By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    improving patient experience
    6 Ways to Improve Patient Satisfaction Within Hospitals
    December 1, 2021
    degree for healthcare job
    What Are The Health Benefits Of Having A Degree?
    March 9, 2022
    custom software development is changing healthcare
    Digital Customer Journey Mapping and its Importance for Healthcare
    July 21, 2022
    Latest News
    Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
    May 16, 2025
    Learn how to Renew your Medical Card in West Virginia
    May 16, 2025
    Choosing the Right Supplement Manufacturer for Your Brand
    May 1, 2025
    Engineering Temporary Hospitals for Extreme Weather
    April 24, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    Can Thinking Younger Make You Live Longer?
    April 20, 2011
    Image
    Obesity’s Outlook Unchanged
    June 13, 2011
    When It’s An Emergency Elderly Not Treated As Well in Hospitals
    July 16, 2011
    Latest News
    Building Smarter Care Teams: Aligning Roles, Structure, and Clinical Expertise
    May 18, 2025
    The Critical Role of Healthcare in Personal Injury Recovery: A Comprehensive Guide for Victims
    May 14, 2025
    The Backbone of Successful Trials: Clinical Data Management
    April 28, 2025
    Advancing Your Healthcare Career through Education and Specialization
    April 16, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: Registries for Breast Implants?
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Technology > Medical Devices > Registries for Breast Implants?
Medical Devices

Registries for Breast Implants?

gooznews
Last updated: September 1, 2011 12:41 pm
gooznews
Share
3 Min Read
SHARE

I’m sorry I couldn’t attend the Food and Drug Administration advisory committee meeting the past two days that learned the two manufacturers of silicone gel breast implants — Allergan and Mentor — failed miserably in enrolling sufficient women for the required follow-up studies of their safety.  According to MedPage Today, “Allergan has mustered only about a 60% follow-up rate after two yea

I’m sorry I couldn’t attend the Food and Drug Administration advisory committee meeting the past two days that learned the two manufacturers of silicone gel breast implants — Allergan and Mentor — failed miserably in enrolling sufficient women for the required follow-up studies of their safety.  According to MedPage Today, “Allergan has mustered only about a 60% follow-up rate after two years for its studies — far short of the goal of 93% — and only one in four patients who received a Mentor implant were followed up after two years.”

I’m sorry I wasn’t there because I would like to have heard the tenor of the questions coming from the outside advisors, and the FDA presentation. What was the company’s excuse? It turns out that both companies asked participants in the studies to complete 25-page questionnaires every year! No wonder most women said “no thanks.”

The advisory committee’s solution? Set up a registry, which will depend on plastic surgeons following their patients and reporting outcomes data. Good lord. Why should we think a voluntary reporting system that relies on the good will of hundreds if not thousands of surgeons, few of whom are reimbursed by insurance and most of whose clientele is more concerned about breast size than health, will be any more successful in collecting data than demanding that two  companies collect the data? It seems to me the companies should be the ones required to set up a fool-proof system for conducting the required decade-long studies. And if they fail to enroll sufficient patients in such studies within the next two years, the devices should be pulled from the market. This will provide Allergan and Mentor with the proper incentives for gathering the requisite information for learning definitively whether there are serious health concerns associated with long-term use of silicone gel breast implants.

More Read

Screen Shot 2015-09-02 at 2.15.28 PM
The Future (Ours) is in China for Medtech
Reducing Readmissions and Costs for Total Joint Replacement
How Big Data Hadoop Can Save Patients from a Crippling Healthcare System
Mobile Health Around the Globe: EyeNetra Offers SmartPhone Eye Diagnostics
Prefilled Syringes: A Ready Answer to Saving Billions of Dollars and Mitigating Medical Errors
TAGGED:breast implant registrybreast implantsmedical devices
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

Clinical Expertise
Building Smarter Care Teams: Aligning Roles, Structure, and Clinical Expertise
Health care
May 18, 2025
Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
Health
May 15, 2025
Learn how to Renew your Medical Card in West Virginia
Learn how to Renew your Medical Card in West Virginia
Health
May 15, 2025
Dr. Klaus Rentrop Shares Acute Myocardial Infarction heart treatment
Dr. Klaus Rentrop Shares Acute Myocardial Infarction
Cardiology
May 13, 2025

You Might also Like

Wi-Fi Alliance® and Continua® Health Alliance Collaborate on Personal Connected Health

February 22, 2011
Health careMedical Devices

What Goes Into The Cost Of A CT Scanner?

October 11, 2019
patient centricity healthcare marketing
BusinesseHealthMedical DevicesMedical InnovationsMobile HealthSocial Media

Patient Centricity and Healthcare Marketing

March 15, 2016

DaVinci Robot Fails to Start During Prostate Cancer Surgery

December 17, 2011
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?