Spinal cord stimulators: ~ 10% are good candidates. Pulling out more than putting in


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PainWeek 2018 has a series of conferences in different cities. This weekend 10/13-10/14, it was in San Diego teaching pain management. Thank those who funded this 2 day program for doctors and healthcare providers to bring us up to date in the field.

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Anesthesiology pain specialist Michael Bottros, MD, Associate Chief of the Division of Pain Medicine, Washington University St. Louis, made a comment on spinal cord stimulators:

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They are pulling out more than they are putting in. Only 10% are good candidates.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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

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Please IGNORE THE ADS BELOW. They are not from me.

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Spinal Cord Stimulators, Advances? A Revolution? How about a lot more research first?


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The new issue of Practical Pain Management has a lead article on Spinal Cord Stimulators, stressing early treatment, a revolution using “new [and] different patterns of electric stimulation.” Advances?

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I don’t have the energy or time to compare these new claims with the information just posted on this site from the International Association for the Study of Pain that details existing evidence with the decades of claims by these companies and abysmal lack of research. Perhaps they could set aside some of the billions in profit they use for PR and give us good research data.

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Chronic pain would make any of us vulnerable to risk our lives for these devices. Research is desperately needed. Here are the new claims:

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Recent Advances

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Ivano Dones, MD, and Vincenzo Levi, MD, of the Functional Neurosurgery Department at the Carlo Besta Neurological Institute in Milan, Italy, highlight “an ongoing revolution” in the treatment of neuropathic pain using “new [and] different patterns of electric stimulation.”3

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Conventional SCS stimulation employs a tonic waveform in which electrical pulses are delivered at a constant frequency, pulse width, and amplitude. It has been found effective for approximately 50% of neuropathic pain patients.4 To help more sufferers, including those who develop a tolerance to conventional stimulation, the researchers say that new types and patterns of stimulation, such as burst and high frequency, should be considered.

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To date, only small studies have been performed on burst stimulation, but Drs. Dones and Levi say the results have been promising. “When compared to conventional SCS,” they state, “burst stimulation gave remarkable long-term pain higher suppression.” In addition to providing greater pain control than the traditional tonic pattern, it was also associated with a decreased incidence of paresthesia (a pins-and-needles sensation).

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Studies have also shown that burst stimulation may be more effective in reducing pain in the axial midline region, an area that conventional tonic stimulation often fails to treat effectively.5 Dr. Dones told PPM that this is because “burst stimulation can recruit more nerve fibers in the spinal cord, thus interfering with their transmission of pain to the brain.”

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The authors cite a small study using high-frequency stimulation that showed 70% of patients “experienced a significant and sustained low back pain and leg pain relief.”6 They note, however, that another study showed no significant difference between the high-frequency mode and a placebo. More studies need to be conducted, they say.

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Joshua Rosenow, MD, director of Functional Neurosurgery and Epilepsy Surgery at Northwestern Medicine in Chicago, IL, applauds these recent advances. New patterns of stimulation, including combinations, he says, “have allowed us to provide a wider population of patients with a significant amount of pain relief.” They have also enabled clinicians to “more precisely match the therapy to the patient,” both now and as pain changes over time.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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

~~

Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

~~~~~

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

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Please IGNORE THE ADS BELOW. They are not from me.

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Spinal Cord Stimulators – Not Allowed to Sue Medtronic – Supreme Court Ruling 2008


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More than any other topic  readers seem to read and comment more about serious problems with the Medtronic spinal cord stimulator than anything else on this site, yet they overlook this post last week: 

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Supreme Court ruling 2008

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Riegel v Medtronic

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Patients Who are Implanted with High-Risk Devices

 

Not Allowed to Sue

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And the problems never get addressed. There is no accountability for the damage to spinal cord that so many experience—the spinal cord for Pete’s sake —and no research on the incidence of the many different problems. If complications were not severe, thousands would not care to search the subject.

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Perhaps a person with a legal background would discuss how that case was won.

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How can this possibly be right? 

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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

~~

Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

~~~~~

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

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Please IGNORE THE ADS BELOW. They are not from me.

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Medical Devices: Supreme Court ruling 2008, Riegel v. Medtronic, Patients Who are Implanted with High-Risk Devices Not Allowed to Sue


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Supreme Court ruling 2008, Riegel v. Medtronic

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Patients Who are Implanted with High-Risk Devices

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Not Allowed to Sue

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If you are not certain you are willing to take on risk, more medical problems, grave risk, even death, do not get a device implant. Keep in mind what some orthopedic surgeons teach: Do not get an joint replacement until you absolutely cannot walk anymore.

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Let me take this opportunity to demand a 5 year followup study of spinal cord stimulators to include every death and every problem regardless of cause. It will never happen. The swamp is impervious to us.

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NPR interview today on risk of implanted medical devices.

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“…40 percent of conditional approvals haven’t had a post-approval study five years after it’s on the market. So people are being subjected to devices that scientists may have had serious concerns about, and yet, they don’t even know if they’re safe or not.

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…DAVIES: This is FRESH AIR. I’m Dave Davies in for Terry Gross….We’re speaking with medical journalist Jeanne Lenzer, who’s written a new book about the risks and implanted medical devices such as artificial joints, cardiac stents and pacemakers. She says they’re approved with far less scrutiny than new drugs, and some can cause serious harm. Her book is called “The Danger Within Us.”

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…Dennis Fegan, this firefighter and paramedic who suffered from epileptic seizures, and out of some desperation, got this vagus nerve stimulator planted in him, this little box with wires that would stimulate the vagus nerve that runs down his body and hopefully ease his epileptic seizures. He ended up in a life-threatening situation in [2006].

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LENZER: So one night, he was awakened about a – with a pain in his throat. About 2 in the morning, he woke up. And he knew that the pain in his throat was associated with a seizure, so he got up, and he put a vertical mark on his calendar on that date….And when his parents found him the next morning, they saw him stumble out of his room and fall unconscious onto the floor. And when he came to, he got up, sat down on a dining room chair and immediately fell face-first into the floor again. This time, you know, he’s afraid of falling again, so he wiggles across the room with his back against the wall. His legs are splayed in front of him. His jeans are soaked with urine. He looks half dead. His parents frantically call for an ambulance. By the time the ambulance gets there, he’s already passed out eight more times.

The paramedics, figuring he’s having seizures – as Dennis thought he was having seizures – gave him seizure medication that they injected in his arm. But it didn’t stop the seizures. So they rush him to the hospital, where the ER doctor also gives him more seizure medicine seeing his seizures. And again, he can’t stop the seizures. And the ER doctor is frantic. He, you know, thumps Fegan on the chest trying to bring him back to life. And that’s when he notices something very curious.

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Fegan’s heart is stopping at precisely three-minute intervals. This makes no sense to the ER doctor. He calls in a cardiologist. The cardiologist rushes downstairs, looks at him. They both see the same thing. And it’s only when the neurologist arrives – Fegan’s neurologist – who says, oh, Fegan has a VNS device, and it’s set to fire at exactly three-minute intervals. So the device, instead of stopping his seizures, was stopping his heart. So they rushed to turn off the device. And when they finally get it turned off, the seizures stop immediately and Fegan doesn’t have anymore. They send him up to the ICU to recover. And the next day, Fegan learns that his heart has been stopped by the device. And that launches him into a decade-long battle with FDA, regulatory authorities and the device manufacturer….

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LENZER: Right. And Fegan gets concerned about other people implanted with the device and wants to know whether it’s happening to other people, so he finds out about the FDA’s MAUDE database. It’s a database where all device adverse events are kept. And when he looks into the database, he sees that many people have actually had very similar experiences to his own, but also, many have died. And he’s wondering, you know, if I’d been found dead, he told me, everybody would have said I died of epilepsy rather than the device. And it’s only because he lived and there’s a recording in the ER of what happened to him that anyone knows it wasn’t because of epilepsy. It was because of the device.

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DAVIES: This raises one of the interesting issues about these devices and their regulation. The FDA has this database at which physicians and hospitals are expected to report problems – adverse events with medical devices. Sounds like it would be a smart way – and the FDA says it is the way – we look for red flags. Why doesn’t it work better?

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LENZER: Well, first of all, there’s a study showing that only about 1 percent of all serious adverse events make it into the FDA’s adverse event database. And something that really surprised me was, it turns out that the more serious the event was, the less likely it was to be reported. Manufacturers are supposed to report these adverse events. And there is some leeway granted to them about determining whether the device event was related or not to the device.

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So, you know, sometimes people cough and sneeze when they have a device. It doesn’t mean the device caused it. The problem is is that there’s no independent party assessing whether these problems are related to the device or not. So leaving that decision to the company presents a real conflict of interest.

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DAVIES: Yeah. So, for example, if someone died because this stimulator had actually stopped his heart, it could appear to be epilepsy and therefore would not appear as an adverse event associated with the device….

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…LENZER: That’s a big problem. And that’s something that I refer to as cure as cause, where – doctors assume that when a patient dies – and I did too when I was in practice – that a patient has a heart attack, they died of a heart attack and the bad heart rhythm that went with it. We don’t assume that it’s the drug or the device that we prescribed for the patient. And that’s a real problem because it turns out that the kind of studies we need – there really shouldn’t even be a decision about whether a side effect is due to the device or not.

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We should just count up all the adverse events, all the deaths that occur in the patients who are implanted and in the control group. And that would give us a far better picture because it turns out that the kind of studies we need – there really shouldn’t even be a decision about whether a side effect is due to the device or not….

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LENZER: Well, he was told that he could have the generator taken out but not the lead wires, the lead wires that tunneled up to his neck and were wrapped around the vagus nerve because many surgeons have found that the wires become enmeshed in scar tissue. And it just becomes too dangerous to try to tease those wires out of the scar tissue. They can tear and destroy the very nerves that are next to them and even the jugular vein and the carotid artery that are right adjacent to the vagus nerve. So it’s too dangerous a surgery, and they left the lead wires in but took the generator out.

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DAVIES: Dennis Fegan was frustrated by what happened to him, and one of the things he considers is a lawsuit. It turns out he is unable to sue and he learns why….

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LENZER: Well, it turns out there was a Supreme Court ruling in 2008 called Riegel v. Medtronic, and it’s also called the pre-emption ruling. And what it means is that patients who are implanted with high-risk devices that went through the premarket approval process called PMA are not allowed to sue. And the basis for that is – is that supposedly they underwent rigorous testing proving the device was safe.

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DAVIES: So patients can sue in the case of a drug that they think has harmed them but not in devices that have gone through this process.

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LENZER: Not in certain devices – that’s right – certain high-risk devices…

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DAVIES: You argue in this book that the FDA does a bad job of regulating these devices because they’ve become heavily influenced, maybe even captured by the industries they regulate….

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LENZER:That’s no longer the case. We’ve had a number of instances now, including an episode dubbed Devicegate in which all of the scientists agreed that certain devices should not be approved because they were unsafe and ineffective. And yet the devices were put on the market over the unanimous opinion of their own scientists when politicians made phone calls to FDA superiors. This is really stunning that politics is trumping science. And it’s getting worse now with 21st Century Cures Act that was passed in late 2016, which essentially is deregulating even further.

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…. Even if we read the studies that are released, we don’t know that we can trust them.

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Other Devices That Are Particularly Problematic

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And I’ll give you two examples of just how difficult the situation is. One of the people I talk about in the book is a man who was harmed by a hip implant. Well, it turns out that man is also an orthopedic surgeon who specializes in hip replacements, and yet he landed up being poisoned by his hip implant from cobalt that leaked out of the hip and destroyed his muscles and tissues and even caused some degree of heart damage.

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Another example is a Medtronic executive that I report on who had a Medtronic device implanted in her spine and suffered just terribly disabling and painful effects from that device. So even people who are insiders and who should know don’t really know….

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The Sprint Fidelis leads that go to defibrillators pacemakers were found to have fractured and cause serious injury and death. And these were implanted in hundreds of thousands of people. And this is one of the problems with devices – is that, you know, what do you do once you’re implanted with something that may be dangerous? Having them removed in 15 to 18 percent of people, nearly 1 in 5 people suffered serious adverse events or death when they tried to remove the leads.

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Hip implants have leaked chromium and cobalt, and there are other problems. Pelvic mesh – again, a seemingly simple device. It’s just mesh after all – surgical mesh. And yet it has grated through tissues like a cheese grater through cheese and caused what’s called fistulas – holes between the rectum and the vagina and causing serious pain, infections, hemorrhage. There are all kinds of problems with medical devices that people might want to think about first.

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And one of the common things I hear from patients is, you know, now that I think of it, my problem wasn’t that serious. So a woman who has a little bit of urinary dribbling when she sneezes or gets excited goes and gets this pelvic mesh put in because a doctor recommends it and then has a lifetime of pain, infections and suffering. So I guess my best advice would be, if you’re not certain you really need something, it might be best to wait….

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LENZER: And ask if your ER doctors know how to take care of you. I mean, there was one tragic case of a woman with a vagus nerve stimulator who called her sister saying, oh, my God, my VNS is shocking me. I can feel it. It’s so painful. I dropped to my knees. And her sister told her, go. Go straight to the ER.

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And the young woman who was about 39 years old, a young mother, said, I can’t because they don’t have the tools to turn this off. I have to wait until my doctor comes in on Monday morning. She didn’t get to see her doctor on Monday morning because her 9-year-old daughter found her dead in the bathroom on Sunday night….

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 Risk of Devices  – New York Times Opinion

by medical journalist Jeanne Lenzer

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When Stephen Tower’s right hip gave out in 2006, he asked his surgeon to implant an artificial one — specifically, a metal-on-metal hip called the ASR XL, made by Johnson & Johnson. He knew what he was talking about: As an orthopedic surgeon, Dr. Tower specializes in complex hip replacements. But what he knew wasn’t enough to protect him from a defect in the device.

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Five years after his surgery, and in excruciating pain, Dr. Tower underwent more surgery, this time to have the device replaced. When the surgeon sliced into his hip, what he saw looked like a crankcase full of dirty oil. Tissue surrounding the hip was black. Cobalt leaking from the ASR hip had caused a condition called metallosis, destroying not only local muscle, tendons and ligaments, but harming Dr. Tower’s heart and brain as well.

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Despite Dr. Tower’s repeated efforts to warn his colleagues and the company that the implants were harming patients, Johnson & Johnson continued to market metal-on-metal hips. While it withdrew the ASR XL model from the market in 2010, citing slow sales, it continued to sell another, similarly problematic model, the Pinnacle, until 2013.

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More than 9,000 patients filed suit against the company, and on Nov. 16, six New York patients won a $247 million trial verdictfor serious harms caused by the Pinnacle hip implants and for failing to warn doctors and patients about its dangers. These suits and others are pulling back the curtain on what some doctors call the Wild West of medicine: the untested and largely unregulated medical device industry.

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About 32 million Americans — or about one in 10 — have at least one medical device implanted, from artificial joints to cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices….

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Although the standard for approval of a new drug usually calls for two randomized, controlled clinical trials, the standard for many medical devices is no standard at all. Since medical devices didn’t come under regulatory control by the F.D.A. until 1976, the agency simply grandfathered in all devices that were already on the market under a provision known as 510(k), which allows manufacturers to sell most new devices without requiring any clinical testing as long as the manufacturer says its product is “substantially equivalent” to an existing device.

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Even when devices are subjected to trials, the F.D.A. sometimes ignores danger signs detected by those studies. In 1997, during the approval process of the vagus nerve stimulator, a device made by Cyberonics to treat epilepsy, an F.D.A. adviser voiced concerns about a high death rate noted in patients with the device. But the agency didn’t stop the device from going to market. Instead, it awarded conditional approval, meaning that Cyberonics would have to conduct safety studies after the device was on the market.

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The agency didn’t even require Cyberonics to inform patients that there was concern about the death rate, or that they were effectively being made unwitting guinea pigs. When Cyberonics finally submitted five studies that it said proved the device was safe, it failed to include death data for any of the studies, a move the F.D.A. defended, saying the agency hadn’t asked the company to count deaths, only to “characterize” deaths.

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How it’s possible to characterize deaths without including any actual data on deaths is anyone’s guess.

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With such shockingly lax regulations, it’s no surprise that device recalls have risen over the years; in 2003, there were eight Class 1 device recalls, which the F.D.A. defines as indicating “a reasonable probability” that a device will “cause serious adverse health consequences or death.” In 2016, that number rose to 117, affecting hundreds of thousands of patients.

..In addition to the 510(k) pathway, medical device companies can avoid clinical testing for the highest risk devices through the supplement pathway by telling the F.D.A. they made a minor change to a previously approved device. The use of these loopholes is widespread: A study published in The Journal of the American Medical Association in 2009 found that only 5 percent of high-risk implanted cardiac devices even partly met the standard for drug testing.

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Metal hips are far from the only devices with catastrophic consequences. In October 2007, Medtronic, a leading medical device manufacturer, recalled the lead wires in its Sprint Fidelis defibrillator after they were found to fracture and misfire, harming or even killing patients. The devices had not been clinically tested and were approved for sale by the F.D.A. through the supplement pathway. But in this case, the “minor change” was a fatal one; the new wire was thinner and prone to fracture.

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By the time of the recall, 268,000 leads had been implanted in patients worldwide, the majority in the United States. After the recall, many patients rushed to have the devices removed, but removal posed its own dangers, causing major complications in 15 percent of patients.

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Even when devices are subjected to trials, the F.D.A. sometimes ignores danger signs detected by those studies. In 1997, during the approval process of the vagus nerve stimulator, a device made by Cyberonics to treat epilepsy, an F.D.A. adviser voiced concerns about a high death rate noted in patients with the device. But the agency didn’t stop the device from going to market. Instead, it awarded conditional approval, meaning that Cyberonics would have to conduct safety studies after the device was on the market.

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The agency didn’t even require Cyberonics to inform patients that there was concern about the death rate, or that they were effectively being made unwitting guinea pigs. When Cyberonics finally submitted five studies that it said proved the device was safe, it failed to include death data for any of the studies, a move the F.D.A. defended, saying the agency hadn’t asked the company to count deaths, only to “characterize” deaths.

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How it’s possible to characterize deaths without including any actual data on deaths is anyone’s guess.

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With such shockingly lax regulations, it’s no surprise that device recalls have risen over the years; in 2003, there were eight Class 1 device recalls, which the F.D.A. defines as indicating “a reasonable probability” that a device will “cause serious adverse health consequences or death.” In 2016, that number rose to 117, affecting hundreds of thousands of patients.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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

~~

Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

~~~~~

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

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Please IGNORE THE ADS BELOW. They are not from me.

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Spinal Cord Stimulators – comment on RSD


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Spinal Cord Stimulators 

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 Craig’s comment

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By no means do I mean to say that I or anyone else has better insight into how to treat pain, but I am against spinal cord stimulators [SCS’s] for treatment of pain due to CRPS, and possibly against use in other situations. I demand that the billions in profit they made be put into a retrospective and prospective study of damage caused by them in order for them to give full informed consent.

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I have 3 goals writing this.

  1. SCS’s

  2. Craig’s experience

  3. The Only Real Answer for severe pain, not damaging the system with opioids

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Informed consent is never given for spinal cord stimulators because it requires truth telling, something our corporations have been reluctant to do. Business ethics are not medical ethics, as we keep being reminded daily in the headlines.

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I enclose, below, a generously expressed and detailed comment by a man who had the patience to sit down and  write the painfully gory details so you can weigh-in on your decision whether to follow your pain specialist’s opinion to give you one. I don’t want anyone to feel suckered into choosing them and if I had pain I’ll admit I’d crave relief too. Anything. I’d be in line before the doors open.

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But if you have CRPS, spinal cord stimulators will create more pain. CRPS evolves unpredictably, by a will of its own. I know some very desperate patients with CRPS everywhere including face, mouth, gums, tongue, organs, trunk, limbs. Spinal cord stimulators will create more pain. Keep in mind, I don’t see the 5 year success stories even for lumbar disc pain. They don’t need me if they are pain free.

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But if you have CRPS and desperate need for pain relief because all else has failed — every known drug in highest possible doses of ketamine, propofol, opioids for weeks in ICU fail to even touch pain— there is one thing, and only one thing to do and I will set it out below. I just sent my recommendation to a patient with CRPS in extreme pain.

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My recommendation, below, is for patients who have nowhere else to turn.

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First I’ll mention the problems Craig encountered with SCS’s. He sent his comment to the opening page of this blog, so I will reproduce below. 

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I am currently undergoing a trial Medtronic SCS. I have had to have it reprogrammed 3 times since it was installed 5 days ago. I have had sensations and issues that I have addressed with my rep and my neurosurgeon. I get a severe headache when the unit is turned on. I get the constant feeling of having to urinate. I have current running through my testicles which they can not seem to program out and I am getting little pain relief. I have had to failed back surgeries, many failed injections and I have CRPS. The leads that were inserted when I was in the table covered my mid back and both legs. After I got to my feet and waited while they programmed the unit in another room. They came in and plugged it in and I no longer had coverage on the right side. My crps is in both legs, my hands, arms and face. The lyrica helped to tamp down some of the burning but I am in pain 24/7 and this was my last resort. I have scar tissue completely surrounding my S1 nerve. By the grace of God, I am on my feet, on crutches. I seem to get a look of disbelief when I tell them the unit is causing these issues or it’s not giving me the relief I was counting on. Relief, only to cause greater issues and pain. Is not relief to me. I can not wait to get this trial out of my back. I believe the leads slipped and that is why I am not getting the full coverage I had on the table. The issues I have had are as follows: severe headache, constant feeling of having to urinate, extreme joint pain, abdominal pain, sleeplessness, involuntary jerking, surges in current even when sitting still. Intense pain around the lead insertion site. Current uncomfortably running through my testicles, regardless of setting. It is my opinion there is still not a lot known about crps and I have read evidence of people have great success with these units. Everyone reacts differently. My body obviously creates a lot of scar tissue and my orthopedic surgeon created a fair amount herself. I can’t imagine even more or being forced into a chair for yet another unlucky decision. The medication helps and I have lived this far without the optimism that it would end soon. I had high hoed for this device but I don’t think it is right for me.

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One of my patients with CRPS was hospitalized for weeks with recurring unusual abscesses and required repeated surgery of hand and forearm. Even before surgery, she had failed opioids, failed ketamine, and was in ICU for weeks and weeks while the same medications were still given along with Propofol and IV Tylenol. Nothing helps her extreme pain.

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Anesthesiologists on staff in ICU threw everything they had at the pain for weeks. Most anesthesia pain doctors would have probably done what they did because that is the limit of tools we have.

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When you have hit the limit of benefit from opioids, ketamine, propofol, we have nothing else that treats pain with one exception: drug holiday.

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Stop all analgesics including Tylenol that destroys the liver as severely as cancer, the severity of which was newly discovered and published yesterday.

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The receptors for these analgesic drugs have up-regulated to such an extent they have caused the situation. Again, I stress, everything that was done during the ICU admissions would be done by any anesthesiology pain specialist. Those are the only tools. They cause the problem. The same for opioid induced hyperalgesia. We used to do it with Parkinson’s drugs in the 80’s.

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The only way to rehabilitate the up-regulation of all those receptors that have now exploded in numbers, immune to anything you throw at them, is stop the drugs.  Stop all of them for weeks, maybe months, years, no one knows, you are all the human guinea pig waiting to happen. But if we restart them, how long do we wait, how quickly will it again lead to this massive hyper-excitable state of pro-inflammatory cytokines that we know have gone wild, flooding the CNS. A flooded engine will not restart.

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Ketamine at least is known to reduce pro-inflammatory cytokines, but the system is too busy exploding, birthing new receptors that take over, and you’ve got a 55 car pile up. Well, more like millions I’d guess. No scientist here. Clnically, when can we resume something after a drug holiday, how soon and which drug? I’d avoid opioids because they create more pro-inflammatory cytokines. Choose ketamine, because they reduce pro-inflammatory cytokines, but if it works at all, stop it at first sign of tolerance, which is the need for increased dose. It becomes less effective. Walk a fine line, endure more pain because unless you do, it will no longer help. Opioids, analgesics of many kinds. 

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How do we get you through a drug holiday because we know withdrawing these drugs will trigger even more pain for possibly weeks until the system settles down?

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Pain storms, hurricanes

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This is complex regional pain syndrome where we see this insanity of pain storms. There is no other condition, unless several neuropathic pains in people with cancer, nowhere I have seen this type of pain in decades except CRPS – comparable to pain of subarrachnoid hemorrhage, blinding pain.

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No one has answers. None. One university does outpatient infusions of ketamine six hours daily for 8 to 12 weeks. Does it help? A small percentage. Outpatient, 6 hours daily, 5 days a week, staying at a hotel, 8 weeks.

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This is CRPS/RSD. No one has answers. It is futile to throw more of the drug in the system. That is my opinion. You have a choice and may choose otherwise. It is your body. You may stay on monthly opioids for decades, until you finally admit how poorly they work. A drug holiday is what we did in the 70s during my ancient training with Parkinson’s patients. They needed full 24-hour support. The American medical system has changed since then and those are not options currently available—cost.

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You need full psychological and psychiatric support.

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The Only Real Answer

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The country needs to invest $10 million to complete the clinical trials needed for an injectable, long-lasting interleukin 10 [IL-10], the anti-inflammatory cytokine. It already has full scientific and animal studies performed by and with the world’s foremost glial scientist at University of Colorado Boulder. Professor Linda Watkins has won awards from many countries. She has been the keynote speaker at the annual academy pain meetings for years. IL-10 can relieve pain for three months in animals that have intractable chronic neuropathic pain. This is not new —–NIH I’m looking at you to fund clinical trials. And those of you who care, do a Kickstarter to fund the clinical trials.

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This is the power of the innate immune system. NIH would rather fund research on the unknowns like stem cells rather than the known. It’s known for decades, NIH does not like to fund pain research. Glia are not all about pain. They are the innate immune system, the key to Alzheimer’s, neurodegenerative diseases, almost all known disease including atherosclerosis. It’s all about inflammation. We need the trials to stop giving drugs that cause inflammation, opioids —–CDC fiats are not as good as a drug that relieves pain, a drug that really works on mechanism. Where will the addicts go if the ER only has IL-10 for pain? That is one way to overspend on ER visits.  And NIH, please get us some real clinical research funding on how to use glia for our benefit. Get us some research on the entourage effect, combining medications to achieve relief especially for neuropathic pain.

Then bring on some crack negotiating teams from insurers to do some negotiation about pharmaceutical prices. Our new president has mentioned that.

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Please bring this to everyone’s attention. One way to get a grip on pain and/or depression is to build hope, help others, and energize behind a goal.

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Kickstarters work to raise tens of millions overnight. 

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IL-10 – animals have been shown to be pain free for three months, already proven in animal studies, by one of the world’s most widely acknowledged pain specialists Professor Linda Watkins, PhD. We need the final steps to fund the clinical trials in humans.

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The material on this site is for informational purposes only.
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It is not legal for me to provide medical advice without an examination.

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

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This site is not for email and not for appointments.

If you wish an appointment, please telephone the office to schedule.

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

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Spinal Cord Stimulators


For some reason my two browsers do not show the comments sent to this post, below, and therefore I am posting them now. I would emphasize the last comment by a very experienced nurse who has seen many complications of spinal cord stimulators. For persons with CRPS/RSD, I have seen many others. The saddest are those who had stimulators inserted and now the pain of CRPS is worst at the site of the “stim.” If the leads are ripped out from under the skin, the track of those leads may forever be the worst pain on the body.

10 Responses to “RSD – CRPS – Complex Regional Pain Syndrome – Long Distance Patients”

  1. Robyn H Says:
    08/04/2010 at 8:16 am  
    I broke my hip and wrist during a fall at a local skating rink in my hometown in Georgia. The hip healed fine after surgery and two weeks later, surgery was performed on my right wrist. Immediately after surgery, the pain was different. I was soon diagnosed with RSD and put on several medications and therapy three times a week. After many weeks of oxycontin, oxycodone, neurotin, topamax, klonopin, robaxin and paxil and four nerve blocks (SGB), it was suggested I receive the spinal cord stimulator. Through research on the internet, I found Jim Broatch with the RSDSA organizaton who advised me there were other alternatives in treating RSD. I discovered Dr. Nancy Sajben in San Diego. She has been treating RSD with oral ketamine and naltrexone. I saw Dr. Sajben in her office July 19th and began treatment. Since beginning treatment, I have been able to go off the opiods and have had a 70% improvement in my range of movement of fingers and arm and decreased pain levels to the extent that I can now tolerate physical therapy. I have had no “flare ups” since beginning treatment. Dr. Sajben has changed my life for the better and given me hope for the future. Thank you, Dr. Sajben!

    • Nancy Sajben MD Says:
      08/04/2010 at 6:00 pm   Remarkably, in one and one-half days, she no longer needed high dose oxycodone which she decreased 95% on her own as pain was 40% better. That was before ketamine reached a dose where it began to have an effect and before naltrexone was prescribed. The later addition of those two helped even more. By the start of week two, she was able to discontinue the last 5% of oxycodone and is 70% better off opioids. She was started on a few other medications than mentioned in her comments: rational polypharmacy. Since January, she was unable to move her fingers, unable to write or pick up anything with the right hand. Less than ten days after we started treatment, the fingers had regained modest motion. She could hold a pen, write, pick things up with the fingers, fold laundry, pack luggage, and best of all her seven year old daughter said: “Mommy, I can hold your hand for real now.” Allodynia and hypersensitivity of the hand is so much better that she is likely to be able now to make progress in physical and occupational therapy. It was too painful prior to her visit. There has not been one flare of CRPS since day one on July 19, 2010, despite using the hand in ways not possible for seven months.

  2. Lori Morris Says:
    01/11/2011 at 6:45 pm   I would first like to thank you for your specialization in CRPS. My husband was diagnosed with CRPS in March 2010. He suffers in his lower left extremity (left foot/ankle) with all the signs of CRPS. He has gone through extensive pain management since that time. He has used oral meds, morphine, oxycontin, and now methadone, and also takes lyrica and nortriptylene along with lortab as needed. He has had no relief with these meds. He has had one nerve block with no relief, so a second block was not attempted. On Friday Jan. 7th the SCS trial was done and today Jan. 10th removed due to it causing pain in his lower back and side. The jolting the SCS caused in these areas could not be over come with reprogramming the SCS. Today, his pain management doctor discussed the Drug Delivery Therapy, which is not crazy about doing and after reading your information regarding SCS and Pumps I too am having second thoughts. However, the doctor did mention that there were 2 clinics that specialized in CRPS. One at John Hopkins and the other at UCLA. His doctor recommends the UCLA clinic and that is how I got to your page. I have been doing my research on CRPS since my husband was first diagnosed and am always looking for anything new in the medical field. I have read all your information regarding the Ketamine and Naltroxene treatments your patients have received and will be discussing these with his local pain management doctor. So, again I just want to thank you in advance for your specialization and your web page. Who knows, we just may meet some day.

    • Nancy Sajben MD Says:
      01/15/2011 at 6:17 pm   CRPS is unlike any other pain syndrome because it can be spontaneous or triggered by something very slight. Pain can involve the entire body. There is a high incidence of suicide. Despite that, there is a hope that it may be entirely reversible or, at least, put into remission. What a joy to see that happen and to share in the recovery!!!

  3. Traci Says:
    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.

    • Nancy Sajben MD Says:
      04/01/2011 at 2:48 am  Traci, thank you for your comments and for placing your second comment in this section where others with CRPS may be more likely to see it.

      One of the simplest ways to respond to the issues you pose is to say that a renowned pain specialist colleague, trained in Anesthesia Pain at Harvard 40 years ago, does not put in spinal cord stimulators, does not recommend them and does not refer patients for them. He trained in how to use them when they came out, just as he trained for morphine pumps. He has never placed either in a patient.

      The common sense question is: Show us the data. Five year long term data with complications. Invasive procedures do have potential risks.

      The body tissue of a person with CRPS is very volatile, very different than any other condition I know. Any surgery, any procedure in that person is a risk not to be taken lightly. Just a needle stick for blood draw or vaccine can trigger CRPS.

      There is no question it is a big money maker. Several can be placed in many patients in a few hours. In no time at all, it has become an industry. And that kind of wealth can control the way pain management is practiced in this country. It doesn’t pay to do anything else. NIH doesn’t try. Show us the research.

      Nothing interests me more than the neuropharmacology approach I use for CRPS and “intractable” pain from the many conditions my patients have. I wish you lived nearby.

  4. Maureen Says:
    01/22/2012 at 5:57 am   
    I just had the scs implanted two weeks ago. I am getting that sharp pain and burning near the battery site. It happens with the scs on or off. I really am wishing I never got it. I feel that the small relief that I am getting is not worth it. Are you telling me that the leads can never come out and no MRI ever? I do believe they can be removed.

    • Nancy Sajben MD Says:
      01/24/2012 at 4:41 pm   
      I believe they can be removed, but they may become tethered to the spinal cord itself. I presume that may occur when they have been in for some time. I do not implant these, but one of the foremost anesthesiology pain specialist in the country, Harvard trained in pain management, will not put these in and will not refer patients for them.

    • Nancy Sajben MD Says:
      01/24/2012 at 4:43 pm   editAgain, specifically, if tethered to the spinal cord, or some other complication, they cannot be removed.

  5. Barb Fosdick Says:
    06/07/2012 at 11:25 pm   editI have been a surgerical 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! Anomymous…. and never allowed them to put one of those things in me…but many tried!

RSD, Complex Regional Pain Syndrome – a case report


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Severe Pain for Three Years,

 80% better in 10 days

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“This has been life altering.”

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This is a very bright young woman who was an all state volleyball player until onset of Complex Regional Pain Syndrome three years ago in the right hand and wrist. It began after blood was drawn from the hand for a chemistry study and, one week later, the fingers turned black, lost blood flow, followed by emergency surgery for removal of a blood clot from the back of her hand. She woke after surgery, tearing the sheet off due to intense pain on light touch — that is called allodynia — and then developed severe edema from the hand to the shoulder.

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It was four excruciating weeks before the diagnosis of complex regional pain syndrome was made.

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CRPS or RSD is a diagnosis that every MD,

every surgeon, every ER doctor,

every psychiatrist and psychologist, every nurse and therapist should know how to diagnose.

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Because she was a minor, they would not do nerve blocks.

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She developed contractures of the fingers and hand,

was unable to move the fingers.

  A major university hospital diagnosed Munchausen Syndrome;

mom was diagnosed with Munchausen’s by proxy.

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This happens so often. This is 2012.

If it’s not the doctors,

it’s the insurance companies

creating roadblocks to diagnosis or treatment or both.

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Why is pain management not taught at medical schools?

Only 3% of schools today give 30 hours instruction in four years, Yale most recently.

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At a major university hospital two hours away, she failed to respond to 14 stellate and brachial plexus blocks. But the wound reopened by itself, the stitch fell out. The psychiatry department evaluated her after she was so drugged with methadone, she does not even recall the interview. They diagnosed Munchausen Syndrome. That changed everything. Relationship went sour. Distrust of MD’s began and was confirmed many times in many places along the northeastern corridor and Texas.

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That fall, she became a student at the university of her dreams. The diagnosis of CRPS was confirmed at their university medical center hospital where they wanted to continue the same blocks that had failed. Elsewhere, the chief of a renowned ivy league university pain service wanted to talk to her only about spinal cord stimulators, declined by the family.

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In May 2010, she qualified for an NIH study of neurotropin double blind 6 weeks on, 6 weeks placebo. Failed.

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She was seen by Dr. Schwartzman in Philadelphia October 2011, and sent from there to NYC to rule out neuroma dorsum right hand, negative.

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On Lyrica, she gained 20 lbs, then back to 130 lbs baseline when off of Lyrica. Intolerance to Morphine – hives, Duragesic – total body itching. Ambien – hallucinations, Lunesta – hyper. Benadryl helped somewhat. Detoxing from Nucynta – lips were bright red.

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Her weight dropped from 130 to 115. Many medications were trialed and failed. Marinol helps pain slightly and gives the best sleep in years, better appetite. It does cause anxiety, but she had not slept in three years, and it gives 4 to 6 hours of good sleep. She developed sharp bitemporal headaches. I advised headache is a side effect of Pristiq —- now thankfully discontinued and better.

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Since August 2011, she has had CRPS pain in the right leg, worse walking, weight bearing.  There is discoloration of the dorsum hand usually, at times along proximal forearm, recently at right foot and leg. She had edema up to the shoulder measuring 30 cm. Nails growth faster at the right hand, possibly less hair growth right hand. Temperature usually cooler on the right hand, at times at night the hand and foot become hotter. No change in sweating noted.

The first year, she had almost total loss of function in the hand with pain and contractures —and forced herself to move the fingers with OT and PT, then home exercise. She still has days when the fingers remain flexed, but 98% of the time there is full movement as she continually tries to use the hand/fingers to write and type. Nose may become ice cold and tingly since CRPS spread to right side of face and right lower limb. At times tingling fingers. She struggles with memory when pain is severe and with lack of sleep.

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Pain ranges 7 to 10, average 8. Edema was significant for one year, now comes and goes. Allodynia is present hands and feet, now a different scale than before when she could not even be in the car.

However, with weight bearing and walking, pain of the right lower limb became most intense.  She will be 21 in July, but on a bad day was unable to leave her bedroom to walk downstairs as pain was too severe. She would communicate with family by loudly calling or texting. It was unthinkable to make plans for the next week due to severe pain. She has osteoporosis with atrophy of the right upper limb, and has had color changes and edema of the hand.

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She lives in an eastern state inland, two hours away from the mid Atlantic seaboard and major medical center. She failed ketamine infusion at a major university medical center on the east coast. The cost and inconvenience was significant and the family did not know that ketamine may fail to have any effect if taking opioid analgesics. Once mom discovered that, she was able to wean off the opioid medication. Ultimately, after many more interventions, much later, in crisis, she did benefit from IV ketamine infusion, and was able to regain some movement of her fingers on the right hand, but there was no lasting relief. It was a struggle to obtain approval through her insurance.

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She has been spending a great deal of time in bed for months. Morning stiffness is widespread for one to two hours. Bending is difficult, feels as if “hit by a bus,” but she does stretching, moving, distraction and Yoga when able.

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Much better in 10 days

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Day one: pain of the entire right side, face, trunk, limbs, rated 7 to 10 on a scale of 10, average 8. She guards the dominant right hand and the signature is difficult. Atrophy of the right upper limb is present, nails longer on the right hand, dusky dark erythema and long jagged scar over the dorsum right hand, mild erythema of the right upper and right lower limbs.

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On the first day, in the office, she tried the first dose of ketamine nasal spray and after a repeat dose, she was puzzled, thinking to herself, then let us know she realized she was able to concentrate. A small dose is not enough to relieve severe pain, but even major depression can vanish at that dose. Two sprays relieved the brain fog of depression; pain was still 8 on a scale of 10. Blood pressure and pulse did not change before and after doses. She felt hopeful.

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In the next few days she was able to do the unthinkable: make plans with friends, walk 45 minutes, become active, and remain active in a way that had not been possible. She was far more active with much less pain.  Over the weekend, six days after she arrived, after we had sequentially added several new medications, she found the dosage of nasal and sublingual ketamine that worked for her. She has actually had times when she was pain free. As noted during prior ketamine infusions, she requires a far higher dose than most patients to achieve effect. The plan now is to use higher doses at home when time permits for best effect, and booster sprays of nasal ketamine as needed when away from home. She can carry it in her pocket. There is no need for ICU infusions and the fight to get insurance coverage for those stays.

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Of great significance, she has even made plans for the entire summer.

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More details of her case will be added, as time permits. For now, this page is here to allow the patient and family and others to send comments. She will continue slow titration of other medications that will take three months before reaching the target dose, before we can assess efficacy. Based on my experience treating chronic intractable neuropathic pain including CRPS, it is possible these medications will be able to stabilize and relieve pain without ketamine.

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See other case reports of treatment of CRPS here, here, and here.

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You can read some of the science of pain, glia and inflammation. Ketamine is significantly anti-inflammatory. Three of her new medications are glial modulators. Treatment of severe chronic pain usually involves rational polypharmacy, not one medication and not medication alone. It requires a holistic approach to heal: P.T., O.T., massage, cognitive behavioral therapy, guided imagery, visualization, positive thinking, remaining active, and other modalities that depend upon the underlying cause: physical, emotional, spiritual, and financial. The treatment for CRPS is not specific for that condition alone, but the gains can be possible with tremendous discipline, effort, single minded determination and the loving support of friends and family.

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Be cautious of spinal cord stimulators. Try everything else first.

They can create pain and scarring or tether the spinal cord.

Be proactive.

Remember that guidelines and strategies for diagnosis and treatment are outdated.

Support RSDSA.org if you can.

They support high quality pain research.

You can go directly to their site or donate to them (not me)

using the link at the top of my site here.

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Patients and doctors do not understand that opioids create pain.

A 2006 publication from Vanderbilt shows how much better pain can be to taper off.

The abstract:

Significant pain reduction in chronic pain patients after detoxification from high-dose opioids.

The article:

Significant pain reduction in chronic pain patients after detoxification from high-dose opioids.

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More on this young woman’s journey coming.

It’s been busy!

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The material on this site is for informational purposes only,

and 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, you will need to telephone my office.

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For My Home Page, click here: 

Welcome to my Weblog on Pain Management!

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