Half of decade-old metal hip implants defective – Life & Style – NZ Herald News
Half of decade-old metal hip implants defective – Life & Style – NZ Herald News. Half of decade-old metal hip …
Half of decade-old metal hip implants defective – Life & Style – NZ Herald News. Half of decade-old metal hip …
Source & full article: Medical device firms push to comply with new FDA rules. Medical device firms push to comply with …
Source article for full text: How does the FDA ‘approve’ medical products? – Medical News Today. How does the FDA ‘approve’ …
Source: Biomet reaches $56 million settlement over faulty hip replacements | Reuters. Biomet reaches $56 million settlement over faulty hip replacements …
The Myth of the Medical-Device Tax WASHINGTON — IN the last few days of negotiations in Congress, repeal of the …
Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants Andrew Testa for The New York Times …
Consumer Reports Urges a Lemon Law For Joint Replacements by Christy Rakoczy, a J.D. Manufacturers of hip and knee replacement …
FiDA Failed Implant Device Alliance: Exposed! : Secret Medical Device Payments to Doctors. Exposed! : Secret Medical Device Payments to …
ASME DC | Journal of Medical Devices | Battery-Less Wireless Instrumented Knee Implant. Battery-Less Wireless Instrumented Knee Implant J. Holmberg, L. …
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 …
Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury. Metal hip patients ‘need annual checks’ …
Smith & Nephew Failure Warning for Birmingham Hip Implant. Smith & Nephew Failure Warning for Birmingham Hip Implant September 27, …
The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com. Doctors Who Don’t Speak Out By BARRY MEIER Published: …
Patients victims of untested medical devices – SFGate. Patients victims of untested medical devices Victoria Colliver Updated 9:21 pm, Tuesday, February …
What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com. EDITORIAL What a Company Knew About Its Metal Hips Published: …
A Few New Year’s Wishes and Thoughts from one of the many MOM ‘Victims’! Well, 2013 is finally here, the …
As was anticipated big layoffs from the medical device manufacturers; the BLAME or FINGER being pointed at the device tax to …
Medical devices – Tom Joyce on device regulation | BMJ. Medical devices – Tom Joyce on device regulation The BMJ …
What Happened to the FDA Request for More Hip Implant Studies? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass …
It is time for Smith and Nephew to be realistic and honest, afterall in their code of ehtics the safety …
Faulty medical implants investigation: Patients treated ‘like guinea pigs’ – Telegraph. Faulty medical implants investigation: Patients treated ‘like guinea pigs’ …
Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs – Telegraph. Faulty medical …
The FDA is there to protect patients? Bullsht | MassDevice – Medical Device Industry News. The FDA is there to …
Hundreds of NZ hip replacements are faulty – National – NZ Herald News. Hundreds of NZ hip replacements are faulty …
Shake-up of EU medical device regulations shocks industry. Source: http://www.buildingbetterhealthcare.co.uk/news/article_page/Shakeup_of_EU_medical_device_regulations_shocks_industry/81250 Shake-up of EU medical device regulations shocks industry Medical Devices | Market Information | Regulatory | …
Medical Devices Vulnerable to Hacking Need Oversight – Businessweek. Bloomberg News Medical Devices Vulnerable to Hacking Need Oversight By Jordan …
Sky News: Hip replacements should be checked – TGA. Hip replacements should be checked – TGA Updated: 08:07, Friday September …
Plaintiffs look to depose new Johnson & Johnson CEO Gorsky in DePuy ASR lawsuit | MassDevice – Medical Device Industry …
Medical Devices. Management of Patients with Metal on Metal Hip Implants. Medsafe and the New Zealand Orthopaedic Association (NZOA) (www.NZOA.org.nz) support …
Sixty sue for dud hip joints – Crime & Courts | IOL News | IOL.co.za. Sixty sue for dud hip …
Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process. Neurosurgeon’s Conflict With Spine Device Company Sheds …
Journal of Medical Case Reports | Abstract | Revision of hip resurfacing arthroplasty with a bone-conserving short-stem implant: a case …
» 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. Wednesday, August 22, 2012 FDA Aims To Smooth Premarket Review …
Recent comment published on Earl‘sview that deserves more notice: Does Smith and Nephew not hear the cries from victims of …
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. The Smith & Nephew R3 Hip Implant …
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 …
Rottenstein Law Group Reports on Research Paper Concluding FDA’s Medical Device Approval Process Needs Reform. Rottenstein Law Group Reports on …
The medical device industry is a dinosaur. Sales people getting paid hundreds of thousands who don’t really know anything about …
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. …
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 FDA Would Create Database of Information By Marianne …
FDA to help medical device sales with expanded pre-market feedback program. FDA to help medical device sales with expanded pre-market …
As lawsuits climb, J&J may have new hip trauma | Smart Business. As lawsuits climb, J&J may have new hip …
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 Ads by …
About Metal-on-Metal Hip Implants. About Metal-on-Metal Hip Implants If you or your loved one has endured a MoM hip implant …
User Fees for Medical Devices: Third Time Lucky? John R. Graham, Director, Health Care Studies Congress recently passed, almost unanimously, S.3187, …
FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier. FDA Proposes …
June 27 2012 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1 Click the link below …
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 Public and …
FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments. FDA Proposes Device ID Regulations for …
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 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 http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-rc00001-01-vol3.pdf. Click the above link …
MDRWeb Medical Device Register On-line from Canon Communications, LLC. Premarket Approval (PMA) Database Premarket Approval (PMA) Database Trade Name: BIRMINGHAM …
P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices. PMA Application: P040033 S017 (Most recently approved supplement) Attribute …
Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL Post-Approval Studies. Post-Approval Studies FDA Home Medical Devices Databases – …
New FDA guidance on considerations used in device approval. New FDA Guidance used in Device Approval THURSDAY, MARCH 29. 2012; FDA …
The US Drug Watchdog Now Urges Plaintiffs Law Firms Worldwide To Contact Them About A Possible International Effort To Help …
Medical Device « DePuy Recall Blog. The Senate Passes Unparalleled Medical Device User Fee Act When the Senate passed the resolution …
MHRA tells surgeons to stop using R3 metal cup liner and extends patient monitoring advice Contact: Press Office 020 3080 …
Smith & Nephew BHR – How can a device manufacturer be denied by the FDA on a 3/2 vote in …
I thought it might be helpful to show what I sent in electronically in advance of the above referenced meeting, …
Thank you Earl and your blog again and thank you folks that have contacted me re: attorneys. I will let …
FDA rule clears medical devices without human testing | devices, – News – The Orange County Register. Published: May 18, …
Zimmer Durom Cup Hip Implant – Waters & Kraus. Zimmer Durom Cup Hip Implant We protect the interests of those …
Are Metal-on-Metal Hip Implants Tied to Increased Cancer Risk? Part Three: Specific Cancer Risks Post Metal-on-Metal Hip Implant. Are Metal-on-Metal …
I am looking for a real answer to a real question- if the Catholic Church was held accountable for their …
Recalls of Medical Devices and Consumer Products Rise to Kick-Off the New Year Mike Rozembajgier 05-14-2012 By Mike RozembajgierMedical device …
Corporate Whistle Blower Center Launches New Initiative to Go After a Very Corrupt US Medical Device Industry and Urges Insiders …
German engineers develop a non-metal hip implant for long-term use | MassDevice.com On Call | MassDevice – Medical Device Industry …
Hip Replacement Crisis in Europe Causes Demand for Medical Device Registry. The global medical crises of dangerous metal-on-metal hip implants …
Metal-on-Metal Hip Implants – Advisories, Warnings & Recalls for the public. Public Communication – Health Canada Issued Important Safety Information …
Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG. Medical Implant Recalls Raises Questions about 510K Review …
I just want to emphasize how important it is for as many of us as possible to send in our …
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0293] Orthopaedic and Rehabilitation Devices Panel of the …
Medical News: has 2 articles, reiteration, (daily.headlines@medpagetoday.com). People must learn about this or nothing will happen other than the medical …
What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs. What is the Status of …
Senators Introduce Safe Medical Devices Act. Senators Introduce ‘Safe Medical Devices Act’ A bipartisan group of U.S. senators is pushing …
FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra. …
Consumer Reports Poll: Consumers Support More Medical Device Oversight Posted: 20 Mar 2012 07:38 AM PDT CONSUMERS UNION NEWS RELEASE …
March 16, 2012 Next week, the U.S. House of Representatives will be voting on H.R. No. 5, which has been …
US Drug Watchdog Warns There Could 100,000s of Failed Metal on Metal Hip Implants Involving US Hip Implant Recipients and …
Press release: MHRA updates advice for metal-on-metal hip replacements : MHRA. Press release: MHRA updates advice for metal-on-metal hip replacements …
Yesterday I was told the total hip resurfacing Smith and Nephew I received 9/2010 must be removed. They are doing …
Howard Sadwin – robbed of life Many of you will have read Howard Sadwin’s story and comments over the last …
FDA warns J&J’s DePuy unit over joint replacements – AlertNet. FDA warns J&J’s DePuy unit over joint replacements 18 Jan …
Correspondence from an “in pain and damaged BHR recipient” To: [deleted doctors name] Biosciences & Implants Unit Medical Devices Division …
Mesh Medical Device Newsdesk » latest news, information and perspective from the regulatory, industry and patient point of view, something …
Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and …
Recent Information from the FDA on Failures This information came from FDA news. The FDA says approximately 44% of device …
More Smith & Nephew BHR – MoM Problems Emerging each day Comment received overnight: I too have a Smith and …
Great to see the activity pick up re: metal on metal hip devices, and yes they can be hazardous to …
Priorities, staffing impede inspections of drug, device makers – JSOnline. Priorities, staffing impede inspections of drug, device makers Some not …
Zimmer knee replacement manufacturer sued for metal on metal design | Louisiana Record. Zimmer knee replacement manufacturer sued for metal …
More and more people are sharing their stories of suffering because of this hip debacle. This is great, let’s others …
The regulatory standards for the approval of medical devices in Australia – Senate Inquiry On 16 June 2011 the Senate …
FDA seeks to include more women in medical device trials. FDA seeks to include more women in medical device trials …
What isn’t being published is the truth regarding the medical device world. by Howard Sadwin Howard’s Opinion: If we obtained …
San Francisco Personal Injury Attorney Analyzes DePuy Lawsuits And Preemption. DePuy Hip Implant Claims & Federal Preemption November 23, 2011 …
For those of you who have been following this blog for some time, you will recall the story of Howard …
MAKO aims to get hip-replacement patients back on feet faster October 10, 2011 — 7:57am ET | By Liz Jones …
Howard’s Story (as written by Howard): My intentions are to tell my story, and for others to listen to my …
The rate at which FDA issues 483s and warning letters is going up, up, up. Source: FDA email circular advertising …
Complaints Surge About Crumbling Artificial Hips on August 23, 2011 Source: fairwarning.org As researchers scramble to assess the health dangers of …
FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices August 19, 2011 Source: Medical Design Online For the first …
IOM chair discusses 510(k) report: origins, findings, response Written by Brian Dunham August 15, 2011 Source: Cardiovascular Business David …
FDA Loosens Premarket Notification Requirements for 30 Medical Device Types Written by: mdcieditor Wednesday, August 10th, 2011 | FDA Medical …
Sadwin gets to the heart of the Issues with FDA 510(k) I spend a good part of my day keeping …
Recall Index – Second Quarter 2011 – Medical Devices Source:expertrecall.com During the second quarter of 2011, FDA Enforcement Reports documented …
Medical Devices — Balancing Regulation and Innovation NEJM | August 10, 2011 | Topics: Drugs, Devices, and the FDA Gregory D. …
Editorial: The wrong prescription on medical devices Article by: EDITORIAL , Star Tribune Updated: August 6, 2011 – 6:19 …
How Safe Are Medical Devices? Published: August 4, 2011 New York Times A prestigious medical group is concerned that most …
Did IOM Put the Final Nail in the Coffin of Metal-on-Metal Hip Implants? Published: August 3, 2011—Shana Leonard Source: MPMN …
FDA Seeks Public Views on Proposed 510(k) Plans August 01, 2011 By a GenomeWeb staff reporter NEW YORK (GenomeWeb News) …
Reforms in the medical devices regulatory framework: Overview of submissions 11 February 2011 Background On 2 November 2010, the TGA released a …
Australian TGA – Reforms in the medical devices regulatory framework Consultation Source: TGA – Click here 2 November 2010 Relevant …
Recall of DePuy Orthopaedics ASR hip replacement device 16 May 2011 Source Therapeutic Goods Administration Recall of DePuy Orthopaedics ASR …
Wright Hip Replacement Lawsuit Filed by Woman from Great Britain Source: AboutlawSuites.com Published: July 29th, 2011 An U.K. woman has …
For Immediate Release Friday, July 29, 2011 Contact: Kaelan Richards 202-225-3661 DELAURO TO FDA: 510(k) MEDICAL DEVICE APPROVAL PROCESS UNSAFE, …
Report: FDA’s Medical Device Approval Process Is Flawed Source: Click here MINNEAPOLIS (WCCO) – More than 100 medical devices have been …
7.29.11 | Arundhati Parmar Source: MedCityNews 510(k) approval process is too big to fail no matter how flawed it may …
U.S. advisers call for new medical device regime Andrew Seaman Reuters Full Edition July 30, 2011 WASHINGTON (Reuters) – An …
Approval process for devices blasted Barry Meier The Boston Globe July 30, 2011 The government’s system for regulating many medical …
Expert group calls for new way to clear medical devices Christine Mai-Duc | Tribune Washington Bureau Source: ongo The Tennessean …
Refer to: Advisory panel calls for revamping FDA approval process for medical devices Good morning: I just read your article …
Advisory panel calls for revamping FDA approval process for medical devices David Brown and N.C. Aizenman The Washington Post Ongo.com …
FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report By Anna Edney – Jul 30, 2011 2:27 …
Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process The report has been released Friday 29 …
Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs Source: FDA Website Statement …
Report could sway FDA device review process Source: Reuters By Andrew Seaman WASHINGTON | Tue Jul 26, 2011 1:40pm EDT (Reuters) – …
Risky pelvic mesh highlights worries about FDA process Untested medical devices found to erode patients’ insides Source: MSNBC.com By Rita Rubin; …
Study Faults Approval Process for Medical Devices BY BARRY MEIER PUBLISHED: JULY 29, 2011 NEW YORK TIMES The government’s system for regulating …
510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release July 28, 2011 by MassDevice staff …
[Earl’s View] Comment: “Bruce Greenfield may be the last New Zealander implanted with a faulty hip joint “ Market share …
Study of Medical Device Rules Is Attacked, Unseen By BARRY MEIER New York Times – Click here Published: July 27, 2011 Allies of …
Remand Denials in Hip Implant MDL Source: click here We’ve just found out about multiple remand denials from the Depuy hip …
Why Are Pharmaceutical Companies Paying The FDA? Posted by Amber Racine J uly 27, 2011 10:31 AM Source: Click here The FDA …
Report: IOM review of the FDA 510(k) process due Friday July 27, 2011 by Brendon Nafziger, DOTmed News Associate Editor; Source …
FDA medical device review times to be subject of House hearing The House Energy & Commerce Committee’s oversight subcommittee is …
Materials Research Gets Under the Skin Scientists push biocompatible materials to interact with their surroundings in intelligent ways By: Stephanie …
Is Medical Device Design Going to the Dogs? Published: May 23, 2011 The Massachusetts-based Worcester Business Journal featured an interesting …
Published: Tue, Nov 30, 2010 – 11:25 am Roundtable: Evolution, Not Revolution, Drives Biomaterials Development MPMN 25th Anniversary Coverage Marcus …
DePuy ASR Hip Implant was Untested Date Published: Monday, April 4th, 2011 Could the controversial recalled DePuy hip replacement devices …
DePuy Hip Implant Recall to be Featured at Senate Hearing on FDA Medical Device Approvals Date Published: Wednesday, April 13th, …
FDA Again Criticized for Medical Device Oversight Date Published: Wednesday, April 13th, 2011 Thousands of medical devices are approved annually …
Former Swimmer Files Suit over DePuy ASR Hip Resurfacing System Date Published: Tuesday, June 28th, 2011 A former competitive swimmer …
Zimmer NexGen Component Recall The Zimmer NexGen MIS tibial component recall affected 68,384 knee components, which were distributed in 13 …
Orthopaedic and Rehabilitation Devices Panel – February 22, 2007 The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Thursday, …
Corin FDA Approvals Source: click here Corin 510K Biolox FDA Approval K103120.pdf Corin Minhip K083312.pdf Corin BIOLOX delta Modular Femoral …
Just in from Howard’s Desk (wheel chair) … I just sent a feedback message to med page. How ridiculous it …