Fw: Special Report on the FDA and Medical Devices

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----- Original Message ----- From: Kathi

Sent: Tuesday, September 10, 2002 11:55 AM

Subject: Special Report on the FDA and Medical Devices

Some of you may remember seeing familiar posts to the following but there is much more here than the few articles you may recognize, so don't pass this up!!! Thanks so much to Ruby for putting more depth to this info by supplying us with this more complete resource! Kathi I found an incredible special report published last month in the Star-Ledger in Newark, New Jersey. Please read this revealing study on the FDA and medical devices. Part of this report was partially reprinted in the Star-Tribune in Minneapolis-St . In that paper, I found an editorial and a response from Medtronics. ( Medtronic is located in Minneapolis) Those links can be found at the end. The eight-month project was supervised by Tom Curran, assistant managing editor for investigations. Please respond with your comments, support and questions to him at tcurran@... or call at (973) 392-4003. Read, "About this Series" to find out the lengths they had to go to to analyze the data they got from the FDA. This is a very long report. To print out everything, including graphics, is about 50 pages. If you do not feel like reading all of it, I've created a summary of this article, for stats and the basic points. I did not include, in my summary, some of the heart breaking stories of what people have gone through. You'll have to read the articles for that. I am attaching my summary as a word doc for easy reading. I do not know how long these links will be up so if you have any trouble accessing anything, please let me know and I'll send the individual articles to you. While they did address the issue of breast implants, they did not give it as much in-depth attention as I would have liked. Finally a mainstream newspaper is reporting on this issue, in Newark, New Jersey of all places. R.M. Rahn - Newark, New Jersey Special Projects http://www.nj.com/specialprojects/implants/index.ssf August 12, 2002 ABOUT THIS SERIES In reporting this project, The Star-Ledger had to devise its own methods for analyzing and interpreting Food and Drug Administration data. http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/aboutimplants.html Part One The Risky World of Implants http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/implants1.html Was Pain Due to Breast Silicone? http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/implantsside1.html A Surefire Profit-Maker Could Cost its Maker Dearly http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/implantsside2.html Implants: By the Numbers http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/graphic15.html Graphics - learn more about ... The Heart: The Silzone Heart Valve http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/graphic9.html The Bladder: The ProtoGen Bladder Sling http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/graphic12.html Part Two Only the Companies Knew When Their Devices Failed http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/implants2.html A Glitch Can Kill, but Pacemaker Users Will Take That Chance http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/implants2side1.html Graphics -learn more about ... The Aorta: The Ancure and AeuRx Grafts http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/graphic1.html Part Three A Hip Maker's Billion-Dollar Mistake http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/implants3.html Cement Hold the Artificial Hip and All is Well - Most Times http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/implants3side1.html Two Men in a Lab Wait for Failed Parts, Then Leap into Action http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/implants3side2.html Graphics -learn more about ... The Hip: The Sulzer Hip Joint http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/graphic4.html When Medical Miracles Fail http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/graphic7.html Bone Cement Syndrome http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/graphic8.html STAR-LEDGER PHOTOS http://www.nj.com/photos/implants/ http://www.startribune.com/ Response from Medtronics N. Oesterle: Implant stories failed to give context-Published 8-17-02 http://www.startribune.com/stories/562/3169512.html Editorial: Medical implants /FDA needs more resources - Published 8-18-02 http://www.startribune.com/stories/561/3169236.html