • Insurance
      • Government
      • Finance
      • Technology
      • Safety & Quality
      • Transformation
        • Patients
        • Operations
        • Care Delivery
        • Payment
      • People
      • Regional News
        • Midwest
        • Northeast
        • South
        • West
      • Digital Edition (Web Version)
    • Digital Health
    • Insights
      • ACA 10 Years After
      • Best Practices
      • Special Reports
      • Innovations
    • Data/Lists
      • Rankings/Lists
      • Interactive Databases
      • Data Points
    • Op-Ed
      • Bold Moves
      • Breaking Bias
      • Commentaries
      • Letters
      • Vital Signs Blog
      • From the Editor
    • Awards
      • Nominate/Eligibility
      • 100 Most Influential People
      • 50 Most Influential Clinical Executives
      • Best Places to Work in Healthcare
      • Excellence in Governance
      • Health Care Hall of Fame
      • Healthcare Marketing Impact Awards
      • Top 25 Emerging Leaders
      • Top 25 Innovators
      • Diversity in Healthcare
        • - Luminaries
        • - Top 25 Diversity Leaders
        • - Leaders to Watch
      • Women in Healthcare
        • - Luminaries
        • - Top 25 Women Leaders
        • - Women to Watch
    • Events
      • Conferences
        • Transformation Summit
        • Women Leaders in Healthcare Conference
        • Social Determinants of Health Symposium
        • Leadership Symposium
      • Galas
        • Health Care Hall of Fame Gala
        • Top 25 Women Leaders Gala
        • Best Places to Work Awards Gala
        • Top 25 Diversity Leaders Gala
      • Virtual Briefings
        • - Hospital of the Future
        • - Value Based Care
        • - Supply Chain Revenue Cycle
        • - Hospital at Home
        • - Workplace of the Future
        • - Strategic Marketing
        • - Virtual Health
      • Webinars
      • Custom Media Event: ESG Summit
    • Listen
      • Podcast - Next Up
      • Podcast - Beyond the Byline
      • Sponsored Podcast - Healthcare Insider
      • Video Series - The Check Up
      • Sponsored Video Series - One on One
    • MORE +
      • Advertise
      • Media Kit
      • Newsletters
      • Jobs
      • People on the Move
      • Reprints & Licensing