• Popular
    • Medicine
    • Radiology
    • Cardiology
    • Surgery
    • Nanomedicine
    • Military Medicine
    • Rehab
  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS
  • Submit PR
  • Log in
Medgadget
Medgadget
  • Popular
    • Medicine
      Biobots Use Optogenetic Muscle Actuators for Movement

      Biobots Use Optogenetic Muscle Actuators for Movement

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Medgadget Visits Healthcareᐩ Expo Taiwan

      Medgadget Visits Healthcareᐩ Expo Taiwan

      Camera Measures Blood Pressure with Quick Look

      Camera Measures Blood Pressure with Quick Look

    • Radiology
      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Fluorescence Imaging System Illuminates Tumor Depth

      Fluorescence Imaging System Illuminates Tumor Depth

      Soft Robot Grows Like a Plant to Travel Through Tight Spaces

      Soft Robot Grows Like a Plant to Travel Through Tight Spaces

      Mining Ultrasound Data to Improve Liver Diagnostics: Interview with Beth Rogozinski, CEO at Oncoustics

      Mining Ultrasound Data to Improve Liver Diagnostics: Interview with Beth Rogozinski, CEO at Oncoustics

    • Cardiology
      Belt Monitors Heart Failure Patients

      Belt Monitors Heart Failure Patients

      Camera Measures Blood Pressure with Quick Look

      Camera Measures Blood Pressure with Quick Look

      Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

      Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

    • Surgery
      Biobots Use Optogenetic Muscle Actuators for Movement

      Biobots Use Optogenetic Muscle Actuators for Movement

      Implantable Device Adheres to Muscle, Treats Atrophy

      Implantable Device Adheres to Muscle, Treats Atrophy

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

      Electrospun Construct Mimics Elasticity of Blood Vessels

      Electrospun Construct Mimics Elasticity of Blood Vessels

    • Nanomedicine
      Extra Hot Nanoparticles for Cancer Therapy

      Extra Hot Nanoparticles for Cancer Therapy

      Making Tumors Tastier for the Immune System

      Making Tumors Tastier for the Immune System

      Improved Membrane Coating for Anti-Cancer Nanoparticles

      Improved Membrane Coating for Anti-Cancer Nanoparticles

      Magnetic Bacteria Target Tumors

      Magnetic Bacteria Target Tumors

    • Military Medicine
      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

      Fingertip Sensor Measures Lithium Levels in Sweat

      Fingertip Sensor Measures Lithium Levels in Sweat

      Fabric Makes Electricity from Movement to Power Wearables

      Fabric Makes Electricity from Movement to Power Wearables

      Wearable Uses Microneedles to Track Metabolism

      Wearable Uses Microneedles to Track Metabolism

    • Rehab
      Implantable Device Adheres to Muscle, Treats Atrophy

      Implantable Device Adheres to Muscle, Treats Atrophy

      Non-Invasive Spinal Modulation for Cerebral Palsy

      Non-Invasive Spinal Modulation for Cerebral Palsy

      Implanted Magnets for Prosthetic Control

      Implanted Magnets for Prosthetic Control

      FDA-Approved At-Home Spirometer: Interview with Charvi Shetty, Co-Founder and CEO at Aluna

      FDA-Approved At-Home Spirometer: Interview with Charvi Shetty, Co-Founder and CEO at Aluna

  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Log in
  • Submit PR
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS

Now we really are surprised

April 13th, 2005 Medgadget Editors Society

An FDA group of advisors has changed its view and recommended allowing women to obtain silicone breast implants, from Mentor Corporation, with certain reservations. It is not clear how this decision relates to a recent ruling we wrote about (Inamed Corp implants). But the FDA advisors have suggested the following set of guidelines, according to the Associated Press:

— Prospective patients must sign consent forms acknowledging implant risks, including that they ultimately may break and require removal or replacement.
— Mentor may sell silicone implants only to board-certified plastic surgeons who complete special hands-on training to insert implants in a way that minimizes odds of breakage.
— Mentor must open a registry to track how patients fare long-term, and it must continue more formal studies to nail down how often implants rupture within 10 years, something no one yet knows.
— Mentor must warn that because implant breaks don’t cause immediate symptoms, patients should get an MRI scan five years after implant insertion and every two years after that. They should consider having broken implants removed to minimize risk of silicone oozing into the breast, or beyond.
“We are holding it to higher standards than other implants,” said FDA adviser Stephen Li, a Florida medical device-testing expert. “This device has a 30-year history that, at best, is checkered. Given that history, it behooves us to have a higher standard.”

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

Sponsored
New Clarius Power Fan HD3 Delivers a First for Handheld Ultrasound: Continuous Scanning

New Clarius Power Fan HD3 Delivers a First for Handheld Ultrasound: Continuous Scanning

Fluidx Unveils New Embolic for Neurovascular Use

Fluidx Unveils New Embolic for Neurovascular Use

Annalise.ai and Nuance Communications (a Microsoft Company) Announce Key Partnership to Improve Patient Outcomes with Workflow-Integrated AI

Annalise.ai and Nuance Communications (a Microsoft Company) Announce Key Partnership to Improve Patient Outcomes with Workflow-Integrated AI

PT Genie Unveils New Brand Identity Reflecting Company’s Transformation and Focus on the Global Future of AI and Machine Learning in Digital Healthcare

Clarius Marketplace Unlocks the Power of AI Innovation for Ultrasound Imaging

Clarius Marketplace Unlocks the Power of AI Innovation for Ultrasound Imaging

interviews & reviews
Balance Boards to Stay Active in the Offfice: Interview with Joel Heath, CEO of FluidStance 

Balance Boards to Stay Active in the Offfice: Interview with Joel Heath, CEO of FluidStance 

Exciting Medtech at the Healthcareᐩ Expo Taiwan

Exciting Medtech at the Healthcareᐩ Expo Taiwan

Medgadget Visits Healthcareᐩ Expo Taiwan

Medgadget Visits Healthcareᐩ Expo Taiwan

Diabetes Management Tech for Type II patients: Interview with Jeffrey Brewer, CEO of Bigfoot Biomedical

Diabetes Management Tech for Type II patients: Interview with Jeffrey Brewer, CEO of Bigfoot Biomedical

Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

In-Office Pediatric Ear Tube Procedures: Interview with Preceptis Medical's Greg Mielke

In-Office Pediatric Ear Tube Procedures: Interview with Preceptis Medical's Greg Mielke

Symani Microsurgical Robotic System: Interview with Mark Toland, CEO of Medical Microinstruments

Symani Microsurgical Robotic System: Interview with Mark Toland, CEO of Medical Microinstruments

  • Subscribe
  • Contact us
  • Submit
  • About
  • Back to top
Medgadget

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

  • About
  • Editorial policies
  • Contact
  • Terms of Service
  • Privacy
  • Submit press release
  • Advertise
© Medgadget, Inc. All rights reserved. | The Medical Revolution Will Be Blogged.
Please support this website by adding us to your whitelist in your ad blocker. Ads are what helps us bring you premium content! Thank you!
Posting....
  • Facebook
  • Twitter
  • LinkedIn
  • Reddit
  • Email