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Earl's View

~ News and Views

Earl's View

Category Archives: FDA Warning

How does the FDA ‘approve’ medical products? – Medical News Today

February 22, 2014

Source article for full text: How does the FDA ‘approve’ medical products? – Medical News Today. How does the FDA ‘approve’ …

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FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers

July 29, 2012

FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers. FDA Employee Surveillance May Indicate …

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Hip implant materials swing sharply to polyethylene | PlasticsToday.com

July 15, 2012

Hip implant materials swing sharply to polyethylene | PlasticsToday.com. Hip implant materials swing sharply to polyethylene By Doug Smock Published: …

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Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1

July 8, 2012

June 27 2012 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1 Click the link below …

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DePuy Exec’s seem to think money comes first – F.D.A. Asked DePuy for Safety Data Just Before Hip Implant’s Phaseout – NYTimes.com

March 24, 2012

F.D.A. Asked DePuy for Safety Data Just Before Hip Implant’s Phaseout – NYTimes.com. Hip Device Phaseout Followed F.D.A. Data Request …

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Johnson & Johnson hit with FDA warning letter | MassDevice – Medical Device Industry News

January 14, 2012

Johnson & Johnson hit with FDA warning letter | MassDevice – Medical Device Industry News. Johnson & Johnson hit with …

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Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

January 7, 2012

Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and …

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Howards View on the FDA and Medical Device Failures

January 7, 2012

Recent Information from the FDA on Failures This information came from FDA news. The FDA says approximately 44% of device …

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Rottenstein Law Group Commends Subcommittee Recommendation of Greater Investigation of Metal-on-Metal Hips to Curb Under-regulation at USFDA

October 24, 2011

Rottenstein Law Group Commends Subcommittee Recommendation of Greater Investigation of Metal-on-Metal Hips to Curb Under-regulation at USFDA The Rottenstein Law …

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US Drug Watchdog Says It’s Urgent They Identify All Recalled DePuy ASR Hip Implant Recipients

October 7, 2011

US Drug Watchdog Says It’s Urgent They Identify All Recalled DePuy ASR Hip Implant Recipients & Applauds NBC News For …

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Spike in Metal-on-Metal Hip Implant Complaints May Point to Looming Disaster

August 28, 2011

Spike in Metal-on-Metal Hip Implant Complaints May Point to Looming Disaster Date Published: Wednesday, August 24th, 2011 Source; News Inferno …

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The rate at which FDA issues 483s and warning letters is going up, up, up.

August 25, 2011

The rate at which FDA issues 483s and warning letters is going up, up, up. Source: FDA email circular advertising …

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FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices

August 20, 2011

FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices August 19, 2011  Source: Medical Design Online For the first …

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IOM chair discusses 510(k) report: origins, findings, response

August 18, 2011

IOM chair discusses 510(k) report: origins, findings, response Written by Brian Dunham   August 15, 2011 Source: Cardiovascular Business David …

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FDA Loosens Premarket Notification Requirements for 30 Medical Device Types

August 15, 2011

FDA Loosens Premarket Notification Requirements for 30 Medical Device Types Written by: mdcieditor Wednesday, August 10th, 2011 | FDA Medical …

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Sadwin gets to the heart of the Issues with FDA 510(k)

August 14, 2011

Sadwin gets to the heart of the Issues with FDA 510(k) I spend a good part of my day keeping …

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Medical Devices — Balancing Regulation and Innovation

August 13, 2011

Medical Devices — Balancing Regulation and Innovation NEJM | August 10, 2011 | Topics: Drugs, Devices, and the FDA Gregory D. …

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IOM Gives FDA The wrong prescription on medical devices & 510(k)

August 7, 2011

  Editorial: The wrong prescription on medical devices Article by: EDITORIAL , Star Tribune Updated: August 6, 2011 – 6:19 …

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Hips and Hip Replacements: What you need to know

August 7, 2011

Hips and Hip Replacements: What you need to know by Thomas W. Miller Ph.D. ABPP, Staff Writer Published Online Aug …

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Recalled DePuy ASR Hip Implant Failure Leads to Lawsuit Filed by the Law Offices of John David Hart

August 7, 2011

Recalled DePuy ASR Hip Implant Failure Leads to Lawsuit Filed by the Law Offices of John David Hart Pecos, New …

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How Safe Are Medical Devices?

August 5, 2011

How Safe Are Medical Devices? Published: August 4, 2011 New York Times A prestigious medical group is concerned that most …

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How ‘Bout Smith & Nephew

August 4, 2011

How ‘Bout Smith & Nephew posted by Karen on 02 Aug 2011 at 6:34 pm All this data refers to …

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Did IOM Put the Final Nail in the Coffin of Metal-on-Metal Hip Implants?

August 4, 2011

Did IOM Put the Final Nail in the Coffin of Metal-on-Metal Hip Implants? Published: August 3, 2011—Shana Leonard Source: MPMN …

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New Chromium and Cobalt Test to Assist the Medical Community

August 4, 2011

August 03, 2011 10:07 AM Eastern Daylight Time NMS Labs Announces Its New Chromium and Cobalt Test to Assist the Medical …

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FDA Seeks Public Views on Proposed 510(k) Plans

August 2, 2011

FDA Seeks Public Views on Proposed 510(k) Plans August 01, 2011 By a GenomeWeb staff reporter NEW YORK (GenomeWeb News) …

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South Australia – DePuy Hip implant class action grows

August 1, 2011

Hip implant class action grows David Jean From The Advertiser August 01, 2011 12:00AM An orthopedic surgeon studies a patient’s …

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Report: FDA’s Medical Device Approval Process Is Flawed

July 31, 2011

Report: FDA’s Medical Device Approval Process Is Flawed Source: Click here MINNEAPOLIS (WCCO) – More than 100 medical devices have been …

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510(k) approval process is too big to fail no matter how flawed it may be

July 31, 2011

7.29.11 | Arundhati Parmar Source: MedCityNews 510(k) approval process is too big to fail no matter how flawed it may …

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Barry Meier – Approval process for devices blasted

July 31, 2011

Approval process for devices blasted Barry Meier The Boston Globe July 30, 2011 The govern­ment’s system for reg­u­lating many med­ical …

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Sadwin Comments on Washington Post Article – Letter to Authors

July 31, 2011

Refer to: Advisory panel calls for revamping FDA approval process for medical devices Good morning: I just read your article …

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Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process

July 31, 2011

Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process The report has been released Friday 29 …

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Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs

July 30, 2011

Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs Source: FDA Website Statement …

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FDA 510K Process – Another Issue – Risky pelvic mesh highlights worries about FDA process

July 30, 2011

Risky pelvic mesh highlights worries about FDA process Untested medical devices found to erode patients’ insides Source: MSNBC.com By Rita Rubin; …

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‘Metal on metal’ hip implants leave some recipients in pain, at risk

July 24, 2011

‘Metal on metal’ hip implants leave some recipients in pain, at risk By Anita Creamer; The Sacramento Bee – click …

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Kohl: FDA’s Post-Market Review of Hip Implants Welcome, But More Scrutiny Needed

July 17, 2011

Kohl: FDA’s Post-Market Review of Hip Implants Welcome, But More Scrutiny Needed [Targeted News Service] WASHINGTON, May 24 — The …

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FDA Letter to: Smith & Nephew Orthopaedics Gmbh 12/21/10

July 10, 2011

FDA Letter to: Smith & Nephew Orthopaedics Gmbh 12/21/10 Department of Health and Human Services Public Health ServiceFood and Drug …

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How to use this Blog – Click on BLOG to get to Home Page

There are over 1,600 posts on this site - and about 30 pages too. The best way to find what you want is to type in the search box.

The front page (home) has the latest post and immediately below it, the last 100 or so which you can click and surf through.

I would love to record your story - we have so much in common I am sure - send it to me via the contact page & then I will be in touch.

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Blogroll

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Facebook

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Government Agencies

  • FDA Information on Metal on Metal Hips
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Hip Info Sites

  • DePuy Hip Recall Information
  • DePuy Victims Blog – for anyone
  • Failed Implant Device Alliance
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  • Metal Hip Problems in the UK – S&N Hip Problems
  • Smith & Nephew Hip Problems – Levin Law
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  • UK – Metal Hip Problems

Legal Help

  • Anapol Schwartz
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  • Transvaginal Mesh Information and Legal Help
  • Viles & Beckman LLC.
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Medical Help

  • Doctor Q/A: Ask Medical Questions
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My Links

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Natural Treatments

  • Natural Treatments and Exercises for Osteoarthritis Pain Relief
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Recent Posts

  • Detailed briefing for FDA on the complications of CoCr arthroprosthetic Metallosis – Dr Stephen Tower
  • Open Letter from Drs Tower & Bridges to Senator Murkowski
  • Dr Steve Tower update for Producers of the Netflix documentary – The Bleeding Edge
  • New hip resurfacing implant could lead to better outcomes for patients?
  • A MAN DESTOYED: THE BIRMINGHAM HIP RESURFACING DISTASTER

Top Posts

  • Australia - Amanda Keller had a hip replacement operation
  • Longer Cemented Stems Better in Hip Revisions
  • Hip Replacement A- Z - All you Need to Know
  • Staple Closure - Greater Than 3 Times The Risk of Infection
  • History - Smith & Nephew Knee Implant Recall - 2003; Oxinium
  • Does Hip Replacement Run in Families - In this Case, Yes...
  • Linda - Metallosis NHS Linda’s story (UK)
  • Mr. Michael Solomon, Sydney Australia Surgeon Gives Advice on Hip Replacement
  • Smith & Nephew's :Response to Wright Medical Technology's Citizen's Petition to Deny PPrIA P040033
  • Wright Medical Filed Petition to Block Smith & Nephews Metal Implant

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