Hi...from a noob who needs direction

[Harrison]

Hi LAC, I just wanted to check and see how you are doing! I hope you are well...any more news on the procedure? Have you learned anything new?

[lac27513]

I'm pretty much down and out trying to figure what to do do next. I figure that I'll be heading to the OR pretty soon. I still have next to no range of motion. The last doc that I saw said that I'd have more ROM with a 3 level fusion than I have now. I'm worried about the damage done to the vertebral body too. I'm uncomfortable sitting, standing,etc. I know I can withdraw from the study, but since my surgeon said that it's fine, it may be messy trying to get it fixed.

[Harrison]

LAC, I am really sorry to hear this. How can we provide support to you in these difficult times? Can you share a bit more about what you are doing to figure out your next steps? Have you had any other diagnostics in the past month?

I hope you can manage the four kids OK in these tough times. Do they watch out for one another? Are they helping you?

If I can help track down information, resources or professionals I am glad to try to help. We are here for you!

[lac27513]

There is very little information on the device itself that I am able to access. I know it has been used in Europe prior to selling the technology to ____. Most companies toot their horns with their success stories so it's hard to find statistcs on problems. Adverse events are glossed over. I thought I had done my homework but I'm afraid that I only found the information that they wanted me to find. Hind sight is 20/20.

[lac27513]

After seeing 2 other neurosurgeons, I did discontinue the ____study. I do have more range of motion and less raspyness in my voice with the 3 level fusion although my husband says that I still sound a little bit like Marge Simpson...it's not nearly as bad. I have the disc and I know needs to go back to the device company. Once I rolled over to long term disability: I lost my job. I am not my job but I was good at it ...and I have 4 teenagers.

I have several issues-

a. The doc lied to me when he said that I met the criteria, when I didn't.
b. He put the artificial disc in incorrectly
c. One of the reasons that I didn't meet the criteria was that I had more than one disc with problems. That disc was equally bad if not worse than the one that he replaced, yet he did nothing to help it.
d. He kept telling me that I was OK, just taking a bit longer than normal to heal. He never admitted that there was anything wrong.

The device company vendor had refused to give my second surgeon the equipment needed to remove the artificial disc until he threatened the FDA. (When you work in pharma or any kind of GMP, GCP, etc. the FDA is the law). Incidentally, he stayed in the OR for the removal. The device company was supposed to file the serious adverse event report.I have only seen one adverse event posted for this disc on the FDA site...it's not mine.

Then I got a call from the FDA telling me that they wanted to know if I happened to know my study number. (I didn't). It is not a large study yet they couldn't find me. The FDA does not usually call people, but it was nice to know that they were jumping on it.

It has been very difficult to find a lawyer because I feel I have been wronged. They should at least pay my copayments for the second surgery. I don't know how many others this doctor has enrolled that didn't meet the study criteria, but local lawyers do not want to end up across the room from hands that feed them either.

One lawyer said that he couldn't think he could say that my problem was significant or permanent. Since I have DDD, I would most likely need to have the surgery some time in the future, so no foul there.

Yes, I gave it to him. Well, I certainly did not need to have 2 surgeries in the same place. There is a risk in going through scar tissue and your skin in your neck is fairly fragile anyway. I didn't need to have been a 3 level fusion or an artificial disc removed if perhaps it was done correctly. I wouldn't need to worry how this may affect the rest of my life. But I do.

The other issue is that it is a clinical trial. I did sign the informed consent, but I didn't meet the criteria, I didn't know he was lying when he told me it was ok. I have notified the state medical board, the study IRB, and the FDA.

I still have found very little information about others in this particular study, but because of the artificial disc and displaced screw, so much vertebral bone had to be removed. They used ____ stem cells and plates for the fusion. I'm praying that this is a unique case. I'm now fused c4 through c7 but feel better than the artificial disc at c5/6.

I am posting this so that people know that doctors do lie. All of this should have been picked up in audits by the device company, the study coordinator and the IRB. So who is following up on these clinical trials? No one apparently. Local lawyers don't like to take cases that involve people that they may need to be on their side in other cases. If the device company wins approval of this device because they think it was placed successfully, then I don't know if I can live with myself. Their data is flawed...the study is flawed.

Another reason that I didn't want to post is because I didn't want a long thread of posts calling me stupid, or I that I should have known better. I thought I had done my homework. I have worked in different facits of the pharma industry and I know that most investigators are not like this. Most really do research in the name of advancing science. I had no reason to not trust this person. But I will have trust issues the rest of my life.

I need to think about about what is best for my family first. If you have any legit suggestions, on what I could do, I'd appreciate it.

Thanks!

[keziah23]

I am sorry this happened to you and I do not think you are at fault in any way, I think medical decisions are often skewed because the bad results are often very hard to find. That's why I like forums such as these where we can discuss our options and outcomes. I just had ADR with an approved device 2 weeks ago and am thus far happy with the results. I hope that you are healing and will be able to, when you are ready, find a new job that is even better than the one before. I wish you luck with your lawsuit because I do think this doctor wronged you in enrolling you in the trial when you did not meet the criteria, I hope there is something that can be done. Best of luck to you.
-Kristi

[Toebin]

LAC, I'm so glad you got that thing taken care of but so sorry you had to go through the wringer to get there. !!!!

Long time no post as life has gotten pretty busy for me, but I still lurk often and pop in from time to time.

Drop me a pm when your about and let me know how things are going now that things appear to be healing up.

Geesh, what a journey you've had !!

[builder5840]

Lac,

That's quit a tuff story, I'm sorry that you have had to go through so much to get where you are now. I hope that with the 3 level surgery you'll finally heal enough to get your life back. I'm not one that believes in suing others, mostly becuase we live in a society that is sue happy. But in your situation I think that your doctor needs to be put in check. Everyone makes mistakes and he should have owned up to his and should have done eveything in his power to fix it, but it appears from your story that he just tried to cover it up at your expense. So good luck with putting the screws to him. He put the screw to you first
But you may also have to decide if going after him is worth the time and energy you'll have to put into it.

Do you really want this trial disc taken off the market becuase of your doctors screw up or is there a real problem with the product?
Like you said you don't want this on your conciesce so hopefully the FDA will take your case seriously and will do a thorough follow up with you.
Can you get any financial assistance from the trail Manufacturer? They may not want your story messing up their getting FDA approval?

Good luck

__________________________________________________ __
Fall from ladder 05
Lots of test and lots of pain
DDD C 5,6,7
opted for two level ADR Discover disc
surgery scheduled January 09 Malaysia

[lac27513]

Well from what I understand, the device company cannot contact me directly. I finally found someone to represent me, so I'm still in the wait and see stage. From what I understand my state has a 3 year standard of limitations which would coincide with the date they are expecting to have approval. Since the vendor stayed in the OR while it was removed, I know that they were aware of the necessity, yet they did not report it. The whole thing has tainted how I feel. If they would have offered to fix it, it would have been different. I was told that I should not expect an apology because that would be an admittance of guilt. While I know this will take a lot of time and effort, I've lost my job because of all of this mess. I'm not a sue-happy person, but there are rules and laws that were put in place in order to protect human subjects. As a result, I feel like I don't have much choice. Thanks for your support. I'll let you know how things go.

[Sandra L]

Wow what a nasty situation. Glad that you have gotten some physical relief.

I don't believe in frivolous lawsuits, but if your lawyer can prove negligence, go for it. Be it the doctor or the manufacturer, you wouldn't want someone else to suffer for something that you could have prevented.

Try to put this in the back of your mind and have a wonderful Christmas and a healthy New Year.

Sandy