2008 update on Dynesys from the USA

[Alastair]

This extract is from a personal e mail from a USA patient


A few years ago, you posted that the dynesys wasn't fairing well in the UK. I've actually become pretty close with another dynesys explantee in the UK. She went on to have a fusion and is not doing that well. I had mine removed in 4 months ago. My facets at L5/S1 fused. I theorize that they were in a late stage of arthrosis and easily fused since the cartilage was broken down. I know your in contact with lots of UK folks and they might not be aware that the dyneys has performed poorly all over the world contrary to what zimmer marketing folks say. I've contacted as many dynesys people as I can find just to let them know what is going on here. It has very small indications. More recent research presented at NASS concluded that degeneration continues in implantees. I just wanted to share this with you as I know you are in touch with lots of patients across the pond.

[dillie]

Hi Alastair
I'm very interested in this posting as someone who's gone downhill fast 2 years after having Dynesys put in at L3/4 in 2004.
I would like to find out more about what's happened with the American Dynesys patients.
I've very recently undergone EMG tests at the National Neuro hospital and been given a diagnosis of partial Cauda Equina. Results showed sacral root lesion which explains the bowel problems but as yet nobody has diagnosed what's caused the leg weakness and muscle wasting in the thighs, plus subluxation of both kneecaps.

I have had countless appointments and tests at Kings Neurology but still no diagnosis there.
I still suspect that Dynesys is the culprit as the severe and sudden pain I had two years after the Dynesys op and then rapid deterioration has not to date been shown to have been caused by anything else.

The surgeon who did the operation says that X-rays in theatre did not appear to show any problem with the screws.
From the research I've done I know that there can be problems with both screws and spacers which do not show on X-ray.
This surgeon has papers on the web discussing this very fact.

I have now been on a knife edge for three years living with the fear that something has damaged the nerves to my quad muscles and subsequently caused the knee subluxation and that I may never be able to walk properly again.

All the surgeons are saying "no surgical target identified" after looking at the MRI scans even though the nerves are showing as bunched at L2/3 on supine and upright MRI scans.

I'm still very scared because apart from the Cauda Equina diagnosis I cannot get the surgeons to discuss the lumbar spine problems or even attempt to explain them to me.
Hoping there's somebody out there who can help me in any way where Dynesys is concerned.

This post has been edited by dillie on Oct 8 2009, 09:46 AM

[Lynda]

Hi there Dillie

I see no one had responded to your post...I suppose this forum isn't visisted often by dynesys recipients. For members who know nothing about the Dynesys Dynamic Stabilization System here's a link to the manufacturers information: The History of Dynesys

I know how long and very difficult it has been for you to get someone to look holistically at your case and that you are still seeking expanations of what is going on.

I admire your strength and determination and appreciate how much your life is affected. I hope you get some definative answers soon and that someone can help you. Wish I could magic it all better for you.

Love

Lynda

xx

[Liz33]

hi dillie,

i'm sorry to hear of your struggles w/the Dynesys. It has been suggested that I have the Dynesys installed behind my 2 Prodisc ADRs at L4-S1 but it is stories like yours (along with some data) that deter me and i've decided against the Dynesys, even though there are some success stories with it. Some failures are the result of screw loosening after a few years, but that does not appear to be the case for you. Some surgeons believe failures are a result of screw placement.

There is a man in the United States (in Georgia) that posts on forums in the US that had neurological problems with the Dynesys at L4-S1, although if i recall his symptoms were nerve pain in his legs, not cauda equina like you're experiencing. I believe placement was fine and there was no evidence of screw loosening. He had the Dynesys removed at both levels and I read that he is doing better, even though his facet joints fused. I can't imagine having it removed b/c i assume there'd be some instability b/c of the decompression typically performed with the initial op. He did not have the segments fused w/the removal. He may be the person that emailed Alastair.

Have you considered removing it?? If you have any indication that your worsening symptoms are related to the Dynesys then i would seriously consider removing it ASAP from your body. I hope you can find a doctor to help you and i hope you can find something to give you some relief.

take care,
Liz

This post has been edited by Liz33 on Mar 29 2009, 07:05 AM

[dillie]

Hi Lynda and Liz
Thankyou for writing. Lynda, you've hung in there for me all the way!! You seen me through all the ups and downs and there's been plenty of those! I really appreciate your support, especially with the knowledge you have of spinal problems.
Liz, I'm sorry you're still having problems following the ADR surgery but I think you're right to hold off where Dynesys is concerned. From what I've read on the web, patient experience and medical opinion, I don't think it's all it's cracked up to be. I've read the postings by the American guy, his leg weakness problems especially when standing as opposed to lying down, were identical to mine.
I have to wait for the results of further tests before my neurologist finally sums up but I don't think I'm going to get a diagnosis for the leg weakness. I remain convinced, with my history and symptoms, that Dynesys has produced more scoliosis at the level above and thats why the nerve roots at that level are bunched up.
Amazingly, the surgeons , to date, refuse to go into any discussion about these MRI images. They just say "no surgical target identified". I'm supposed to accept that.
If I didn't have a brain and a certain amount of perception based on my symptoms then I suppose I would have done. It's very insulting actually.
I shall have to embark on very intensive muscle strengthening exercises to stop myself going further downhill and I'm very lucky to have a boyfriend who's well versed in remedial exercise and who's giving me support.
Along with my ADR friends of course !!!

[Lynda]

Hi Dillie

Saw this today and thought of you:

Study finds Dynesys dynamic stabilization ineffectual against disc degeneration

Investigators also found evidence contrary to the theoretical advantages of Dynesys treatment.

Here's the link to further info:
http://www.orthosupersite.com/view.asp?rID=37762

Best wishes

Lynda

[ajj1001]

Not sure if you have seen this, it sounds opposite to last findings?

http://www.orthosupersite.com/view.asp?rid=39295

Lumbar stabilizer performed better than posterolateral fusion in reducing leg pain

By Susan M. Rapp
1st on the web (April 28, 2009)

TORONTO — More than 50% of patients with lumbar spondylolisthesis or stenosis treated with a dynamic posterior spine stabilization system achieved clinical success that was maintained through 24 months postop, according to results of a prospective, randomized, controlled investigational device exemption trial.

The U.S. multicenter study sought to determine efficacy and safety of the Dynesys spine stabilization system (Zimmer), by comparing outcomes and complications to those in similar patients randomized for instrumented posterolateral fusion (PLF).

“The 24-month data were very successful for both the Dynesys and the fusion cohort with statistically significant improvement being demonstrated in several components of the Dynesys study,” Reginald J. Davis, MD, said in a presentation at the North American Spine Society 23rd Annual Meeting, here.

[dillie]

Long time since I've posted but after 3 years I finally have an MRI result which shows L2/3 vertebral slip above the Dynesys of L3/4, along with a ' right posterolateral disc protrusion possibly compressing the right L3 nerve root.'

I was hoping to get some help surgically as my mobility is much worse and I'm only able to sleep on my back due to severe hip pain. Some days I can't walk at all due to muscle spasm across my lower back and down my legs and I need crutches to take the pain off my right hip which is now showing arthritis.

I've been told to go to my GP and get local physio........

I now intend getting a valuation abroad.

This post has been edited by dillie on Oct 3 2009, 05:23 PM

[Lynda]

Oh Dillie,

I truly truly hope you get help abroad and there is a positive outcome for you. I certainly admire your perseverance and determination and you are in my thoughts.

Very best wishes my friend

Lynda

xx

[dillie]

Hello again my friend!
Thanks for being there ....as always!

Forgotten my posting was in FAQ......couldn't find me.
My priority now is to try and protect my hip joint which is taking all the strain with the further vertebral slip, which confirms what I said earlier this year.
Looks like crutches if I can't get surgical help for the time being.
Oh well, lets get the Full English on the go and shift gear!
Speak soon and thanks again for your support,
Lynette

This post has been edited by dillie on Oct 4 2009, 08:46 AM

[Gilly]

Good Luck with your quest, Dillie, I wish you all the very best. It is no joke being in pain all the time and not getting any proper answers or solutions.
The full English sounds good though!!!!
Love Gilly xxxxx

[dillie]

Thanks Gilly
I don't do Full English too often.......a moment on the lips - a lifetime on the hips!
Am making arrangements to see someone else, can't keep getting passed around like a parcel!?
Lynette x

[dillie]

Wishing you every success with your forthcoming surgery Gilly, you're in excellent hands,
Thinking of you
Lynette x

[Lynda]

American Food and Drug Administration orders study on dynamic-stabilization systems:

Thought this would fit in well here. Interesting?



2nd UPDATE: FDA Orders Studies On Spinal Devices

(Adds comment from DePuy Spine, Medtronic spokeswomen in sixth and seventh paragraphs.)

By Jon Kamp
Of DOW JONES NEWSWIRES

The U.S. Food and Drug Administration said Monday that companies making or hoping to sell so-called dynamic-stabilization systems for spinal surgery must run studies to collect data on "a number of potential safety issues."

The list of companies includes units of Johnson & Johnson (JNJ) and Zimmer Holdings Inc. (ZMH). There isn't enough clinical data to determine whether these systems provide enough spinal stability to allow for complete fusion, the FDA said in a release, since system components may loosen, bend or break over time.

"If fusion does not occur, a patient's condition could worsen and possibly require additional surgical procedures," the agency said.

It is requiring post-market studies, which are for already approved devices, to review these potential risks. The agency also is asking manufacturers of new systems or components to submit clinical information for agency review before these products are marketed.

These studies must address the fusion rate for dynamic-stabilization systems compared with traditional systems, the FDA said. The studies also must include information on serious events and subsequent surgeries linked to these devices, plus reasons for failure.

A spokeswoman for J&J's DePuy Spine unit said the company had just received the FDA's notification and is evaluating how to best comply with this new requirement.

A spokesman for Zimmer, which doesn't have this type of product approved for fusion but has submitted an application, said the company didn't have a comment late Monday. A spokeswoman for medical-devices heavyweight Medtronic Inc. (MDT), which has a big spine business, said the company will work with the FDA in complying with the request.

While older, rigid stabilization systems immobilize spinal segments, the newer systems - the first was approved 12 years ago - have design features that allow for some flexibility while still facilitating fusion.

The FDA said it's not recommending changes regarding the use of dynamic- stabilization systems until it collects and reviews clinical data to better understand how these devices are being used. With that information, the agency said it will consider whether changes to product labels or additional testing requirements are needed.

The FDA said patients who have or are considering implantation of one of these systems should consult with their health-care practitioner.

-By Jon Kamp, Dow Jones Newswires; 617-654-6728; jon.kamp@dowjones.com

(END) Dow Jones Newswires
10-05-091954ET
Copyright © 2009 Dow Jones & Company, Inc.


The Wall Street Journal


American FDA orders studies on dynamic-stabilization systems

[dillie]

Very interesting Lynda, thanks for that.
Lynette