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Earl's View

~ News and Views

Earl's View

Tag Archives: Food & Drug Administration

My Hip Replacement Operation by James Howard Kunstler

July 1, 2012

My Hip Replacement Operation by James Howard Kunstler. My Bad Hip – A Melodrama in Three Acts – With Additional Notes by …

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Emotions Can Affect Recovery From Hip Surgery

July 1, 2012

Emotions Can Affect Recovery From Hip Surgery. Emotions Can Affect Recovery From Hip Surgery ScienceDaily (June 26, 2007) — Orthopaedic …

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SMART IDEA :: Technology could monitor hip replacements for signs of wear | News | The Engineer

July 1, 2012

Technology could monitor hip replacements for signs of wear | News | The Engineer. Technology could monitor hip replacements for …

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FDA Reports16,800 Metal On Metal Hip Implant Adverse Events

July 1, 2012

FDA Reports16,800 Metal On Metal Hip Implant Adverse Events | The Legal Examiner Phoenix. FDA Reports16,800 Metal On Metal Hip …

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STRYKER REJUVENATE HIP IMPLANT RECALLED | West Palm Beach Personal Injury Attorneys Blog

July 1, 2012

STRYKER REJUVENATE HIP IMPLANT RECALLED | West Palm Beach Personal Injury Attorneys Blog. By Ami Romanelli posted in Products liability …

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DePuy Pinnacle Hip Implant Failure Initiative Considered “Vital”

July 1, 2012

DePuy Pinnacle Hip Implant Failure Initiative Considered “Vital”. The U.S. Drug Watchdog has a goal of identifying every single one …

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FDA panel sees little use for metal-on-metal hips | CTVNews

July 1, 2012

FDA panel sees little use for metal-on-metal hips | CTVNews. The Associated Press; Published Friday, Jun. 29, 2012 8:25AM EDT This …

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Biomet Hip Lawsuit – Biomet Magnum Hip Implant

July 1, 2012

Biomet Hip Lawsuit Recent News | Seedol.com. Biomet Hip Lawsuit Recent News –  Biomet Magnum Hip Implant 06/29/2012 A Biomet Hip …

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FDA Probes Safety Issues Associated with Metal Hip Implants | Qmed

June 30, 2012

FDA Probes Safety Issues Associated with Metal Hip Implants | Qmed. FDA Probes Safety Issues Associated with Metal Hip Implants …

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FDA to study growing failure rate of metal hip devices – USATODAY.com

June 30, 2012

FDA to study growing failure rate of metal hip devices – USATODAY.com. The Food and Drug Administration is meeting with …

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Pennsylvania woman to address FDA panel on husband’s hip-replacement recall – Philly.com

June 30, 2012

Pennsylvania woman to address FDA panel on husband’s hip-replacement recall – Philly.com. Pennsylvania woman to address FDA panel on husband’s …

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FDA probes safety issues with metal hip implants

June 30, 2012

FDA probes safety issues with metal hip implants – Rolla, MO – The Rolla Daily News. WASHINGTON — Metal hip …

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Justice for Hip Failures: DePuy ASR Recall: Nearly 16,800 adverse events reported for metal-on-metal hips, including DePuy ASR and Biomet Magnum

June 30, 2012

Justice for Hip Failures: DePuy ASR Recall: Nearly 16,800 adverse events reported for metal-on-metal hips, including DePuy ASR and Biomet …

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Suffering of Thousands Prompts FDA Hearing about Hip Implants

June 30, 2012

Suffering of Thousands Prompts FDA Hearing about Hip Implants. Suffering of Thousands Prompts FDA Hearing about Hip Implants Thousands of …

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Safety Of All-Metal Hip Implants Under US Scrutiny – International Business Times

June 30, 2012

Safety Of All-Metal Hip Implants Under US Scrutiny – International Business Times. By Anna Yukhananov June 27, 2012 9:25 AM …

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FDA Considers Metal Hip Injuries — A Bit Too Late for Some Victims – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts

June 30, 2012

FDA Considers Metal Hip Injuries — A Bit Too Late for Some Victims – Florida Mass Tort Attorneys, Lawyers | …

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J&J Sold Transvaginal Mesh Implants After FDA Ordered Company To Cease Marketing – SFGate

June 30, 2012

J&J Sold Transvaginal Mesh Implants After FDA Ordered Company To Cease Marketing – SFGate. J&J Sold Transvaginal Mesh Implants After …

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Medical Device « The Senate Passes Unparalleled Medical Device User Fee Act

June 30, 2012

Medical Device « DePuy Recall Blog. The Senate Passes Unparalleled Medical Device User Fee Act When the Senate passed the resolution …

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FDA panel sees little use for metal-on-metal hips – SFGate

June 30, 2012

FDA panel sees little use for metal-on-metal hips – SFGate. FDA panel sees little use for metal-on-metal hips MATTHEW PERRONE, …

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Stuart’s update – The never ending ASR story! Another painful year goes by!

June 30, 2012

The never ending ASR story! Another painful year goes by! If I still had my Johnson and Johnson De Puy …

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Metal on Metal Hip Disaster – F.D.A. Hearing to Focus on Replacement Hips

June 27, 2012

F.D.A. Hearing to Focus on Replacement Hips By BARRY MEIER Published: June 26, 2012 The Food and Drug Administration will …

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Press release: MHRA tells surgeons to stop using R3 metal cup liner and extends patient monitoring advice : MHRA

June 26, 2012

MHRA tells surgeons to stop using R3 metal cup liner and extends patient monitoring advice Contact: Press Office 020 3080 …

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FiDA Failed Implant Device Alliance

June 26, 2012

FiDA Failed Implant Device Alliance. Failed metal on metal hips: U.S. lab rats! FDA probes safety issues with metal hip …

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FDA PMA – how this hides the guilty and stops The Damaged and Suffering from getting Justice – Smith & Nephew

June 17, 2012

Smith & Nephew BHR – How can a device manufacturer be denied by the FDA on a 3/2 vote in …

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Jack’s call for help – Legal help sought – Cormet Hip -Isn’t there some way to get beyond PMA preemptive device approval?

June 14, 2012

Legal help sought – Cormet Hip -Isn’t there some way to get beyond PMA preemptive device approval? Like so many …

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Comment Example: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

June 5, 2012

I thought it might be helpful to show what I sent in electronically in advance of the above referenced meeting, …

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Another S&N Victim spat out by the lawyers… Lives ruined and S&N gets off free….

June 3, 2012

Hi Howard, I just received the following message today when I checked my email: Dear Mr. Brooks, I obtained an …

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Thanks from Howard

June 3, 2012

Thank you Earl and your blog again and thank you  folks that have contacted me re: attorneys. I will let …

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Howard’s Lament – Lawyers dodge the tough jobs!

June 1, 2012

I am sharing my latest experience with a large law firm that did represent me up until yesterday. I received …

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FDA rule clears medical devices without human testing | devices, – News – The Orange County Register

May 24, 2012

FDA rule clears medical devices without human testing | devices, – News – The Orange County Register. Published: May 18, …

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Howard poses some important questions….

May 24, 2012

I am looking for a real answer to a real question- if the Catholic Church was held accountable for their …

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Recalls of Medical Devices and Consumer Products Rise to Kick-Off the New Year | ExpertRECALL | Recall Management, Product Retrieval, Recall Logistics

May 22, 2012

Recalls of Medical Devices and Consumer Products Rise to Kick-Off the New Year  Mike Rozembajgier 05-14-2012 By Mike RozembajgierMedical device …

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FDA’s $6.4 Billion Plan for Quick Reviews Moves to Senate – Businessweek

May 22, 2012

FDA’s $6.4 Billion Plan for Quick Reviews Moves to Senate – Businessweek. Medtronic’s capsure sense lead, a device that is …

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40’s Woman Ruined by Smith & Nephew Hip Implant

May 13, 2012

I am a 48 year old female who had a smith and nephew metal on metal hip implanted in 2007. …

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Preparing for Hip Replacement Surgery

May 13, 2012

Preparing for Hip Replacement Surgery. Hip replacement has become a common and safe procedure — about 285,000 people in the …

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Metal-Free, High-Tech Composite Hip Implant – TMD – Today’s Medical Developments

May 13, 2012

Metal-Free, High-Tech Composite Hip Implant – TMD – Today’s Medical Developments. Metal-Free, High-Tech Composite Hip Implant Some hip replacements do …

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German engineers develop a non-metal hip implant for long-term use | MassDevice.com On Call | MassDevice – Medical Device Industry News

May 13, 2012

German engineers develop a non-metal hip implant for long-term use | MassDevice.com On Call | MassDevice – Medical Device Industry …

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Smart orthopedic implants, devices on the way as OrthoSensor secures $15M

May 13, 2012

Smart orthopedic implants, devices on the way as OrthoSensor secures $15M. Talk about convergence. A health company that’s working in …

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Whitehall man with two defective hip implants wants to be heard by the FDA – mcall.com

May 12, 2012

Whitehall man with two defective hip implants wants to be heard by the FDA – mcall.com. By Milton D. Carrero, …

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Hip Replacement Crisis in Europe Causes Demand for Medical Device Registry

May 12, 2012

Hip Replacement Crisis in Europe Causes Demand for Medical Device Registry. The global medical crises of dangerous metal-on-metal hip implants …

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Metal-on-Metal Hip Implants – Advisories, Warnings & Recalls for the public

May 12, 2012

Metal-on-Metal Hip Implants – Advisories, Warnings & Recalls for the public. Public Communication – Health Canada Issued Important Safety Information …

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Health Canada Recommends Patients to Be Careful About Metal-On-Metal Hips | French Tribune

May 12, 2012

Health Canada Recommends Patients to Be Careful About Metal-On-Metal Hips | French Tribune. Submitted by Nimisha Sachdev on Thu, 05/10/2012 …

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Defective DePuy Hips: The Empire (Johnson & Johnson) Strikes Back :: Accident and Injury Lawyer Blog

May 12, 2012

Defective DePuy Hips: The Empire (Johnson & Johnson) Strikes Back :: Accident and Injury Lawyer Blog. May 10, 2012, by …

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Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG

May 12, 2012

Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG. Medical Implant Recalls Raises Questions about 510K Review …

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Another Lawsuit Filed Against DePuy over Pinnacle Hip Replacement device – Hip Implants – Zimbio

May 12, 2012

Another Lawsuit Filed Against DePuy over Pinnacle Hip Replacement device – Hip Implants – Zimbio. Another Lawsuit Filed Against DePuy …

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Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery – Hip Implants – Zimbio

May 12, 2012

Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery – Hip …

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Health Canada Issues Warning for Metal-on-Metal Hip Replacement Dangers – Hip Implants – Zimbio

May 12, 2012

Health Canada Issues Warning for Metal-on-Metal Hip Replacement Dangers – Hip Implants – Zimbio. Health Canada Issues Warning for Metal-on-Metal …

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FDA: ‘Streamlined’ Reporting Process re: Ortho/Rehab/Device Committee Meeting

May 3, 2012

This is just an idea on how we might make it easier on those of us who want to report …

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MoM Hip Victim Stories to the Orthopedic and Rehab Devices Panel of Med. Devices Advisory Commitee

May 1, 2012

I just want to emphasize how important it is for as many of us as possible to send in our …

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June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

April 27, 2012

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0293] Orthopaedic and Rehabilitation Devices Panel of the …

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Metals from hip replacements present toxic risk for millions, investigation warns

April 25, 2012

Metals from hip replacements present toxic risk for millions, investigation warns Ryan Jaslow (CBS News) Millions of people with metal …

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Howard shares more views

April 25, 2012

Medical News: has 2 articles, reiteration, (daily.headlines@medpagetoday.com). People must learn about this or nothing will happen other than the medical …

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Judge consolidates Wright Conserve hip replacements into MDL | Consumer Drug Report | For Informed Drug Consumers

March 24, 2012

Judge consolidates Wright Conserve hip replacements into MDL | Consumer Drug Report | For Informed Drug Consumers. Judge consolidates Wright …

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What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs

March 24, 2012

What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs. What is the Status of …

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Rottenstein Law Group Incensed–But Not Surprised–by News That Johnson & Johnson Marketed Vaginal Mesh Implant Without FDA Approval

March 24, 2012

Rottenstein Law Group Incensed–But Not Surprised–by News That Johnson & Johnson Marketed Vaginal Mesh Implant Without FDA Approval. Rottenstein Law …

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200 Irish Patients Plan DePuy ASR Hip Implant Lawsuit | NewsInferno

March 24, 2012

200 Irish Patients Plan DePuy ASR Hip Implant Lawsuit | NewsInferno. 200 Irish Patients Plan DePuy ASR Hip Implant Lawsuit …

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FDA Confirms Johnson & Johnson Prolift Pelvic Mesh Product Sold for Over 3 Years without Necessary FDA Clearance

March 24, 2012

FDA Confirms Johnson & Johnson Prolift Pelvic Mesh Product Sold for Over 3 Years without Necessary FDA Clearance. The FDA …

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Senators Introduce Safe Medical Devices Act

March 24, 2012

Senators Introduce Safe Medical Devices Act. Senators Introduce ‘Safe Medical Devices Act’ A bipartisan group of U.S. senators is pushing …

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FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra

March 24, 2012

FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra. …

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Gynecare Prolift Mesh Sold by J&J Without FDA Approval | InjuryBoard Fort Worth

March 24, 2012

Gynecare Prolift Mesh Sold by J&J Without FDA Approval | InjuryBoard Fort Worth. Gynecare Prolift Mesh Sold by J&J Without …

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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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Stuart’s nightmare gets worse – DePuy ASR is the curse of our generation

March 21, 2012

The ASR, just when I thought it was over, its the gift that keeps on giving!! Well, the second opinion …

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Consumer Reports Poll: Consumers Support More Medical Device Oversight

March 21, 2012

Consumer Reports Poll: Consumers Support More Medical Device Oversight Posted: 20 Mar 2012 07:38 AM PDT CONSUMERS UNION NEWS RELEASE     …

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Hip patients: Why weren’t we told? – National – NZ Herald News

March 17, 2012

Hip patients: Why weren’t we told? – National – NZ Herald News. Hip patients: Why weren’t we told? By Phil …

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British doctors urge against metal hip joints – Boston.com

March 14, 2012

British doctors urge against metal hip joints – Boston.com. British doctors urge against metal hip joints By Maria Cheng AP …

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Metal-on-Metal Hips Need Work More Quickly

March 14, 2012

  By John Gever, Senior Editor, MedPage Today Published: March 12, 2012 Revision of total hip replacement surgery within five years …

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Consumer Reports taps ire over bad medical devices

March 14, 2012

(Reuters) – Consumer Reports, the 76-year-old publication best known for its reviews of automobiles and refrigerators, is trying to galvanize …

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Howard Sadwin’s Suffering from Metal-on-Metal Hip Implant | Mesh Medical Device Newsdesk

March 7, 2012

Howard Sadwin’s Suffering from Metal-on-Metal Hip Implant | Mesh Medical Device Newsdesk. Suffering in Silence: Howard Sadwin’s Story of Metal-on-Metal …

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Metal-on-Metal Hip Implants > Concerns about Metal-on-Metal Hip Implant Systems

March 3, 2012

Metal-on-Metal Hip Implants > Concerns about Metal-on-Metal Hip Implant Systems. Concerns about Metal-on-Metal Hip Implant Systems All artificial hip replacement …

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Metal Hips in Britain Require Longer Monitoring, Regulators Say – NYTimes.com

March 1, 2012

Metal Hips in Britain Require Longer Monitoring, Regulators Say – NYTimes.com. Britain Extends Monitoring for People With Metal Hips By …

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DePuy ASR – Make Your own mind up – Document – 2009 E-Mail on Hip Device – NYTimes.com

February 23, 2012

Document – 2009 E-Mail on Hip Device – NYTimes.com. Document: 2009 E-Mail on Hip Device Published: February 21, 2012 RelatedIn …

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Stuart Asks: “Where to from here?”

February 19, 2012

“Where to from here?” I have spent a great deal of time contemplating this weekend as you may have seen …

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J&J DePuy – Hip Implant that U.S. Rejected Was Sold Overseas

February 16, 2012

Hip Implant U.S. Rejected Was Sold Overseas By BARRY MEIER Published: February 14, 2012 The health care products giant Johnson & …

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Anon. replies to Katie’s Smith & Nephew BHR torment…

February 2, 2012

Hi Katie, I too am living in BHR MOM hell at present, and I am awaiting results on trace metal …

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Kiwis told of implant poison risk – Metal on Metal

January 31, 2012

My View: in this article the medical “authority says only DePuy metal on metal hips are a problem (abridged)” – …

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Mark’s Story – another Smith & Nephew BHR disaster – 18 Months

January 26, 2012

Yesterday I was told the total hip resurfacing Smith and Nephew I received 9/2010 must be removed. They are doing …

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The Power of the Birmingham Hip Resurfacing – NOT

January 21, 2012

Howard Sadwin – robbed of life Many of you will have read Howard Sadwin’s story and comments over the last …

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FDA warns J&J’s DePuy unit over joint replacements – AlertNet

January 19, 2012

FDA warns J&J’s DePuy unit over joint replacements – AlertNet. FDA warns J&J’s DePuy unit over joint replacements 18 Jan …

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Novel – Dual Pivot Hip | Hip Replacement, Total Hip Replacement | Total Joint Joint

January 15, 2012

Dual Pivot Hip | Hip Replacement, Total Hip Replacement | Total Joint Joint. Dual Pivot Hip Jan,13,2012 16:39 Filed in: …

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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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Biomet Receives FDA Clearance for Two New Products

January 12, 2012

Biomet Receives FDA Clearance for Two New Products: E1(R) Humeral Bearing for the Comprehensive(R) Reverse Shoulder System and the Comprehensive(R) …

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Katie’s Full Story – Metal on Metal BHR Mess

January 10, 2012

Hello Earl The following is an account of my personal experience with osteoarthritis, our healthcare system, and the Birmingham Hip …

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Mesh Medical Device Newsdesk

January 8, 2012

Mesh Medical Device Newsdesk » latest news, information and perspective from the regulatory, industry and patient point of view, something …

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Prisoner in own home at 43 – Smith & Nephew BHR disaster – again (UK)

January 8, 2012

Hi, there have been many posts recently regarding Smith and Nephew and I would like you to share my story …

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China Kanghui Holdings Receives FDA Approvals for Hip and Knee Systems – MarketWatch

January 7, 2012

China Kanghui Holdings Receives FDA Approvals for Hip and Knee Systems – MarketWatch. Jan. 6, 2012, 7:31 a.m. EST China …

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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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FDA probes JNJ, Bard and others on transvaginal mesh risks | MassDevice – Medical Device Industry News

January 7, 2012

FDA probes JNJ, Bard and others on transvaginal mesh risks | MassDevice – Medical Device Industry News. FDA probes JNJ, …

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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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AAOS Releases TO on MoM Hip Implants

January 5, 2012

AAOS Releases TO on MoM Hip Implants. AAOS Releases TO on MoM Hip Implants Kristy L. Weber, MD, and Fareeha …

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Hip implant lawsuits pile up – Canada – CBC News

January 4, 2012

Hip implant lawsuits pile up – Canada – CBC News. Hip implant lawsuits pile up Newer devices rushed to market, …

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Howard View – on a few things

December 30, 2011

Great to see the activity pick up re: metal on metal hip devices, and yes they can be hazardous to …

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India State FDA Files Complaint against DePuy with Mumbai Police | DePuy Hip Replacement Lawsuit Information Site

December 29, 2011

India State FDA Files Complaint against DePuy with Mumbai Police | DePuy Hip Replacement Lawsuit Information Site. India State FDA …

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FDA – Priorities, staffing impede inspections of drug, device makers – JSOnline

December 29, 2011

Priorities, staffing impede inspections of drug, device makers – JSOnline. Priorities, staffing impede inspections of drug, device makers Some not …

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Hip and Knee Implants: Old Ones May Be Better Than New Ones « AARP

December 29, 2011

Hip and Knee Implants: Old Ones May Be Better Than New Ones « AARP. Hip and Knee Implants: Old Ones …

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Howard’s View – Get Your Health Right is Number One Priority

December 28, 2011

More and more people are sharing their stories of suffering because of this hip debacle. This is great, let’s others …

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The regulatory standards for the approval of medical devices in Australia – Senate Inquiry

December 25, 2011

The regulatory standards for the approval of medical devices in Australia – Senate Inquiry On 16 June 2011 the Senate …

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Recalled DePuy ASR Hip Implant Lawsuits Filed By The Law Offices Of John David Hart – TheStreet

December 24, 2011

Recalled DePuy ASR Hip Implant Lawsuits Filed By The Law Offices Of John David Hart – TheStreet. Recalled DePuy ASR …

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New Models of Hip and Knee Implants Not Better, Study Finds – NYTimes.com

December 23, 2011

New Models of Hip and Knee Implants Not Better, Study Finds – NYTimes.com. New Models of Implants Not Better, Study …

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FDA seeks to include more women in medical device trials

December 20, 2011

FDA seeks to include more women in medical device trials. FDA seeks to include more women in medical device trials …

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Howard Sdwin: What isn’t being published is the truth regarding the medical device world

December 17, 2011

What isn’t being published is the truth regarding the medical device world. by Howard Sadwin Howard’s Opinion: If we obtained …

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Bill Would Require More Monitoring of Implants – NYTimes.com

December 16, 2011

Bill Would Require More Monitoring of Implants – NYTimes.com. Bill Would Require More Monitoring of Implants By BARRY MEIER Published: …

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Smith & Nephew sees shares fall on leaked details – Yahoo! UK & Ireland Finance

December 11, 2011

Smith & Nephew sees shares fall on leaked details – Yahoo! UK & Ireland Finance. Smith & Nephew sees shares …

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New report highlights metal hip implant problems | Reuters

December 11, 2011

New report highlights metal hip implant problems | Reuters. New report highlights metal hip implant problems By Toni Clarke Wed …

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DePuy Hip Recall | Pinnacle Hip Recall News

December 11, 2011

DePuy Hip Recall | Pinnacle Hip Recall News. Plaintiff Claims His Metal Poisoning Preceded DePuy Hip Recall Shay Morrigan | …

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Howard Gets A New Hip – But Still Wants Justice

November 23, 2011

For those of you who have been following this blog for some time, you will recall the story of Howard …

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BE SURE PEOPLE DEMAND ASPIRATION IF THEY HAVE A METAL HIP!

November 11, 2011

Blog Reader Comment Comment: Thanks for keeping this blog.  I got a pair of JNJ pinnacle implants in on 4/08 …

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Proper Joint Alignment Could Avoid Many Hip Replacement Surgeries

November 5, 2011

  Proper Joint Alignment Could Avoid Many Hip Replacement Surgeries Posted on October 31, 2011 DePuy Pinnacle and other brands …

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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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How Ions May Cause Metal-on-Metal Hip Implants to Go Bad

October 7, 2011

How Ions May Cause Metal-on-Metal Hip Implants to Go Bad Home › MPMN › Medtech Pulse Blog › How Ions May Cause Metal-on-Metal Hip Implants …

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Earl – Update – Surgeon Says Problem is only with Zimmer Metal on Metal

October 4, 2011

Letter from Surgeon So all good with my Zimmer device…   MY View: I would be extremely bloody unlucky if …

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Earl – Update – Hope I didn’t get the short straw – FDA Recalls Zimmer Trabecular Metal Modular Acetabular System

October 3, 2011

MY View: I would be extremely bloody unlucky if this particular batch number was used in my revision operation! If …

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Osteoporosis Drug May Help Users Avoid Hip Replacement

October 2, 2011

Osteoporosis Drug May Help Users Avoid Hip Replacement Source: Rottenstein Law Group Posted on September 26, 2011 Results of a …

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Barry Meier – New York Times – Remedy Is Elusive as Metallic Hips Fail at a Fast Rate

October 1, 2011

Remedy Is Elusive as Metallic Hips Fail at a Fast Rate By BARRY MEIER Source New York Times Published: September …

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FDA Recalls Zimmer Trabecular Metal Modular Acetabular System

October 1, 2011

FDA Recalls Zimmer Trabecular Metal Modular Acetabular System Published on: September 30th, 2011 12:02am  This Press Release (OPENPRESS) September 30, …

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UK Says Metal Hip Replacements More Troublesome

September 23, 2011

UK Says Metal Hip Replacements More Troublesome from: The Associated Press | September 16, 2011 LONDON (AP) — People who …

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UK says metal hip replacements more troublesome – J&J DePuy – almost 30% replacement rate

September 18, 2011

UK says metal hip replacements more troublesome Associated Press, 09.16.11, 11:59 AM EDT LONDON — People who get metal hip …

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Pardon my skepticism…DePuy being Promoted by Actress who has had bilateral hip replacement

September 17, 2011

My View: Isn’t J&J DePuy involved in the biggest legal debacle this side of the orthopaedic boondocks – ASR, Pinnacle …

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Metal Hips Failing Fast, Report Says – Of those patients in the British group who received the device six years ago, about 29 percent have since had it replaced.

September 17, 2011

Metal Hips Failing Fast, Report Says By BARRY MEIER Published: September 15, 2011 New York Times In a troubling development …

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Determining Material Characteristics of Hip Implants: 3-D Microscopy Is the Answer

September 17, 2011

Determining Material Characteristics of Hip Implants: 3-D Microscopy Is the Answer Roger Posusta and Matt Novak, PhD ; Created 2011-09-12 …

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Howard Sadwin’s Story – a lesson in perserverance…

September 17, 2011

Howard’s Story (as written by Howard): My intentions are to tell my story, and for others to listen to my …

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Generic Orthopedic Implants’ Time Has Come

August 30, 2011

Generic Orthopedic Implants’ Time Has Come Written by  Blair Rhode, MD, Sports Medicine Orthopedic Surgeon and owner, RoG Sports Medicine …

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Beaumont woman files suit against DePuy over hip implant

August 30, 2011

Beaumont woman files suit against DePuy over hip implant 8/29/2011 7:36 PM By Michelle Keahey, East Texas Bureau  A Beaumont woman …

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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 Australian – Medical devices in spotlight

August 27, 2011

Medical devices in spotlight Sue Dunlevy From: The Australian August 27, 2011 12:00AM Bob Lugton, on his boat outside his home …

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Facebook Decision to Withdraw Special Privileges From Drugmakers

August 25, 2011

Rottenstein Law Group Notes With Approval Facebook Decision to Withdraw Special Privileges From Drugmakers PRWEB.COM Newswire (PRWEB) August 24, 2011 …

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Groundswell of Grievances Against Manufacturers of Defective, Dangerous Hip Replacement Devices

August 25, 2011

Rottenstein Law Group Heeds Groundswell of Grievances Against Manufacturers of Defective, Dangerous Hip Replacement Devices NEW YORK, Aug. 24, 2011 …

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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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Complaints Surge About Crumbling Artificial Hips

August 24, 2011

Complaints Surge About Crumbling Artificial Hips on August 23, 2011 Source: fairwarning.org As researchers scramble to assess the health dangers of …

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INSIGHT – DePuy’s handling of hip recall sparks questions =2

August 23, 2011

INSIGHT – DePuy‘s handling of hip recall sparks questions =2 22 Aug 2011 12:21 Source: reuters // Reuters METAL POISONING …

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Hip Implant Complaints Surge, Even as the Dangers Are Studied

August 23, 2011

Hip Implant Complaints Surge, Even as the Dangers Are Studied By BARRY MEIER and JANET ROBERTS Source: The New York …

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Zimmer Blinks First on Physician Payments

August 21, 2011

Zimmer Blinks First on Physician Payments By David P. Hamilton | April 21, 2008 Source; bnet.com Is the ethical backlash …

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JOHNSON & JOHNSON : DePuy Orthopaedics Receives FDA 510(K) Clearance for TRUMATCH

August 20, 2011

JOHNSON & JOHNSON : DePuy Orthopaedics Receives FDA 510(K) Clearance for TRUMATCH ® Personalized Solutions for TRUMATCH® Personalized Solutions Brings …

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Reverse shoulder arthroplasty has given new hope to patients suffering from severe arthritis

August 20, 2011

Since it was first approved by the FDA for broad use in the United States in 2004, reverse shoulder arthroplasty …

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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 – Words of Encouragement

August 15, 2011

As usual your site provided me with information that pertains to me and probably many other people. I noticed comments …

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Birmingham Hip Resurfacing or Surface Replacement Arthroplasty (BHR) With Stem

August 14, 2011

Birmingham Hip Resurfacing or Surface Replacement Arthroplasty (BHR) With Stem Source: We Care India Birmingham Hip Resurfacing or Surface Replacement …

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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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FDA Enforcement Reports documented 233 medical device recalls involving nearly 16 million units

August 13, 2011

Recall Index – Second Quarter 2011 – Medical Devices Source:expertrecall.com During the second quarter of 2011, FDA Enforcement Reports documented …

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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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Zimmer Targeting Legal Advertising in NexGen Knee Replacement Fight

August 10, 2011

Zimmer Targeting Legal Advertising in NexGen Knee Replacement Fight Date Published: Monday, August 8th, 2011 Source: News Inferno Zimmer Holdings …

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Derek McMinn addresses Metal on Metal Hip Implants

August 9, 2011

My View: Great that such an authority in the area has taken the time, along with his team, to address …

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Bio-Engineering – Need a new hip? Someday you may grow your own…

August 8, 2011

Need a new hip? Someday you may grow your own By Dennis Thompson HealthDay Reporter Updated: Aug 06, 2011 11:00 …

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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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“The Rich get Richer” – DePuy $27M Upgrade

August 5, 2011

DePuy plans $27 million upgrade Sherry Slater | The Journal Gazette Last updated: August 4, 2011 6:09 p.m. One of …

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Travel with Confidence – Doctor Devises Microchip to Manage Implant Patient Records

August 5, 2011

Dr. Lee Berger creates RFID chip called the Ortho-Tag to Manage Implant Patient Records By Don E. Smith Jr.; Email …

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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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Economic Sense at Smith & Nephew But will it improve things for Patients?

August 4, 2011

Smith & Nephew Restructures and Refocuses Source: Orhopedic Design & Technology The news that Smith & Nephew plc is combining …

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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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Hip Implant Removal – Total Hip Revision

July 31, 2011

Hip Implant Removal – Total Hip Revision With my total right hip revision planned for 1 Sept 2011, I happened …

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Australian TGA – Reforms in the medical devices regulatory framework: Overview of submissions

July 31, 2011

Reforms in the medical devices regulatory framework: Overview of submissions 11 February 2011 Background On 2 November 2010, the TGA released a …

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Australian TGA – Reforms in the medical devices regulatory framework

July 31, 2011

Australian TGA – Reforms in the medical devices regulatory framework Consultation Source: TGA – Click here 2 November 2010 Relevant …

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Australian TGA Response to Recall of DePuy ASR Hip Replacement

July 31, 2011

Recall of DePuy Orthopaedics ASR hip replacement device 16 May 2011 Source Therapeutic Goods Administration Recall of DePuy Orthopaedics ASR …

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British Woman files product liability lawsuit against Wright Medical Technology

July 31, 2011

Wright Hip Replacement Lawsuit Filed by Woman from Great Britain Source: AboutlawSuites.com Published: July 29th, 2011 An U.K. woman has …

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US Congress Women Rosa L. DeLauro Takes FDA To Task Over Comments re IOM Report

July 31, 2011

For Immediate Release Friday, July 29, 2011 Contact: Kaelan Richards 202-225-3661 DELAURO TO FDA: 510(k) MEDICAL DEVICE APPROVAL PROCESS UNSAFE, …

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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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U.S. advisers call for new medical device regime

July 31, 2011

U.S. advisers call for new medical device regime Andrew Seaman Reuters Full Edition July 30, 2011 WASH­INGTON (Reuters) – An …

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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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Expert group calls for new way to clear medical devices

July 31, 2011

Expert group calls for new way to clear medical devices Christine Mai-Duc | Tribune Washington Bureau Source: ongo The Tennessean …

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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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Advisory panel calls for revamping FDA approval process for medical devices

July 31, 2011

Advisory panel calls for revamping FDA approval process for medical devices David Brown and N.C. Aizenman The Washington Post Ongo.com …

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FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report

July 31, 2011

FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report By Anna Edney – Jul 30, 2011 2:27 …

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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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Report could sway FDA device review process

July 30, 2011

Report could sway FDA device review process Source: Reuters By Andrew Seaman WASHINGTON | Tue Jul 26, 2011 1:40pm EDT (Reuters) – …

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Will the DePuy Pinnacle Bring the Next Wave of Lawsuits?

July 30, 2011

Will the DePuy Pinnacle Bring the Next Wave of Lawsuits? July 21, 2011, 10:30:00AM. By Heidi Turner; Source: click here Denver, …

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DePuy Hip Recall Takes Toll on Johnson & Johnson Finances

July 30, 2011

DePuy Hip Recall Takes Toll on Johnson & Johnson Finances July 22, 2011Posted In: Johnson & Johnson updates By The Bradley Law …

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Barry Meier – Study Faults Approval Process for Medical Devices

July 30, 2011

Study Faults Approval Process for Medical Devices BY BARRY MEIER PUBLISHED: JULY 29, 2011 NEW YORK TIMES The government’s system for regulating …

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510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release

July 30, 2011

510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release July 28, 2011 by MassDevice staff …

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Profit rises 23 percent at Zimmer

July 29, 2011

Profit rises 23 percent at Zimmer Staff, news services Published: July 28, 2011 3:00 a.m. Zimmer Holdings Inc. on Wednesday reported …

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WOW!!! Intelligent OrthoSensor Devices Provide Real-Time Reporting on The Condition of Your Orthopaedic Implant

July 29, 2011

Intelligent OrthoSensor Devices Provide Real-Time Reporting on The Condition of Your Orthopaedic Implant by GAVIN CORLEY on Jul 28, 2011 • 12:04 pm Link: OrthoSensor… Published here – …

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Sadwin has a few other Pithy Points for the Orthopaedic “Big Guys”…

July 29, 2011

[Earl’s View] Comment: “Bruce Greenfield may be the last New Zealander implanted with a faulty hip joint “ Market share …

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Sadwin Doesn’t buy the BHR Story …

July 29, 2011

Howard is currently sitting around minus a hip, lucky to be alive post BHR – little wonder… After reading article ” …

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Barry Meier – Study of Medical Device Rules Is Attacked, Unseen

July 29, 2011

Study of Medical Device Rules Is Attacked, Unseen By BARRY MEIER New York Times – Click here Published: July 27, 2011 Allies of …

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Veterans are Put through Another War – Hip Recall

July 28, 2011

Veterans from America’s wars that have been through hip implant surgical treatment in VA hospitals or in other places might …

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Report: IOM review of the FDA 510(k) process due Friday

July 28, 2011

Report: IOM review of the FDA 510(k) process due Friday July 27, 2011 by Brendon Nafziger, DOTmed News Associate Editor; Source …

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Dozens suing over DePuy hip replacement

July 27, 2011

Dozens suing over hip replacement device Posted: Jun 15, 2011 9:29 AM; By Courtney Fasano, Multimedia Journalist – bio | email Source – click here WAUSAU …

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Smith & Nephew’s Exclusive OXINIUM Material for Hip Replacement Implants Chosen for Premium Reimbursement in Japan

July 27, 2011

Smith & Nephew‘s Exclusive OXINIUM Material for Hip Replacement Implants Chosen for Premium Reimbursement in Japan By Benzinga Staff  Source – …

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McMinn Centre Patient Video’s

July 26, 2011

  Related articles McMinn Centre Data Suggests How Bad DePuy ASR was v. Others on the Market (earlsview.com) Mr McMinn, …

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McMinn Centre Data Suggests How Bad DePuy ASR was v. Others on the Market

July 26, 2011

Response to Channel 4’s ‘Dispatches’ Program The Dispatches program ‘Going Under the Knife’ aired on the 16th of May 2011 and ‘The One Show‘ program aired …

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Rottenstein Law Group Curious About Reserves Set Aside by Johnson & Johnson for DePuy Victims

July 25, 2011

Rottenstein Law Group Curious About Reserves Set Aside by Johnson & Johnson for DePuy Victims The Rottenstein Law Group, which …

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Sadwin Raises More Questions – Will They Ever Be Answered?

July 25, 2011

Why don’t we hear more from those with defective Smith & Nephew Hips? Earl, you are right, are people afraid of speaking …

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How Long Do Hip Replacements Last?

July 24, 2011

How Long Do Hip Replacements Last? By Jonathan Cluett, M.D., About.com Guide Updated July 08, 2011 Question: How Long Do …

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Ceramic Hip Replacement Surgery

July 24, 2011

Ceramic Hip Replacement Surgery By Jonathan Cluett, M.D., About.com Guide Updated August 02, 2010 Hip replacement is among the most …

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Computer-Assisted Hip Replacement Surgery – A More Accurate Placement of the Implant Ensures Better Outcomes for the Patient

July 24, 2011

Computer-Assisted Hip Replacement Surgery – A More Accurate Placement of the Implant Ensures Better Outcomes for the Patient March 26, …

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Ceramic-on-Ceramic Hip Implant Let Patients Stay Active Longer

July 24, 2011

A hip alternative: Ceramic-on-Ceramic Hip Implant Let Patients Stay Active Longer February 22, 2006 By: David Blaha Website: http://www.hip-replacement-care.com For …

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History – Smith & Nephew Receives US FDA Approval For Ceramic-On-Ceramic Hip

July 24, 2011

Smith & Nephew Receives US FDA Approval For Ceramic-On-Ceramic Hip June 25, 2006 By: Victor Rocha Website: http://www.hip-replacement-care.com    Smith & …

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Options for Hip Replacements – different materials

July 24, 2011

Advanced wear-reducing hip replacements What are some of the advanced wear-reducing materials available for revision hip surgery? OXINIUM◊ Oxidized Zirconium …

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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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Associate Professor Michael J. Neil – Doesn’t Recommend Resurfacing

July 23, 2011

Why we don’t recommend resurfacing any more http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts Medical Device Alert: All metal-on-metal (MoM) hip replacements (MDA/2010/033) Issued: 22 April …

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Total Joint Replacement or Stem Cells

July 23, 2011

My View: Dr Sheinkop makes some great points which MUST be considered… Total Joint Replacement or Stem Cells By Mitchell B. …

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New Stryker Hip Replacement System looks Good

July 23, 2011

Stryker MDM X3 Hip Replacement System Gets US Green Light by Gene Ostrovskyon Feb 11, 2011 • 9:54 am Source: …

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Hip-replacement recall hurts profits at Johnson & Johnson

July 23, 2011

Hip-replacement recall hurts profits at Johnson & Johnson 7:23 AM, Jul. 20, 2011  Source – click here Written by Michael …

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