Skip to main content
Subscribe
  • Sign Up Free
  • Login
  • Subscribe
  • News
    • Current News
    • Providers
    • Insurance
    • Government
    • Finance
    • Technology
    • Safety & Quality
    • Digital Health
    • Transformation
    • ESG
    • People
    • Regional News
    • Digital Edition (Web Version)
    • Patients
    • Operations
    • Care Delivery
    • Payment
    • Midwest
    • Northeast
    • South
    • West
  • Opinion
    • Bold Moves
    • Breaking Bias
    • Commentaries
    • Letters
    • Vital Signs Blog
    • From the Editor
  • Events & Awards
    • Awards
    • Conferences
    • Galas
    • Virtual Briefings
    • Webinars
    • 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 Innovators
    • Diversity in Healthcare
      • - Luminaries
      • - Top 25 Diversity Leaders
      • - Leaders to Watch
    • Women in Healthcare
      • - Luminaries
      • - Top 25 Women Leaders
      • - Women to Watch
    • Digital Health Transformation Summit
    • ESG: The Implementation Imperative Summit
    • Leadership Symposium
    • Social Determinants of Health Symposium
    • Women Leaders in Healthcare Conference
    • Best Places to Work Awards Gala
    • Health Care Hall of Fame Gala
    • Top 25 Diversity Leaders Gala
    • Top 25 Women Leaders Gala
    • - Hospital of the Future
    • - Value Based Care
    • - Hospital at Home
    • - Workplace of the Future
    • - Digital Health
    • - Future of Staffing
    • - Hospital of the Future (Fall)
  • Multimedia
    • Podcast - Beyond the Byline
    • Sponsored Podcast - Healthcare Insider
    • Video Series - The Check Up
    • Sponsored Video Series - One on One
  • Data Center
    • Data Center Home
    • Hospital Financials
    • Staffing & Compensation
    • Quality & Safety
    • Mergers & Acquisitions
    • Data Archive
    • Resource Guide: By the Numbers
    • Surveys
    • Data Points
  • Newsletters
  • MORE+
    • Contact Us
    • Advertise
    • Media Kit
    • Jobs
    • People on the Move
    • Reprints & Licensing
MENU
Breadcrumb
  1. Home
  2. Technology
March 05, 2016 12:00 AM

Is Essure warning a game changer?

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

    Dr. Aileen Gariepy began noticing about a decade ago that implanting a form of permanent birth control called Essure was more difficult than advertised, and that women frequently had to revisit her office to make sure it worked properly.

    The OB-GYN said she's one to “trust, but verify,” so she began her own research. In 2011, she published a study in the journal Obstetrics and Gynecology that found Essure's success rate was lower than advertised, and lower than the alternative, surgical tubal ligation. The results led Gariepy, now an assistant professor at the Yale School of Medicine, to more aggressively emphasize the product's risks.

    “Now, I may have only one woman a year who wants it,” she said. Before then, about 75% of her patients were opting for Essure.

    Last week, the Food and Drug Administration recommended that labeling for Bayer's Essure should also highlight specific concerns. The agency gave it a black-box warning and a checklist for patients to initial indicating that they understand a suite of potential adverse events.

    While the FDA says the device remains an appropriate option for the majority of women, the black box could be a game-changer for clinicians. By adding its most serious warning label, the FDA is saying “suggestive evidence is compelling and consequences are high,” said Dr. Terry Fairbanks, director of MedStar Health's National Center for Human Factors in Healthcare. Practitioners might decide the device is too difficult to justify or defend, he said.

    Boxed warning regulations were first instituted in 1979 to call attention to drugs with serious or life-threatening risks. The FDA could not say how many regulated products include the warnings. “There wouldn't be much use from a regulatory standpoint to keep track of a number,” an FDA spokesman said.

    Essure checklist

    Physicians must confirm that patients understand the risks of:

  • A pregnancy occurring outside the uterus, which can lead to serious or life-threatening complications

  • A 1% to 4% chance of the device puncturing the uterus and/or fallopian tubes

  • The device moving into the abdomen; rates for how often this occurs are “undetermined”

  • Persistent pain, muscle weakness, excessive fatigue, hair loss, weight and/or mood changes

  • Needing a hysterectomy to remove the uterus in complex cases, which may not be covered by insurance

  • Allergic reactions resulting in chest pain, vomiting and other symptoms not reported in original trials

    Source: Examples from the Food and Drug Administration's draft recommendations

  • Last year, Essure drew scrutiny when an FDA database found more than 5,000 reports of adverse events, including unintended pregnancies, complications during removal and fetal deaths.

    Bayer later said that it had received more than 17,000 adverse-event reports from around the globe. The company estimated that about 750,000 women use Essure, and about 70% of them are in the U.S.

    The FDA guidance recommends a warning that states the device's nickel coils have led to “perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, persistent pain, and allergy or hypersensitivity reaction.” It also notes that some women needed abdominal surgery to have Essure removed.

    Whether a black-box warning affects sales of Essure remains to be seen. While the associated risks are gaining attention, there are still benefits. It remains the only nonsurgical, non-hormonal permanent birth control on the market, and it does not require general anesthesia to implant, said Dr. William Maisel, deputy director for science at the FDA's Center for Devices and Radiological Health.

    That's why the device rapidly gained popularity after its 2002 market approval. For years, patients and physicians waited for a non-surgical approach to sterilization.

    MH Takeaways

    Clinicians must have frank conversations with their patients about the risks and benefits of using Essure, which now carries a black- box warning.

    By 2012, the original manufacturer, Conceptus, saw net sales top $140 million.

    “It's a good example of how physicians allowed ourselves to be duped by information that we wanted,” Gariepy said. “We cannot rely on pharmaceutical representatives to tell us whether or not something is really beneficial for our patients.”

    If fewer women opt for Essure, that could show that clinicians are better at communicating the risks, said Dr. Elizabeth Micks, a member of a panel that authored a 2013 practice bulletin on the benefits and risks of sterilization for the American College of Obstetrics and Gynecology.

    A black box will be a strong reminder to physicians that the product is not right for everyone, and that the recommended three-month follow-up is critical, Micks said.

    The FDA wants Bayer to conduct a new post-market observational study on the device's risks in a real-world setting. The study must include more than 2,000 patients, compare Essure to tubal ligation, and follow patients for at least three years.

    The manufacturer said last week that it is cooperating with the FDA.

    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
    Chat-GPT-healthcare-2.png
    Why Boston Children's wants to hire a ChatGPT expert
    Screen Shot 2018-12-19 at 1.36.49 PM.png
    GE HealthCare stock drops despite revenue growth
    Most Popular
    1
    More healthcare organizations at risk of credit default, Moody's says
    2
    Centene fills out senior executive team with new president, COO
    3
    SCAN, CareOregon plan to merge into the HealthRight Group
    4
    Blue Cross Blue Shield of Michigan unveils big push that lets physicians take on risk, reap rewards
    5
    Bright Health weighs reverse stock split as delisting looms
    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 © 1996-2023. Crain Communications, Inc. All Rights Reserved.
    • News
      • Current News
      • Providers
      • Insurance
      • Government
      • Finance
      • Technology
      • Safety & Quality
      • Digital Health
      • Transformation
        • Patients
        • Operations
        • Care Delivery
        • Payment
      • ESG
      • People
      • Regional News
        • Midwest
        • Northeast
        • South
        • West
      • Digital Edition (Web Version)
    • Opinion
      • Bold Moves
      • Breaking Bias
      • Commentaries
      • Letters
      • Vital Signs Blog
      • From the Editor
    • Events & Awards
      • 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 Innovators
        • Diversity in Healthcare
          • - Luminaries
          • - Top 25 Diversity Leaders
          • - Leaders to Watch
        • Women in Healthcare
          • - Luminaries
          • - Top 25 Women Leaders
          • - Women to Watch
      • Conferences
        • Digital Health Transformation Summit
        • ESG: The Implementation Imperative Summit
        • Leadership Symposium
        • Social Determinants of Health Symposium
        • Women Leaders in Healthcare Conference
      • Galas
        • Best Places to Work Awards Gala
        • Health Care Hall of Fame Gala
        • Top 25 Diversity Leaders Gala
        • Top 25 Women Leaders Gala
      • Virtual Briefings
        • - Hospital of the Future
        • - Value Based Care
        • - Hospital at Home
        • - Workplace of the Future
        • - Digital Health
        • - Future of Staffing
        • - Hospital of the Future (Fall)
      • Webinars
    • Multimedia
      • Podcast - Beyond the Byline
      • Sponsored Podcast - Healthcare Insider
      • Video Series - The Check Up
      • Sponsored Video Series - One on One
    • Data Center
      • Data Center Home
      • Hospital Financials
      • Staffing & Compensation
      • Quality & Safety
      • Mergers & Acquisitions
      • Data Archive
      • Resource Guide: By the Numbers
      • Surveys
      • Data Points
    • Newsletters
    • MORE+
      • Contact Us
      • Advertise
      • Media Kit
      • Jobs
      • People on the Move
      • Reprints & Licensing