Bi-Level ADR FDA Approval in U.S.?
 

Although I too have many questions regarding the pros, cons, successes, and horror stories regarding ADR surgery, I am convinced after so many years in pain, so many different tests and treatments, medications, procedures, and the opinions of 5+ surgeons that my best option to treat the DDD which has left me with annular tears in my L4/L5 and L5/S1 discs is the bi-level ADR surgery on these. Especially, due to the pain and indications that I have other discs which already have more minor issues.

My question is, that after waiting for over a year (based upon when I believe the procedure was submitted to the U.S. FDA) for the procedure to be approved in the U.S. there does not appear to be any way to get the status of where this stands! I have not even been able to confirm it was ever submitted to the FDA! I've gone to the www.fda.gov website, and that is so confusing it is useless to me. I don't know where to look or who to ask.

Does anyone have any resources or answers for me to look into? I have researched the possibilities of going out-of-country and or paying out-of-pocket in the U.S. and neither make sense to me. Any complications from the procedure (which I would have to beg, borrow, and steal to pay for) would not be covered by my medical insurance! I am already living week-to-week and cannot leave my wife and children in such a financial bind.

Any information or suggestions would be greatly appreciated. Thank you so much, and good luck to all.

hang in there! Your family and friends are all by your side.

Thanks
 

Thank you, honey but I really wasn't searching for a response from my wife (although I do appreciate it)! Guess it isn't a good idea to be on the same site(s) as you are.

hi jjames,

sorry for the battle w/FDA approvals.

i would recommend contacting Synthes, the manufacturers of Prodisc, if you have not already re: anticipated FDA approval of two-level lumbar Prodisc, http://www.synthes.com/html/. I've spoken w/them pre- and post-op and they are very helpful.

Dr. Yue should be able to give you the inside scoop as well. Is Dr. Yue still participating in the Activ-L trial? If so, sometimes doctors in the trials can petition the FDA for a compassionate exemption (or something like that) for two-level cases.

Would your insurance pay for one-level Prodisc as part of a hybrid operation (w/a fusion)?

if i remember correctly, there is a guy on this forum that recently had a 4-level lumbar Prodisc w/Dr. Yue... i can't remember his name, but i'm sure Dr. Yue would... wonder how he made that happen?!

Best of luck,
Liz

Jjames,

I would see if your insurance can really deny you treatment after an "unapproved" or "not certified" surgery. I think they are going beyond what it says in their policy book. If your policy book does not say that then they shouldn't be able to do that.
Even my crappy insurance pays for my post-ADR treatment.

I have seen this before and I think this is illegal.
Health insurance sucks but they do have some obligations especially when you or your company is paying for a service.

I ditto all of the above, too. Fight. I did and got my surgery approved and then I fought some more when BC did not pay for it.
Do not give up and throw up your hands and throw in the towel.
I don't know your exact circumstances but there are resources out there to help you.

Kimmers

Hi JJames and Cathyjp
 

Jjames,

I went to Germany for my 4 level and my insurance pays for all doctor and procedures needed in my follow up, both Medicare and my secondary, Anthem Blue Cross/Shield. Medicare will not cover any ADR in or out of country. Am trying to get my secondary to cover, after the fact, which they previously said they would do (even got a check for $99) for a bill at St. Elisabeth, Straubing, Germany). Then they started giving me the run around which I expected, but will keep trying.

I went to Germany for surgery: 1) no one would do a 4-level here and one of the gurus of multiple levels is Dr. Bertagnoli, so why not go to the one with the most experience. 2) even if there was someone here that would do it, out of pocket, even with flights and hotels, was cheaper in Germany.

You are so close to Dr. Yue at Yale, I would make an appointment with him. He is probably the most experienced on the east coast, and has been involved in the clinical study and approval of the ProDisc-C made by Synthes in PA. He and Dr. B have written articles together and he has trained with Dr. B here and in Germany. If anyone can help you with a decision and with insurance, I'm sure he could.

Kimmers I think?? this happens in the early stages, before it goes into clinical studies and the FDA becomes involved. Somehow they get insurance companies to pay for "a fusion", the manufacture donates the device, instruments, maybe pays the doctor, hospital, something? I read that paulam310 received a 3-level ProDisc-C in 2004 with Dr. Delamarter and his insurance paid. That was before PD-C was in clinical trials?, it only got FDA approval for 1-level in December 2007. So who knows what happens. What good is FDA approval if your insurance won't pay.

Maybe with Obama, some of this will get changed. Republicans don't yell at me, I'm one of you and don't believe in socialized medicine (talk to the Canadians). The insurance companies profits are huge and the exec's are paid well, so I'd think it would be moral of them to "share", opps there I go again. SORRY, didn't mean to :rant: and rave.

Good luck Jjames! I think the post from your wife and your response were great.

Sandy

JJames, guess I should read everything. I see you are going to Dr. Yue. Boy if he can't help you, the only thing that may work is calling Synthes and asking for their help?? Sandy

Thank you all so much ...
 

I at least wanted to thank all of you so much for your insight and thoughts. I am not feeling very well at all today - alright, honestly I feel horrible. I have an appt with Dr Yue on April 1st. I will reply in greater length when I feel better, but I wanted everyone to know how much I appreciated the responses. Thank you.

Five (5) surgeons, understand.
Four (4) surgeons on this side;
differing recommendations.


The two-level lumbar results may not be totally compiled or published. I suggest from my recall of professional journal abstracts (Spine, ISSLS, The Spine Journal, European Spine Journal) is there may be FDA controlled testing of two-level lumbar ADR, TDR, TDA, IVD ...

Clinical Trials website, as an example see Prodisc two-level is public information; this link may expire as it is a search link. Clinical Trials Identifier is NCT00295009 , but his leads you back to the Prodisc single-level.


FDA
I am a layperson, not a governmental law expert, not a medical professionial, ... FDA Center for Device and Radiological Health (CDRH www.fda.gov/cdrh ) is responsible for Artificial Disc Replacements . ADR is subject to Pre-Market Approval (PMA).


FDA CDRH PMA Frequently Asked Question (FAQs, link) :

How can I find more information about a PMA under review?

Before FDA approves or disapproves a PMA, FDA will not disclose the existence of the PMA unless it previously has been publicly disclosed or acknowledged. Even if the existence of the PMA has been publicly disclosed or acknowledged, data or information contained in the file are not available for public disclosure. However, FDA may disclose a summary of portions of the safety and effectiveness data, if disclosure is relevant to public consideration of a specific pending issue.

There is other language I read on CDRH on information disclosure that provides a blanket or shield on disclosure. I read the policy, but can not find it now.


The FDA is not required to disclose preliminary ( two-level ADR ) results. FDA CDRH is not a patient's best source of clinical data before approval.

One example of this might be the Aesculap Activ-L lumbar Artificial Disc Replacement. There was a press release from the German company's American subsidiary that the FDA Clinical Trial started, or about to start, and nothing showed up in searches of FDA, FDA/CDRH or ClinicialTrials.Gov.

Thanks for the reply, Liz.
 

Thank you for your response, Liz. My wife has been in almost constant contact with someone at Synthes ever since Dr. Yue informed us of my best surgical option (in his opinion) and we were denied by my medical insurance. Dr. Yue seems to me to have moved away from the Activ-L and is strongly urging me to go with ProDisc.

I do not know if my med ins would pay for the hybrid operation, but I also don't think it is in my best interest - the fusion part concerns me greatly.

Perhaps all the battles with the ins companies have taken their toll on Dr. Yue, but he really gives me the impression that I must either wait for my medical insurance to pay or I need to show up at his office with a briefcase full of cash!