Blogs about: Asr Hip

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FDA: Metal on Metal Hips, higher failure rates for women

FDA Panel Discussing Safety of Metal-On-Metal Hip Implants Published June 27, 2012 Dow Jones Newswires The Food and Drug Administration on Wednesday convened a two-day advisory panel meeting to discus… more →

Failed implant Device Alliance

FDA: Metal on Metal Hips, higher failure rates for women

explanthis wrote 11 months ago: FDA Panel Discussing Safety of Metal-On-Metal Hip Implants Published June 27, 2012 Dow Jones Newswir … more →

Tags: 510k, Medicare, FDA, depuy, adverse event, revision surgery, Congress, consumers union, Public Citizen

Join #sppchat May 17 1ET Consumers Union MDUFA

explanthis wrote 1 year ago: link Join Our Twitter Chat on May 17: “What Consumers Need To Know About Medical Device User Fee Bil … more →

Tags: Adverse Events, 510k, FDA, Medical Devices, Product Recall, revision surgery, post-market data, Surgical Mesh, patient safety

Patient Harm Ignored: MDUFA legislation

explanthis wrote 1 year ago: link FDA Cuts a Deal to Fast Track Drugs and Devices By MERRILL GOOZNER, The Fiscal Times May 1 … more →

Tags: Adverse Events, 510k, Medical Devices, revision surgery, post-market data, Surgical Mesh, consumers union, ProPublica, pcori

ProPublica criticizes implanted medical device oversight. — 2 comments

explanthis wrote 1 year ago: LINK Four Medical Implants That Escaped FDA Scrutiny by Lena Groeger
ProPublica, Today, 11:32 a.m. ( … more →

Tags: Adverse Events, joint replacement, 510k, FDA, Medical Devices, Product Recall, Patient Advocate, revision surgery, post-market data

June 27 and 28, 2012-FDA public meeting on failed hips

explanthis wrote 1 year ago: UK and Australian Registries: Patient Harm   (Meeting notice and panel roster bolded … more →

Tags: Adverse Events, joint replacement, 510k, FDA, Medical Devices, IOM, Product Recall, depuy, revision surgery

Consumer Reports Investigates Safety of Implanted Medical Devices — 4 comments

explanthis wrote 1 year ago: LINK Is your implanted medical device safe? Mar 28, 2012 6:05 AM You might assume so, but many impla … more →

Tags: Adverse Events, joint replacement, 510k, FDA, IOM, Product Recall, depuy, revision surgery, post-market data

Wall Street Journal: Faulty Devices

explanthis wrote 1 year ago: LINK (Fida blog bold/underline added.) FDA Plans ID-Tag System to Detect Faulty Devices By THOMAS M. … more →

Tags: Adverse Events, 510k, FDA, Medical Devices, IOM, Product Recall, revision surgery, Surgical Mesh, Congress

Implanted Device Risk: Congress Favors Industry Lobby or Patient Safety

explanthis wrote 1 year ago: http://bit.ly/JDd5Zk FDA rips Europe’s system for medical device reviews      … more →

Tags: Adverse Events, joint replacement, 510k, FDA, Medical Devices, Product Recall, revision surgery, post-market data, Surgical Mesh

The U.S. joint replacement registry 4 years later: none!!! — 1 comment

explanthis wrote 1 year ago: (link) August 2008 AAOS Journal endorsed a national registry      (FiDA Blog bold/und … more →

Tags: Adverse Events, joint replacement, 510k, FDA, Medical Devices, IOM, Product Recall, revision surgery, post-market data

Consumers Union Letter in New York Times

explanthis wrote 1 year ago: Medical Device Oversight Lax   (LINK) (FiDA Blog bolding added.) LETTER Safety of Medical … more →

Tags: Adverse Events, joint replacement, 510k, FDA, Medical Devices, IOM, Product Recall, revision surgery, post-market data

Wall Street Journal: FDA regulation not adequate ICD's — 1 comment

explanthis wrote 1 year ago: http://online.wsj.com/article/SB10001424052702303772904577333941715666550.html     … more →

Tags: Adverse Events, joint replacement, 510k, FDA, Medical Devices, IOM, Product Recall, revision surgery, post-market data

Consumer Reports Medical Device Alert to Consumers elicits industry response

explanthis wrote 1 year ago: The medical device industry unleashes two hired women wordsmiths. Consumers Union is independent of … more →

Tags: Adverse Events, joint replacement, 510k, FDA, Medical Devices, IOM, Product Recall, revision surgery, post-market data

UK victim: registry will reduce implant harm — 1 comment

explanthis wrote 1 year ago: LINK St Helens mum left in agony by medical mesh launches campaign to save others   by Liz … more →

Tags: joint replacement, 510k, FDA, Medical Devices, Product Recall, revision surgery, post-market data, adverse adverse event, Surgical Mesh

Global Regulation: IOM report on Medical Products

explanthis wrote 1 year ago: The press release of this IOM report was on CSPAN2 today and medical products (including devices) we … more →

Tags: Adverse Events, joint replacement, 510k, FDA, Medical Devices, IOM, Product Recall, depuy, revision surgery

CBS Sunday Morning: When Medical Implants Fail

explanthis wrote 1 year ago: DIRECT LINK April 1, 2012 9:27 AM             … more →

Tags: Adverse Events, 510k, FDA, Medical Devices, IOM, Product Recall, depuy, revision surgery, post-market data

Consumer Reports: Most medical implants not tested

explanthis wrote 1 year ago: LINK to full article CR Investigates: Dangerous medical devices Most medical implants have never bee … more →

Tags: Adverse Events, joint replacement, 510k, Product Recall, depuy, revision surgery, post-market data, Surgical Mesh, patient safety

Hospital Consent Forms do not inform patients about joint replacement purgatory.

explanthis wrote 1 year ago: When you sign the hospital consent form you should be informed  the device company has a federa … more →

Tags: joint replacement, 510k, FDA, Product Recall, Patient Advocate, revision surgery, post-market data, Surgical Mesh, medical abandonment

POGO-Freedom of Information and the Public's Right to Know is personal!

explanthis wrote 1 year ago: http://pogoblog.typepad.com/pogo/2012/03/senate-judiciary-committee-talks-foia-and-the-publics-right … more →

Tags: joint replacement, FDA, Medical Devices, IOM, Product Recall, adverse event, revision surgery, post-market data, Riegel v. Medtronic

Failed hips: J&J putting profit first — 1 comment

explanthis wrote 1 year ago: LINK HERE to full article Hip Device Phaseout Followed F.D.A. Data Request By BARRY MEIER  … more →

Tags: Adverse Events, joint replacement, 510k, FDA, Medical Devices, IOM, Product Recall, depuy, revision surgery


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