Spinal Cord Stimulators – Adverse Effects and Possible Paralysis

08/10/2014 – Traci Patterson, Owner, Advanced Pathways Hypnosis

In April 2014, the Wall Street Journal published an analysis of adverse events associated with spinal cord stimulators:

 

.When Spine Implants Cause Paralysis, Who Is to Blame?

 

These events were submitted to the FDA or were obtained from medical malpractice law suits. “In many cases, the injuries occurred after patients’ spinal cords were punctured or compressed by the stimulator electrodes….The FDA’s database contains 58 unique reports of paralysis with report or event dates from 2013, compared with 48 in the prior year.” The spinal cord stimulators were made by various companies.

 

“Researchers at Duke University medical center recently found that nearly one in every 100 spinal stimulator patients experienced some degree of spinal cord or spinal nerve root damage, said Shivanand P. Lad, a Duke Neurosurgeon and the study’s lead researcher. The study, based on insurance claim records of 12,300 stimulator patients has been submitted for presentation at an upcoming medical meeting.”

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“A 2011 study based on adverse event reports submitted by device makers found the rate of paralysis or motor weakness in patients implanted with a commonly used type of stimulator was considerably lower, at around 3.8 per 1000, with about 60% of patients eventually experiencing complete or partial recovery.”

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Medtronic updated its product label in February to note “that scar tissue can form around device electrodes and cause nerve damage, including progressive quadriparesis, or gradual weakening of all four limbs.”

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“Medtronic estimates that as many as 50,000 people in the U.S. are implanted with spinal stimulators each year from all device makers.”

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“Stimulators cost between $20,000 and $60,000 each and have estimated global sales of $1.5 billion annually….”

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The FDA “cautions that the agency’s database cannot be used to ascertain comprehensive rates of adverse events because the events are under reported and often contain incomplete or incorrect information.”

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The article describes a man with 40 years of back pain who had a spinal cord stimulator implanted at the University of Texas Southwestern Hospital, Dallas. He complained of numbness in his legs. A blood clot was removed on an urgent basis, but damage was irreversible. He was paralyzed from the waist down and left in a wheelchair.

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Spinal cord stimulators (abbreviated SCS) can cause many more problems that paralysis. They can cause pain, tethering of the cord, scarring of the battery pack that can slide across the back, infection that may cause death, and many other complications. Electrodes may not always be able to be removed and remain permanently scarred into the cord. Deeply troubling is that an MRI can never be done again even if the patient has cancer or stroke.  This information has been reported by various physicians including Dr. Sajben.

 

As a patient that was diagnosed with Complex Regional Pain Syndrome (CRPS) and got to the point of what I called, ‘no return’.  Meaning my pain management doctor and other doctors had nothing more to offer me other than a Spinal Cord Stimulator or that is all they knew to offer me shall we say, so I moved forward with it (having a Spinal Cord Stimulator implanted) back in 2010.  In hind sight I will state that it was the worst mistake that I made in the treatment of my condition and this is why.  This is a look at what I wrote to a physician doing a study on spinal cord stimulators in 2011 after I had a very successful trial!

 

I currently have a Medtronic SCS it was implanted early 2010 and I ended up having swelling in my Lt (affected) foot/ankle every time I would charge the “re-chargeable battery”. No one at Medtronic could figure out the issue. I turned into their “human lab rat”. After several months of this I was told to switch from a rechargeable battery to a non-rechargeable battery. Thus another operation… which I did. After this surgery (I have a paddle with 16 electrodes) all 8 electrodes on the Lt side that used to supply stimulation to my Lt foot/ankle now hit my pelvic area – thus I can no longer utilize these electrodes. And out of the 8 electrodes on the Rt 2 are providing stimulation to my Lt foot and the other 6 are hitting the wrong areas. In addition to this I have had continual instances where I am getting a very sharp pain/ sharp twinge (like a jolt) around where the electrodes area. When this happens if I turn off the SCS the pain immediately stops. I’ve been on a conference call with a Senior Engineer of Medtronic and a local Rep in person with me to do reprogramming… The Engineer only wanted to know if the electrodes were putting out stimulation. He didn’t want to know what the amperage was at before I could feel it or in what part of the body the stimulation was felt. These should have been critical pieces of information. All he wanted to state was that the electrodes were working. As for the Sharp Pain / Sharp Twinges that continue to occur in the electrode area their Senior Engineer has no idea what is causing this. He asked me to run an experiment the next time it happened – I did exactly what he wanted and reported back the findings. I have yet to hear back from Medtronic. They do not want to back up their product and they are not willing to admit that there is a problem. Although I have 2 doctors including a Neurosurgeon that feel there is some type of fault in their product or that it is faulty. Hopefully this gives you some additional information you were seeking. Please feel free to email me if you would like to discuss further. I am continuing my uphill battle with Medtronic.

I have spoken with Medtronic as recently as yesterday and they cannot explain the continual sharp pain/sharp twinge that I continue to get where the paddle that holds the electrodes is placed. The “Patient Relations Rep” that has been assigned to me, (at one point she tried to tell me she was from their “Legal Department” and she was later introduced by a team member as a “Patient Relations Representative”), doesn’t feel this is a big issue. She told me yesterday that this is “just medicine” and sometime they can get it right and other times it just doesn’t work out… The Senior Engineer at their company cannot figure out what the problem is, so he just wants to reset the “INS”. I asked exactly what the “INS” was and the Patient Relations Rep couldn’t answer that question. I have already had my system reset numerous times (too many to count) and reprogrammed numerous times.

The trial was approximately $25,000; the hospital expenses alone and cost for the SCS implant were over $150,000 and the secondary surgery to replace the rechargeable battery with a non-rechargeable battery was approximately $53,000. This is all for a system the now has 2 out of 16 electrodes that hit the correct area, creates an intermittent sharp pain/sharp twinge in the spinal area where the electrodes/paddle is placed, and they aren’t sure how to resolve this issue. But I was told yesterday that their system was working properly by their rep.”

 

Here is what happened after the above referenced correspondence / issues:

 

I did have the Medtronic SCS explanted. Medtronic could NEVER explain why their unit was having issues and I even released it to their lab for processing.

My pain management doctor, neurologist and neurosurgeon all told me they had nothing more to offer me accept to try a different type of SCS, so I was convinced to have a ‘Boston Scientific’ SCS implanted as a replacement. This was the end of 2011.  This particular SCS was only in for a couple of months and I began to have issues with the stimulation that was being delivered. I had their top reps working with me. I also had some other odd sensations happening that I was very aware of. Thus, I had my Neurosurgeon do some searching online to see if there were any write-up on scar tissue build up due to ‘Spinal Cord Stimulators’.  The reason we looked into this area was because I kept loosing signal strength and the ability to control the stimulation. He had never heard of any issues and had never seen any literature on this problem, but he was willing to do the research. I knew I was in trouble when I received a person email back from my Neurosurgeon within 24 hours of my request for information… He found 2 articles in medical journals about scar tissue from Spinal Cord Stimulators causing paralysis in patients. We then did what imaging we could do as no MRI was possible with a SCS. We found that I was within this category after just a few months!

Please keep in mind that the surgery to input the SCS(s) in my back also caused my CRPS to move into my back. This was a huge issue for me. Now on top of that I had to go through yet another surgery to have the SCS removed immediately to prevent paralysis from my waist down.

I was never told about any possibility of build-up of scar tissue around my Dura. I was never told about a possible complication of paralysis. I asked if I needed to be concerned about my CRPS moving into my back with the implant of the SCS and I was told, “NO”… Yet, it happened.

I personally sent in information to the FDA regarding my case with the SCS(s), my Neurosurgeon wrote up a case study on me (with my permission), my Neurologist submitted a report to the FDA regarding my issues with both Medtronic and Boston Scientific and we all tried to do our part to get the information out there.

As a patient, if you have issues like this happen to you, you need to be willing to report it so that others can be aware of it. Otherwise the DME companies (i.e. Medtronic, Boston Scientific, etc…) will not release the information unless they are pressured.

Now you may be saying that this is just one patient and this is just a fluke.  No, it isn’t.  Look at the statistics that are just starting to come out.  The interesting thing is that I have spoken with my own pain management doctor recently about the use of ‘Spinal Cord Stimulators and to inquire about his outlook on them since he went through this with me.  My pain management doctor is also a professor at well-known medical university in Southern Californian in addition to having his own practice.  Our recent conversation has outlaid several things in his opinion.  First of all he feels many pain management doctors and/or surgeons or pushing the spinal cord stimulators as they are, ‘quick and easy’ in their eyes.  He feels that the physicians need to be very selective with the patients and it is the physicians’ responsibility to know the possible outcomes (i.e. side effects of the implantation of a foreign device in your body) and not just the possible complications from a basic surgery.

Where are the five year studies that show benefit?  Even with no complications, how long do they continue to relieve pain?  Electrodes move and/or they malfunction. There is little to no federal investment in medications that relieve pain, but these devices are garnering sales of $1.5 billion annually without showing lasting benefit. This is a very big source or income for pain specialists, but what is the gain for patients?  How can we weigh the pros and cons of this money generating device?

So many of chronic pain patients that have failed to get better after basic therapies and trying just a small regiment of medications are given only one choice by their pain management doctors:  spinal cord stimulator.  One choice.  This is a very big business, but where is the five year data?

This is very unfortunate, because physicians and the manufacturers are giving the patients false hope.  They tell the patients that the Spinal Cord Stimulator will help stop their pain.  They never discuss the fact that the CRPS/RSD can move into the back with the implant or surgery.  They never talk about what happens when they can’t get the coverage with the stimulation that they hoped for.  This means that the patient does not get as much relief as previously thought.  They never talk about the fact that this is not a way to get rid of 100% of the pain.  At best it will knock it down by 40% or maybe a bit more, but the longer you have the SCS in those figures go down due to the build-up of scar tissue.

Yes, there are some success stories out there with the SCS or they would not be utilized, but it is critical for every patient to know all of the information prior to making this decision.

At what point will the physician open up their thinking to allow their patients access to additional options for pain management?  There are different options available now!  The more informed the physicians are the better off their patients will be when it comes to their conditions, their health and their outcomes.

If you would like information of alternative treatments for chronic pain, CRPS/RSD, fibromyalgia, cancer pain, PTSD, stress/anxiety reduction or insomnia please contact Traci at Advanced Pathways Hypnosis.  Call today to set up a FREE consultation:

714.717.6633 | Traci@AdvancedPathways.com   |   http://www.AdvancedPathways.com