• Resources
  • Blog
  • Journalists
  • Log In
  • Sign Up
  • Data Privacy
  • Send a Release
Cision PR Newswire: news distribution, targeting and monitoring home
  • News
  • Products
    • Overview
    • Distribution by PR Newswire
    • Cision Communications Cloud®
    • Cision IR
    • Sponsored Placement
    • All Products
  • Contact
    • General Inquiries
    • Request a Demo
    • Editorial Bureaus
    • Partnerships
    • Media Inquiries
    • Worldwide Offices

 

When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All News Releases
      • All Public Company
      • English-only
      • News Releases Overview

      • Multimedia Gallery

      • All Multimedia
      • All Photos
      • All Videos
      • Multimedia Gallery Overview

      • Trending Topics

      • All Trending Topics
  • Business & Money
      • Auto & Transportation

      • All Automotive & Transportation
      • Aerospace, Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads and Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking and Road Transportation
      • Auto & Transportation Overview

      • View All Auto & Transportation

      • Business Technology

      • All Business Technology
      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • Business Technology Overview

      • View All Business Technology

      • Entertain­ment & Media

      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • Entertain­ment & Media Overview

      • View All Entertain­ment & Media

      • Financial Services & Investing

      • All Financial Services & Investing
      • Accounting News & Issues
      • Acquisitions, Mergers and Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • Financial Services & Investing Overview

      • View All Financial Services & Investing

      • General Business

      • All General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls and Research
      • Trade Show News
      • General Business Overview

      • View All General Business

  • Science & Tech
      • Consumer Technology

      • All Consumer Technology
      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • Consumer Technology Overview

      • View All Consumer Technology

      • Energy & Natural Resources

      • All Energy
      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil and Gas Discoveries
      • Utilities
      • Water Utilities
      • Energy & Natural Resources Overview

      • View All Energy & Natural Resources

      • Environ­ment

      • All Environ­ment
      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • Environ­ment Overview

      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • All Heavy Industry & Manufacturing
      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation and Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking and Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • Heavy Industry & Manufacturing Overview

      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • All Telecomm­unications
      • Carriers and Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • Telecomm­unications Overview

      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • All Consumer Products & Retail
      • Animals & Pets
      • Beers, Wines and Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food & Beverages
      • Furniture and Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • Consumer Products & Retail Overview

      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • Entertain­ment & Media Overview

      • View All Entertain­ment & Media

      • Health

      • All Health
      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • Health Overview

      • View All Health

      • Sports

      • All Sports
      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • Sports Overview

      • View All Sports

      • Travel

      • All Travel
      • Amusement Parks and Tourist Attractions
      • Gambling & Casinos
      • Hotels and Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • Travel Overview

      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • All Policy & Public Interest
      • Advocacy Group Opinion
      • Animal Welfare
      • Congressional & Presidential Campaigns
      • Corporate Social Responsibility
      • Domestic Policy
      • Economic News, Trends, Analysis
      • Education
      • Environmental
      • European Government
      • FDA Approval
      • Federal and State Legislation
      • Federal Executive Branch & Agency
      • Foreign Policy & International Affairs
      • Homeland Security
      • Labor & Union
      • Legal Issues
      • Natural Disasters
      • Not For Profit
      • Patent Law
      • Public Safety
      • Trade Policy
      • U.S. State Policy
      • Policy & Public Interest Overview

      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • All People & Culture
      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • People & Culture Overview

      • View All People & Culture

      • In-Language News

      • español
      • português
      • Česko
      • Danmark
      • Deutschland
      • España
      • France
      • Italia
      • Nederland
      • Norge
      • Polska
      • Portugal
      • Россия
      • Slovensko
      • Suomi
      • Sverige
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • Sponsored Placement
  • All Products
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • PR Newswire: news distribution, targeting and monitoring
  • Send a Release
    • ALL CONTACT INFO
    • Contact Us

      888-776-0942
      from 8 AM - 10 PM ET

  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • News in Focus
    • Browse All News
    • Multimedia Gallery
    • Trending Topics
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • All Products
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR

FDA Takes New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

News provided by

U.S. Food and Drug Administration

Feb 25, 2020, 10:57 ET

Share this article

Share this article


SILVER SPRING, Md., Feb. 25, 2020 /PRNewswire/ -- Today, we are taking several important steps to make the use of laparoscopic power morcellators (LPMs) safer in gynecologic surgeries, including granting marketing authorization for updated labeling of the PneumoLiner containment system (a device that contains tissue to be morcellated during certain gynecologic surgeries), releasing a draft guidance recommending the addition of specific safety information to the product labeling for LPMs, and issuing a Safety Communication recommending that an LPM only be used in certain gynecologic surgeries with a containment system that is compatible with the LPM. 

LPMs are used during laparoscopic (minimally invasive) surgeries to cut tissue into smaller pieces so the tissue can be removed through a small incision site. These devices can be used in a variety of surgeries, including various gynecologic surgeries such as a myomectomy, a surgical procedure to remove uterine fibroids from a woman's uterus. While laparoscopic surgeries are associated with shorter post-operative recovery time and a reduced risk of infection compared to traditional surgery, there are known risks associated with the use of LPMs, specifically in gynecologic surgeries. For example, current scientific evidence indicates that cancerous tissue may be present in uterine fibroids presumed to be benign (non-cancerous). When LPMs are used in surgeries where unsuspected cancerous tissue is present, there is a risk that morcellation could spread cancerous tissue throughout the body, decreasing a woman's long-term survival.

The FDA has taken many actions over the years to ensure the safe and effective use of LPMs. Some of these actions include the issuance of a Safety Communication, holding a panel meeting to seek outside expert opinions, issuance of an FDA guidance recommending the addition of safety statements to the labeling for LPMs, and ensuring that up-to-date information regarding LPMs for gynecologic use is publicly available on the agency's website.

In 2016, the FDA authorized the use of a first-of-kind tissue containment system, called the PneumoLiner, for use with certain LPMs to isolate uterine tissue that is not suspected to contain cancer. The device includes a containment bag where the tissue to be removed is placed in the bag and sealed such that morcellated tissue is not spread throughout the abdominal cavity during the morcellation process. Although the device effectively contains morcellated tissue, to ensure that the benefits of this device continued to outweigh the risks, this device was only authorized for use in specific patient populations, including women without uterine fibroids undergoing hysterectomy and pre-menopausal women with fibroids who wish to maintain their fertility. We also required specific warnings to be included in the labeling so that both patients and health care providers were aware of the risks of morcellation during certain gynecologic procedures.

Today, we are providing marketing authorization for the PneumoLiner containment system with updated labeling. While the device itself remains unchanged since its prior marketing authorization, today's clearance updates the labeling for this device to better define the appropriate patient population for the safe and effective use of this device, including stating that the device should only be used in women who have fibroids if they are pre-menopausal and under 50 years old. The likelihood of unsuspected cancer in women undergoing hysterectomy or myomectomy increases with age such that the benefit-risk profile of using LPMs is worse in older women when compared to younger women.

In addition to our efforts to ensure these devices are used in the appropriate patient population, as uncontained power morcellation has been associated with the spread of cancerous tissue, we are issuing draft guidance proposing to update our recommendations in the 2014 final guidance concerning the content and format of certain labeling information for LPMs. Specifically, the FDA is recommending that the labeling of LPMs include contraindications and warnings highlighting the following information regarding the risks of use of LPMs in gynecologic surgeries:

  • The risk of occult cancer, including uterine sarcoma, increases with age, particularly in women over 50 years of age. This information should be shared with patients when considering surgery with the use of these devices.
  • Uncontained power morcellation has been associated with the spread of benign uterine tissue, i.e., parasitic myomas and disseminated peritoneal leiomyomatosis.
  • Laparoscopic power morcellators should only be used with a containment system. The containment system should be compatible with the laparoscopic power morcellator.
  • Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
  • Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are post-menopausal or over 50 years of age, or candidates for en bloc tissue removal through the vagina or via a mini-laparotomy incision.

We believe that the inclusion of accurate and detailed information in the labeling for LPMs, such as what is recommended in the draft guidance, will help both health care providers and patients understand the risks of using these devices, and aid in their decision to determine whether morcellation could be appropriate for them. 

Finally, today we are issuing an updated Safety Communication that provides important information to patients and health care providers on the risks associated with LPMs when used in certain gynecologic surgeries. This Safety Communication now recommends that an LPM only be used in certain surgeries with a containment system that is compatible with the LPM. This communication also contains recommendations for patients and health care providers if they are considering using LPMs for gynecologic surgery—such as discussing the risks and benefits of all available treatments options to determine whether morcellation is appropriate—and provides specific questions that patients can use to start a dialogue with their physician.  

Ensuring the safety of women's health devices, including LPMs, remains a top priority for the agency. In taking these actions and making these recommendations, we considered available scientific information pertaining to the risk of spreading uterine tissue with uncontained power morcellation during gynecologic surgeries. We will continue to review information on laparoscopic power morcellation, including the latest data and evolving scientific literature, and are committed to continued communication to the public regarding our current thinking.  

Additional Resources:

  • Laparoscopic Power Morcellators FDA web page
  • UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate [Safety Communication]
  • Product Labeling for Laparoscopic Power Morcellators Draft Guidance for Industry and Food and Drug Administration Staff

Media Contact: Alison Hunt, 240-402-0764
Consumer Inquiries: Email or 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

 

SOURCE U.S. Food and Drug Administration

Related Links

http://www.fda.gov

Modal title

Also from this source

FDA Releases Action Plan for Rare Neurodegenerative Diseases,...

FDA Releases Action Plan for Rare Neurodegenerative Diseases,...


FDA Denies Authorization to Market JUUL Products...

FDA Denies Authorization to Market JUUL Products...

Explore

More news releases in similar topics

  • Medical Pharmaceuticals
  • Pharmaceuticals
  • Health Care & Hospitals
  • Biotechnology

Contact Cision

  • Cision Distribution 888-776-0942
    from 8 AM - 9 PM ET

  • Chat with an Expert
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices

Products

  • Cision Communication Cloud®
  • For Marketers
  • For Public Relations
  • For IR & Compliance
  • For Agency
  • For Small Business
  • All Products

About

  • About PR Newswire
  • About Cision
  • Become a Publishing Partner
  • Become a Channel Partner
  • Careers
  • COVID-19 Resources
  • Accessibility Statement
  • Asia
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Mexico
  • Middle East
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

My Services

  • All New Releases
  • Online Member Center
  • ProfNet

Contact Cision

Products

About

My Services
  • All News Releases
  • Online Member Center
  • ProfNet
Cision Distribution Helpline
888-776-0942
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2022 Cision US Inc.