Monday, December 3, 2007

Spine surgery and all of the new "devices"


Every MONTH it seems like another new DEVICE OR PROCEDURE for Spine Surgery is approved. There are new and less invasive ways to fuse different levels of the spine, especially the lumbar and cervical discs. There are new tools, devices and procedures. The only problem is after all the surgery and the pain of fusions most patients are no better off and in most cases worse than before. How do I know? I have been there done that, I have researched it for 20 years and I receive comments and e-mails of people just like me, a living mass of pain.

Since I believe that man was created by a higher power, if he had meant for the spine to be rigid, he would have made it that way.

Now enter the Charite' artificial disc which was first developed in Berlin, Germany almost 20 years ago with dismal results. Depuy Industries owned by Johnson and Johnson purchased the company that owned the disc and of course got it pushed through the FDA with a short clinical trial, spine surgeons started implanting the device in the USA, in the L4-L5 area of back patients.
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"Seven months later, on May 13, 2005, the Street.com, reported that Dr Charles Rosen, an associate clinical professor of spine surgery at the University of California at Irvine, was calling for an immediate recall of the Charite, pointing out fundamental flaws in J&J's study design.

He told the Street that J&J compared the Charite to BAK cages in spinal fusions, a failed procedure that had not been performed in years. According to Dr Rosen, the comparison is "the worst possible operation to compare these things to."

J&J responded by saying the BAK was the standard treatment for degenerative disc disease at the time of the study.

According to the Street, Dr Rosen said J&J ignored the first patients who underwent the surgery, and that exclusion of such a significant portion of the sample size can seriously compromise the quality of statistical data.

Dr Rosen, who is also the founder of the UCI Spine Center, told the Orange County Register on April 12, 2006, that the Charite can cause more pain than it cures.

Forty-five year old, Dane Titsworth, from a hospital bed at UCI Medical Center, recovering from his fourth back surgery, told the Register, that the pain he experienced with the Charite he had implanted in May 2005, was like driving a big rig over your legs.

After the Charite surgery, Mr Titsworth said the pain became unbearable and cost him his job with State Farm Insurance, and nearly his marriage.

Dr Rosen fused the part of his spine where another surgeon had implanted the disc.

The Charite does not absorb shock like a healthy disc or mimic natural motion, Dr Rosen told USA Today on July 25, 2006, and a dislocation or fracture of the disc can also cause problems, he said.

In March 2006, Dr Rosen says, eight more patients like Mr Titsworth contacted him, who have more pain in their back with the Charite than without it.

In May 2006, Medicare decided to stop paying for the device in patients over 60, noting that the $30,000 to $50,000 surgery had not been sufficiently tested for long-term affects.

Blue Cross and Blue Shield also determined that more research was needed over a longer period of time, although insurance plans in each state determine coverage decisions individually, according to USA Today.

On October 20, 2005, the Bagolie Friedman law firm announced the formation of the "International Charite Artificial Disc Practice Group," based on a belief that numerous people in the US and abroad, "suffer Charite artificial disc failure," and that "Johnson and Johnson is responsible for manufacturing a medical device they knew or should have known was unreasonably dangerous in an attempt to capture some of the lucrative multi billion dollar back surgery market."

"We will be reviewing potential cases from the United States, Australia and Europe," said Mr Bagolie.

On June 5, 2006, the Street.com reported that Chicago-based attorney, Pete Flowers, has more than 200 clients who have complications from the Charite and who are seeking reparations from DePuy Spine.

Twenty-eight lawsuits have been filed, Mr Flowers told the Street, and he expects an additional 40 to 50 more to be filed this month. Dane Titsworth is a client of the firm.

Mr Flowers' clients claim the Charite is defective and that J&J improperly marketed the device and did not adequately warn of the disc's dangers.

"Most of these people are between 25 and 45 years old," he told the Street.com. "A lot of them have lost their jobs, their spouses, their families, their houses -- everything."

Since the disc was approved in the US, more than 5,000 people have received the implant, says DePuy Spine's Bill Christianson, vice president of regulatory affairs, according to USA Today on July 25, 2006."

Lawsuits Multiply

13 comments:

Anonymous said...

You write:
The only problem is after all the surgery and the pain of fusions most patients are no better off and in most cases worse than before.

Do you think that about all surgery? I just found out that I have a bulging disk and I am pretty sure my family dr is sending me to a surgeon. I have done research and it seams it is very typical to have surgery for this (can't think of the name of the surgery now-not fusion). Do you know the one I'm speaking of? If you do, do you have an opinion?

Jerry said...

Discectomy is the name of the procedure to remove the bulge from a bulging or ruptered disc. If it is real bad you will have pain running out the hip and down the leg if it is lumbar. That nerve is called the Sciatic nerve. Just remember if you are going to a surgeon, operating is what they get paid for. You wll have to make your own decision about surgery. I have had 2 in the L4-L5, and L5-S1 area and I am much worse off than before the surgery. You can find all kinds of information on the internet about it. I would try conservative treatments before I would even consider any kind of spinal surgery. Hope that helps.

Anonymous said...

Steriod injections first!!! Then stay away from the laser treatment!!!

I had a fusion 3 months ago and am doing great!!!

Check out spinehealth.net, I think,,,,it's a board full of people that have had surgery and share the stories

medical said...

The condition begins, usually in the thoracic or middle back region, in childhood when a child is developing. When physicians examine a child, they can often see physical abnormalities such as uneven shoulders or hips or the prominence of ribs. An x-ray is usually taken to confirm, and depending on the curvature, treatment options are addressed.
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Jennifer said...

I agree with you that every MONTH it seems like another new DEVICE OR PROCEDURE for Spine Surgery is approved.
Thanks,
Orthopedic and Spine Institute

Waqas said...

Dorn Spinal Therapy was developed by a gentleman by the name of Dieter Dorn in Germany in the 1970's. Mr. Dorn, a farmer, had no medical training and sought out treatment for relief of his long term back pain. He had the fortune to meet a healer who performed a gentle procedure on him that eased his pain by helping vertebrae and joints sliding back into proper alignment. Spine surgery Germany

Nazia said...

When it involves minimally invasive lumbar spine surgery, the more critical is the surgical approach since only a tiny cut is made. As an instance, as a way to decompress the spinal canal and/or the nerve roots properly, the anterior endoscopic method is undertaken to the cervical spine. Some of these procedures are assisted by video for better visualization. Spine surgery Germany

Spine Surgeon Los Angeles said...

If you have problems with your back, the best thing to do is to go to a specialist who knows exactly what he is doing. Although Orthopedic doctors have the know-how when it comes to these types of surgeries, an expert who focuses on the spine and spine surgery is still your best bet, such as Spine Surgeon Los Angeles.

Sofia said...

Scoliosis is something that can attack a sufferer on two fronts. Firstly, it can cause great pain and discomfort in the sufferer, especially if it affects them from a young age. This can mean also that some sufferers spend a lot of time on medication and even in bed due to the unbearable pain that they can suffer. Spinal surgery in Thailand

Hinza said...

Today's spinal surgeons have sophisticated tools at their disposal for diagnosing the condition causing a problem in the spine. CT scanners have developed to offer the best in visualization of the tissues, with three dimensional imaging possible, and Magnetic Resonance Imaging (MRI) with contrast can show very accurate pictures of the spine and surrounding tissues to diagnose and treat back issues. With excellent diagnostic techniques, the surgeon has a much better canvas with which to work, so he or she doesn't need to make major incisions to see it. Centers for Spinal surgery in Thailand

Anonymous said...

It’s surprising such a high percentage of people don’t seek non-surgical treatments first. Sometimes they work, but sometimes spine surgery is inevitable. Solutions can’t be rushed and there is no need to foolishly undergo surgery.

Anonymous said...

It’s surprising such a high percentage of people don’t seek non-surgical treatments first. Sometimes they work, but sometimes spine surgery is inevitable. Solutions can’t be rushed and there is no need to foolishly undergo surgery.

orthopaedic spine specialists Houston, TX said...

So true! people need to be so very careful nowadays, especially because of the innumerable treatments available..