Amid shocks and burns, spinal-cord stimulators are more dangerous than many patients know
In this Nov. 16, 2018, photo, Jim Taft watches The History Channel from the confines of his bed at his home in West Columbia, S.C. Mr. Taft has experienced debilitating health issues after a neurosurgeon implanted Boston Scientific’s Precision spinal cord stimulator in his back in 2014. (AP photo/Sean Rayford)
COLUMBIA, South Carolina — Desperate for relief after years of agony, Jim Taft listened intently as his pain management doctor described a medical device that could change his life.
It wouldn’t fix the nerve damage in his mangled right arm, Mr. Taft and his wife recalled the doctor saying, but a spinal-cord stimulator would cloak his pain, making him “good as new.”
But Mr. Taft’s surgically implanted stimulator failed when a wire along his spine broke. After an operation to repair it, he said the device shocked him so many times that he couldn’t sleep and even fell down a flight of stairs. Today, the 45-year-old Mr. Taft is a prisoner in his own bed, barely able to get to the bathroom by himself.
“I thought I would have a wonderful life,” he said. “But look at me.”
For years, medical device companies and doctors have touted spinal-cord stimulators as a panacea for millions of patients suffering from a wide range of pain disorders, making them 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.
The FDA data contains more than 500 reports of people with spinal-cord stimulators who died, but details are scant, making it difficult to determine if the deaths were related to the stimulator or implant surgery.
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.
The FDA acknowledges its data have limitations, including mistakes, omissions and under-reporting that can make it difficult to determine whether a device directly caused an injury or death. But it rejects any suggestion of failed oversight.
“There are over 190,000 different devices on the U.S. market. We approve or clear about a dozen new or modified devices every single business day,” Jeffrey Shuren, the FDA’s medical device director said at an industry conference in May. “The few devices that get attention at any time in the press is fewer than the devices we may put on the market in a single business day.”
In the last 50 years, the medical device industry has revolutionized treatment for some of the deadliest scourges of modern medicine, introducing devices to treat or diagnose heart disease, cancer and diabetes.
Pete Corby, who injured his back working as a movie stuntman, said a spinal-cord stimulator helped him deal with his constant pain and stop using the opioids he’d become dependent on.
Medical device companies have “invested countless resources — both capital and human — in developing leading-edge compliance programs,” said Janet Trunzo, head of technology and regulatory affairs for AdvaMed, the industry’s main trade association.
At the same time, medical device makers also have spent billions to try to influence regulators, hospitals and doctors.
Mr. Taft’s neurosurgeon, Jason Highsmith of Charleston, S.C., implanted the device in April 2014. But Mr. Taft and his wife say the device never worked.
Dr. Highsmith said an electrode in Mr. Taft’s stimulator broke from “vigorous activity,” though Mr. Taft said that would not have been possible due to his condition.
In October 2014, Dr. Highsmith said he operated on Mr. Taft to install a new lead, tested the battery and reinserted it. Still, Mr. Taft’s medical records show that he continued to report numbness, tingling and pain.
The stimulator was surgically removed in August 2015.
Dr. Highsmith said the overwhelming majority of his spinal-cord stimulator patients gain significant pain relief.
That’s little comfort for Mr. Taft.
“This is my death sentence,” Mr. Taft said, stretched out beneath his bed’s wooden headboard on which he’s carved the words “death row.”
“I’ll die here,” he said.
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.
“Chronic pain is one of the largest health-care burdens we have in the U.S. It’s more than heart disease, cancer and diabetes combined,” Dr. Falowski said in an interview.
He referred the AP to Corby, as one of his surgical patients who was helped by a spinal-cord stimulator.
Mr. 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.
“I was actually buying them on the street … a little like a druggie because I couldn’t get them anymore” from his pain doctor, Mr. Corby said.
Dr. Falowski said opioids are good for acute pain, but were never meant to treat long-term chronic pain. For him, that’s where spinal-cord stimulators come in.
If they’re used early enough for pain, they can prevent people from going on opium-based pain killers, said Dr. Falowski, who speaks at neuromodulation conferences and teaches other doctors how to implant stimulators.
Since 2013, device manufacturers have paid Dr. Falowski — or St. Luke’s University Health Network in Fountain Hill, Pa., where he works — nearly $863,000, including $611,000 from St. Jude or its new parent company, Abbott, according to the Centers for Medicare and Medicaid Services database. The payments range from consulting fees to travel and entertainment expenses.
Dr. Falowski said he has conducted research and done other work for manufacturers, adding, “The contracts with industry are with my hospital and not with me.”
St. Luke’s told the AP that it keeps the majority of the payments from device makers, but that Dr. Falowski “may receive a portion of these payments through his annual compensation.”
Another of Dr. Falowski’s patients was Lisa Snyder of Kempton, Pa., who was searching for relief from a painful nerve disorder. By the time she came to Dr. Falowski, she had cycled through three spinal-cord stimulators, which were removed for reasons ranging from infection to rejection.
“Not everybody could do it, but he was confident he could,” she said.
After her fourth implant this March, “I complained about this battery right away. I knew it was positioned funny. It burned,” Ms. Snyder said.
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.”
Abbott said that many of the “adverse events” reports in the FDA’s data stemmed from a device that was voluntarily recalled in 2011. The company added that feeling a temperature increase at the implant site “is often a reality for rechargeable spinal-cord stimulation systems,” which is why the company is now concentrating on devices that do not need to be recharged.
Ms. Snyder said she felt like Dr. 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, Ms. Snyder said, Dr. 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,” Ms. Snyder recalled.
Dr. Falowski then scheduled immediate surgery to remove the stimulator, she said.
Dr. Falowski called Ms. 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.”
“The physician is not present during the entire programming session, but provides oversight and direction….The only time programming sessions are billed is when the physician is actively seeing the patient during a visit which was the case with this patient,” he said.
Ms. Snyder disputed the doctor’s characterization of her and became angry after being told Dr. Falowski and his hospital received money from manufacturers.
“They need to be a little bit upfront,” she said.
Dr. Falowski said doctors do important work for medical device companies, and he has been involved in device development, education, clinical trials and research.
“You’re trying to help patients and you realize as a physician by yourself you’re not going to generate $200 million to make the next best implant for a patient and it’s going to take a company to do that,” he said. “So I think the important part in that relationship is transparency and disclosures.”
Experts interviewed by the AP said doctors are not legally required to tell their patients about financial relationships with medical device manufacturers, but that it would be the right thing to do.
“The patient should be fully informed before consenting to a procedure,” said Genevieve P. Kanter, an assistant professor at the University of Pennsylvania who specializes in internal medicine, medical ethics and health policy.
All Ms. 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.
“My fear is I’ll be like this forever,” she said.
Originally published on Post-Gazette.com