Off Label Use of Devices - Uninformed Consent

I am pretty much at the end of my wits as to what to do about this issue: In September, 2010, my wife and I met with a neurosurgeon to discuss a long-coming need for cervical surgery. At the consultation, we came to the conclusion that I really needed to get it done. The doctor discussed in layman terms the procedure. This was going to be a 2-level Anterior Cervical Disc Fusion procedure. I told him how I had taken quite a while to make this final decision because I was in hopes that newer technology has finally been approved, besides using the bone plug from the hip. He said, Oh no, they don't do that anymore. So with relief, we continued. He talked about the plastic cages that would be used and that he had done thousands of these with great success. Feeling confident, we proceeded. The surgeon's office obtained Pre-Authorization from my insurance.
The surgery was a one-night stay ordeal. Awesome! However, immediate complications set in. Swelling of the vocal area, difficulty swallowing, difficulty breathing. My wife called his office and explained that there may be something wrong. They said, No, everything was expected, but to keep taking the steroid prescribed. Two days go by. Even more swelling, loss of voice, swallowing was very hard and difficult. Called office again. Same reply. Just keep taking the prescription. Day four: Called again with same complaint. We were told that everything was expected and to keep taking the meds. That weekend we considered going to the local ER we were very concerned. It seemed to settle down late that night so I didn't go. My first post-surgery office visit was one month after surgery. At that visit, the doctor asked how I was doing. I could barely speak with a wispy voice, my neck was swollen big time, swallowing was like swallowing a quarter sideways, and I was having headaches. He said he did not know why I would be having this problem and that everything would be okay. He set another visit for one month later. Month Two: Went to doctor. Still having continued swelling, hoarse voice, aching into my chest and tips of my shoulders, swallowing was still same. He just said again that he did not know what would be causing this and that I should not be having problems. Needless to say, he did not help very much. He set another visit for one month later. Month Three: By this time, I convinced there was something wrong and at the office visit asked him if there one of the other surgeons has reviewed my case. There are 4 surgeons in this clinic. I said that it seemed prudent that if a patient is having ongoing problems that the surgeon didn't know their causes, that he would consult with his comrades. But he said he did not need to do that. I asked if there was something that could be done to check. A test or anything? He said, yes. An CT scan could be done. He couldn't do an MRI because of the titanium metal that held the neck together. He said he would see me in ONE month again. This meant waiting for another month just to get the CT scan done. On the way home my wife and I marveled over why he would wait another month even to get the test done?? At 3 and 1/2 months post-surgery, we received a letter from my insurance company saying that the payments already made to the surgeon and hospital were going to be denied and retracted because the BMP (Bone Morphogenetic Protein) used in the ACDF procedure was considered Experimental or investigative, Non-FDA approved for cervical appliation, and the insurance would not cover this. This is AFTER they had paid most all the bills mind you. Needless to guess, we were shocked! At NO time or in any way did the surgeon tell us, infer, or allude to the fact that this material he used was experimental or the like. IF he had said anything to cause us to even maybe think this was experimental, I know I would have declined the procedure, knowing my insurance would not cover it. Many people at my work talk about the denial of service due to things like this.
At the 4th month office visit, I brought the letter with me. Well, I was reacting to this BMP big time. The surgeon continued to say there was no reason for my complications and he did not know why this was happening. I asked why would my insurance company consider this to be experimental? He said it was their way of trying to get out of paying the bill. I asked him point blank, was this BMP experimental? He said that it was Off-Label, but was not experimental. I asked him to explain the difference. He could not clearly without mumbling say just what that difference was. He took a copy of the letter and said he would get with his business office and would work something out. I immediately went to the internet and googled BMP. There are hundreds of pages of information about it on the web. Detailed explanations of complications Exactly as I was experiencing. So? I have ended up going to Stanford University Neurology and they said that they are very aware of this BMP use Off-label in cervical and that is why they do not use it at all. They also said there was nothing could be done, that the procedure was irreversible. I am now unemployed and permanently disabled on SSI and have continued to have pain and loss of strength in my arms. I still have swallowing difficulty although the hoarseness has gotten better. The sides of my neck and collar bones where they near my voice box are constantly nagging and aching and I am still on long term pain meds. I talked at length with the surgeon's administrative office and the insurance company and have found out that the way they got the Pre-Authorization was by hiding the specific code number for the BMP inside another code number such that the use of BMP was not clearly disclosed to the insurance company. It was the hospital's billing that uncovered the BMP to my insurance company, thus the letter.
I have discussed my issue with 10 attorneys over the last 1 1/2 years. They say I have a very strong or merited case, BUT, professional witnesses are expensive and contingency cases are difficult to get an attorney to take. Through perseverance and arguing with the hospital, the amount of the bill ($65,000) has been reduced, but we are stuck with paying the remainder. I just went to see a pain specialist today for my annual check-in for medication review. Also Stanford returned a reply to me that they are in receipt of the last MRI which they suggested strongly I get once or twice a year due to osteophyte possibilities in my cervical fusion area. They are concerned with bone growth in adjacent areas around the plastic cages inside which they used these sponge spacers and the Bone Morphogenetic Protein as a bone growth stimulant.
I have pages of details from the FDA including their printed Medical Alerts dating back to two years before my surgery, regarding the life-threatening issues with BMP in the cervical area. I know there is no way that this surgeon had no idea why I was having my difficulties immediately following surgery, and mostly persists to today.
If anyone knows anyone that could help me, I need to get this financial burden off my back. And lastly, there should be a way to warn people about this surgeon and the admitted fact that he actually has only done a few 2-level discectomies and has used the BMP only on 10% of his cases. This is what he notes in his office notes of which I have copies. I have lost my career and put a burden on my wife who has been a champion in taking care of me during the months in which I could hardly lift my head. Thanks for reading.

I for one feel bad for you. I

I for one feel bad for you. I had a similar thing happen to me with my back. I am in constant pain take pain pills.I am retired from a major company but was working to supplement my income and lost that job due to all this. the doc won the malpractice suit I had filed. the state I live in the doc usually wins. wish you good luck. p.s. the doc is still in business and making big bucks. he is a pain managment doc.(ha ha ha). the procedure he did he screwed it up.another doc had to fix it but would not admit in court it was screwed up because it would have been going against another doc.

http://www.aaos.org/news/aaos

http://www.aaos.org/news/aaosnow/may12/managing6.asp

Analysis and clinical tips
Physician-directed off-label use of medical devices and drugs is acceptable and legal as long as such use is within the standard of care applicable to that community and has a rational basis grounded in clinical judgment. If any concerns or reservations about a device have been raised, disclosure and discussion with the patient is prudent. If the physician has financial ties and benefits related to the off-label use of a medical device or drug, disclosure of such ties and of the intended off-label use is similarly prudent and ethical. Disclosure is mandatory if the drug or device to be used in an off-label manner is part of a clinical investigation or other experimental study.

If in doubt, physicians can ask themselves if they, in the patient’s shoes, would deem the information material and relevant to making an informed choice about surgery. The off-label status, as discussed and as confirmed by judicial rulings, is unrelated to medical practice, and is therefore outside the realm of required disclosures under the informed consent doctrine. In fact, characterizing the routine use of an otherwise beneficial and proven device as “unapproved” or “off-label” may lead to patient anxiety, confusion, and perhaps rejection of an otherwise beneficial operation.

But are there other considerations that the patient probably should know about? These might include payments from the manufacturer related to the off-label use, promotional activity at meetings on behalf of the manufacturer, knowledge of complications specific to the contemplated use, and lack of personal and/or medical community experience with outcomes related to off-label use of the device. The bottom line is that if the physician, as the patient, would want to know these things to make an informed decision, then these issues should be part of the discussion and disclosure during the informed consent process.

I am so very sorry for your situation it brings tears to my eyes...and that dr. needs to be disciplined.

THE ABOVE WON'T MAKE YOUR DAY but -- this happens simply because patients don't know enought to ASK about WHAT devices, prosthesis, drugs will be used during the surgery. They have a RIGHT to know but unscrupulous drs. take advantage of big corps. "side payments" for using their NEW stuff whatever it is!!
This is criminal to say the least...and causes more damage to patients every year than anyone knows. Lawyers have a tough time nailing off-label cases because the mfgr. is lurking in the background and have the FDA blessing to do such despicable things to vulnerable patients.

We all need to be less trusting and forewarn ANY patient going into surgery to GRILL the surgeon on these issues before consenting. My son is facing surgery soon and I'm TERRIFIED that there is some subliminal plan to use some off-label drug or device that could increase the danger of the outcome. I have advised he ask certain questions about the procdedure devices and drugs and let me be there when the dr answers him but he won't hear of it [a guy thing!]

So the best I can hope for is that he brings home the consent form and AMENDS it with "I do not give consent for any drug or device that is experimental, off-label or not the "standard of care"
The dr might drop him - who knows???

I KNOW I was used for experimental surgery-but what happens behind closed doors is too hard to prove [and the surgeons count on that!]
All we have is knowing that one day those surgeons who harmed patients will be justly rewarded with as much suffering they caused patients like you. Believe me it DOES COME.
May God keep you safe from other drs. like these.

"If anyone knows anyone that

"If anyone knows anyone that could help me, I need to get this financial burden off my back"

That is the most despicable thing about your case- having to PAY for the dr's betrayal
Sadly all you could do is give a NEG RATING to the dr on RMD

and
1-- could file bankruptcy
2-- file small claims for pittance of the amount
3-- just ignore the bills - and let your credit go bye-bye

and there is always #4
write the local news reporter and discuss how this type of thing is in the PUBLIC'S general interest
[need to know] naming the mfgr, hospital and dr.
And it might be a good documentary for some sharp media?
Titled: Off-Brand - what does it mean for patients??

Thank you to everyone who has

Thank you to everyone who has replied here. I realize that there are others out there who can relate to my situation. I suppose that is somewhat bitter/sweet. Bitter in that nothing really can be done; sweet in that I am not alone and know that somebody understands. I have written a letter to the surgeon several times, never mailing them. I have tried to file Maude Reports with the FDA, but their online entry forms do not work and I really don't know the answers to many of the questions. As for online critique for the doctor, I guess that is my last resolve. The most important thing now is for my wife and I to get this out of our minds and lives. Thanks again for everything that was replied here. I am thankful that there is a God in heaven who cares for us, and nothing is beyond his sight or reach. So, beyond doing something to find consolation, I think the only consolation that exists is just knowing that God has a plan for us and the sooner we get our hearts and minds in gear in His direction and plan, the better. Take care, everyone. I will check back here on this board from time to time to see if maybe I can be of help to someone in their situations.

send the doctor a demand

send the doctor a demand letter for your money back, if he doesn't respond take it to an attorney.

Protiusmime, go to the

Protiusmime, go to the surgeon's page on RateMDs and post a brief rating. You may have to wait a few hours for it to display.

Then, go to your own rating, and click on the highlighted characters which indicate your ability to "respond" to the rating. A text edit box will appear, initiating a forum thread similar to this one, but attached to your rating.

Copy your opening comments from this thread and paste them in that text edit box. Edit it as necessary (a few paragraph breaks would be helpful) and click on "Save". Your story will now be seen by anyone viewing the surgeon's ratings page.

I just re-read your story

I just re-read your story once again.

I am horrified at what happened to you.

I think that you need to share your story in a very clear and understandable way - clear enough for anyone to fully understand. Adding spaces would be helpful.

Further unnecessary harm needs to be prevented, and by telling your story you may prevent further harm.

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