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Old 07-19-2004, 11:05 PM   #1
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Exclamation Cortisone injections & informed consent

I would like to know if any of you think that there should be a law that requires doctors to obtain a patient's informed consent before injecting the person with cortisone. Basically I would like for doctors to be required by law to inform their patients about the risks and benefits of cortisone injections before an injection is administered. Then the patient can decide, based on this information, whether or not to allow the doctor to proceed with the injection. Maybe the law would even require doctors to have the patients sign a waiver (after reading a form about the risks and benefits) before receiving the cortisone injections.

What do you all think about this? Is it even possible to have a law such as this?

I am very interested in making sure that what happened to me does not happen to anyone else. I was given 1 cortisone shot in my foot as the very 1st line of treatment, and I was told that the cortisone would be great for my foot. I was never informed that there are possible adverse outcomes. I was naive and put my full faith in the podiatrist. Then a month later during a check-up visit with him, he had the cortisone shot ready and injected me again. Soon after that second shot the fat pad on the ball of my foot started to atrophy. Currently, the fat pad has atrophied to the point where I'm walking on bone. I can no longer walk around for hours like I used to, and after only a little while on my feet, I'm in pain. I am young and I have to live with this for the rest of my life because it is permanent. Plus, the cortisone weakened my tendons and muscles, so I'm having all kinds of problems with that foot. A recent MRI showed that my 2nd metatarsal has some edema, whereas the pre-cortisone MRI showed no edema. My new podiatrist told me today that the ball of my foot looks like that of an 80 year old's foot. I had a full fat pad before the two cortisone shots.

I realize that what happened to my foot doesn't happen to everyone. But it can happen...it happened to me! I wish I could do something to get the word out to people that cortisone comes with side effects, some of the side effects may show up right away, and some side effects may show up years later. Some people may never experience side effects, though.

If it is possible to create a law requiring doctors to obtain a patient's informed consent prior to administering a cortisone injection, I would give my time and effort to help create the law.

Any comments about this?

By the way, have any of you experienced a bad outcome from cortisone shots?

 
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Old 07-20-2004, 07:12 AM   #2
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Re: Cortisone injections & informed consent

I can't say I've had an immediate bad outcome but I can say that over the years from having such shots my cartilage and tendons are pretty well shot. During an ACL reconstruction back in 94 the doctor told me my cartilage was the consistency of a wet sponge and he proceeded to show me the scoping photos where a pick actually fell through my cartilage. When asked how did this happen he said he felt is was from the repeated injects I had since I was about 16.

Doctors get upset with me when I refuse to have these injections. In fact one pain management doctor through me out of his office when I said no I would not submit myself to them. I think he thought I was pill abuser and didn't put any thought into the fact that I already had damage from these injections.

I agree with you, they should tell you the long term affects prior to having them done as well as not shut the door on you if you choose not to partake in them.

 
Old 07-20-2004, 11:28 AM   #3
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Re: Cortisone injections & informed consent

They do used informed consent forms for epidurals due to risk of seizue, spinal fluid leaks and death, but they don't discuss the long term problems of frequent steroid use. Like steroid induced Osteo perrosis.

A study was done where epidurals were done, some with cort and lido some with saline and lidocaine, amazingly the difference between the test and the control was minmal, says alot about the placebo effect. The article actually suggested that more studies need to be done to rule out the posibility that a saline epidural would help somepeople. Salt water injected into the spine has got to have curative properties? NOT
There haven't been significant clinical studies of steroids used in oral form, dose packs such as depomedrol and inter joint injection of steroids. These meds can be used for off label purposes and a doc can zap you with steroids any where he wants at any time and there is no informed consent because the probelms aren't well documented other than the problems with ESI's.
See the Burton report next page.
Good luck, Dave

 
Old 07-20-2004, 11:30 AM   #4
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Re: Cortisone injections & informed consent

While the subarachnoid space was first "discovered" by Egyptians practicing mummification in 3,500 B.C. the epidural space was not, apparently, discovered by the medical profession until the 1920s when air and then Lipiodol (an iodinated poppy seed oil, first developed by Sicard and Forestier in Paris, France), were used to outline this structure for diagnostic purposes (referred to as "epidurography"). Epidurography was soon recognized as being an inexact diagnostic study unable to provide good information regarding the contents of the spinal canal but an excellent means of locating and identifying the epidural space.

Epidurography was soon replaced by contrast agents being introduced, by needles, into the subarachnoid (intrathecal) space. Thus the diagnostic study myelography was born. It was readily appreciated, from the beginning, that myelography was much more informative than epidurography. It wasn't long afterwards however that Lipiodol was found to be not only a relatively poor contrast agent because of its viscosity but was also highly neurotoxic to the tissues and nerves of the delicate subarachnoid space. Because of this Lipiodol "fell into disuse".

It is important to recognize that the epidural and subarachnoid spaces are very different in their response to foreign body substances. The epidural space is forgiving, the subarachnoid space is not. When potentially neurotoxic substances are introduced into the epidural space for diagnostic or therapeutic purposes great care needs to be taken to assure that they are not actually placed into the more fragile and pristine subarachnoid space. Because clinically significant adhesive arachnoiditis is typically associated with a lifetime of continuing agony it represents a serious potential disaster for any patient in whom unsafe materials are injected. This circumstance demands that when epidural injections are performed patients be informed regarding the potential risks of such a therapy. Despite the seriousness of this problem and good scientific documentation in the medical literature on this subject there does not yet exist a general level of awareness among the medical profession regarding this grave dilemma. Some justify the ill-advised introduction of toxic substances into the epidural space by blind technique as being a "standard of care". It must be clearly understood that a harmful procedure can never be considered a "standard of care".

Only when physicians actually see, with their own eyes, these problems do they seem to have this appreciation. In 1977 a symposium on the "Complications From Methylprednisolone Acetate (Depo-Medrol®) concluded that the only way to prevent the unfortunate complications was to completely discontinue the use of "Depo-Medrol within the spinal canal" (D Nelson et al, Delaware Medical Journal, Vol. 49, No. 6, 1977).

Methylprednisolone is a synthetic glucocoticoid (steroid). It wasn't known by Nelson et al in 1977 that Depo-Medrol®, as a suspension, also contained preservatives and potentiators such as polyethylene glycol, known better as a anti-freeze in car cooling systems.

Ethylene glycol has turned out to be the primary toxic agent in producing adhesive arachnoiditis.

How did glucocorticoid suspensions end up in the subarachnoid space? It appears that the intraspinal (subarachnoid) instillation of methylprednisolone suspension (Depo-Medrol®, Upjohn Company, Kalamazoo MI) began in 1960 as a ill-advised attempted treatment of adhesive arachnoiditis (created by oil myelography) and demyelinating disease (i.e. multiple sclerosis). Complications relating to this use began to be documented in the medical literature within 10 years and this particular practice then basically fell into disuse.

How then did epidural steroid injections (ESI) become such a popular non-specific treatment for low back pain? There is no question but that this "shotgun" therapy has become fashionable in the United States. It's popularity seems to relate, to a large degree, to be a "knee-jerk" means of quickly dealing with a patient presenting with back pain. As we shall see the reasons for this are not always medical. The only rationale for ESI appears to be based on the anti-inflammatory action of steroids and the observation that many patients with back pain recover spontaneously if their initial pain is moderated. Statistics show the same result with most forms of other non-invasive therapies such as physical therapy and chiropractic manipulation. The medical enthusiasm for epidural steroid injections is, however, not shared universally.

In the early 1990s, at a national spine meeting, a highly respected spine specialist from Washington, D.C., presented a paper reporting his double-blinded clinical study on ESI and concluded that there was no objective evidence of benefit from the administration of epidural steroids to treat back pain. At the end of his presentation the author was questioned as to if he continued to use epidural steroids in his practice given the fact that he had just reported on a lack of objective efficacy. The specialist surprisingly admitted that despite his study, both he and his associates, continued to use the procedure.

In a 1999 review of 13 studies published on the use of epidural steroids 8 of the reports showed no measurable benefits (Rozenberg S et al: Efficacy of epidural steroids in low back pain and sciatica, Rev. Rhum. Engl. Ed., 66:79-85, 1999 (Feb)). Quite frankly, there are few areas of medicine today where so much invasive therapy is matched by so little understanding of actual patient diagnosis as in this area of treatment or of the potential disasters looming for the unsuspecting patient.

There is a remarkable amount of ignorance on the part of many physicians performing ESI. This observation essentially guarantees that informed consent based on an explanation of real risk to a patient is the exception rather than the rule. In fact, ( and astonishing as it may seem), many physicians performing epidural steroid injections do not even understand the relationship of this procedure to the possibility of creating adhesive arachnoiditis months later. This is because they are not the ones who see the patient in follow-up or are present when these patients become incapacitated. Another clear-cut example of the New Guinea Syndrome.

Only recently, due to the power of the internet, have patients been provided with access to valid information on the subject of ESI. Most patients and their physicians still have little understanding (despite adequate information in the medical literature) about the remarkable level of patient suffering possible when clinically significant adhesive arachnoiditis is produced.

 
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