Skip to main content
Subscribe
  • Login
  • My Account
  • Logout
  • Register For Free
  • 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
  • Blogs
    • AI
    • Deals
    • Layoff Tracker
    • HLTH 2024
    • Sponsored Content: Vital Signs Blog
  • Opinion
    • Letters
    • From the Editor
  • Events & Awards
    • Awards
    • Conferences
    • Galas
    • Virtual Briefings
    • Webinars
    • Nominate/Eligibility
    • 100 Most Influential People
    • 50 Most Influential Clinical Executives
    • 40 Under 40
    • Best Places to Work in Healthcare
    • Healthcare Marketing Impact Awards
    • Innovators Awards
    • Diversity Leaders
    • Leading Women
    • Best in Business Awards
    • The 2030 Playbook Conference
    • Innovations in Patient Experience
    • Leading Women Conference & Awards Luncheon
    • Leadership Summit
    • Workforce Summit
    • Best Places to Work Awards Gala
    • Diversity Leaders Gala
    • - Looking Ahead to 2025
    • - Financial Growth
    • - Hospital of the Future
    • - Value Based Care
    • - Looking Ahead to 2026
  • Multimedia
    • Podcast - Beyond the Byline
    • Sponsored Podcast - Healthcare Insider
    • Sponsored Video Series - One on One
    • Sponsored Video Series - Checking In with Dan Peres
  • Data & Insights
    • Data & Insights Home
    • Hospital Financials
    • Staffing & Compensation
    • Quality & Safety
    • Mergers & Acquisitions
    • Skilled Nursing Facilities
    • Data Archive
    • Resource Guide: By the Numbers
    • Surveys
    • Data Points
  • Newsletters
  • MORE+
    • Contact Us
    • Advertise
    • Media Kit
    • Jobs
    • People on the Move
    • Reprints & Licensing
    • Sponsored Content
MENU
Breadcrumb
  1. Home
  2. Providers
December 12, 2013 11:00 PM

Docs, regulators take new look at minimally invasive obesity devices

Jaimy Lee
  • Tweet
  • Share
  • Share
  • Email
  • More
    Reprints Print

    Waning patient interest in procedures that treat obesity is prompting physicians and federal regulators to re-evaluate how new obesity devices that are minimally invasive should be regulated and reimbursed.

    Physicians say that many obese patients are choosing not to have surgery because bariatric procedures that are currently available are invasive, expensive, sometimes permanent and have significant health risks in both the short- and long-term.

    “The major trend is the move away from conventional surgery to endoscopic or oral … approaches,” said Dr. Pankaj Jay Pasricha, director of the center for neurogastroenterology at Johns Hopkins Medicine in Baltimore. “There is a push toward device procedures that do not require incisions.”

    This is why the Food and Drug Administration and the American Gastroenterological Association plan to hold a public workshop Dec. 19 and 20 to discuss the regulation and reimbursement of minimally invasive procedures and medical devices that treat morbid obesity and other metabolic diseases.

    An estimated 80 million adults and 15 million children in the U.S. are obese. Of the drugs that have come to market to reduce weight in patients, several have been withdrawn and newer drugs lead to modest weight loss.

    About 200,000 people in the U.S. undergo bariatric surgery each year, a number that makes up less than 1% of the nation's total adult obese population.

    There are only two devices currently on the market that treat obesity—the Lap-Band Gastric Banding System, which Allergan recently sold to Apollo Endosurgery, and the Realize Gastric Band, which is marketed by Johnson & Johnson's Ethicon Endo-Surgery business unit. (Gastric bypass and sleeve gastrectomy procedures do not implant devices.)

    Utilization of the bands is declining, and the sleeve gastrectomy procedure has started to replace them, said Dr. Lee Kaplan, director of Massachusetts General Hospital's Weight Center in Boston. While the bands were used in nearly half of bariatric surgeries three years ago, they are now being used in about 10% of these surgeries, and that change in utilization has been attributed to how invasive the procedures are and a better understanding about their effectiveness, he added.

    The FDA has already recognized some of the challenges in bringing obesity devices to market. Agency officials late last year proposed a benefit-risk assessment that they say would provide a more consistent pathway to approval.

    The assessment would take into account the different benefits and risks of these types of devices in development, noting that devices aiming for greater weight loss would carry a different risk profile than those aiming for lower amounts of weight loss, according to an article published in Surgical Endoscopy in December 2012.

    “We are moving away from our 'one-size-fits-all' approach to clinical trial outcomes for these devices,” FDA officials wrote. “This paradigm aims to help industry assess the anticipated risk of their devices and to size their study better so that the data will be sufficient for a regulatory decision.”

    Physicians say payers must also begin to change the way they evaluate obesity devices for coverage. For example, a health plan might cover a procedure that leads to a 60% weight loss for a patient but not one—if such a procedure were available—that provides a 20% to 30% weight loss, even though it's a less invasive procedure that has fewer side effects, is potentially reversible and can be done in one day.

    These factors “have not traditionally been taken into account” by insurers, Pasricha said. “A lot of patients want that choice.”

    Follow Jaimy Lee on Twitter: @MHjlee

    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
    mh-20250513-Yellowstone-rural
    How 24 rural hospitals look to improve value-based care
    mh-20250509-dementia
    Federal dementia pilot has rocky rollout for some providers
    Most Popular
    1
    'Legendary' Hemsley takes over at UnitedHealth amid rough seas
    2
    Big retail tried to disrupt healthcare—who is making a dent?
    3
    These are the regulations the AHA wants RFK Jr. to scrap
    4
    Downside risk, upside payment highlight new CMS innovation agenda
    5
    Medicaid cuts bill clears key House committee
    Sponsored Content
    Modern Healthcare A.M. Newsletter: Sign up to receive a comprehensive weekday morning newsletter designed for busy healthcare executives who need the latest and most important healthcare news and analysis.
    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
    • Help Center
    • Advertise with Us
    • Ad Choices
    • Sitemap
    Editorial Dept
    • Submission Guidelines
    • Code of Ethics
    • Awards
    • About Us
    Legal
    • Terms and Conditions
    • Privacy Policy
    • Privacy Request
    Modern Healthcare
    Copyright © 1996-2025. 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)
    • Blogs
      • AI
      • Deals
      • Layoff Tracker
      • HLTH 2024
      • Sponsored Content: Vital Signs Blog
    • Opinion
      • Letters
      • From the Editor
    • Events & Awards
      • Awards
        • Nominate/Eligibility
        • 100 Most Influential People
        • 50 Most Influential Clinical Executives
        • 40 Under 40
        • Best Places to Work in Healthcare
        • Healthcare Marketing Impact Awards
        • Innovators Awards
        • Diversity Leaders
        • Leading Women
        • Best in Business Awards
      • Conferences
        • The 2030 Playbook Conference
        • Innovations in Patient Experience
        • Leading Women Conference & Awards Luncheon
        • Leadership Summit
        • Workforce Summit
      • Galas
        • Best Places to Work Awards Gala
        • Diversity Leaders Gala
      • Virtual Briefings
        • - Looking Ahead to 2025
        • - Financial Growth
        • - Hospital of the Future
        • - Value Based Care
        • - Looking Ahead to 2026
      • Webinars
    • Multimedia
      • Podcast - Beyond the Byline
      • Sponsored Podcast - Healthcare Insider
      • Sponsored Video Series - One on One
      • Sponsored Video Series - Checking In with Dan Peres
    • Data & Insights
      • Data & Insights Home
      • Hospital Financials
      • Staffing & Compensation
      • Quality & Safety
      • Mergers & Acquisitions
      • Skilled Nursing Facilities
      • Data Archive
      • Resource Guide: By the Numbers
      • Surveys
      • Data Points
    • Newsletters
    • MORE+
      • Contact Us
      • Advertise
      • Media Kit
      • Jobs
      • People on the Move
      • Reprints & Licensing
      • Sponsored Content