FDA Seeks Data on Risks of Metal Poisoning from Hip Replacements – AboutLawsuits.com
FDA Seeks Data on Risks of Metal Poisoning from Hip Replacements – AboutLawsuits.com. FDA Seeks Data on Risks of Metal …
Tag Archives: FDA
Mitigating Migraines – How To Fight Migraines Naturally
Mitigating Migraines – How To Fight Migraines Naturally. This looks like a useful site – if you suffer migraines like …
Global Corporate Crime – DePuy in India
India issues recall, commences criminal investigation into defective ASR hip implant Four Corners By Peter Cronau: exclusive Updated 5 hours …
Medical device firms push to comply with new FDA rules
Source & full article: Medical device firms push to comply with new FDA rules. Medical device firms push to comply with …
Congressional Investigation Finds FDA’s Unprecedented Whistleblower Surveillance Program Was Unlawful
Congressional Investigation Finds FDA’s Unprecedented Whistleblower Surveillance Program Was Unlawful | The Dissenter. Congressional Investigation Finds FDA’s Unprecedented Whistleblower Surveillance …
How does the FDA ‘approve’ medical products? – Medical News Today
Source article for full text: How does the FDA ‘approve’ medical products? – Medical News Today. How does the FDA ‘approve’ …
Vaginal Mesh Implants – Guest Post by Agnes Jimenez
Vaginal Mesh Implant: Important Things You Need To Know Before Having a Surgery Vaginal mesh surgery steams has been a …
Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser | MassDevice
Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser | MassDevice. March 11, 2013 by Arezu …
VICTORY FOR MoM Sufferer – Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com
Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com. VICTORY & JUSTICE: J.&J. Loses …
Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants
Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants. FDA Safety Communication: Metal-on-Metal Hip Implants Date Issued: Jan. 17, 2013 Audience: Orthopaedic …
DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable
Trial plaintiff says J&J hips defective, company says not liable. Trial plaintiff says J&J hips defective, company says not liable …
Oh Really … Why am I not believing you?…. Hip Replacement Device – NYTimes.com
Hip Replacement Device – NYTimes.com. Oh Really Mr DePuy – are we as stupid as you look? Published: March 4, …
FDA cracks down on all-metal hip replacements
http://news.consumerreports.org/health/2013/01/fda-cracks-down-on-all-metal-hip-replacements.html FDA cracks down on all-metal hip replacements Manufacturers who want to keep selling all-metal hips will have to prove …
Open Letter – Surgeon-industry COI and the CME content of AAOS 2013 addressing MoM hip complications.
Surgeon-industry COI and the CME content of AAOS 2013 addressing MoM hip complications. By Stephen Tower, Orthopedic SurgeonAffiliated Professor UAA …
J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg
J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg. J&J Profit Pursuit Led to Defective Hip, Lawyer Argues …
J&J gambled on hip implant safety, lawyer alleges – latimes.com
J&J gambled on hip implant safety, lawyer alleges – latimes.com. J&J gambled on hip implant safety, lawyer alleges Johnson & …
Metal Debris in Patients’ Bloodstream is “Harmless,” J&J Toxicologists Say
The metal debris Johnson & Johnson (J&J)’s DePuy ASR hip implant shed into a man’s bloodstream and tissue is harmless, …
Smith & Nephew Failure Warning for Birmingham Hip Implant
Smith & Nephew Failure Warning for Birmingham Hip Implant. Smith & Nephew Failure Warning for Birmingham Hip Implant September 27, …
Researchers Say DePuy Hip Ancestry Shows 510(k) Flaws | MDDI Medical Device and Diagnostic Industry News Products and Suppliers
Researchers Say DePuy Hip Ancestry Shows 510(k) Flaws | MDDI Medical Device and Diagnostic Industry News Products and Suppliers. Published: …
Bullshit-R-Us …. J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg
J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg. J&J’s Toxicologist Says Metal From Recalled Hip Harmless By Maurice …
Yeah, right…. J&J’s Floyd Says Hip Sales Halted for Business Reasons – Bloomberg
J&J’s Floyd Says Hip Sales Halted for Business Reasons – Bloomberg. J&J’s Floyd Says Hip Sales Halted for Business Reasons …
DePuy Trial Continues Despite Talks of Settlement – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts
DePuy Trial Continues Despite Talks of Settlement – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts. DePuy Trial Continues …
Some Surgeons Do Speak & Shout – but Those that Should Listen Don’t Hear…
By Stephen Tower Orthopedic Surgeon Affiliated Professor UAA WWAMI School of Medicine Earl, Barry Meier’s recent article in the NYT …
The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com
The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com. Doctors Who Don’t Speak Out By BARRY MEIER Published: …
Business: Washington Post Business Page, Business News
Business: Washington Post Business Page, Business News. J&J’s President Visited Hip Surgeon Before Recall, Jury Told Maurice Possley, David Voreacos …
Patients victims of untested medical devices – SFGate
Patients victims of untested medical devices – SFGate. Patients victims of untested medical devices Victoria Colliver Updated 9:21 pm, Tuesday, February …
J&J Feared Metal Backlash Would Hurt Hip Sales, Jury Told – Bloomberg
J&J Feared Metal Backlash Would Hurt Hip Sales, Jury Told – Bloomberg. J&J Feared Metal Backlash Would Hurt Hip Sales, …
“What a Mistake,” says DePuy Hip Recipient
“What a Mistake,” says DePuy Hip Recipient. “What a Mistake,” says DePuy Hip Recipient February 14, 2013, 01:30:00PM. By Jane …
What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com
What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com. EDITORIAL What a Company Knew About Its Metal Hips Published: …
DePuy ASR Lawsuit Update: Toxicologist Testifies That Plaintiff Kransky Has High Levels of Metal in His Blood – Yahoo! Finance
DePuy ASR Lawsuit Update: Toxicologist Testifies That Plaintiff Kransky Has High Levels of Metal in His Blood – Yahoo! Finance. …
DePuy ASR Trial Update: J&J Engineer-Suggested Redesign Meant to Minimize Metallic Debris Never Implemented, Parker Waichman LLP Reports – SFGate
DePuy ASR Trial Update: J&J Engineer-Suggested Redesign Meant to Minimize Metallic Debris Never Implemented, Parker Waichman LLP Reports – SFGate. …
Kransky vs DePuy ASR Trial Update – Day 2-4
Kransky vs DePuy ASR Trial Update – Day 2-4 guy in charge of testing safety of DePuy ASR was a …
Howard Sadwin’s Story – Video – Smith & Nephew BHR Hell
Here is Howard’s story – told by him
J&J metal hip failed because of toxic debris – expert at trial | Reuters
J&J metal hip failed because of toxic debris – expert at trial | Reuters. J&J metal hip failed because of …
J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg
J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg. J&J Failed to Weigh Hip Metal Debris Risk, …
During Trial, New Details Emerge on DuPuy Hip – NYTimes.com
During Trial, New Details Emerge on DuPuy Hip – NYTimes.com. During Trial, New Details Emerge About Hip Maker By BARRY …
Dangers of toxic hip implants used in Britain kept secret for years – Telegraph
Dangers of toxic hip implants used in Britain kept secret for years – Telegraph. Dangers of toxic hip implants used …
MPs call for criminal inquiry into toxic hip implants – Telegraph
MPs call for criminal inquiry into toxic hip implants – Telegraph. MPs call for criminal inquiry into toxic hip implants …
J&J Had ‘Inappropriate’ Risk Controls for Hip, Jury Told – Bloomberg
J&J Had ‘Inappropriate’ Risk Controls for Hip, Jury Told – Bloomberg. J&J Had ‘Inappropriate’ Risk Controls for Hip, Jury Told …
J&J Failed Own Safety Test in Hip Design, Witness Says – Bloomberg
J&J Failed Own Safety Test in Hip Design, Witness Says – Bloomberg. J&J Failed Own Safety Test in Hip Design, …
Trial underway in hip implant lawsuit – latimes.com
Trial underway in hip implant lawsuit – latimes.com. Trial underway in hip implant lawsuit Bloomberg News January 25, 2013, 3:57 p.m. …
Ed’s Smith & Nephew BHR hell gets worse before better…
by Ed Larsen When I first became aware of “Earls View” and contributed to the Blog regarding my personal experience …
Brooks asks if the orthopaedic companies are above the law?
it’s now become apparent that for those of us in the US, and seemingly the rest of the world, for …
Looks like BS, Smells like BS, Must be BS…. Hip Study: Smith & Nephew touts study results for new metal-on-metal implants | MassDevice – Medical Device Industry News
Hip Study: Smith & Nephew touts study results for new metal-on-metal implants | MassDevice – Medical Device Industry News. Hip …
Laurel’s Story – Smith & Nephew BHR Hip Resurfacing Ruins Another Life
In August of 2008 at the age of 49 I had a Birmingham Resurfacing of my right hip. This hip had …
Metal-on-metal hip implant risks ‘unique’ – Health – CBC News
Metal-on-metal hip implant risks ‘unique’ – Health – CBC News. Metal-on-metal hip implant risks ‘unique’ FDA gives recommendations on how …
Cardiologist William Maisel (deputy director for science at the FDA) Arrested In Prostitution Sting Operation – Forbes
Cardiologist William Maisel Arrested In Prostitution Sting Operation – Forbes. Larry Husten, Contributor I’m a medical journalist covering cardiology news. …
FDA Action on Metal on Metal Hips – too little, too late…
by Howard Sadwin Another Smith & Nephew Birmingham Hip Device friend of mine and I read the new and exciting …
FDA cracks down on all-metal hip replacements
FDA cracks down on all-metal hip replacements.’ Source: http://news.consumerreports.org/health/2013/01/fda-cracks-down-on-all-metal-hip-replacements.html FDA cracks down on all-metal hip replacements Jan 18, 2013 11:48 AM …
Dr Tower writes to Senator re concerns about the regulatory malfeasance at the FDA – Metal-on-Metal hip replacement debacle
Sunday, January 6, 2013 Dear Senator Begich, I am very appreciative of your personal reply to my concerns about the …
Howard Sadwin – Video of Howard’s battle with the damage from Smith & Nephew BHR hip
Howard has put together a video outlining his problems with the damage to his health and life caused by the …
Come out front Smith & Nephew – we have had your medicine – time for yours…
Why does it appear Smith and Nephew is trying to hide behind the pre-emption laws and not face accountability. Their …
FDA Executive Summary Memorandum – Metal-on-Metal Hip Implant Systems – June 27-28, 2012 Meeting
I. Introduction and Purpose of Advisory Panel Meeting Hip arthroplasty devices, including metal-on-metal (MoM) hip systems, have been …
Howard’s View on the FDA’s lack of action on MoM hip studies…
What happened to the the FDA‘s request, NOTHING HAPPENED. The FDA gets heat put on them especially in todays enviornment …
What Happened to the FDA Request for More Hip Implant Studies? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts
What Happened to the FDA Request for More Hip Implant Studies? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass …
The Dangers of Using Transvaginal Mesh
By Carlos Santiago Many women who were suffering from Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (STI) sought medical …
Howard Says – And We Agree – Come Clean Smith & Nephew
It is time for Smith and Nephew to be realistic and honest, afterall in their code of ehtics the safety …
Lorraine – natural treatments may work on artificial joints too?
Earl, I read your letters every day. So many people having difficulties world wide. I have the Stryker TritonCeramic-on Ceramic Alumina. Recall reasons, contaminated …
The FDA is there to protect patients? Bullsh*t …
The FDA is there to protect patients? Bullsht | MassDevice – Medical Device Industry News. The FDA is there to …
FDA Asks Judge to Dismiss Spying Suit Filed by Employees – Businessweek
FDA Asks Judge to Dismiss Spying Suit Filed by Employees – Businessweek. Bloomberg News FDA Asks Judge to Dismiss Spying …
FDA warns Zimmer over manufacturing of hip devices – chicagotribune.com
FDA warns Zimmer over manufacturing of hip devices – chicagotribune.com. FDA warns Zimmer over manufacturing of hip devices Reuters 4:58 …
This is AMAZING – Implanted Eye Device
FDA Panel Says Yes to Implanted Eye Device. FDA Panel Says Yes to Implanted Eye Device By David Pittman, Washington Correspondent, …
Medical Devices Vulnerable to Hacking Need Oversight – Businessweek
Medical Devices Vulnerable to Hacking Need Oversight – Businessweek. Bloomberg News Medical Devices Vulnerable to Hacking Need Oversight By Jordan …
Stryker Recalls Neptune Devices After Death Reported – Bloomberg
Stryker Recalls Neptune Devices After Death Reported – Bloomberg. Stryker Recalls Neptune Devices After Death Reported By Michelle Fay Cortez …
FDA Presentation Describes Corrosion of Metal Hip Implants
A presentation at a Food and Drug Administration (FDA) meeting about metal-on-metal hip implants covered the life-threatening corrosion that occurs …
Where are the Transvaginal Mesh Studies Requested by the FDA? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts
Where are the Transvaginal Mesh Studies Requested by the FDA? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts. …
YAHOO — Smith & Nephew Birmingham Hip Lawsuit Filed Over Metal Poisoning – AboutLawsuits.com
Source: Smith & Nephew Birmingham Hip Lawsuit Filed Over Metal Poisoning – AboutLawsuits.com. Smith & Nephew Birmingham Hip Lawsuit Filed Over …
Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process
Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process. Neurosurgeon’s Conflict With Spine Device Company Sheds …
MUST READ – Two MoM Presentations to the FDA on MoM hips
Two very informative presentations to the FDA on Metal on Metal Hips Click on the links to download …
» Medical device units recalled in Q2 represent eight-quarter high | MedCity News
» Medical device units recalled in Q2 represent eight-quarter high | MedCity News. Medical device units recalled in Q2 represent …
FDA Aims To Smooth Premarket Review process | Bloomberg BNA
FDA Aims To Smooth Premarket Review process | Bloomberg BNA. Wednesday, August 22, 2012 FDA Aims To Smooth Premarket Review …
FDA Executives Knew About Plan to Spy on Whistle-Blower Scientists
FDA Executives Knew About Plan to Spy on Whistle-Blower Scientists. FDA Executives Knew About Plan to Spy on Scientists August …
FDA SpyGate — New Revelations Challenge The New York Times Investigation of Agency “Enemies List”
FDA SpyGate — New Revelations Challenge The New York Times Investigation of Agency “Enemies List,” Raise More Questions About the …
Stryker Hip Implant Lawsuit | Stryker Trident Hip Recall
Stryker Hip Implant Lawsuit | Stryker Trident Hip Recall. New York Woman Seeks $6 Million for Stryker Hip Implant Injuries …
Cry from the Heart – Where is Mr Smith & his Nephew?
Recent comment published on Earl‘sview that deserves more notice: Does Smith and Nephew not hear the cries from victims of …
Pre Market Approval – Why does the Law shelter Smith & Nephew & others like them?
Premarket Approval by the FDA – why do we lose out? Reading this recent law review article by Professor Ralph Hall, …
Smith & Nephew R3 Hip Liner Recall Lawyer – Hip Implant Lawsuit Attorney
Smith & Nephew R3 Hip Liner Recall Lawyer – Hip Implant Lawsuit Attorney. The Smith & Nephew R3 Hip Implant …
Dems urge FDA to boost medtech recall database | MassDevice.com
Dems urge FDA to boost medtech recall database | MassDevice.com On Call | MassDevice – Medical Device Industry News. Dems …
Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes
Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes. Loophole in FDA’s Approval Process for …
The US Medical Device Market is a Dinosaur – Mike comments
The medical device industry is a dinosaur. Sales people getting paid hundreds of thousands who don’t really know anything about …
Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno
Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno. Rival Tried to …
FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers
FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers. FDA Employee Surveillance May Indicate …
Protection to paranoia for FDA’s surveillance program | Editorials | Tri-CityHerald.com
Protection to paranoia for FDA’s surveillance program | Editorials | Tri-CityHerald.com. Protection to paranoia for FDA’s surveillance program Published: July …
What does the FDA have to Hide? Who do they work for??
FDA shouldn’t be spying on whistle-blowers – Tampa Bay Times. FDA shouldn’t be spying on whistle-blowers In Print: Saturday, July …
Smith and Nephew BHR: Mr. Smith, his nephew, and the incident involving their missing BHR Modular Head
I have posted a few things around here and owe a debt of gratitude to Earl, as do we all. …
Bard Must Pay $5.5 Million Over Vaginal Mesh Implants – Bloomberg
Bard Must Pay $5.5 Million Over Vaginal Mesh Implants – Bloomberg. Bard Must Pay $5.5 Million Over Vaginal Mesh Implants …
Wright Medical Filed Petition to Block Smith & Nephews Metal Implant
Wright Medical Filed Petition to Block Smith & Nephews Metal Implant. Wright Medical Filed Petition to Block Smith & Nephews …
Is the US Medical Device Industry Heading the Way of the Dinosaur?
Plastics News – Report calls for changes in medical device sector. Report calls for changes in medical device sector By …
Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register
Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register. …
FDA surveillance operation draws criticism from lawmakers | Reuters
FDA surveillance operation draws criticism from lawmakers | Reuters. FDA surveillance operation draws criticism from lawmakers WASHINGTON | Sun Jul …
Delays and Difficulties in Assessing Metal-on-Metal Hip Implants – The Law Offices of John David Hart
Delays and Difficulties in Assessing Metal-on-Metal Hip Implants – The Law Offices of John David Hart. Delays and Difficulties in …
Total Hip Modular Necks – Is this the next phase of Hip Failures?
Total Hip Modular Necks – Is this the next phase of Hip Failures?. Total Hip Modular Necks – Is this …
FDA – Overview of Medical Device Regulation > Information about MDUFA III
Overview of Medical Device Regulation > Information about MDUFA III. Information about MDUFA III Congress recently authorized the Medical Device …
Medical Device ID Proposal Unveiled – GovInfoSecurity
Medical Device ID Proposal Unveiled – GovInfoSecurity. Medical Device ID Proposal Unveiled FDA Would Create Database of Information By Marianne …
Smith And Nephew Hip Replacement Recall Lawsuit Attorney
Smith And Nephew Hip Replacement Recall Lawsuit Attorney. Saunders & Walker PA 3491 Gandy Blvd. North Suite 200 Pinellas Park, …
FDA to help medical device sales with expanded pre-market feedback program
FDA to help medical device sales with expanded pre-market feedback program. FDA to help medical device sales with expanded pre-market …
Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions
Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions. FDA NEWS RELEASE For Immediate Release: …
FDA to guide device makers on marketing application – chicagotribune.com
FDA to guide device makers on marketing application – chicagotribune.com. FDA to guide device makers on marketing application Ads by …
Stryker Recalls Two Metal-on-Metal Hip Implants
Stryker Recalls Two Metal-on-Metal Hip Implants. Stryker Recalls Two Hip Implants July 9, 2012 — Stryker Corp. announced a voluntary …
Dr Stephen (Steve) Tower to Join the Earl’sview site – to answer patient questions
Earlsview Over the year since I set up Earlsview as part of my “anger management” the site has had nearly …
FDA – User Fees for Medical Devices: Third Time Lucky?
User Fees for Medical Devices: Third Time Lucky? John R. Graham, Director, Health Care Studies Congress recently passed, almost unanimously, S.3187, …
FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today
FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today. FDA Faces Daunting Task as Health Apps Multiply By …
FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier
FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier. FDA Proposes …
MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA
MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA. MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA Cheryl Clark, …
Stryker recalls two metal-on-metal hip products for fear of corrosion
Stryker recalls two metal-on-metal hip products for fear of corrosion. Stryker recalls two metal-on-metal hip products for fear of corrosion …
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2
June 28 2012 – Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2 Click the link …
Biomet M2a Magnum Metal-on-Metal Hip Replacement Lawsuit
News Headline Story | equities.com. Biomet M2a Magnum Metal-on-Metal Hip Replacement Lawsuit Alleges Defective Implant Caused Oregon Woman to Suffer …
FDA releases proposed UDI rule; reaction generally positive
FDA releases proposed UDI rule; reaction generally positive | Healthcare Finance News. July 06, 2012 | Rene Letourneau, Editor WASHINGTON …
Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today
Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today. Governmental Oversight of Potentially Dangerous Medical Devices Public and …
FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments
FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments. FDA Proposes Device ID Regulations for …
Early Clinical Experience With the Use of the Birmingham Hip Resurfacing System | Orthopedics
Early Clinical Experience With the Use of the Birmingham Hip Resurfacing System | Orthopedics. Early Clinical Experience With the Use …
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
FDA Executive Summary Memorandum Metal-on-Metal Hip Implant Systems Prepared for the June 27-28, 2012 Meeting of the Orthopaedic and Rehabilitation Devices …
SMITH & NEPHEW BHR – FDA Papers – Appendix G: Summary of MoM Hip Resurfacing Post-Approval Studies
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 …
Smith & Nephew BHR – Food and Drug Administration, HHS
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 …
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)
FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, …
FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR…
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 …
Wright Medical’s Response to Smith & Nephew’s Response to WMT request to Deny BHR PMA
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 …
Smith & Nephew’s :Response to Wright Medical Technology’s Citizen’s Petition to Deny PPrIA P040033
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 …
FDA Pre Market Approval (PMA) of Birmingham Hip Resurfacing (BHR) System – P040033
HOW DID THEY GET APPROVAL? Birmingham Hip Resurfacing (BHR) System – P040033. Birmingham Hip Resurfacing (BHR) System PMA Approval P040033a …
All the Reasons WHY Smith & Nephew Birmingham Hip Resurfacing Should NOT have gotten PMA from the FDA
All the Reasons WHY Smith & Nephew Birmingham Hip Resurfacing Should NOT have gotten PMA from the FDA This makes …
New FDA guidance on considerations used in device approval
New FDA guidance on considerations used in device approval. New FDA Guidance used in Device Approval THURSDAY, MARCH 29. 2012; FDA …
Antidepressant proves effective in alleviating osteoarthritis pain Depression
Antidepressant proves effective in alleviating osteoarthritis pain Depression | Pharmaceutical & Medical Packaging News. Antidepressant proves effective in alleviating osteoarthritis …
Recipients Injured By Metal-On-Metal Hips Speak Out Against Dangers of MoM Hips – SFGate
Recipients Injured By Metal-On-Metal Hips Speak Out Against Dangers of MoM Hips – SFGate. Recipients Injured By Metal-On-Metal Hips Speak …
WHO CAN YOU TRUST??? Pharmaceutical Giant GSK to Pay $3B in Largest-Ever Health Care Fraud Case
Pharmaceutical Giant GSK to Pay $3B in Largest-Ever Health Care Fraud Case – Yahoo! News. Pharmaceutical Giant GSK to Pay …
Howard Sadwin’s Suffering from Metal-on-Metal Hip Implant | Mesh Medical Device Newsdesk
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 …
FDA Reports16,800 Metal On Metal Hip Implant Adverse Events
FDA Reports16,800 Metal On Metal Hip Implant Adverse Events | The Legal Examiner Phoenix. FDA Reports16,800 Metal On Metal Hip …
DePuy Pinnacle Hip Implant Failure Initiative Considered “Vital”
DePuy Pinnacle Hip Implant Failure Initiative Considered “Vital”. The U.S. Drug Watchdog has a goal of identifying every single one …
FDA panel sees little use for metal-on-metal hips | CTVNews
FDA panel sees little use for metal-on-metal hips | CTVNews. The Associated Press; Published Friday, Jun. 29, 2012 8:25AM EDT This …
FDA Probes Safety Issues Associated with Metal Hip Implants | Qmed
FDA Probes Safety Issues Associated with Metal Hip Implants | Qmed. FDA Probes Safety Issues Associated with Metal Hip Implants …
FDA to study growing failure rate of metal hip devices – USATODAY.com
FDA to study growing failure rate of metal hip devices – USATODAY.com. The Food and Drug Administration is meeting with …
Pennsylvania woman to address FDA panel on husband’s hip-replacement recall – Philly.com
Pennsylvania woman to address FDA panel on husband’s hip-replacement recall – Philly.com. Pennsylvania woman to address FDA panel on husband’s …
FDA probes safety issues with metal hip implants
FDA probes safety issues with metal hip implants – Rolla, MO – The Rolla Daily News. WASHINGTON — Metal hip …
Suffering of Thousands Prompts FDA Hearing about Hip Implants
Suffering of Thousands Prompts FDA Hearing about Hip Implants. Suffering of Thousands Prompts FDA Hearing about Hip Implants Thousands of …
FDA Considers Metal Hip Injuries — A Bit Too Late for Some Victims – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts
FDA Considers Metal Hip Injuries — A Bit Too Late for Some Victims – Florida Mass Tort Attorneys, Lawyers | …
J&J Sold Transvaginal Mesh Implants After FDA Ordered Company To Cease Marketing – SFGate
J&J Sold Transvaginal Mesh Implants After FDA Ordered Company To Cease Marketing – SFGate. J&J Sold Transvaginal Mesh Implants After …
Medical Device « The Senate Passes Unparalleled Medical Device User Fee Act
Medical Device « DePuy Recall Blog. The Senate Passes Unparalleled Medical Device User Fee Act When the Senate passed the resolution …
FDA panel sees little use for metal-on-metal hips – SFGate
FDA panel sees little use for metal-on-metal hips – SFGate. FDA panel sees little use for metal-on-metal hips MATTHEW PERRONE, …
FiDA Failed Implant Device Alliance
FiDA Failed Implant Device Alliance. Failed metal on metal hips: U.S. lab rats! FDA probes safety issues with metal hip …
FDA PMA – how this hides the guilty and stops The Damaged and Suffering from getting Justice – Smith & Nephew
Smith & Nephew BHR – How can a device manufacturer be denied by the FDA on a 3/2 vote in …
Howard’s Lament – Lawyers dodge the tough jobs!
I am sharing my latest experience with a large law firm that did represent me up until yesterday. I received …
Recalls of Medical Devices and Consumer Products Rise to Kick-Off the New Year | ExpertRECALL | Recall Management, Product Retrieval, Recall Logistics
Recalls of Medical Devices and Consumer Products Rise to Kick-Off the New Year Mike Rozembajgier 05-14-2012 By Mike RozembajgierMedical device …
FDA’s $6.4 Billion Plan for Quick Reviews Moves to Senate – Businessweek
FDA’s $6.4 Billion Plan for Quick Reviews Moves to Senate – Businessweek. Medtronic’s capsure sense lead, a device that is …
Long Term Use of Bone-Strengthening Drugs Could Lead to Weaker Bones | Virtual-Strategy Magazine
Long Term Use of Bone-Strengthening Drugs Could Lead to Weaker Bones | Virtual-Strategy Magazine. Saturday, May 12th 2012 (PRWEB) May …
Whitehall man with two defective hip implants wants to be heard by the FDA – mcall.com
Whitehall man with two defective hip implants wants to be heard by the FDA – mcall.com. By Milton D. Carrero, …
Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG
Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG. Medical Implant Recalls Raises Questions about 510K Review …
Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery – Hip Implants – Zimbio
Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery – Hip …
MoM Hip Victim Stories to the Orthopedic and Rehab Devices Panel of Med. Devices Advisory Commitee
I just want to emphasize how important it is for as many of us as possible to send in our …
June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0293] Orthopaedic and Rehabilitation Devices Panel of the …
Metals from hip replacements present toxic risk for millions, investigation warns
Metals from hip replacements present toxic risk for millions, investigation warns Ryan Jaslow (CBS News) Millions of people with metal …
Howard shares more views
Medical News: has 2 articles, reiteration, (daily.headlines@medpagetoday.com). People must learn about this or nothing will happen other than the medical …