Looking for other abused clinical trial subject for Stryker Spine CerviCore Disc - implant

I too have the cervicore disc placed in 06' Seattle area.  I have never had ANY pain relief although I've been told "nothing is wrong, your surgery went perfect."  Although post surgery mylograms still show a narrowing with nerve impingement (Dr say's that it wouldn't hurt me!!!)  I was on pain management for 4 years but quit taking the medicine after they stopped having any effect on the pain.  And also because every Doctor I saw continually told me that they would not treat me as long as I was on ANY pain medication!  I have been told to seek "therapy" by many doctors and have been told I have "adjustment disorder" because I complain about the pain constantly.  I live with DAILY pain in the neck/shoulder area and haven't had a full nights sleep in more than 6 years!  About 6 months- 1 year after my surgery I was trying to look at the stars and felt something snap in my lower neck/shoulder area (where I have a constantly strained muscle).  After the snap I actually had a little more movement in the neck but worse muscle cramps in the area.  About 2 years ago (when I stopped taking my meds) I started developing these large areas of swelling/rash on all parts of my body that itch like crazy and will swell so large that I can't go out in public for fear of being called the Elephant Man.  Doctors say it is a food allergy!  LOL! Allergist says there is no way to tell.  I eliminated everything from my diet and found it isn't food related.  I also have funny rash in my GI tract which the biopsy comes back "similar" to ulcerative colitis!  Right after surgery I started having jaw problems.  I actually wondered if the DR was too rough on my jaw during surgery and expected it to get better.  NOPE!  Now I have constant migraines (hospitalized 4 times), my jaw pops out of the socket and constantly is pushed to one side.  Now I wonder if this is ALL related to my implant!  Even after surgery, post surgery Mylograms, EMGs, etc... I still have problems in my shoulder and now more pain in my neck.  This surgery has made my life worse than it was before surgery! I lost my business of 7 years due to the inability to be at work enough.  I can't get ANY help to feel better and can't get any doctors to take me serious!  

Since my last note posted, I have been having more and more problems with spasms and dropping things, especially with my right hand. Tingling, numbness, pins and needles also becoming more frequent. I am now far worse off than I was before the surgery. I requested full records from Dr. who did surgery four different times now. I have received only a very small part of the records.(pre and post surgery x-rays, some exam notes) . I have requested complete records including surgery records, and was told that Stryker has those records. I have also been tested annually since my surgery in 2006, but have not received any of the blood work results or follow-up exam notes( with one exception being a copy of physicians notes from my last visit that states" has problems related to the implant". I would really like to know if anyone else is having any luck in getting Stryker to admit there is a problem and help those of us who are stuck with this mess in our necks. Dr. recently set me up for PT again at his PT office, but then informed me that Stryker would not pay for the PT. I requested information from the Dr about the results of the study, and was told that Stryker does not share that information with the Dr., so he has no idea how it went. I see ads on TV about recalls and settlements for other failed metal-on-metal implants. Does anyone know if there is any efforts being put forth to help those of us who were talked into being guinea pigs for this study? I would really like to speak to anyone who is going through this same agony, or is aware of anything that can relieve the constant pain. Does it get any better if it is taken out, or is the damage done???? _[removed]_ 

Hey Melinda,
I just wanted to let you know that I also have a lot of trouble swollowing. When you look at my Exray, it shows the placement is somewhat forward and the cervicore disc rests on my Esophogus. When it gets inflamed or if i get a sore throat. OMG, I can feel it really bad. I have gotten used to it, thru the years, but sitll, I know that it is causing irreversible damage. Stryker, I do believe has covered ALL of our complaints and WE are all unfortunately Stuck with the consequences of their wrong doing. I would love to have mine out, but I know its too dangerous. I have TONS of problems Ranging from the swollowing issue to dysfunction of my right arm. I lose all control at times of it. Will drop anything that I am holding. Again. I know that there has been a lot of cover ups done and its up to all of us here to bust this wide open. We all need to ban together and go after them TOOTH AN NAIL.

Oh and also, I get choked alot on food and my meds. This is definately something that I did not sign up for.. Thats for sure.

Yes, Im still here Tara, Also, to let you guys know, I have a Cervicore facebook page. Look up Cervicore on FB and I would be glad to add you there as well.

Well, it sounds like there is more to the failed or improper placements of Styker disc. I've complained to Stryker and their lawyers when I sent certified letters to all the board members. Not one board member responded to me. (ond member is a Stryker family with a last name of Stryker).....She is listed on their web page, Board Member')

Mine (fyi) was a failed c-6 c-7 in 2006. I have all the symtoms as many of you. They scheduled an MRI after many Myelograms in 2011. The original surgeon finally saw me after 5yrs, and ordered the MRI with concern of his partners work faulty.

Stryker had me sign another form (adendum) to keep me the patient in the program for 9 yrs in lieu of 3. But they would not pay for the MRI and I lost my insurance. I've been dumped and the doctors  office say the FDA (federal) gave Stryker permission to drop this patient from the clinical trial with no responsibility whatsoever.

I'm screwed as most attorney's have told me as we all are at this time. I appreciate all pushing on a movement that has hurt and pained us for life an no recourse!

If anybody knows of a class action suit going yet, please advise me immediately, please......Thanks Dave

Please contact me Philomena.55

Dave, please contact me on my gmail.com email account. Just add gmail dot com to my screen name here : Philomena.55. There is a group of us who are going to take action. We would like to have your input. We are all CerviCore victims and we also have an account on Facebook. Look for us there too. We will prevail - the trial was halted and the devices implanted in our cervical spines were contaminated with known and unknown pathogens. Also, were you prescreened for metal allergies or told that there was nickel in the CerviCore? If not, your surgeon and Stryker criminally violated your human rights. I have found approximately 11 severely injured CerviCore victims - all of us are being abused and violated by this corporation. The New York Times may be interested in interviewing us - I am going to contact journalist named Barry Meiers and want to give him contact names. Also, the Wall Street journal may be interested in hearing our stories too. Everyone is wondering why the CEO of Stryker, Stephen MacMillan was ousted by the board directors in February 2012' the same week we received our letters stating the trial was "abruptly halted" ... The FDA does not sign off on a clinical trial patient by saying the doctor or sponsor has no responsibility. You are being conned by the surgeon, if they told you this. The FDA is not allowed to get involved in personal injury mal practice or product liability issues.

Discgusted wrote:

David Dowling wrote:

Well, it sounds like there is more to the failed or improper placements of Styker disc. I've complained to Stryker and their lawyers when I sent certified letters to all the board members. Not one board member responded to me. (ond member is a Stryker family with a last name of Stryker).....She is listed on their web page, Board Member')

Mine (fyi) was a failed c-6 c-7 in 2006. I have all the symtoms as many of you. They scheduled an MRI after many Myelograms in 2011. The original surgeon finally saw me after 5yrs, and ordered the MRI with concern of his partners work faulty.

Stryker had me sign another form (adendum) to keep me the patient in the program for 9 yrs in lieu of 3. But they would not pay for the MRI and I lost my insurance. I've been dumped and the doctors  office say the FDA (federal) gave Stryker permission to drop this patient from the clinical trial with no responsibility whatsoever.

I'm screwed as most attorney's have told me as we all are at this time. I appreciate all pushing on a movement that has hurt and pained us for life an no recourse!

If anybody knows of a class action suit going yet, please advise me immediately, please......Thanks Dave

Please contact me Philomena.55

David, It is imperative that you contact Philomena.55 or me at _[removed]_. We know what you are going through right down to the litagation. Please contact us so we can fight Stryker and their evil surgeons. Looking forward to hearing from you.

Becky, You are smart not to trust anyone in the Medical field especially with Cervicore in you. They will all lie to you in order to protect each other. I had Cervicore in me and experienced all of the symptoms that you have... I also had it removed and know the dangers of this disc... please contact me immediately at _[removed]_ or contact Philomena.55. I truly know the pain you are going through and look forward to hearing from you.

Attention CerviCore Victims:

     Did your surgeon disclose to you that there was nickel in the CerviCore device? Were you given a metal prescreening test for all of the metals in the disc as required by FDA protocol for metal on metal spinal systems prior to implanting the disc? Did you submit to blood tests for HIV, all Hepatitises, and immune diseases (RF)? If not, then you surgeon did NOT FOLLOW the trial protocol if the trial was legitimate at the time your device was implanted.

     The CerviCore Disc had been submitted to the FDA Black Box on December 21, 2007. This is the government database where "trial devices that are NOT APPROVED or cleared by US FDA" are required to be registered if they are NOT APPROVED FOR ANY USE. A little history on the CerviCore trial might help you understand the dilemma that we CerviCore victims are now trapped in. The trial was given a "conditional approval" IDE. This means that the sponsor, Stryker Spine had 45 days to implement the "conditions" - also, if the conditions related to the consent form, it was mandatory that compliance be immediate otherwise, the IDE became invalid. We will never know what these conditions were until we can get our hands on the Master File. But the fact that there were so many violations of protocol and the study ended up in the black box for "trial of device not approved or cleared by the US FDA" under a delayed posting calls into question the legitimacy of the entire trial. All surgeries after 2007 were definitely unauthorized implants.

     I would like to have a meet up conference with all CerviCore subjects who would like to be proactive. My plan is for us to report our ADVERSE EVENTS TO THE FDA MAUDE DATABASE. This is what this database is for. All you have to do is google FDA MAUDE and you will have the link to the form. We should all discuss this at a meet up on my forum SpineTalk. I will email everyone a link and this will activate a private account on the forum. We can talk in private there in PMs about our strategy for exposing this clinical trial charade that has permanently injured our spines as well as caused a toxic reation to the nickel from metal poisoning. My point is, we need to get seriously organized otherwise we will suffer and die without any medical care or concern. This is a scandal for Stryker and no one is going to want to get tainted by this -- so we will be ignored by physicians. Therefore, our only recourse is to bring this to the attention of the proper authorities and expose Stryker for its biomedical deception and medical malfeasance. Our human rights were violated in ways that only happened in Nazi Germany -- and this must STOP.

I can be reached at Philomena.55 at gmail dot com. Or just email me in private.

 

What is Medical Device Reporting?

• The Medical Device Reporting (MDR) regulations require manufacturers who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident.

• MDR regulations require User Facilities (e.g., hospitals, laboratories) to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities must report medical device related serious injuries to the manufacturer.

See also:

Medical Device Reporting (MDR)43

Device Advice: Medical Device Reporting (MDR)44

p, keep up the good work. All the victims need to come together.

P, Talk with you later.

There are attorneys that can help you. Contact Philomena.55.

I too had the replacement, and it has made everything worse. They won't remove it because of an artery runs in front and if they nick it you cAn bleed to death. I had mine fused with the disc remaining in...