Spinal Cord Stimulators – Paralysis, Adverse Effects


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

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When Spine Implants Cause Paralysis, Who Is to Blame?

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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.

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“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 [my emphasis] 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 —none of my patients remember being told about this. 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 weight the pros and cons of this money generating device?

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So many of my patients that have failed the small handful of medications now available for chronic pain were given only one choice by every major pain center: spinal cord stimulator. One choice. This is a very big business but where is the five year data?

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One of my patients with Complex Regional Pain Syndrome, in remission since 2010, submitted a comment on this my site:

 

06/07/2012 at 11:25 pm   I have been a surgical nurse for 40 years and have seen many patients receive SCS…and many, many fail, or return to surgery for fractured electrode wires, misplaced wires, or infected battery pockets, besides complicated problems, or “lack of positive results, or battery revisions, or electrode repositionings.” Some patients have even developed spinal fluid leaks when the spinal dura layer has been torn during implanting the electrode wires, and they develop severe headaches, and have to return to surgery for the leak to be repaired. Many pain management doctors are convincing patients that this is a great way to treat their pain, and they find out in 2-6 months that they wish they never had agreed to it. Sure, there are some patients that get some relief, but this procedure has been pushed on the population of chronic pain patients, when they are at their worse condition, and willing to try anything….at any expense, and the companies and implanting doctors are getting the money. More patients need to learn the truth about these devices! Anonymous…. and never allowed them to put one of those things in me…but many tried!

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Elsewhere on my site, Traci writes a very sad comment:

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03/29/2011 at 6:01 am I posted on your main blog, but haven’t heard back. I know you wanted information regarding issues or problems with Spinal Cord Stimulators, so here is some information that you can add to your file. I can also be contacted for additional information because this issue continue to date.

In one of your posts you asked for input from patients that currently have a SCS. 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 batter. 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 their 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 spoke with Medtronic as recently as yesterday and they can not 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 can not 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 aproximately $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 aproximately $53,000. This is all for a system the now has 2 out of 16 electrodes that hit the correct area, creates an intermitent 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.

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The material on this site is for informational purposes only.

It is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

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Please understand that it is not legal for me

to give medical advice without a consultation.

If you wish an appointment, please telephone my office.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Palmitoylethanolamide (PEA) – Boosting Its Anti-inflammatory Immune Response


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Discovery could lead to new immune-response drugs for allergies, illnesses and injuries

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Improved spinal cord injury & inflammation in mice

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Medical news November 17, 2009, announced that “UC Irvine pharmacology researchers have discovered a way to boost levels of a natural body fat that helps decrease inflammation, pointing to possible new treatments for allergies, illnesses and injuries related to the immune system.”

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“For decades, it has been known that this fat, called palmitoylethanolamide (PEA), is a potent anti-inflammatory substance that reduces both allergic symptoms and occurrences of rheumatic fever, but researchers understood little about how PEA works.”

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I”n a study appearing online in the Proceedings of the National Academy of Sciences, Daniele Piomelli, the Louise Turner Arnold Chair in Neurosciences at UCI, and colleagues found that levels of PEA are tightly regulated by immune system cells. In turn, PEA helps control the activity of these cells, which are called into action to fight infection, disease and injury in the body.”

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They found a protein, an enzyme that breaks down molecules that control cell inflammation and deactivates PEA. They then created a novel compound that prevents the breakdown.

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“When given to rodents, the compound increased the levels of PEA in their immune cells and reduced the amount of inflammation elicited by an inflammatory substance. Furthermore, when administered to the spinal cords of mice after spinal cord injury, the compound decreased inflammation associated with the trauma and improved the recovery of motor function.”

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UCI is collaborating with the Italian Institute of Technology in Genoa to develop a range of immune-response drugs. 

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Source: University of California – Irvine

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Refer an earlier post on PEA here.

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Palmitoylethanolamide is sold as PeaPure, a food supplement, available from the Netherlands and imported by a local pharmacy here. I have submitted a paper for publication on the treatment of vulvodynia and proctodynia with PeaPure and a topical cream. That source will be posted once it is accepted.

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I have been seeing some exciting responses to treatment of intractable pain with PeaPure. I invite others who use it to add comments below so that we may all learn from your experience.

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~~~~~

The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~~~~

Please understand that it is not legal for me

to give medical advice without a consultation.

If you wish an appointment, please telephone my office.

.

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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