Posted on 10/16/2010 5:55:24 PM PDT by huckster25
http://www.moremonmouthmusings.net/2010/10/14/is-the-entire-nj-mainstream-media-in-the-tank-for-pallone/
The FDA made an extraordinary and unprecedented move today when it announced that it was rescinding its 2008 approval of a medical device. The FDA said that the approval was made in error, after the product had already been rejected, based upon political pressure made by Congressman Frank Pallone and Steve Rothman as well as Senators Frank Lautenberg and Robert Menendez. All four knee jerks waged their campaign for the product’s approval by the FDA after receiving significant campaign contributions from the product’s manufacturer.
ReGen Biologics Inc.’s orthopedic knee device shouldn’t have been cleared for marketing in 2008, U.S. regulators said after a one-year investigation into complaints that political pressure led to the decision.
Hmmm, wonder what the party of the perps was?
Wanna bet?
ReGen “is currently weighing its options” about Menaflex, said Gerald E. Bisbee Jr., the company’s chief executive officer and chairman, in an e-mail. “The product has been approved and in use successfully in Europe for nearly 10 years with approximately 3,000 patients and there has never been a safety issue associated with the device.”
Congressman Frank Pallone and Steve Rothman as well as Senators Frank Lautenberg and Robert Menendez ..Democrat, Democrat, Democrat & Democrat
PDF] Menaflex
File Format: PDF/Adobe Acrobat - Quick View
CMI is now Menaflex. Menaflex. COLLAGEN MENISCUS IMPLANT .... Europe for the lateral meniscus and is now in clinical use. The American multicenter study ...
www.menaflex.be/media/files/Menaflex_Patient_Brochure.pdf?
Menaflex™ collagen meniscus implant
Menaflex is cleared for sale in Europe and several other countries around the world. It is not yet available in the United States. ...
www.kneesforyou.com/menaflexcollagenmeniscusimplant.php - Cached - Similar
Clinical Studies | Collagen Meniscus Implant | Menaflex
Peer-reviewed Publications on Menaflex clinical results .... European Society of Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA), Innsbruck, ...
www.menaflex.com/en-us/en/clinical-studies.php - Cached - Similar
They should be in jail
1 INDICT, 2 INDICT, 3 INDICT, 4 INDICT!
The warp is with the FDA.
“The product has been approved and in use successfully in Europe for nearly 10 years with approximately 3,000 patients and there has never been a safety issue associated with the device.”
http://www.arthritistoday.org/news/menaflex-knee-device-mistake089.php
In December 2008, despite unfavorable reviews by scientific experts, the FDA approved the device for sale in the United States under political pressure from four congressmen, as well as one of its own commissioners.
A clinical trial of the device found that it failed to work any better than routine surgery, and in reviewing the implant’s safety record, a panel of experts commissioned by the FDA noted that patients who received the Menaflex faced an “unduly lengthy recovery period” of six months and adverse events that included second surgeries.
And this happened BEFORE government run health care.
My problem isn’t with the product, it is with the influence peddling.
That doesn’t really excuse the unethical and probably illegal manner in which those four Congress critters acted does it?
‘“The product has been approved and in use successfully in Europe for nearly 10 years with approximately 3,000 patients and there has never been a safety issue associated with the device.”’
In the US medical treatments are never approved based upon licensing or usage in foreign countries. Only FDA regulated clinical trials, in the US or abroad are accepted. The reason is that both safety and efficacy trials there are less trustworthy.
I agree...the problem is the FDA.....Congress critters shouldn’t even be involved!
All independents, I'd have to presume.
Probably why crappy drugs like Lyrica get approved too. Side effects are awful, and about 50% can’t take it because of one or more of them.
The product should be on the market the politicians should be in jail. Instead we take the product off and reelect the pols.
It’s no wonder America is in trouble!
Robert Menendez is real scum
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