Evidence Lacking for Spinal Cord Stimulators

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By Drs. Ian Harris, Adrian Traeger and Caitlin Jones

In an episode of the Australian Broadcasting Corporation’s “Four Corners” this week, the use of spinal cord stimulators for chronic back pain was brought into question.

Spinal cord stimulators are devices implanted surgically which deliver electric impulses directly to the spinal cord. They’ve been used to treat people with chronic pain since the 1960s.

Their design has changed significantly over time. Early models required an external generator and invasive surgery to implant them. Current devices are fully implantable, rechargeable and can deliver a variety of electrical signals.

However, despite their long history, rigorous experimental research to test the effectiveness of spinal cord stimulators has only been conducted this century. The findings don’t support their use for treating chronic pain. In fact, data points to a significant risk of harm.

What Does the Evidence Say?

One of the first studies used to support the effectiveness of spinal cord stimulators was published in 2005. This study looked at patients who didn’t get relief from initial spinal surgery and compared implantation of a spinal cord stimulator to a repeat of the spinal surgery.

Although it found spinal cord stimulation was the more effective intervention for chronic back pain, the fact this study compared the device to something that had already failed once is an obvious limitation.

Later studies provided more useful evidence. They compared spinal cord stimulation to non-surgical treatments or placebo devices (for example, deactivated spinal cord stimulators).

A 2023 Cochrane review of the published comparative studies found nearly all studies were restricted to short-term outcomes (weeks). And while some studies appeared to show better pain relief with active spinal cord stimulation, the benefits were small, and the evidence was uncertain.

Only one high-quality study compared spinal cord stimulation to placebo up to six months, and it showed no benefit. The review concluded the data doesn’t support the use of spinal cord stimulation for people with back pain.

The experimental studies often had small numbers of participants, making any estimate of the harms of spinal cord stimulation difficult. So we need to look to other sources.

A review of adverse events reported to Australia’s Therapeutic Goods Administration found the harms can be serious. Of the 520 events reported between 2012 and 2019, 79% were considered “severe” and 13% were “life threatening”

.We don’t know exactly how many spinal cord stimulators were implanted during this period, however this surgery is done reasonably widely in Australia, particularly in the private and workers compensation sectors. In 2023, health insurance data showed more than 1,300 spinal cord stimulator procedures were carried out around the country.

In the review, around half the reported harms were due to a malfunction of the device itself (for example, fracture of the electrical lead, or the lead moved to the wrong spot in the body). The other half involved declines in people’s health such as unexplained increased pain, infection, and tears in the lining around the spinal cord.

More than 80% of the harms required at least one surgery to correct the problem. The same study reported four out of every ten spinal cord stimulators implanted were being removed.

The cost here is considerable, with the devices alone costing tens of thousands of dollars. Adding associated hospital and medical costs, the total cost for a single procedure averages more than $A50,000 (US$ 32,542). With many patients undergoing multiple repeat procedures, it’s not unusual for costs to be measured in hundreds of thousands of dollars.

Rebates from Medicare, private health funds and other insurance schemes may go towards this total, along with out-of-pocket contributions.

Insurers are uncertain of the effectiveness of spinal cord stimulators, but because their implantation is listed on the Medicare Benefits Schedule and the devices are approved for reimbursement by the government, insurers are forced to fund their use.

Industry Influence

If the evidence suggests no sustained benefit over placebo, the harms are significant and the cost is high, why are spinal cord stimulators being used so commonly in Australia? In New Zealand, for example, the devices are rarely used.

Doctors who implant spinal cord stimulators in Australia are well remunerated and funding arrangements are different in New Zealand. But the main reason behind the lack of use in New Zealand is because pain specialists there are not convinced of their effectiveness.

In Australia and elsewhere, the use of spinal cord stimulators is heavily promoted by the pain specialists who implant them, and the device manufacturers, often in unison. The tactics used by the spinal cord stimulator device industry to protect profits have been compared to tactics used by the tobacco industry.

A 2023 paper describes these tactics which include flooding the scientific literature with industry-funded research, undermining unfavourable independent research, and attacking the credibility of those who raise concerns about the devices.

Many who suffer from chronic pain may feel disillusioned after watching the Four Corners’ “Pain Factory” report. But it’s not all bad news. Australia happens to be home to some of the world’s top back pain researchers who are working on safe, effective therapies.

New approaches such as sensorimotor retraining, which includes reassurance and encouragement to increase patients’ activity levels, cognitive functional therapy, which targets unhelpful pain-related thinking and behaviour, and old approaches such as exercise, have recently shown benefits in robust clinical research.

If we were to remove funding for expensive, harmful and ineffective treatments, more funding could be directed towards effective ones.

Ian Harris, MD, is a Professor of Orthopedic Surgery at University of New South Wales.  He is a practicing orthopedic trauma surgeon and directs a research unit specializing in surgical outcomes and the evidence base for surgery.

Adrian Traeger, PhD, is a Research Fellow at the Institute for Musculoskeletal Health at The University of Sydney. He is a physiotherapist who specializes in treating low back pain and other musculoskeletal conditions.

Caitlin Jones, PhD, is a postdoctoral research associate at the University of Sydney. Her research evaluates the benefits and harms of treatments for musculoskeletal conditions.

This article originally appeared in The Conversation and is republished with permission.

Study Finds Why Some Patients Do Poorly with Spinal Cord Stimulators

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By Pat Anson, PNN Editor

Spinal cord stimulators (SCSs) are often considered the treatment of last resort for people with severe back or leg pain, who don’t respond well to more conventional ways of treating pain.

The neuromodulation devices are surgically placed near the spine and send out mild electrical impulses to mask pain signals. Because stimulators are invasive and have poor success rates, it’s customary for patients to go through a short trial period before having the devices surgically implanted.

A new study has documented why some patients do well with stimulators and others don’t.

In a retrospective analysis, researchers at the University of Kansas Medical Center looked at 237 patients who received SCSs, about a third of them considered “nonresponders.” They found that people with severe pain and disability who fear physical activity because of the pain it might cause – a condition known as kinesiophobia – are significantly less likely to respond to the devices.

The study is being presented this month at the annual meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA).

Researchers analyzed several patient characteristics, such as their age, gender, body mass index, history of spinal surgery, diabetes, alcohol and tobacco use, psychiatric illness, and use of opioids. None appeared to have an association with how a patient responds to SCS.

But researchers found that three out of four (76%) nonresponders had clinically high levels of kinesiophobia, compared to about half (56%) of those who did respond to SCS treatment. Nonresponders were also more likely to have severe pain, disability, and to complain or worry about their pain – a condition known as “catastrophizing.”

“Collectively, our findings indicate a clinically relevant association of high levels of kinesiophobia, greater disability, severe pain intensity and pain catastrophizing, as subtle indicators, and possible predictive factors to nonresponders,” researchers said.

“As such, it may be appropriate to utilize preoperative screening tools for these factors to help optimize patient selection and predict a patient’s response to neuromodulation. Furthermore, if risk factors are present, it might be prudent to consider a pre-rehabilitation program with pain neuroscience patient education prior to SCS therapy to address these modifiable risk factors and potentially enhance outcomes in neuromodulation.”

About 50,000 spinal cord stimulators are implanted annually in the U.S. The devices are often touted as a safer alternative to opioid pain medication, although a growing number of studies have questioned their safety and efficacy.

A recent Cochrane review of SCSs concluded the devices work no better than a placebo for treating chronic low back pain, and provide little to no benefit in improving quality of life. That negative review led some doctors who perform the surgeries to demand a retraction from Cochrane because of “striking errors in the methodology, execution and conclusions” of the study.

Meanwhile, a 2018 investigation found that SCSs have some of the worst safety records of medical devices and called for better FDA oversight of their growing use in pain management. A subsequent FDA review of complaints involving stimulators found that nearly a third were reports of unsatisfactory pain relief.

Yet another recent study found that many patients given stimulators did not reduce their use of opioids, and continued getting procedures such as epidurals, corticosteroid injections and radiofrequency ablation to relieve their pain.

FDA Recalls Abbott Stimulators for Technical Malfunction

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By Pat Anson, PNN Editor

After receiving reports of dozens of injuries, the Food and Drug Administration has issued a Class I recall for two models of implantable neurostimulators due to a technical malfunction. The recall affects over 155,000 of Abbott’s Proclaim and Infinity devices, which are primarily used in spinal cord and deep brain stimulation.

Although Class I recalls are the most serious type of recall because they may result in injuries or death, patients are not being advised at this time to have the devices surgically removed. The stimulators were implanted in some patients as far back as 2015.

The malfunction occurs when the devices are temporarily turned off when a patient is having magnetic resonance imaging (MRI). There have been 186 complaints of patients being unable to turn the devices back on once the MRI ends, resulting in a loss of therapy and 73 injuries. No deaths have been reported.

In July, Abbott sent an “urgent medical device correction” letter to healthcare providers who install the devices, to clarify instructions on how to exit MRI mode.

The letter also advises providers to tell patients not to delete their device controller’s connection to Bluetooth if a malfunction occurs, and to update their systems and consult with a physician before having an MRI scan.   

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Abbott estimates that only about 0.06% of the recalled devices malfunctioned, with 0.03% of them resulting in loss of therapy and additional surgery.   

The following devices are included in the recall:

Implantable neurostimulators are an invasive treatment of last resort for people with chronic back, leg or head pain. The devices are surgically implanted near the spine or brain, and emit low-level electrical impulses to block pain signals.

About 50,000 spinal cord stimulators (SCSs) are implanted annually in the U.S. and their use is growing – in part because of the belief they’ll reduce the need for opioids and other pain therapies. A recent study found that many patients with stimulators did not reduce their use of opioids, epidurals, corticosteroid injections or radiofrequency ablation; and about one in five had complications so severe the devices had to be removed or revised.

A 2018 study found that SCSs have some of the worst safety records of medical devices tracked by the FDA. An FDA review of adverse events involving stimulators found that nearly a third were reports of poor pain relief. The review also identified nearly 500 deaths linked to the devices, along with nearly 78,000 injuries and 30,000 malfunctions.

FDA Expands Use of Spinal Cord Stimulators to More Types of Back Pain

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By Pat Anson, PNN Editor

The U.S. Food and Drug Administration continues to expand the use of spinal cord stimulators, despite a growing body of research that questions the safety and effectiveness of the devices.

This month the FDA approved the use of Abbott’s spinal cord stimulators for the treatment of chronic back pain in people who are unable to get corrective surgery – known as non-surgical back pain -- because they are too medically frail or have numerous degenerative disc problems. Those patients are usually treated with pain medication, physical therapy or spinal injections.

FDA approval was granted after a clinical study showed that SCS devices equipped with Abbott's BurstDR technology provided significant pain relief, better physical function, and improved quality of life in 200 patients with non-surgical back pain. The devices are surgically placed near the spine and emit mild electrical impulses to disrupt pain signals before they reach the brain. 

Participants in the study had chronic and disabling back pain for an average of nearly 13 years before getting the devices.

"We have struggled with how to treat people who weren't considered a good surgical candidate because we didn't have clear, data-driven treatment options for non-surgical back pain," Timothy Deer, MD, CEO of the Spine and Nerve Centers of the Virginias, said in an Abbott press release. "This new indication for Abbott's SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain."

BurstDR stimulation uses mild electrical pulses — or bursts — without creating an uncomfortable tingling sensation in the spine known as paresthesia.  All of Abbott's SCS devices use BurstDR technology.

Nine out of ten patients who received BurstDR therapy experienced significantly better function or pain relief, with pain levels reduced an average of nearly 70 percent. The improvements were sustained 12 months after the devices were implanted.

"This FDA expanded indication approval for our SCS devices is a significant step forward in Abbott's goal to provide treatment access to those who suffer daily with chronic back pain but are not eligible for corrective surgery," said Pedro Malha, vice president of neuromodulation for Abbott.

SCS devices were long considered a treatment of last resort for people with severe back, neck and leg pain, but in recent years the FDA has expanded use of the devices for conditions such as painful diabetic neuropathy. The devices are often promoted as safer alternatives than opioid pain medication.

Recent research, however, has raised questions about the safety, efficacy and long-term benefits of the devices. A recent Cochrane review concluded the stimulators work no better than a placebo for treating chronic low back pain, and provide little or no improvement in quality of life.  In a review of 13 clinical trials, researchers found little clinical data on the long-term effectiveness of SCSs, and noted that most of the studies lasted less than a month, were poorly blinded, or funded by device makers.

A 2018 study by investigative journalists found that SCSs have some of the worst safety records of medical devices tracked by the FDA.

A 2020 FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief. Other common adverse events are nerve damage, infections, and device malfunctions that may lead to further surgeries.

A 2022 study found that patients who get the devices did not reduce their use of opioids, and continued getting medical procedures such as injections, epidurals and radiofrequency ablation.

Study Finds Spinal Cord Stimulation Has No Benefit for Back Pain

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By Pat Anson, PNN Editor

A scathing new Cochrane review is raising more questions about the safety, efficacy and long-term benefits of spinal cord stimulators, medical devices that are increasingly used to treat chronic back pain.  

Cochrane reviews are considered the gold standard in medical research because they use robust methodology to gather good quality evidence and reduce the impact of biased, poor-quality studies.

The review by Australian researchers concluded that spinal cord stimulation (SCS) works no better than a placebo for treating chronic low back pain, and provides little to no benefit in improving quality of life.

The devices are surgically placed near the spine and connected to batteries implanted under the skin, which send electrical impulses into the spine to mask pain.

“Spinal cord stimulation is invasive and has a great financial cost to people who choose surgery as a last resort to alleviate their pain. Our review found that the long-term benefits and harms are essentially unknown,” said lead author Adrian Traeger, PhD, a Research Fellow at the Institute for Musculoskeletal Health at the University of Sydney. “Our review of the clinical data suggests no sustained benefits to the surgery outweigh the costs and risks.”

Treager and his colleagues analyzed the results of 13 clinical trials of SCS devices, looking at data from almost 700 patients with low back pain. They found little to no clinical data on the long-term effectiveness of SCS because most of the studies lasted less than a month, were poorly blinded, or had selective reporting bias.

The researchers also found that side effects from SCS surgery were poorly documented, preventing them from assessing the level of risk involved. Serious adverse events include nerve damage, infection, and the devices’ electrical leads moving, all of which may lead to more surgeries.

“Data in this review do not support the use of SCS to manage low back pain outside a clinical trial. Current evidence suggests SCS probably does not have sustained clinical benefits that would outweigh the costs and risks of this surgical intervention,” they concluded. 

Findings from the Cochrane review have been submitted to Australia’s Department of Health and Aged Care, which is reviewing the effectiveness of spinal cord stimulators. The devices' long-term safety and performance are also being re-assessed by Australia's Therapeutic Goods Administration (TGA).

“Our review found that the clinical benefit of adding spinal cord stimulation to treat low back pain remains unknown. When coupled with the reality that these devices are very expensive and often break down there is clearly a problem here that should be of concern to regulators,” said Chris Maher, PhD, Co-Director of Sydney Musculoskeletal Health.

Increasing Use of Stimulators

About 50,000 spinal cord stimulators are implanted annually in the U.S. and their use is growing. The devices are no longer limited to patients with back, neck and leg pain. In 2021, the FDA expanded the use of SCS to treat chronic pain from diabetic neuropathy. Stimulators are also being used on patients with Complex Regional Pain Syndrome (CRPS).

A 2018 study by investigative journalists found that SCSs have some of the worst safety records of medical devices tracked by the FDA. A 2020 FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief. A more recent study found that patients with the devices did not reduce their use of opioids, and continued getting procedures such as epidurals, corticosteroid injections and radiofrequency ablation.

Although evidence is growing that questions the safety and effectiveness of SCS, medical device companies continue to roll out new stimulators with more advanced technology. This week Nevro said it would release the first SCS system in the U.S. that uses artificial intelligence to optimize pain relief for each patient. The HFX iQ SCS system is designed for patients with diabetic neuropathy or chronic back and leg pain.

"This is an exciting time in spinal cord stimulation -- better waveforms, more conditions we can treat, and a massive treasure trove of patient data," said Usman Latif, MD, an interventional pain specialist and consultant to Nevro.

“What if we could take all the programming experience and clinical outcomes of tens of thousands of patients across the country, including what programs worked and what didn't, and bring the power of all that knowledge into the palm of our patient's hand -- with them 24/7, monitoring them, and offering them the best program for their exact situation with a tap on the screen. HFX iQ is the future of medicine, where expanded data holds the promise of new capabilities and improved care."

In addition to the U.S. release of HFX iQ, Nevro has asked for approval from regulators in Europe and Australia.

FDA Approves Smallest Rechargeable Spinal Cord Stimulator

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By Pat Anson, PNN Editor

The Food and Drug Administration has approved a new spinal cord stimulator that’s being touted as the smallest implantable neuromodulation device of its kind on the market. Abbott’s Eterna stimulator can also be recharged wirelessly as few as five times a year, unlike other stimulators that need recharging daily or weekly.

Spinal cord stimulators (SCSs) are an invasive treatment of last resort for people with chronic back or leg pain. The devices are surgically implanted near the spine and connected to batteries placed under the skin. The implants send low-level electrical impulses into the spine to block pain signals.

Abbott says it developed Eterna after extensive studies with pain patients and healthcare providers, who wanted a smaller implant with less need for recharging.

Eterna utilizes the company’s BurstDR stimulation, which mimics the natural firing patterns of nerves to provide pain relief without the tingling sensation of other simulators.

"Abbott's low-dose BurstDR stimulation is clinically proven to reduce pain, improve people's ability to perform everyday activities, and reduce emotional suffering associated with pain," Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias, said in a statement provided by Abbott.

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"Until now, it wasn't available on a rechargeable device that was this small, and that only needs to be charged a few times a year. This makes a big difference in comfort for many patients who now can have access to the best of both worlds – a small, best-in-class rechargeable device with superior stimulation therapy."

Another advantage of the Eterna SCS system is that patients with the device can still have full-body MRI scans – a critical need for those who need access advanced imaging and diagnostics. The devices can also been monitored and programmed with a mobile app.

About 50,000 SCSs are implanted annually in the U.S. and their use is growing – in part because of the belief they’ll reduce the need for opioids and other pain therapies.

A recent study found that premise to be untrue. Researchers at the University of California San Francisco School of Medicine found that pain patients with stimulators did not reduce their use of opioids, epidurals, corticosteroid injections or radiofrequency ablation compared to a control group. About a fifth of the patients experienced complications so severe the devices had to be removed or revised.

A 2018 study found that SCSs have some of the worst safety records of medical devices tracked by the FDA. An FDA review of adverse events involving stimulators found that nearly a third were reports of poor pain relief. The review also identified nearly 500 deaths linked to the devices, along with nearly 78,000 injuries and 30,000 malfunctions.

SCS’s are no longer limited to patients with intractable back and neck pain. Last year the FDA expanded the use of stimulators to include lower limb pain from diabetic neuropathy.  Stimulators are also being used on patients with Complex Regional Pain Syndrome (CRPS).

Spinal Cord Stimulators Fail to Reduce Opioid Use

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By Pat Anson, PNN Editor

A large new study is raising questions about the long-term effectiveness of spinal cord stimulators and whether they really help patients reduce their use of opioids and other pain treatments.

Researchers at the University of California San Francisco (UCSF) School of Medicine analyzed health data for 1,260 patients who received permanent stimulators and found that — when compared to a control group — the devices did not reduce their use of opioids, epidurals, corticosteroid injections or radiofrequency ablation after two years. About a fifth of the patients experienced complications so severe the devices had to be removed or revised.

Spinal cord stimulators (SCSs) are considered an invasive treatment of last resort for people with chronic back or leg pain, because the devices have to be surgically implanted near the spine and connected to batteries placed under the skin. The implants send electrical impulses into the spine to mask pain.

About 50,000 SCSs are implanted annually in the U.S. and their use is growing – in part because of the belief they’ll reduce the need for opioids and other pain therapies.

But UCSF researchers found that SCS patients actually filled more opioid prescriptions after one year than a control group of pain patients (CMM) who did not get the devices. The use of other medications and procedures by SCS patients declined slightly after one year, but there were no significant differences between the two groups after two years.

“The lack of reduction in pharmacotherapy, epidural and facet corticosteroid injections, and radiofrequency ablations at 2 years among patients receiving SCS compared with those receiving CMM suggests that SCS was providing insufficient pain relief to forego other therapies or improve rates of depression or anxiety, as prescriptions for these drug classes did not decline,” lead author Sanket Dhruva, MD, an Assistant Professor of Medicine at UCSF, wrote in JAMA Neurology.

“Because most patients still had their permanent SCS in place at 2 years, some may receive prolonged benefit from this modality, although we were not able to identify this through reductions in opioid use or nonpharmacologic pain interventions.”

Researchers also found that the total cost of care was about $39,000 higher for SCS patients in the first year, while health costs were similar for the two groups in the second year.

‘Sobering Insights’

"The findings appear to belie the popular belief that SCS may result in reduced opioid medication usage or overall fewer physician visits in the years immediately following device implant," wrote Prasad Shirvalkar, MD, and Lawrence Poree, MD, both from the UCSF Division of Pain Medicine, in an accompanying editorial.

“Using robust propensity matching, the present study provides sobering insights that SCS does not appear to reduce chronic opioid use or the utilization of health care resources compared with CMM in the first 2 years after implant. We believe this will help mitigate excessive enthusiasm of SCS as a panacea for chronic pain syndromes and illuminate biases of SCS hype cycle that can possibly be fueled by industry-related conflicts of interest.”

Stimulators are no longer limited to patients with chronic back, neck and leg pain. Last year the FDA expanded the use of SCSs to include pain from diabetic neuropathy. Stimulators are also now being used on patients with Complex Regional Pain Syndrome (CRPS).

A 2018 study by a team of investigative journalists found that SCSs have some of the worst safety records of medical devices tracked by the FDA. A 2020 FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief. The review also identified nearly 500 deaths linked to the devices, along with nearly 78,000 injuries and 30,000 device malfunctions.

FDA Approves Device That Uses Artificial Intelligence to Treat Chronic Pain

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By Pat Anson, PNN Editor

The Nevro Corporation says it has won approval from the Food and Drug Administration for an advanced spinal cord stimulator (SCS) that uses artificial intelligence to individualize treatment for each patient.

Nevro says its Senza HFX iQ stimulator “learns from patients” as they use the device and develops customized algorithms for treating chronic back pain, leg pain and pain from diabetic neuropathy.

"HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalizes care," D. Keith Grossman, Chair and CEO of Nevro, said in news release.

"Pain is variable from patient to patient and over time. Using the big data from our HFX Cloud patient database, our unique HFX Algorithm was developed to identify those programs where patients have been more likely to get relief in the real world.  HFX iQ takes direct input from each patient on their pain and quality of life measures to get smarter over time and recommend program changes.”

Nevro says patients will start with a program most likely to provide pain relief, and then adjusts it over time based on patient input and medical data, such as pain scores, activity levels and changes in use of pain medication. Patients can also adjust their pain relief programs through an app on their smartphones.

Spinal cord stimulators are usually considered the treatment of last resort for people with intractable or severe chronic pain that doesn’t respond to other therapies. The surgically implanted devices emit low levels of electricity that reduce the intensity of pain signals.

Unlike older stimulators, Senza stimulators use electric pulses of 10 kHz, a high frequency that doesn’t create an uncomfortable tingling sensation and delivers more pain relief. Last year the FDA approved Senza stimulators for the treatment of painful diabetic neuropathy, making it the first spinal cord stimulation system approved for that condition. Until then, most SCS devices were only approved for patients with severe back pain.

About 50,000 stimulators are implanted in the U.S. every year, with failure rates for the devices estimated at 25 to 30 percent. Most patients are required to undergo psychological testing and a trial treatment before getting a SCS.

The FDA has come under scrutiny for its regulation of stimulators and other medical devices.  A 2020 report by Public Citizen accused the FDA of “dangerously lax” oversight of stimulators, which were linked to 156,000 injuries and 931 deaths.  The agency responded to the report by sending a letter to healthcare providers reminding them to only implant stimulators after a trial period that demonstrates the device are effective. An FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief.

Nevro says it will begin a limited release of Senza HFX iQ later this year, with a full market launch in the U.S. in early 2023. Nevro is also seeking approval of HFX iQ in Europe.  

High-Frequency Spinal Cord Stimulators Provide More Pain Relief

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By Pat Anson, PNN Editor

Spinal cord stimulators are often considered the treatment of last resort for patients with intractable or severe chronic pain. The surgically implanted devices emit low levels of electricity that reduce pain signals, but have high failure rates and often have to be removed because they’re ineffective, cause infections or need new batteries.

Two new studies suggest there are ways to improve the success rate of spinal cord stimulators (SCS) through improved patient selection and the use of high-frequency devices.

Low-frequency SCS (50 Hz) was first approved by the Food and Drug Administration for intractable back and leg pain in 1989. Six years later, the FDA approved high-frequency devices (10,000 Hz), that deliver pulses of electrical stimulation that are shorter in duration, lower in amplitude and do not cause paresthesia, an irritating sensation of tingling or prickling.

In a retrospective study of 237 patients who received stimulators between 2004 and 2020, researchers at the University of California San Diego School of Medicine reported that high-frequency devices were more effective at reducing pain and opioid use than low-frequency ones.

The study findings, published in the journal Bioelectronic Medicine, also show that male patients benefit more than women from high-frequency neuromodulation.

"Our work was sparked by a growing literature that demonstrate sex specific immune pathways differentially contribute to chronic pain processes," said senior author Imanuel Lerman, MD, an associate professor of anesthesiology at UC San Diego Health. "The observed parameter-specific (high versus low frequency) sex-based differences in spinal cord stimulation efficacy and opiate use are definitely intriguing.”

It’s not clear why men benefit more than women, but researchers believe it may be due to the male hormone testosterone having a modulating effect on pain signals. The sex differences may also be due to males and females processing chronic pain differently.

"Clearly more work needs to be done to carefully characterize sex specific pain regulatory pathways that may prove responsive to specific types of neuromodulation and or pharmaceutical therapies," said Lerman.

Improved Patient Selection  

Although most patients are required to undergo psychological testing and a trial treatment before getting a SCS, failure rates for the devices remain high at around 25 to 30 percent. With about 50,000 stimulators implanted in the U.S. every year, that means thousands of patients are getting poor results.

To improve patient outcomes, researchers at Florida Atlantic University developed machine-learning algorithms to help predict which patients may benefit from SCS. Working with a cohort of 151 SCS patients, they evaluated 31 features or characteristics in each patient.  

Researchers found two distinct clusters of patients which differ significantly in age, duration of chronic pain, preoperative pain levels and pain catastrophizing scores. They used computers to fine-tune the results, identifying the 10 most influential features that contribute the most to a successful SCS implant.

Results of the study, published in the journal Neurosurgery, demonstrate for the first time the ability of machine-learning algorithms to predict long-term patient response to SCS placement. The next step is to validate the data in future patients to ensure that the algorithm is useful in real-world situations, not just computer models.

"Our study resulted in the development of a model to predict which patients would benefit from spinal cord stimulation," said lead author Julie Pilitsis, MD, dean and vice president of medical affairs at Florida Atlantic University's Schmidt College of Medicine.  "After we validate this work, our hope is that this machine-learning model can inform a clinical decision support tool to help physicians better choose which patients may be most appropriate."

SCS is no longer limited to patients with intractable back and neck pain. Last year the FDA expanded the use of SCS to include lower limb pain from diabetic neuropathy.  Stimulators are also being used on patients with Complex Regional Pain Syndrome (CRPS).

A decision to get a SCS shouldn’t be taken lightly. A 2018 study by a team of investigative journalists found that stimulators have some of the worst safety records of medical devices tracked by the FDA. A 2020 FDA review of adverse events involving SCS found that nearly a third were reports of unsatisfactory pain relief. The review also identified nearly 500 deaths linked to the devices, along with nearly 78,000 injuries and 30,000 device malfunctions.

FDA Approves Spinal Cord Stimulator for Diabetic Neuropathy

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By Pat Anson, PNN Editor

Like many other people with diabetic neuropathy, Lee Cagle suffered from burning and stinging sensations in his legs – pain so severe that he used sheets at night to build a small tent around his feet so that the fabric didn’t touch his skin and trigger another flare.

The 33-year-old Arkansas man tried pain medications such as hydrocodone and gabapentin (Neurontin), but didn’t like their side effects or potential for addiction.

“I don’t want to get hooked on pain meds. I’ve seen people hooked on pain meds and I didn’t want that for myself,” Cagle told PNN. “I only used them on the worst of worse days, when I could not fall asleep because I was in so much pain.”

Last year Cagle heard about a clinical trial for people with painful diabetic neuropathy (PDN) and decided to take a chance, enrolling in the study to see if a Nevro spinal cord stimulator could relieve his pain. The device emits mild electrical pulses to disrupt pain signals before they reach the brain. 

“It was almost instantaneous. The ease of the pain that it gave me,” Cagle said. “I felt so much better.”

The results from his two-week trial were so promising that Cagle agreed to have the stimulator permanently implanted along his spine during an outpatient procedure. That was nine months ago.

“I’m a completely different person now, compared to what I was before I got it put in my back,” said Cagle, who had only one minor setback when one of the electrodes leading from the stimulator failed.      

Cagle was one of 113 patients with PDN who had Nevro stimulators implanted during the clinical trial. Several dropped out of the study due to adverse events such as infections and two had their devices removed.

Most of those who remained reported significant pain relief of at least 50% and improved quality of life.

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The overall results were so promising that the Food and Drug Administration recently approved Nevro’s Senza stimulators for the treatment of PDN, making it the only spinal cord stimulation system approved for that condition. The Senza stimulators are unique because they use high frequency electric pulses of 10 kHz, a frequency that doesn’t create an uncomfortable tingling sensation that’s common with other stimulators.

"The substantial pain relief and improved quality of life demonstrates that 10 kHz Therapy can safely and effectively treat this patient population," said lead investigator Dr. Erika Petersen, Professor of Neurosurgery and Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences. "I'm grateful to my co-investigators and the patients who participated in this study, as the results and this approval will have far-reaching impact on the lives of PDN patients."

‘Dangerously Lax’ Oversight

FDA approval of the Nevro stimulator for PDN is a significant expansion of the medical device market. Of the 34 million Americans with diabetes, about one in five have painful neuropathy, a condition that develops when high blood glucose levels damage peripheral nerves. Until now, most spinal cord stimulators were only approved for patients with severe back pain.

FDA approval also comes at a time when the agency is under growing scrutiny for its regulation of medical devices, particularly spinal cord stimulators. A 2020 report by Public Citizen accused the FDA of “dangerously lax” oversight of stimulators, which were linked to 156,000 injuries and 931 deaths. Ironically, the report noted that spinal cord stimulators are often touted as safer alternatives to opioid medication.  

“In the midst of the opioid crisis, medical device companies and medical centers that implant spinal cord stimulators increasingly have been marketing spinal cord stimulation as an alternative to opioids for chronic pain,” the report found. “Importantly, no evidence was provided that spinal cord stimulators reduce the use of opioids.”  

The FDA responded to the Public Citizen report by sending a letter to healthcare providers reminding physicians to only implant stimulators after a trial period that demonstrates the device provides effective pain relief. An FDA review of adverse events involving spinal cord stimulators found that nearly a third were reports of unsatisfactory pain relief. Even worse, the review identified nearly 500 deaths linked to the devices between 2016 and 2020.

A new study published this week in JAMA Internal Medicine concluded that the FDA’s adverse events reporting system for medical devices may significantly underestimate the number of deaths that actually occur. Researchers found the system relies too heavily on adverse events reported by device manufacturers.

The Center for Medicare Services (CMS) is also taking a harder look at spinal cord stimulators. On July 1, CMS implemented a new rule requiring Medicare patients to get prior authorization before a stimulator is implanted. The agency said there has been significant expansion in the use of spinal cord stimulators – about 50,000 are now implanted every year in the U.S. – but it could find no medical reason to justify the increasing number of procedures.

“After reviewing all available data, we found no evidence suggesting other plausible reasons for the increases, which we believe means financial motivation is the most likely cause," CMS said.

Industry groups and some members of Congress lobbied hard against the CMS rule, saying prior authorization would create “significant barriers to access to medically necessary procedures.”    

For patients who are desperate for pain relief, who find medication ineffective or difficult to obtain, spinal cord stimulation may be one of the few options remaining. Asked if he would recommend the Nevro stimulator to other DPN patients, Lee Cagle said he would.

“Definitely. Most definitely. I’m a totally different person now,” he said. “If Nevro came in with something else, if they needed me for a trial study, I wouldn’t hesitate.”  

Tiny Electrode Could Expand Use of Spinal Cord Stimulators

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By Pat Anson, PNN Editor

A tiny inflatable device – about the width of a human hair – could make spinal cord stimulation less invasive and more practical for millions of people who suffer from chronic back or leg pain, according to researchers at the University of Cambridge.

Long considered the treatment of last resort, spinal cord stimulators (SCSs) are bulky devices implanted along the spine that use electrode wires connected to a battery to emit electric currents that block pain signals from reaching the brain. About 50,000 stimulators are surgically implanted every year, but many wind up being removed due to complications from surgery or because they are ineffective.

“Our goal was to make something that’s the best of both worlds – a device that’s clinically effective but that doesn’t require complex and risky surgery,” said Christopher Proctor, PhD, a research fellow at Cambridge’s Department of Engineering and one of the senior authors of a study published in Science Advances. “This could help bring this life-changing treatment option to many more people.”

Proctor and his colleagues developed a miniaturized electrode that is so small it can be rolled up into a tiny cylinder, inserted into a needle, and implanted into the epidural space of the spinal column.

As the video below shows, the device can then be inflated with water or air so that it unrolls like a tiny air mattress and covers part of the spine. When connected to a battery, the ultra-thin electrode can send small electric currents to the spinal cord, just like a traditional stimulator.

“In order to end up with something that can be implanted with a needle, we needed to make the device as thin as possible,” said co-author Ben Woodington, a PhD candidate in Cambridge’s Department of Engineering.

Researchers made the device with flexible electronics used in the semiconductor industry; tiny fluidic channels used in drug delivery; and shape-changing materials used in robotics.

“Thin-film electronics aren’t new, but incorporating fluid chambers is what makes our device unique – this allows it to be inflated into a paddle-type shape once it is inside the patient,” said Proctor.  

Early versions of the device were so thin they were invisible to x-rays, which surgeons would need to confirm the device was in the right place before inflating it. Researchers added some bismuth particles to make the device visible without increasing the thickness too much.

The experimental device has only been tested in human cadavers. More extensive testing and clinical trials will be required before the device can be used on patients – possibly in two or three years. The Cambridge research team is currently working with a manufacturer to further develop and improve the device.

“The way we make the device means that we can also incorporate additional components – we could add more electrodes or make it bigger in order to cover larger areas of the spine with increased accuracy,” said senior co-author Damiano Barone, MD, a clinical lecturer in Cambridge’s Department of Clinical Neurosciences.

“This adaptability could make our SCS device a potential treatment for paralysis following spinal cord injury or stroke or movement disorders such as Parkinson’s disease. An effective device that doesn’t require invasive surgery could bring relief to so many people.”

“This technology has the potential to transform clinical treatment, significantly improve pain management for so many people, and reach patients who cannot be treated with existing devices,” said Rachel Atfield, PhD, Commercialisation Manager at Cambridge Enterprise, which has patented the device.

A 2018 study by a team of investigative journalists found that spinal cord stimulators have some of the worst safety records of medical devices tracked by the U.S. Food and Drug Administration. A review of FDA data found over 500 deaths and 80,000 injuries involving stimulators since 2008. Patients reported being shocked or burned by the devices and many had them removed.  

Healthcare Is a Human Right That We Deserve

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By Jennifer Kain Kilgore, PNN columnist

I shouldn’t have to write this. But here I am because of headlines like these:

“FTC Refunds Almost $3.9 Million to Purchasers of Deceptively Advertised Quell Wearable Pain-Relief Device”

My body went numb after reading that. The Quell, which I wore for four years, that I blogged about, that I recommended to friends and family? That Quell?

The Federal Trade Commission slapped parent company NeuroMetrix for deceptive advertising. Specifically, the company was cited for claiming the Quell works throughout the whole body and not just where it’s worn.

“NeuroMetrix settled the case – without admitting or denying the allegations – for $4 million. The company also agreed to stop claiming that Quell provides relief for chronic or severe pain beyond the knee area where the device is worn,” PNN reported.

Soon enough I was receiving texts -- “Is this true?” “Does it not work?”

It worked for me, but that’s not why I’m writing this. My testimonial is still and will remain on NeuroMetrix’s website. The company didn’t ask me to come to their defense. Despite the bad press, that gadget worked for me.

NEUROMETRIX IMAGE

NEUROMETRIX IMAGE

Getting a $50 refund from NeuroMetrix in my PayPal account, though? The company’s silence and tacit admission made a helpless rage boil inside where anger has been simmering for weeks and months and years.

It made me as angry as when desperate pain patients called my law office, asking if I would draft legislation or talk sense to their doctors. Or when a genuinely good product came on the market but took advantage of customers. Or when the Sackler family didn’t go to prison after their pharmaceuticals created the conditions for the national opioid epidemic to truly explode. That bubbling anger began to rise.

Where should I direct this rage? At the callers? At the makers of the SpineGym, who took their crowdsourced money and failed to deliver on their promises? At the Sacklers? No, of course not. It’s not about them. My anger is bigger than that.

I shouldn’t have to write a reaction piece about the FTC’s decision. I shouldn’t have to draft laws to change a healthcare system in which pain patients are discounted, dismissed, and even overlooked.  Sometimes our limitations and physical pain prevent us from seeking the help we need.  

I shouldn’t have had to write for Pain News Network in the first place, though I’m thankful for the opportunity to do so. I became a columnist in order to try all the gadgets claiming to cure back and neck pain. If my doctors wouldn’t help me, I would help myself.

And there it is.

A record-breaking number of citizens have already voted. Despite their overwhelming voices, a Supreme Court justice was just appointed whose legal interpretation could dismantle the Affordable Care Act, which is on the Supreme Court Docket on November 10, just seven days after the most important election in history.

If you’re reading this, health insurance is crucially important to you or someone you love. Right now, our president’s legal team is in court attempting to kill the ACA without any kind of replacement during a global pandemic that has killed over 231,000 Americans.

But that’s not why I’m writing this.

I used to blog about my journey through the healthcare system. By the time I’d graduated from the Quell to an implanted spinal cord stimulator (which also works), I’d exhausted myself. It was time to focus on finally, finally healing. You know, being a normal person again.

The spinal cord stimulator -- controversial for sure, and not a surefire bet -- ended up working beyond my wildest dreams. Even though I’ve pulled on wires and scar tissue, my life has been partially restored. My doctor said the Quell was a good indicator as to whether a SCS would even work. If the Quell helped, so would a spinal cord stimulator.  

Before the SCS, I wasn’t able to consistently work as an attorney; I could barely leave my house. I was dependent on my husband for everything from insurance to carrying bags of groceries.

After the SCS, I can do yoga and pilates. I can lift laundry baskets. I can go to work and sit through a two-hour deposition. I can be an actual person again.

But that’s not why I’m writing this.

I shouldn’t have spent sixteen years of my life begging for help. I shouldn’t have to become a patient advocate and a writer for an online publication because I couldn’t otherwise afford pain-relief devices.

I shouldn’t have to write this.

I shouldn’t have to fight my insurance company to get my treatments covered. I shouldn’t have to stagger bill payments to various hospitals so as not to overdraft my account. I shouldn’t be paying for my spinal cord stimulator more than a year after its implantation.

I shouldn’t -- we shouldn’t -- have to do these things. We shouldn’t have to fight so hard to live in what’s supposedly the greatest country on earth.  What’s so great about living in fear? Fear of the unknown, the future, access to healthcare resources, and effective treatments? I’ve lived in fear for long enough, and so have you.

I shouldn’t be here. You shouldn’t be here, reading this. This website shouldn’t exist, and we shouldn’t have to fight so hard. But one in five Americans adults has chronic pain, and something must be done.

Healthcare is a human right, and we deserve it.  So VOTE.  Protect your loved ones by protecting healthcare.

Jennifer Kain Kilgore is an associate attorney at MALIS|LAW, working in civil litigation. She has chronic back and neck pain after two car accidents. 

‘Injectrode’ Could Revolutionize Neuromodulation Pain Treatment

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By Pat Anson, PNN Editor

A team of scientists and engineers has developed a flexible electrode that can be injected into the body to stimulate damaged nerves, relieve chronic pain and treat other conditions.

The so-called “injectrode” could revolutionize neuromodulation therapy by eliminating the need for invasive spinal cord stimulators and other surgically implanted medical devices.

Researchers used a liquid silicone base -- similar to surgical glue – and mixed it with small metal particles to make it electrically conductive.

When injected around a nerve and allowed to cure, the injectrode performs much like a metal wire, but remains flexible.

Current neuromodulation treatments often rely on rigid implanted devices that can cost hundreds of thousands of dollars, require complex surgeries to install, and often fail or need to be replaced.

IMAGE COURTESY OF NEURONOFF

"Typical implants are really stiff, and so as the body moves, they wear and tear and break down. Our liquid cures, and the result is much closer to the normal elasticity of tissue. You can actually stretch it and increase its size 150 percent to 200 percent without losing its conductivity," says co-author Kip Ludwig, PhD, a professor of biomedical engineering and neurological surgery at University of Wisconsin-Madison.

“By virtue of its simplicity, the Injectrode has the potential to be less invasive, more robust, and more cost‐effective than traditional electrode designs, which could increase the adoption of neuromodulation therapies for existing and new indications.”

Ludwig and his colleagues reported their findings in the journal Advanced Healthcare Materials.

The injectrode has been tested on laboratory animals to stimulate their nervous systems. It was used in pigs to induce heart rate changes by stimulating the vagus nerve in the neck, an approach that's shown promise for treating heart failure, hypertension, lupus and cluster headaches.

"We essentially went through the standard repertoire of electrochemical tests to show this acts like a standard wire electrode that could be used to stimulate the nerve," says co-author James Trevathan, PhD, a postdoctoral fellow in Ludwig's lab.

Ludwig co-founded Neuronoff, a company based on the injectrode, with Case Western Reserve University biomedical engineering professor Andrew Shoffstall, PhD, and Neuronoff CEO Manfred Franke, PhD. Neuronoff recently secured a $2.1 million grant from the National Institutes of Health to further develop the injectrode to stimulate spinal nerves as a treatment for chronic back pain.

The researchers are testing a scheme in which they inject the fluid around the nerve, then extrude a thin insulated string of the material back to just underneath the surface of the skin, where they inject more of the composite material. Then they can use a basic transcutaneous electrical nerve stimulation (TENS) unit to stimulate the nerve from the surface of the skin.

"We're making a bypass from the surface of the skin to the location we want to stimulate," says Ludwig, who envisions using a robotic surgical system to install the injectrode in a procedure similar to getting a tattoo.

"As we learn more and more about how to interface with the nervous system, we're not limited to what we've implanted through an invasive surgical procedure. We can actually change how we stimulate, how we talk to the nerve, because we're essentially just routing our connection to this deep nerve back to the surface of the skin."

Spinal cord stimulators have some of the worst safety records among medical devices, according to a 2018 report by investigative journalists. Stimulators are often touted as safer alternatives to opioid pain medication, but a review of FDA data found over 500 deaths and 80,000 injuries involving stimulators since 2008. Patients reported being shocked or burned by the devices and many had them removed.  

Why Do Doctors Keep Pushing Invasive Procedures on Me?

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By Mike Emelio, Guest Columnist 

I'm not a cynical person by nature, but I'm seeing a very clear pattern with interventional pain management doctors. Why is it that every doctor I've seen who is certified in interventional pain medicine (at least 8 of them already) demonize opioid medication and insist on pushing their non-FDA approved injections, radiofrequency ablations, pain pumps and spinal cord stimulators? 

This approach is even more absurd when you consider the fact that invasive procedures tend to have low rates of efficacy and are known to create scar tissue and nerve damage, both of which can cause more pain.  

As if this weren't ridiculous enough, in spite of explaining to these doctors how epidural steroid injections not only didn't work for me, but robbed me of my life by tripling my pain and making my condition much worse (see “Disabled by the War on Opioids”), every single one of the doctors I've seen still tries to push more of those injections on me.  

My head spins every time I hear them try to sell me on more injections. Are they deaf, insane, just trying to make their wallets fatter, or all three?

On what planet does it make sense to do more of what made a thing worse? 

Ever since my life was ruined by those injections 5 years ago, I've been desperately trying to find a doctor who truly cares about my well-being and wants to help me. My search has been fruitless so far.  

Sadly, it just keeps getting worse. The latest doctor I started seeing keeps pushing a pain pump on me. That is as absurd as it gets. Multiple doctors have told me that the reason those injections made my back pain worse is because they caused adhesive arachnoiditis or nerve damage – both of which can be made worse with invasive procedures.  

Why would any doctor push a pain pump on me? I could understand it for a patient with a history of drug abuse, but that is not the case with me. Not only do I have zero history of drug or alcohol abuse, but I have taken my pain meds responsibly for many years. Why should I submit to being put under anesthesia, cut open and have a device implanted in me, all which can have serious complications, when I can get the same medication in a pill that I took responsibly for many years? 

All of the surgeons say that my best option for improved quality of life is pain medication and staying as active and mobile as possible. Yet every interventional pain management doctor ignores their advice and pushes for injections, spinal cord stimulators or pain pumps. Why would they do that?  

It's simple.  According to my Medicare statements, a doctor makes about $75 per visit to write and maintain prescription medications. But with the injections, it's $1,000 and up!

Many times I've personally seen doctors perform unnecessary tests that pay them a lot of money and only for that reason. This is not just my opinion, as other doctors I've seen have confirmed this. Not all doctors are like this and I wouldn't even venture to say most, but the fact is there are plenty of them out there. 

I'm not saying any of this to bash doctors. I'm sharing this information in hopes that people take the time to get educated, be vigilant and be their own advocate when it comes to their healthcare. Doctors are only human. They're just as susceptible to flaws as anyone else. I can't impress enough on all of you to look out for yourselves and get second, third, fourth and even fifth opinions if needed.

If you think that sounds excessive, just think about what happened to me. They took away what was working for me and used a non-FDA approved procedure on me that wasn't even designed for what they were using it for. The end result was that it crippled me, robbed me of my ability to work, forced me into a life of poverty and disability, and took away my freedom, my dignity and my ability to properly care for myself. 

Simply put... It has devastated my life.

I don't post any this for sympathy. I am only trying to educate and inform people about what can happen if they put too much faith in doctors without doing some research. What happened to me is a prime example of just how essential it is that we patients be as proactive as possible, be our own advocates and protect ourselves. 

Michael Emelio lives in Florida.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Faulty Medical Devices Blamed for Thousands of Deaths

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By Pat Anson, PNN Editor

The U.S. Food and Drug Administration said today it would take steps to modernize and improve its oversight of medical devices in the wake of a scathing new report that found faulty devices were responsible for over 83,000 deaths and 1.7 million injuries worldwide in the last decade.

The “Implant Files” project, a year-long joint investigation by the International Consortium of Investigative Journalists (ICIJ) and over 50 media partners, found that the FDA approved many devices with little clinical testing and rarely pulled them off the market when problems arose.

Spinal cord stimulators have some of the worst safety records among the 4,000 devices tracked by the FDA, the ICIJ found. Stimulators are implanted near the spine and send electric currents to block pain signals from reaching the brain. The devices are often touted as safer alternatives to opioid pain medication and about 60,000 are now implanted annually.

But a review of FDA data found over 500 deaths and 80,000 injuries involving stimulators since 2008. Patients reported being shocked or burned by the devices and many had them removed.  

“I thought I would have a wonderful life,” a disabled 45-year old South Carolina man told the Associated Press. “But look at me.”

Jim Taft’s doctor told him a spinal cord stimulator would cloak the chronic pain in his severely injured right arm and make him “good as new.” But a wire in the device broke and after an operation to repair it, Taft said it shocked him so many times he had trouble sleeping and fell down a flight of stairs. The stimulator was removed within a year of being implanted and Taft is now bedridden.  

“This is my death sentence,” Taft said from his bed. “I’ll die here.”

Outdated FDA Review Process

Artificial hips, pain pumps, spinal disc replacements and hundreds of other devices were also found to be faulty, raising concern about the level of scrutiny they received before going on the market.   

“In contrast to drugs, many surgical innovations are introduced without clinical trial data or centrally held evidence,” Professor Derek Alderson, president of the Royal College of Surgeon, told The Guardian.  “This is a risk to patient safety and public confidence.”

FDA commissioner Scott Gottlieb, MD, said his agency would modernize its “outdated” 40-year old review process for medical devices.

“The new technology that we’re seeing holds tremendous public health promise for patients. But with the advances also come new complexities that can make the review of safety and effectiveness more challenging,” Gottlieb said in a statement.

“Advances in material science, digital health, 3D printing and other technologies continue to drive an unparalleled period of invention in medical devices. It’s vital that the FDA’s regulatory approach continue to evolve and modernize to safely and efficiently advance these opportunities. Not only must we keep pace with this complexity and innovation, but we must also stay ahead of the new and evolving risks that sometimes accompany this progress.”

Gottlieb said about 20% of medical devices are based on technology that is more than 10 years old. He said the FDA would consider releasing a list of those devices in order to stimulate the use of newer technologies.

“To be clear, we don’t believe devices that rely on old predicates are unsafe, or that older devices need to be removed from the market. However, we believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device,” Gottlieb said.

Do you have a medical device and want to check its safety record? The ICIJ has a database of over 70,000 recalls, safety alerts and safety notices in 11 countries. You can search by the device name or manufacturer by clicking here.