Injuries & Deaths from Spinal Cord Stimulators

Spinal Cord Stimulators | Pain Management Specialist in San Diego & La Jolla – 11/26/2018 — Nancy Sajben MD

Since opioids have become so restricted, all kinds of other, previously found lacking, pain management methods are enjoying an unearned revival as desperate patients search for some relief to make their lives bearable.

The Washington Post is behind a paywall, so I’m showing the excerpts from the article that Dr. Sajben posted:

Washington Post Reports Injuries & Deaths from Spinal Cord Stimulators – Excerpts below are from the November 25 report linked here  

one of the fastest-growing products in the $400 billion medical device industry. Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief.

But the stimulators — devices that use electrical currents to block pain signals before they reach the brain — are more dangerous than many patients know, an Associated Press investigation found.

They account for the third-highest number of medical device injury reports to the U.S. Food and Drug Administration, with more than 80,000 incidents flagged since 2008.

Patients report that they have been shocked or burned or have suffered spinal-cord nerve damage ranging from muscle weakness to paraplegia, FDA data shows.

Among the 4,000 types of devices tracked by the FDA, only metal hip replacements and insulin pumps have logged more injury reports.

Medical device manufacturers insist spinal-cord stimulators are safe — some 60,000 are implanted annually — and doctors who specialize in these surgeries say they have helped reduce pain for many of their patients.

Most of these devices have been approved by the FDA with little clinical testing, however, and the agency’s data shows that spinal-cord stimulators have a disproportionately higher number of injuries compared to hip implants, which are far more plentiful.

The AP reported on spinal stimulators as part of a nearly yearlong joint investigation of the global medical devices industry that included NBC, the International Consortium of Investigative Journalists and more than 50 other media partners around the world.

Reporters collected and analyzed millions of medical records, recall notices and other product safety warnings, in addition to interviewing doctors, patients, researchers and company whistleblowers.

The media partners found that, across all types of medical devices, more than 1.7 million injuries and nearly 83,000 deaths were reported to the FDA over the last decade.

The investigation also found that the FDA — considered by other countries to be the gold standard in medical device oversight — puts people at risk by pushing devices through an abbreviated approval process, then responds slowly when it comes to forcing companies to correct sometimes life-threatening products.

Devices are rarely pulled from the market, even when major problems emerge.

Once approved, medical device companies can use countless supplementary requests to alter their products, even when the changes are substantial.

For example, there have been only six new spinal-cord stimulator devices approved since 1984, with 835 supplemental changes to those devices given the go-ahead through the middle of this year, the AP found. Medtronic alone has been granted 394 supplemental changes to its stimulator since 1984, covering everything from altering the sterilization process to updating the design.

….Dr. Walter J. Koroshetz, director at the neurological disorders and stroke division at the National Institutes of Health, said trials for medical devices like spinal-cord stimulators are generally small and industry-sponsored, with a “substantial” placebo effect.

“I don’t know of anyone who is happy with spinal-cord technology as it stands,” Koroshetz said. “I think everybody thinks it can be better.”

In April 2014, Boston Scientific’s Precision stimulator was implanted in Taft by Jason Highsmith, a Charleston, South Carolina, neurosurgeon who has received $181,000 from the company over the past five years in the form of consulting fees and payments for travel and entertainment. A Boston Scientific sales representative was in the operating room — a common practice, the AP found.

From the time Taft was cut open and the device placed inside his body, he had nothing but problems, according to hundreds of pages of medical records reviewed by the AP. The device began randomly shocking him, and the battery burned his skin.

Taft and his wife complained repeatedly, but said his doctors and a Boston Scientific representative told them that spinal-cord stimulators don’t cause the kind of problems he had.

Again, because pain cannot be measured by the doctors, they simply claim it does not exist.

That runs counter to Boston Scientific’s own literature, which acknowledges that spinal stimulators and the procedures to implant them carry risks, such as the leads moving, overstimulation, paralysis and infections.

That also is not reflected in the AP’s analysis of FDA injury reports, which found shocking and burning had been reported for all major models of spinal-cord stimulators.

For Boston Scientific devices, infection was the most common complaint over the past decade, mentioned in more than 4,000 injury reports.

Even over almost 30 years, this number is very high.

Taft said had he known the devices hurt so many people, he would have reconsidered getting one. A Boston Scientific sales representative tried reprogramming the device, he said, but nothing worked.

“I told them that it feels like the lead is moving up and down my spine,” Taft said. “They said, ‘It can’t move.’” But in July 2014, X-rays revealed the lead indeed had moved — two inches on one side.

We pain patients are unusually aware of our bodily sensations and can often accurately describe what’s going on inside. Though doctors insist we cannot possibly feel these sensations, the above is more proof that we do.

That October, Highsmith said, he operated on Taft to install a new lead, tested the battery and reinserted it.

Still, Taft’s medical records show that he continued to report numbness, tingling and pain. During a January 2015 appointment, a physician assistant wrote that the device “seemed to make his pain worse.”

The doctor said the overwhelming majority of his spinal-cord stimulator patients gain significant pain relief.

“Unfortunately, in spite of the major medical breakthroughs with devices like these, some patients still suffer from intractable pain,” he said.

In the letter from the company’s legal department, Boston Scientific also noted that federal law shielded manufacturers from personal liability claims involving medical devices approved by the FDA.

George Davis, 57, had three Medtronic spinal-cord implants between 2003 and 2007 after a car accident mangled his back. They temporarily reduced some of his pain, but he said the non-rechargeable batteries that were supposed to last for years never did and he tired of multiple surgical removals.

In 2015, his pain management doctor urged him to try Boston Scientific’s Precision Spectra, which he called the best on the market. Unlike Davis’s old models, it had a rechargeable battery.

Within weeks of his surgery, Davis said, he started feeling pain shooting down his back and legs and a burning sensation at the implant site. After his skin started turning black, the doctor performed emergency surgery to remove the device.

Months later, Davis reluctantly agreed when his doctor urged him to try another Boston Scientific model but found that device even worse.

Over the next year, he spent more than 100 days in and out of hospitals battling a life-threatening infection. Today, Davis says he has trouble getting out of bed.

For years, Valerie McJunkin had been seeking relief from a rare neurological disorder that made her legs and feet feel like they were on fire. So when a medical device company sales representative and her West Virginia pain management doctor recommended what sounded to her like a “miracle device,” she was all in.

They said a new kind of stimulator — one that targeted a bundle of sensory nerve cells in the lower back — was better than a spinal-cord device. She just needed to undergo a weeklong trial.

since the trial did seem to help, she went ahead with the implant.

Within days, though, the device began randomly shocking her — a sharp pain that felt like a lightning bolt.

When McJunkin called her doctor and the Abbott representative, she said they suggested that she was at fault because “stimulators don’t do that.”

I’m so tired of hearing how doctors (and

We’re used to the lies and misleading statements from sales representatives, but even our doctors don’t believe what we know to be true.

How can a doctor claim to provide “medical care” when he doesn’t believe what the patient is saying about their symptoms?

It wasn’t until she received a certified letter from Abbott in March that she learned it wasn’t all in her head: The company said her device was being recalled due to a glitch that could cause patients some “discomfort.”

“Discomfort” is a code word for excruciating pain.

In early September, McJunkin invited an AP reporter to accompany her when she met with her doctor and the company sales representative to request the device be removed.

The Abbott salesman and her doctor both suggested she get another stimulator, saying she had run out of options, especially since her doctor couldn’t write prescriptions for opioids because of a government crackdown

Her doctor claimed he “couldn’t” prescribe opioids, even though this is not true.

I wonder if all these doctors that say “they can’t prescribe opioids” really believe that, or if they are just afraid of “getting in trouble”…the typical response of moral cowards.

If she didn’t get another stimulator, he said, she faced a lifetime of pain.

Is that a treat or a promise?

“You trust your doctor. You think he’s going to do the right thing,” she said. She paused, fighting back tears. “I just wanted to live without pain. But now that hope is gone.”

In late October, her doctor removed the device.

The experience of nearly all the 40 patients interviewed by the AP mirrored McJunkin’s:

Their pain was reduced during the trial but returned once their stimulators were implanted.

This seems very important: during the trial, the device is only attached to the patient, but not implanted, and it works. Later, when the device is implanted, the troubles start.

It seems there’s something happening differently between these two conditions.

Or, it could be that the trial is successful mainly from the placebo effect (and desperate hope for relief of pain). Later, after the device is implanted, the placebo effect wears off and all that’s left are complications from a useless device and multiple surgeries.

Most of the patients interviewed by the AP said the adjustments to their devices were performed by sales representatives, often with no doctor or nurse present. That includes one patient who was billed for programming as if the doctor was in the room, though he was not.

“People who are selling the device should not be in charge of maintenance,” Gofeld said. “It’s totally unethical.”

In the Justice Department case involving Medtronic, a salesman who said he earned as much as $600,000 a year selling spinal-cord stimulators claimed sales representatives encouraged physicians to perform unnecessary procedures that drove up the costs for Medicare and other federal health programs.

It’s a lucrative business .

Analysts say stimulators and the surgery to implant them costs between $32,000 and $50,000, with the device itself constituting $20,000 to $25,000 of that amount. If surgery is performed in a hospital, the patient usually stays overnight, and the hospital charges a facility fee for obtaining the device. Costs are typically covered by insurance.

The AP found that doctors can make more money if they perform the surgery at physician-owned outpatient surgery centers, since the doctor buys the device, marks it up and adds on the facility fee.

While manufacturers and top FDA officials tout stimulators as a weapon in the battle against opioids, neurosurgeons like Steven Falowski are the front-line evangelists.

He referred AP to Corby, as one of his surgical patients who was helped by a spinal-cord stimulator.

Corby got the device more than two years ago and says that, after some initial adjustments, he hasn’t had any further problems. He says he wouldn’t trade the stimulator for opioids.

Falowski, who speaks at neuromodulation conferences and teaches other doctors how to implant stimulators.

Since 2013, device manufacturers have paid Falowski — or St. Luke’s University Health Network in Fountain Hill, Pennsylvania, where he works — nearly $863,000, including $611,000 from St. Jude or its new parent company, Abbott

AP’s analysis showed Abbott products were more likely than other major models to include reports of a hot or burning sensation near the site of the battery, with about 5,600 injury reports since 2008 referring to the words “heat” or “burn.”

….Snyder said she felt like Falowski’s nurse and physician assistant downplayed the problems and that the reprogramming of her device was conducted by the Abbott sales representative, with no medical staff present. On at least one occasion, she was charged as if the medical staff was there, when she said they weren’t, according to insurance bills reviewed by the AP.

Despite insisting nothing was wrong with the unit, Snyder said, Falowski called her one day out of the blue. “He said ‘Under no circumstances are you to turn it on.’ I asked him why and he wouldn’t say,” Snyder recalled..Falowski then scheduled immediate surgery to remove the stimulator, she said..

Falowski called Snyder a difficult patient and said she was receiving “100 percent pain relief” when she had the stimulator removed, adding that she “remained very appreciative of her care.” He added that programming is “performed under the direction of a physician.”

….All Snyder ever wanted was to feel better. Today, she often is immobilized by pain..

Before the latest stimulator, she could walk, stand and cook meals.

Now, she finds it hard to get out of bed and rarely leaves her house.

She says the device has ruined her life…

For prior several posts on this site:

Earlier in October 2018, Dr. Sajben had posted this:

Spinal Cord Stimulators, Advances? A Revolution? How about a lot more research first? | Pain Management Specialist in San Diego & La Jolla – 10/02/2018 — Nancy Sajben MD

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?

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.

Chronic pain would make any of us vulnerable to risk our lives for these devices. Research is desperately needed.

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