TIP of Iceberg in re Stryker CerviCore Criminal Charade: Breaking News: Blue Cross Blue Shield Regence states: Stryker Spine CerviCore does NOT have an approved IDE (investigational device exemption) - the Status of the CerviCore artificial disc has been registered in the government archives as WITHHELD. The WITHHELD APPROVAL STATUS has been in effect since 2007. There is evidence that the Withheld Approval Status went into effect shortly after the CerviCore trial submitted a report to the MAUDE Adverse Event database on July 6,2006. And pursuant to the Code of Federal Regulations, the sponsor was required to halt the study while the cause of the malfunction was evaluated and submitted to the FDA for further determination on whether to terminate the study (approval withheld) or reinstate the study. Reinstating the study would have required notifying the subjects already implanted with the CerviCore of the serious malfunctioning. clinicaltrials.gov/ct2/results?term=CT+002-04 According to BCBS Regence Medical Policy Manual for May 1, 2013 - CerviCores IDE status is REVOKED by the FDA. See link, page 1 under artificial replacement device and print out policy manual for safety risks and harm caused by metal on metal spinal implant devices. blue.regence/trgmedpol/surgery/sur127.pdf The list of complications for the metal on metal TDR devices are life threatening if the device is left in the spine after it has clinically failed - yet Stryker Spine is maintaining in Federal Product Liability Lawsuit that they have a valid IDE and that there were no adverse events reported from the study sites. Does any one smell rotten cheese from Denmark? Now that it is public knowledge that the Conditional Approval CerviCore IDE had been REVOKED by the FDA, this explains why Stryker Spine covertly registered the CerviCore under its Corporate clinical trial identifying number: CT 002-04 on 12/21/2007 in the archives for trial device not previously approved for any use by FDA. Trial device IDE applications that were never approved for any use by the FDA are BLACK BOXED ( ordered to the lock box) and pursuant to Title VIII, mandated to be registered in the archives for studies that were never approved. It is a crime to induce volunteers into unauthorized human experimentation under the pretext that the trial device had been approved by the FDA and had obtained and maintained a valid IDE. The only reason SS registered the CerviCore trial into the archived database on 12/21/2007 is due to the mandate in PLAW 110-85 Title VIII Section 801 enacted on September 26, 2007 requiring that within 90 day from enactment, all ongoing clinical trials and defunct unapproved clinical trials had to register their trial in the appropriate database by 12/26/2007 or risk a $10,000.00 a day FINE for non-compliance. This explains why the CerviCore a/k/a CT 002-04 was registered in the archives as a Black Boxed Trial of Device NOT PREVIOUSLY APPROVED OR CLEARED BY THE US FDA FOR ANY USE - (Record - Delayed Posting) . What concerns me is the fact that the FDA has turned a blind eye to unauthorized human experimentation with the Stryker Spine CerviCore implant - raising suspicion that the FDA is actively colluding with Stryker to cover up this crime against the human rights of the severely injured subjects. The Injured CerviCore subjects who registered complaints with the FDA have never heard word one back - some complaints were filed as far back as 2006 regarding injuries from the metal on metal device - and although the device had been black boxed after the reported malfunction - and a series of complaints filed between 2006 and 2010, the FDA has allowed the public to believe that the CerviCore trial had a valid IDE - in spite of the concrete evidence in their own databases to the contrary. This is the source of the problem - and it could only mean that someone inside the FDA was paid a pretty penny to cover up and conceal from the public these serial human rights crimes against 288 CerviCore victims. The Blue Cross Blue Shield does not make statements lightly when it clarifies the status of an approval for an investigational device. BCBS works very closely with the FBI investigating health care fraud. If their agents were informed that the CerviCore had its IDE REVOKED - then this is solid evidence that there is a criminal conspiracy taking place within the FDA to cover up their agents involvement with Stryker executives to bury the evidence of the CerviCore malfunctioning very early in the trial - and with only a questionable conditional approval. Some serious housekeeping is in order to find out who was behind subverting complaints from the CerviCore victims between 2006 and 2010 to the present. I personally have filed several complaints about the Stryker CerviCore device causing tumors and life threatening injuries I have incurred from this lethal metal on metal spinal implant. And as far as I know, absolutely NOTHING is being done to insure the numerous injured CerviCore victims that their injuries will be evaluated and the device removed. Stryker is refusing to remove the CerviCore - and is forcing us to live with an implant that is causing tumors to develop and turn carcinogenic. Stryker is now claiming that the CerviCore trial was a success and there were no adverse event complaints reported. Yet, if one were to research the MAUDE database - one will find a report of a malfunctioned CerviCore device that broke apart in the subjects spine in June 2006. https://accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=739251 Just as the FDA now claims undue political pressure was responsible for the FDA approving Meneflex Knee Patch and is now revoking the approval and clearance for marketing, the same standard must apply to the CerviCore. A public announcement that the CerviCore never maintained a valid approval for human experimentation - except that rogue CIA influence by the name of Howard E Cox put pressure on the FDA to covertly hide the CT 002-04 CerviCore trial in the black box to protect PROFITs and disclosure of the real risks of the metal on metal CerviCore posed to the public. Corporate Elitists, like Howard E. Cox have nothing but contempt for humanity or the rights of human subjects whose spines Stryker destroyed - Strykers track record of corruption and incompetent manufacturing processes are notorious - but somehow, Stryker always gets away with their criminal wrongdoing. A deeper look into the unholy relationship between Stryker executives and upper level management could provide the answers we CerviCore victims deserve. If the corrupt influences deeply embed in the FDA are not brought to justice, all of the fine words about protecting the public health and claims of transparency are nothing more than an ongoing continuing abuse of power that in the end will only make the US rule of law a laughing stock in the world. nytimes/2010/10/15/health/policy/15fda.html?_r=0 blue.regence/trgmedpol/surgery/sur127.pdf This is the deception that has been perpetrated on the clinical trial subjects since November, 2005 until present. Stryker has been denying claims of severely injured volunteers leaving us to suffer the torturous adverse effects of metallosis, tumors, cysts and tissue and bone necrosis (to name a few of the painful conditions caused by this device). Now that our insurance companies know that the CerviCore device had been revoked or worse, never approved by the FDA, they will NOT provide the coverage we desperately need for revision surgery and post surgery rehabilitation. That is, unless the Secretary of Health and Human Services Kathleen Sebelius intervenes on our behalf - and publicly exposes Strykers fraud on the government and the permanently injured volunteers. academyhealth.org/files/2008/sunday/washington5/6_8_2008_11_00/zarind.ppt Trials for Devices that are not approved with an IDE or cleared for a 510k will not be posted publicly. The trials for devices that are not approved with an IDE must register in the FDA lock box. The trials for devices that are not approved with an IDE cannot file an application for a PMA - without compliance with regulations for a valid IDE. clinicaltrials.gov/ct2/results?term=CT+002-04
Posted on: Mon, 17 Nov 2014 03:55:42 +0000
Recently Viewed Topics
© 2015