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Earl's View

~ News and Views

Earl's View

Monthly Archives: July 2012

Adverse outcomes in hip arthroplasty: l… [J Bone Joint Surg Am. 2012] – PubMed – NCBI

July 29, 2012

Adverse outcomes in hip arthroplasty: l… [J Bone Joint Surg Am. 2012] – PubMed – NCBI. J Bone Joint Surg …

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Australia – Waiting list mix-up adds to 83-year-old’s suffering | Geelong, VIC, Australia

July 29, 2012

Waiting list mix-up adds to 83-year-old’s suffering | Geelong, VIC, Australia. News Geelong Waiting list mix-up adds to 83-year-old’s suffering …

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Minimally Invasive Total Hip Replacement Speeds Recovery – Yahoo! News

July 29, 2012

Minimally Invasive Total Hip Replacement Speeds Recovery – Yahoo! News. Minimally Invasive Total Hip Replacement Speeds Recovery PRWeb – Tue, Jul 24, …

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Australia – ABGII Modular Femoral Stem and Modular Neck – hip replacement system

July 29, 2012

ABGII Modular Femoral Stem and Modular Neck – hip replacement system. ABGII Modular Femoral Stem and Modular Neck – hip …

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Aggressive Early Débridement for Treatment of Acutely Infected Cemented Total Hip Arthroplasty : CORR – Clinical Orthopaedics and Related Research

July 29, 2012

Aggressive Early Débridement for Treatment of Acutely Infected Cemented Total Hip Arthroplasty : CORR – Clinical Orthopaedics and Related Research. …

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Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno

July 29, 2012

Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno. Rival Tried to …

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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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What’s new in hip op surgery | Arthritis Research UK

July 29, 2012

Earlsview: nice informative article but not sure we can really find any way to agree with the use of MoM …

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UK – Metal on metal hip replacement, should you be concerned?

July 29, 2012

Metal on metal hip replacement, should you be concerned?. Metal on metal hip replacement, should you be concerned? 20/07/2012 Hip …

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Protection to paranoia for FDA’s surveillance program | Editorials | Tri-CityHerald.com

July 28, 2012

Protection to paranoia for FDA’s surveillance program | Editorials | Tri-CityHerald.com. Protection to paranoia for FDA’s surveillance program Published: July …

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How hundreds of patients are dying of thirst in hospital: The story of a 22-year-old who died in hospital from dehydration shocked Britain. But his tragedy is horrifyingly common | Mail Online

July 28, 2012

How hundreds of patients are dying of thirst in hospital: The story of a 22-year-old who died in hospital from …

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What does the FDA have to Hide? Who do they work for??

July 28, 2012

FDA shouldn’t be spying on whistle-blowers – Tampa Bay Times. FDA shouldn’t be spying on whistle-blowers In Print: Saturday, July …

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Pig tissue seen fixing knee injury that sidelined Lin – and maybe you | The News Journal | delawareonline.com

July 28, 2012

Pig tissue seen fixing knee injury that sidelined Lin – and maybe you | The News Journal | delawareonline.com. Pig …

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Prosthetic implant under development

July 28, 2012

Prosthetic implant under development. ScienceDaily (July 26, 2012) — Thousands of veterans and warfighters returning to the U.S. suffer with limb …

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USA – Terry Speaks from His Personal Hell re BioMet Magnum M2A

July 27, 2012

Be very vigilant and alert with your health if you have a metal on metal device. I had written before …

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Lee’s post Smith & Nephew BHR Problems Continue….

July 27, 2012

I am 12 weeks post-op today (July 27 2012), following revision surgery of a BHR I received in Dec 2003, …

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Smith and Nephew BHR: Mr. Smith, his nephew, and the incident involving their missing BHR Modular Head

July 26, 2012

I have posted a few things around here and owe a debt of gratitude to Earl, as do we all. …

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Bard Must Pay $5.5 Million Over Vaginal Mesh Implants – Bloomberg

July 25, 2012

Bard Must Pay $5.5 Million Over Vaginal Mesh Implants – Bloomberg. Bard Must Pay $5.5 Million Over Vaginal Mesh Implants …

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Stryker Orthopedics Recalls Metal Hip Implant Components

July 25, 2012

Stryker Orthopedics Recalls Metal Hip Implant Components. Stryker Hip Implant Recall Stryker Recalls Unknown Number of Potentially Defective Devices On …

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Medical News: Stryker Recalls Hip Implants – in Public Health & Policy, FDA General from MedPage Today

July 25, 2012

Medical News: Stryker Recalls Hip Implants – in Public Health & Policy, FDA General from MedPage Today. Stryker Recalls Hip …

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Wright Medical Filed Petition to Block Smith & Nephews Metal Implant

July 25, 2012

Wright Medical Filed Petition to Block Smith & Nephews Metal Implant. Wright Medical Filed Petition to Block Smith & Nephews …

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Enhanced recovery program in total hip arthroplasty Dwyer AJ, Tarassoli P, Thomas W, Porter P – Indian J Orthop

July 25, 2012

Enhanced recovery program in total hip arthroplasty Dwyer AJ, Tarassoli P, Thomas W, Porter P – Indian J Orthop. Year : …

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News Headline Story | equities.com

July 25, 2012

News Headline Story | equities.com. Rottenstein Law Group Learns of New Research Showing Link Between Hip Replacement Surgery and Heart …

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UK – S&N BHR HELL – Trevor (General Practitioner) Gets Rude Response from Smith & Nephew

July 24, 2012

Trevor (General Practitioner) Needs Revsion – Dud Smith & Nephew BHR – Just like DePuy ASR I am a GP …

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Troubled Hip Implants Require Additional Patient Monitoring | Goldberg & Osborne

July 23, 2012

Troubled Hip Implants Require Additional Patient Monitoring | Goldberg & Osborne. Troubled Hip Implants Require Additional Patient Monitoring JULY 20, …

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Hip implant recalled | 6minutes

July 23, 2012

Hip implant recalled | 6minutes. Hip implant recalled 23 July, 2012 Michael Woodhead  The ABGII Modular Femoral Stem and Modular Neck …

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Back Back Surgery for 2012 – Kathleen Mosko

July 22, 2012

Back Surgery for 2012 [Kindle Edition] $0.99 – so, yes you can afford it! Kathleen Mosko (Author), William Smith (Author) …

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Is the US Medical Device Industry Heading the Way of the Dinosaur?

July 21, 2012

Plastics News – Report calls for changes in medical device sector. Report calls for changes in medical device sector By …

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Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register

July 21, 2012

Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register. …

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New research association started: Magnesium implants shall facilitate bone fracture healing

July 21, 2012

New research association started: Magnesium implants shall facilitate bone fracture healing. New research association started: Magnesium implants shall facilitate bone …

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‘Toxic’ hip replacement fears – UK Health News – Isle of Man Today

July 21, 2012

  ‘Toxic’ hip replacement fears – UK Health News – Isle of Man Today.   ‘Toxic’ hip replacement fears   …

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Hip Reconstruction Technique Provides Good Outcomes for Athletes

July 21, 2012

Hip Reconstruction Technique Provides Good Outcomes for Athletes. Hip Reconstruction Technique Provides Good Outcomes for Athletes By Health Canal | …

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Anthony’s BHR hell. Just like DePuy. Come on Mr Smith & your Nephew – own up.

July 18, 2012

i had a bhr in 2003,after complaining about swelling and cicking in my hip i was told it was scar …

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FDA surveillance operation draws criticism from lawmakers | Reuters

July 16, 2012

FDA surveillance operation draws criticism from lawmakers | Reuters. FDA surveillance operation draws criticism from lawmakers WASHINGTON | Sun Jul …

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Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices | NewsInferno

July 16, 2012

Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices | NewsInferno. Stryker Metal Hip …

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Delays and Difficulties in Assessing Metal-on-Metal Hip Implants – The Law Offices of John David Hart

July 16, 2012

Delays and Difficulties in Assessing Metal-on-Metal Hip Implants – The Law Offices of John David Hart. Delays and Difficulties in …

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Biomet M 2 a Hip Implants | Defect Hip Implant Lawyers

July 16, 2012

Biomet M 2 a Hip Implants | Defect Hip Implant Lawyers. Biomet M 2 a Hip Implants Biomet Orthopedics started …

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Hematogenous Infection of Total Hip Arthroplasty With Actinomyces Following a Noninvasive Dental Procedure | Orthopedics

July 16, 2012

Hematogenous Infection of Total Hip Arthroplasty With Actinomyces Following a Noninvasive Dental Procedure | Orthopedics. Hematogenous Infection of Total Hip …

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Exercise and dementia: four new studies | Health, Medical, and Science Updates

July 16, 2012

Exercise and dementia: four new studies | Health, Medical, and Science Updates. Exercise and dementia: four new studies Posted on …

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POLICE STATE??? F.D.A. Surveillance of Scientists Spread to Outside Critics – NYTimes.com

July 15, 2012

F.D.A. Surveillance of Scientists Spread to Outside Critics – NYTimes.com. In Vast Effort, F.D.A. Spied on E-Mails of Its Own …

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Levin, Fishbein, Sedran & Berman Alerts Hip Patients to Stryker Rejuvenate Recall – Health News – redOrbit

July 15, 2012

Levin, Fishbein, Sedran & Berman Alerts Hip Patients to Stryker Rejuvenate Recall – Health News – redOrbit. Levin, Fishbein, Sedran …

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DePuy ASR Hip Settlements – Rottenstein Law Group

July 15, 2012

DePuy ASR Hip Settlements. Rottenstein Law Group DePuy ASR Hip Settlements Both law firm web sites and mass media articles …

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Failure rates of stemmed metal-on-metal hip replacements : The Lancet

July 15, 2012

Failure rates of stemmed metal-on-metal hip replacements : The Lancet. The Lancet, Volume 380, Issue 9837, Page 105, 14 July …

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Hip Prostheses: New JRC report summarises current knowledge and identifies further research needs — Institute for Health and Consumer Protection – (JRC-IHCP), European Commission

July 15, 2012

Hip Prostheses: New JRC report summarises current knowledge and identifies further research needs — Institute for Health and Consumer Protection …

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Biomet M2a Magnum device – Multidistrict Consolidation Sought

July 15, 2012

Law Offices of John David Hart: Multidistrict Consolidation Sought In Biomet… — FORT WORTH, Texas, July 9, 2012 /PRNewswire/ —. …

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DePuy & Transvaginal Mesh Lawsuit Settlement Funding Leads Legal-Bay to Banner 2nd Quarter – MarketWatch

July 15, 2012

DePuy & Transvaginal Mesh Lawsuit Settlement Funding Leads Legal-Bay to Banner 2nd Quarter – MarketWatch. July 10, 2012, 5:45 a.m. …

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Total Hip Modular Necks – Is this the next phase of Hip Failures?

July 15, 2012

Total Hip Modular Necks – Is this the next phase of Hip Failures?. Total Hip Modular Necks – Is this …

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FDA – Overview of Medical Device Regulation > Information about MDUFA III

July 15, 2012

Overview of Medical Device Regulation > Information about MDUFA III. Information about MDUFA III Congress recently authorized the Medical Device …

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Medical Device ID Proposal Unveiled – GovInfoSecurity

July 15, 2012

Medical Device ID Proposal Unveiled – GovInfoSecurity. Medical Device ID Proposal Unveiled FDA Would Create Database of Information By Marianne …

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Bull rider with titanium hip pursues his rodeo dream – Shawnee, OK – The Shawnee News-Star

July 15, 2012

Bull rider with titanium hip pursues his rodeo dream – Shawnee, OK – The Shawnee News-Star. Bull rider with titanium …

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US Drug Watchdog Now Calls All Metal Hip Implant Failures the Biggest Disaster Ever

July 15, 2012

US Drug Watchdog Now Calls All Metal Hip Implant Failures the Biggest Disaster Ever for up to 500,000 U.S. Citizens …

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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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NIH adds more information on hip replacement in its NIHSeniorHealth.gov website

July 15, 2012

NIH adds more information on hip replacement in its NIHSeniorHealth.gov website. NIH adds more information on hip replacement in its …

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Smith And Nephew Hip Replacement Recall Lawsuit Attorney

July 15, 2012

Smith And Nephew Hip Replacement Recall Lawsuit Attorney. Saunders & Walker PA 3491 Gandy Blvd. North Suite 200 Pinellas Park, …

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FDA to help medical device sales with expanded pre-market feedback program

July 15, 2012

FDA to help medical device sales with expanded pre-market feedback program. FDA to help medical device sales with expanded pre-market …

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Newer hip reconstruction technique provides good outcomes for athletes

July 15, 2012

Newer hip reconstruction technique provides good outcomes for athletes. Public release date: 14-Jul-2012 Contact: Lisa Weisenberger lisa@aossm.org 847-655-8647 American Orthopaedic …

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Bernstein Liebhard LLP Launches Stryker Hip Recall Lawyer Website – SFGate

July 15, 2012

Bernstein Liebhard LLP Launches Stryker Hip Recall Lawyer Website – SFGate. Bernstein Liebhard LLP Launches Stryker Hip Recall Lawyer Website …

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Smith & Nephew BHR FDA-required Post-Approval Studies

July 15, 2012

Smith & Nephew BHR FDA-required Post-Approval Studies Post-Approval Studies In January 2005, the oversight responsibility of the Post-Approval Studies Program …

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Consider other options before Joint Surgury – Stephen S. Rodrigues, MD

July 15, 2012

Consider other options before Joint Surgury – Stephen S. Rodrigues, MD I am a family doc in Dallas TX, in …

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No cancer rise in hip implant patients – Health – Fleetwood Weekly News

July 14, 2012

No cancer rise in hip implant patients – Health – Fleetwood Weekly News. No cancer rise in hip implant patients …

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Patient undergoes four joint replacement surgeries – Times Of India

July 14, 2012

Patient undergoes four joint replacement surgeries – Times Of India. Patient undergoes four joint replacement surgeries Umesh Isalkar, TNNJul 11, …

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‘Toxic’ hip replacement fears – Health – Belfast Newsletter

July 14, 2012

‘Toxic’ hip replacement fears – Health – Belfast Newsletter. ‘Toxic’ hip replacement fears Published on Saturday 14 July 2012 09:28 …

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Failing metal hip implants could be releasing toxic nanoparticles

July 14, 2012

Failing metal hip implants could be releasing toxic nanoparticles. Failing metal hip implants could be releasing toxic nanoparticles Scientists have …

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As lawsuits climb, J&J may have new hip trauma – Pinnacle metal-on-metal hip system has nearly 1,600 lawsuits pending

July 14, 2012

As lawsuits climb, J&J may have new hip trauma | Smart Business. As lawsuits climb, J&J may have new hip …

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Smith & Nephew’s BHR PMA approval by the FDA despite lack of scientifically valid trials and BHR Conflict of Interest

July 14, 2012

FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, …

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Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions

July 14, 2012

Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions. FDA NEWS RELEASE For Immediate Release: …

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FDA to guide device makers on marketing application – chicagotribune.com

July 14, 2012

FDA to guide device makers on marketing application – chicagotribune.com. FDA to guide device makers on marketing application Ads by …

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Stryker Recalls Two Metal-on-Metal Hip Implants

July 14, 2012

Stryker Recalls Two Metal-on-Metal Hip Implants. Stryker Recalls Two Hip Implants July 9, 2012 — Stryker Corp. announced a voluntary …

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Stryker Recalls ABG II and Rejuvenate Modular-Neck Stems for Risks Posed by Corrosion and Wear : US Recall News

July 14, 2012

Stryker Recalls ABG II and Rejuvenate Modular-Neck Stems for Risks Posed by Corrosion and Wear : US Recall News. Stryker …

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Defective Hip Implant Lawyers Offer Free Case Reviews for Stryker Hip Implant Claims – Times Union

July 14, 2012

Defective Hip Implant Lawyers Offer Free Case Reviews for Stryker Hip Implant Claims – Times Union. Defective Hip Implant Lawyers …

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Dr Stephen (Steve) Tower to Join the Earl’sview site – to answer patient questions

July 14, 2012

Earlsview Over the year since I set up Earlsview as part of my “anger management” the site has had nearly …

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About Metal-on-Metal Hip Implants

July 14, 2012

About Metal-on-Metal Hip Implants. About Metal-on-Metal Hip Implants If you or your loved one has endured a MoM hip implant …

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Smith & Nephew – Class 2 Recall R3 Constrained Acetabular Liner

July 10, 2012

Medical & Radiation Emitting Device Recalls. Class 2 Recall R3 Constrained Acetabular Liner Date Posted October 18, 2010 Recall Number …

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FDA – User Fees for Medical Devices: Third Time Lucky?

July 8, 2012

User Fees for Medical Devices: Third Time Lucky? John R. Graham, Director, Health Care Studies Congress recently passed, almost unanimously, S.3187, …

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FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today

July 8, 2012

FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today. FDA Faces Daunting Task as Health Apps Multiply By …

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FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier

July 8, 2012

FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier. FDA Proposes …

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MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA

July 8, 2012

MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA. MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA Cheryl Clark, …

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Stryker recalls two metal-on-metal hip products for fear of corrosion

July 8, 2012

Stryker recalls two metal-on-metal hip products for fear of corrosion. Stryker recalls two metal-on-metal hip products for fear of corrosion …

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Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2

July 8, 2012

June 28 2012 – Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2 Click the link …

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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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Long-Term Health Risks Associated with Genotoxic Nanoparticles Released by Failing Metal-on-Metal Hip Implants

July 8, 2012

Long-Term Health Risks Associated with Genotoxic Nanoparticles Released by Failing Metal-on-Metal Hip Implants. Long-Term Health Risks Associated with Genotoxic Nanoparticles …

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Biomet M2a Magnum Metal-on-Metal Hip Replacement Lawsuit

July 8, 2012

News Headline Story | equities.com. Biomet M2a Magnum Metal-on-Metal Hip Replacement Lawsuit Alleges Defective Implant Caused Oregon Woman to Suffer …

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FDA releases proposed UDI rule; reaction generally positive

July 8, 2012

FDA releases proposed UDI rule; reaction generally positive | Healthcare Finance News. July 06, 2012 | Rene Letourneau, Editor WASHINGTON …

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Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today

July 8, 2012

Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today. Governmental Oversight of Potentially Dangerous Medical Devices Public and …

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FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments

July 8, 2012

FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments. FDA Proposes Device ID Regulations for …

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METAL ON METAL TOTAL HIP RESURFACING AS AN ALTERNATIVE TO TOTAL HIP ARTHROPLASTY

July 8, 2012

CTAF ASSESSMENT – METAL ON METAL TOTAL HIP RESURFACING AS AN ALTERNATIVE TO TOTAL HIP ARTHROPLASTY http://www.google.com.au/url?sa=t&rct=j&q=&esrc=s&source=web&cd=42&ved=0CFIQFjABOCg&url=http%3A%2F%2Fwww.ctaf.org%2Ffiles%2F769_file_Hip_resurfacing_W.pdf&ei=Ovr4T5bGI-yUiAfA5tzhBg&usg=AFQjCNGpF8andIjM3eQZ9JGMI58FwHyo7w&sig2=IPuN6AUkPw1Tt6yzEYt32Q. Or download the …

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Joint Replacements For Baby Boomers

July 8, 2012

Joint Replacements For Baby Boomers. Joint Replacements For Baby Boomers MARILYNN MARCHIONE   05/23/11 09:56 AM ET    SHARE THIS STORY SAN DIEGO …

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Hip resurfacing: A boon for Boomers or too risky?

July 8, 2012

Hip resurfacing: A boon for Boomers or too risky?. Hip resurfacing: A boon for Boomers or too risky? By Annie …

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Metal on metal hip resurfacing using the BHR, Cormet 2000, or Conserve Plus devices does not meet CTAF criteria 3-5 for safety, efficacy and improvement in health outcomes for patients as an alternative to total hip arthroplasty

July 8, 2012

Metal on metal hip resurfacing using the BHR, Cormet 2000, or Conserve Plus devices does not meet CTAF criteria 3-5 for …

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Early Clinical Experience With the Use of the Birmingham Hip Resurfacing System | Orthopedics

July 8, 2012

Early Clinical Experience With the Use of the Birmingham Hip Resurfacing System | Orthopedics. Early Clinical Experience With the Use …

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Meeting of the Orthopaedic and Rehabilitation Devices Advisory Panel June 27-28, 2012 Metal-on-Metal Hip Systems

July 8, 2012

Meeting of the Orthopaedic and  Rehabilitation Devices Advisory Panel June 27-28, 2012 Metal-on-Metal Hip Systems http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM310217.pdf. This is a PDF …

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Outcomes of Birmingham Hip Resurfacing: A Systematic Review

July 8, 2012

Outcomes of Birmingham Hip Resurfacing: A Systematic Review. Asian J Sports Med. 2012 March; 3(1): 1–7. PMCID: PMC3307960 Outcomes of Birmingham Hip Resurfacing: …

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FDA Executive Summary Memorandum – Metal-on-Metal Hip Implant Systems Prepared for the June 27-28, 2012 Meeting of the Orthopaedic and Rehabilitation Devices Advisory Panel Gaithersburg Hilton, Gaithersburg, Maryland

July 8, 2012

FDA Executive Summary Memorandum Metal-on-Metal Hip Implant Systems Prepared for the June 27-28, 2012 Meeting of the Orthopaedic and Rehabilitation Devices …

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SMITH & NEPHEW BHR – FDA Papers – Appendix G: Summary of MoM Hip Resurfacing Post-Approval Studies

July 8, 2012

SMITH & NEPHEW BHR – FDA Papers – Appendix G:  Summary of MoM Hip Resurfacing Post-Approval Studies Source: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309356.pdf. Download PDF …

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Smith & Nephew BHR – Food and Drug Administration, HHS

July 8, 2012

http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol8/pdf/CFR-2011-title21-vol8-sec888-5.pdf. PDF File: Food and Drug Administration, HHS CFR-2011-title21-vol8-sec888-5 Food and Drug Administration, HHS 513(f) of the act) into class III …

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SUMMARY OF SAFETY AND EFFECTIVENESS DATA PREMARKET APPROVAL APPLICATION P040033 SMITH & NEPHEW BHR BIRMINGHAM HIP RESURFACING SYSTEMf

July 8, 2012

Source: www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4181b1_03_SSED_BHR_080505.pdf. SUMMARY OF SAFETY AND EFFECTIVENESS DATA PREMARKET APPROVAL APPLICATION P040033  SMITH & NEPHEW BHR   BIRMINGHAM HIP RESURFACING SYSTEM …

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Attachment B – Ragab AA., validity of Self-Assessment Outcome Questionnaires: Patient-Physician Discrepancy in Outcome Interpretation, 39 Biomed. Sci. Instrum. 579-84 (2003)

July 8, 2012

http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-cp00001-03-Attachment-B-vol1.pdf. Biomed Sci Instrum. 2003;39:579-84. Validity of self-assessment outcome questionnaires: patient-physician discrepancy in outcome interpretation. Ragab AA. Department of Orthopedics, …

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FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, at 12 (Sept. 8, 2005)

July 8, 2012

FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, …

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Attachments to Wright Medical’s request to Deny PMA to Smith & Nephew BHR

July 7, 2012

Dockets:. Dockets Management Back 2005P-0440 CP 1 Volume 1 Citizen Petition Attachment A – FDA, Summary Minutes, Meeting of the Orthopedic …

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FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR…

July 7, 2012

FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-pdn0001-vol2.pdf. Dear Mr.  Roberts: Food and Drug …

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Dockets: 2005P-0440: To deny approval of Smith & Nephew’s premarket approval application (PMA) for the Birmingham hip resurfacing system (P040033) based on the data currently submitted in support of the PMA

July 7, 2012

Dockets: 2005P-0440: To deny approval of Smith & Nephew’s premarket approval application (PMA) for the Birmingham hip resurfacing system (P040033) …

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Wright Medical’s Response to Smith & Nephew’s Response to WMT request to Deny BHR PMA

July 7, 2012

Wright Medical’s Response to Smith & Nephew‘s Response to WMT request to Deny BHR PMA http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-rc00001-01-vol3.pdf. Click the above link …

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Smith & Nephew’s :Response to Wright Medical Technology’s Citizen’s Petition to Deny PPrIA P040033

July 7, 2012

http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-c000001-01-vol2.pdf. Smith & Nephew‘s :Response to Wright Medical Technology‘s Citizen’s  Petition to Deny PPrIA P040033 Smith & Nephew, Inc.  is …

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Premarket Approval (PMA) Database – BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

July 7, 2012

MDRWeb Medical Device Register On-line from Canon Communications, LLC. Premarket Approval (PMA) Database Premarket Approval (PMA) Database Trade Name: BIRMINGHAM …

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P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices

July 7, 2012

P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices. PMA Application: P040033 S017 (Most recently approved supplement) Attribute …

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Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL

July 7, 2012

Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL Post-Approval Studies. Post-Approval Studies FDA Home Medical Devices Databases – …

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Smith & Nephew – BHR PMA – FIRST OF A KIND PMA – WHO PULLED WHAT STRINGS????

July 7, 2012

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm127516.pdf. Hip Prostheses The Birmingham Hip Resurfacing (BHR) System, P040033, by  Smith & Nephew Orthopaedics was approved on May 9, …

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FDA Pre Market Approval (PMA) of Birmingham Hip Resurfacing (BHR) System – P040033

July 7, 2012

HOW DID THEY GET APPROVAL? Birmingham Hip Resurfacing (BHR) System – P040033. Birmingham Hip Resurfacing (BHR) System PMA Approval P040033a …

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Despite the Reasons AGAINST – FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP Resurfacing Technology

July 7, 2012

WHO PULLED WHAT STRINGS???? Smith & Nephew | FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP …

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All the Reasons WHY Smith & Nephew Birmingham Hip Resurfacing Should NOT have gotten PMA from the FDA

July 7, 2012

All the Reasons WHY Smith & Nephew Birmingham Hip Resurfacing Should NOT have gotten PMA from the FDA This makes …

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New FDA guidance on considerations used in device approval

July 7, 2012

New FDA guidance on considerations used in device approval. New FDA Guidance used in Device Approval THURSDAY, MARCH 29. 2012; FDA …

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Depression – dealing with and overcoming it. | Envision Hypnotherapy

July 6, 2012

Depression – dealing with and overcoming it. | Envision Hypnotherapy. Depression – dealing with and overcoming it. “Tis nothing good …

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Arthritis and Gout

July 6, 2012

Arthritis and Gout. Arthritis and Gout Gout is a form of arthritis — an inflammation of the joints — that …

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Depression and whether a behavioral problem is mental illness

July 6, 2012

Depression and whether a behavioral problem is mental illness. Depression and whether a behavioral problem is mental illness by DR. …

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Guide To Emotional And Nervous Breakdowns

July 6, 2012

Guide To Emotional And Nervous Breakdowns. Aug 30, 2008 An emotional, nervous and mental breakdown includes breakdown or temporary fall …

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10 Signs & Symptoms of Depression in Men – Symptoms – Depression

July 6, 2012

10 Signs & Symptoms of Depression in Men – Symptoms – Depression. 10 Signs & Symptoms of Depression in Men …

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When a Spouse Has Anxiety

July 6, 2012

When a Spouse Has Anxiety. If your spouse has anxiety disorder, it can place a large strain on the relationship. …

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Clinical depression can exacerbate Knee osteoarthritis symptoms in elder patients

July 6, 2012

Clinical depression can exacerbate Knee osteoarthritis symptoms in elder patients. Clinical depression can exacerbate Knee osteoarthritis symptoms in elder patients …

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Omega-3s May Help Treat Depression, Osteoarthritis and Prostate Cancer | Doctor Murray

July 6, 2012

Omega-3s May Help Treat Depression, Osteoarthritis and Prostate Cancer | Doctor Murray. Omega-3s May Help Treat Depression, Osteoarthritis and Prostate …

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S-Adenosyl-L-Methionine for Treatment of Depression, Osteoarthritis, and Liver Disease

July 6, 2012

archive.ahrq.gov/clinic/epcsums/samesum.pdf. S-Adenosyl-L-Methionine for Treatment of Depression, Osteoarthritis, and Liver Disease Overview The objective of this report was to conduct a search …

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What Causes Depression and Anxiety

July 6, 2012

What Causes Depression and Anxiety | Natural Treatments and Exercises for Osteoarthritis Pain Relief. What Causes Depression and Anxiety Posted …

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Depression and Pain Management – cause and effect

July 6, 2012

Depression and Pain Management – cause and effect | Natural Treatments and Exercises for Osteoarthritis Pain Relief. Depression and Pain …

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Seasonal variations in depression and ost… [J R Coll Gen Pract. 1984] – PubMed – NCBI

July 6, 2012

Seasonal variations in depression and ost… [J R Coll Gen Pract. 1984] – PubMed – NCBI. J R Coll Gen …

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SAMe Treats Osteoarthritis, Depression, and Liver Disease

July 6, 2012

SAMe Treats Osteoarthritis, Depression, and Liver Disease | Bastyr Center for Natural Health. SAMe Treats Osteoarthritis, Depression, and Liver Disease …

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Antidepressant proves effective in alleviating osteoarthritis pain Depression

July 6, 2012

Antidepressant proves effective in alleviating osteoarthritis pain Depression | Pharmaceutical & Medical Packaging News. Antidepressant proves effective in alleviating osteoarthritis …

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Osteoarthritis and Depression | Osteoarthritis Blog

July 6, 2012

Osteoarthritis and Depression | Osteoarthritis Blog. OSTEOARTHRITIS AND DEPRESSION May 1, 2011 Depression usually isn’t associated with knee osteoarthritis.  But since …

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Evidence to Support the National Action Plan for Osteoarthritis, Rheumatoid Arthritis and Osteoporosis:

July 6, 2012

Evidence to Support the National Action Plan for Osteoarthritis, Rheumatoid Arthritis and Osteoporosis: Opportunities to Improve Health-Related Quality of Life …

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Osteoarthritis depressed mood | Arthritis Research UK

July 6, 2012

Osteoarthritis depressed mood | Arthritis Research UK. Osteoarthritis pain ‘determines depressed mood’ Published on 07 October 2011 Osteoarthritis pain is …

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Osteoarthritis and Depression | Insulite Osteoarthritis System

July 6, 2012

Osteoarthritis and Depression | Insulite Osteoarthritis System. Osteoarthritis and Depression Chronic joint pain or osteoarthritis sometimes go hand-in-hand with depressed …

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Gene findings raise arthritis hopes – Eight new genes for osteoarthritis

July 6, 2012

Gene findings raise arthritis hopes – PA News Feeds – Evening Standard. Gene findings raise arthritis hopes Osteoarthritis, progressive damage …

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Depression Can Worsen Knee Pain

July 6, 2012

Knee Osteoarthritis | Depression Arthritis | Arthritis Today Magazine. Depression Can Worsen Knee Pain Treating mental as well as physical …

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Depression and Osteoarthritis – A Guide to Depression and Osteoarthritis

July 6, 2012

Depression and Osteoarthritis – A Guide to Depression and Osteoarthritis. Osteoarthritis and Depression Depression Should Not Be Disregarded in Osteoarthritis …

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Depression and osteoarthritis.

July 6, 2012

Depression and osteoarthritis. [Am J Med. 2008] – PubMed – NCBI. Am J Med. 2008 Nov;121(11 Suppl 2):S16-9. Depression and osteoarthritis. …

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LOOK AFTER YOUR LUNGS!

July 6, 2012

Created by: http://www.OnlineNursingPrograms.com

Rheumatoid Arthritis and Depression

July 6, 2012

Rheumatoid Arthritis and Depression. Rheumatoid Arthritis and Depression Posted on April 30, 2012 by Lana As you know, rheumatoid arthritis …

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The burden of depression in patients with rheumatoid arthritis

July 6, 2012

The burden of depression in patients with rheumatoid arthritis. The burden of depression in patients with rheumatoid arthritis An ever‐increasing …

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Discovery Health “Is there a link between arthritis and depression?”

July 6, 2012

Discovery Health “Is there a link between arthritis and depression?”. Is there a link between arthritis and depression? by HowStuffWorks.com …

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Depression and Rheumatoid Arthritis

July 6, 2012

Depression and Rheumatoid Arthritis. Disability and a recent diagnosis of rheumatoid arthritis (RA) are associated with a greater risk for …

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Is Depression Contributing to Pain

July 6, 2012

Is Depression Contributing to Pain. Pain in the arms, legs and back. Fatigue and sleep­lessness. Problems associated with arthritis and …

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Arthritis Linked to Depression

July 6, 2012

Arthritis Linked to Depression | LiveScience. Arthritis Linked to Depression LiveScience Staff Date: 30 April 2012 Time: 09:49 AM ET …

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Avoiding Arthritis–Related Depression and Anxiety

July 6, 2012

Avoiding Arthritis–Related Depression and Anxiety – Osteoarthritis Center – EverydayHealth.com. Avoiding Arthritis-Related Depression and Anxiety What you can do to …

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Recipients Injured By Metal-On-Metal Hips Speak Out Against Dangers of MoM Hips – SFGate

July 3, 2012

Recipients Injured By Metal-On-Metal Hips Speak Out Against Dangers of MoM Hips – SFGate. Recipients Injured By Metal-On-Metal Hips Speak …

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WHO CAN YOU TRUST??? Pharmaceutical Giant GSK to Pay $3B in Largest-Ever Health Care Fraud Case

July 3, 2012

Pharmaceutical Giant GSK to Pay $3B in Largest-Ever Health Care Fraud Case – Yahoo! News. Pharmaceutical Giant GSK to Pay …

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Autism, depression, and serotonin transporter links are the subject of a recent study | Health, Medical, and Science Updates

July 2, 2012

Autism, depression, and serotonin transporter links are the subject of a recent study | Health, Medical, and Science Updates. Autism, …

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CSU-developed implant shows promise

July 2, 2012

CSU-developed implant shows promise New knee joint implant creates self-lubricating surface, lasts longer 8:37 PM, Jun 30, 2012 CSU professor …

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Managing Chronic Pain and Depression in Arthritis

July 1, 2012

Managing Chronic Pain and Depression in Arthritis. Managing Chronic Pain, Depression & Antidepressants: Issues & Relationships by Michael Clark, M.D., M.P.H. …

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Arthritis and Depression

July 1, 2012

Arthritis and Depression. Arthritis and Depression What is depression and how does it relate to arthritis? Depression is a mental …

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Millions of arthritis sufferers ‘are battling depression’ | Mail Online

July 1, 2012

Millions of arthritis sufferers ‘are battling depression’ | Mail Online. Millions of arthritis sufferers ‘are battling depression’ By JENNY HOPE …

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Arthritis Depression | Arthritis Anxiety | Arthritis Today Magazine

July 1, 2012

Arthritis Depression | Arthritis Anxiety | Arthritis Today Magazine. One-Third of People With Arthritis Have Anxiety and Depression A new …

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One-Third of Adults with Arthritis Suffer From Depression and Anxiety Too

July 1, 2012

One-Third of Adults with Arthritis Suffer From Depression and Anxiety Too | Healthland | TIME.com. ARTHRITIS – Arthritis Patients Often Have …

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