When Spine Implants Cause Paralysis, Who Is to Blame?
Spinal-Cord Simulators Are Intended to Relieve Pain
By JOSEPH WALKER CONNECT
April 15, 2014 7:19 p.m. ET
Rick Greenwood checked in for an overnight stay at a Dallas hospital two years ago to have a spinal-cord stimulator implanted in his back. The surgery was meant to relieve the back pain that had troubled him for more than 40 years, but when he left the hospital one month later, he was pushed out in a wheelchair, paralyzed from the waist down.
Mr. Greenwood, 66 years old, is among more than 100 patients who have experienced partial or permanent paralysis in recent years after having spinal-cord stimulators inserted in their backs, according to a Wall Street Journal analysis of adverse-event reports submitted to the U.S. Food and Drug Administration, and a review of medical malpractice lawsuits. In many cases, the injuries occurred after patients' spinal cords were punctured or compressed by the stimulator electrodes, which are implanted in a narrow cavity of the spine called the epidural space, according to experts who reviewed the reports.
In all, the FDA's database contains 58 unique reports of paralysis with report or event dates from 2013, compared with 48 in the prior year. The paralyzed patients received spinal stimulators made by a variety of companies, including the three biggest: Medtronic Inc., MDT +0.76% St. Jude Medical Inc. STJ -1.87% and Boston Scientific Corp. BSX +1.12%
Doctors say the frequency of paralysis, while thought to be relatively uncommon, varies according to implanters' experience and skill levels, and isn't well understood because of a lack of independent data. Researchers at Duke University Medical Center recently found that nearly one in every 100 spinal stimulator patients experienced some degree of spinal-cord or spinal nerve-root damage, which typically results in injuries ranging from muscle weakness to complete paraplegia, said Shivanand P. Lad, a Duke neurosurgeon and the study's lead researcher. The study, based on insurance claim records of 12,300 stimulator patients, has been submitted for presentation at an upcoming medical meeting.
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A 2011 study based on adverse event reports submitted by device makers found the rate of paralysis or motor weakness in patients implanted with a commonly used type of stimulator was considerably lower, at around 3.8 per 1,000, with about 60% of affected patients eventually experiencing complete or partial recoveries. Patient outcomes weren't available in 29% of cases, and 10% of patients had no recovery.
Doctors who implant the devices point to a problem that may be causing the injuries: poor physician awareness about the risks of operating near the spinal cord and the techniques for mitigating dangers. Insufficient training and a lack of surgical guidelines have left some doctors ill-prepared to perform the procedure, experts say.
Medical societies usually develop training standards and disseminate practice guidelines, but spinal stimulators are implanted by a variety of physicians—anesthesiologists, neurosurgeons and orthopedic spine surgeons—and no single medical society is responsible for issuing guidelines and tracking performance, doctors say.
"For someone who hasn't done a lot of them, it looks like a fairly straightforward and simple procedure, and it attracts people who aren't familiar with the risks," says Gilbert J. Fanciullo, director of pain medicine at the Dartmouth-Hitchcock Medical Center in New Hampshire, who performs the procedure himself.
Companies acknowledge spinal stimulator procedures carry risks, but note that alternative treatments, such as more invasive spine surgeries or pain medications, are also associated with adverse events. Companies note the risk of paralysis is disclosed in product manuals and marketing materials for the devices.
"The well-known complications of spinal-cord stimulation, including the rare incidence of paralysis, must be weighed against the reported risks of dependence and tolerance associated" with pain drugs and the risks involved with multiple back surgeries, Amy Jo Meyer, a St. Jude Medical spokeswoman, said in an email.
Donna Marquard, a Medtronic spokeswoman, says the company actively monitors adverse event reports in the FDA's database, in customer complaint data and in returned product analyses. Ms. Marquard said this review process led the company to update its product labeling in February to reflect the risk that scar tissue can form around device electrodes and cause nerve damage, including progressive quadriparesis, or a gradual weakening of all four limbs.
Boston Scientific said it didn't know of any "case of paralysis that was related to a Boston Scientific product malfunction or defect."
Medtronic estimates that as many as 50,000 people in the U.S. are implanted with spinal stimulators each year from all device makers—for back pain or other problems including peripheral nerve pain. The stimulators are matchbook-size pulse generators implanted near the waist that send low currents of electricity through wires threaded up the back to electrodes near the spinal cord. Scientists think the stimulation distracts the brain from fully recognizing pain signals sent from the spine.
Stimulators cost between $20,000 and $60,000 each, doctors say, and have estimated global sales of $1.5 billion annually, split mainly among St. Jude Medical, Boston Scientific and Medtronic.
Doctors say that spinal stimulators are an effective way to significantly reduce pain caused by nerve damage, and can even help patients reduce their dependence on pain medication. A Medtronic-funded study found that spinal stimulators in combination with conventional medical management helped 48% of patients to reduce their pain by 50% or greater after six months, compared to 9% of patients who were treated with conventional medical management alone. However, a third of stimulator patients experienced device-related complications within one year, and nearly a quarter of patients had to undergo additional surgery to resolve the complications.
FDA spokeswoman Jennifer Rodriguez cautions that the agency's database cannot be used to ascertain comprehensive rates of adverse events because the events are underreported, and often contain incomplete or incorrect information.
A perception that stimulator implants are easy to perform, combined with uneven training across different medical specialties, is often at the root of surgical complications, says Robert M. Levy, director of the Marcus Neuroscience Institute at Boca Raton Regional Hospital in Florida and editor in chief of a medical journal focused on nerve stimulation. Doctors specializing in pain management often perform the surgery, but their training doesn't always include hands-on instruction in the procedure, Dr. Levy says. Device makers offer weekend training courses, but Dr. Levy and other physicians said the courses aren't sufficient.
The companies say their training is high-quality, but that physicians shouldn't rely on that alone.
Patients like Mr. Greenwood, who was paralyzed in 2012, are left questioning whether their complications could have been avoided.
Several hours after his procedure, Mr. Greenwood says he began complaining to nurses at the University of Texas Southwestern Medical Center of numbness in his legs. An emergency procedure was performed later that night to remove a blood clot that was pressing his spinal cord, but the damage was irreversible, according to Mr. Greenwood's medical records.
Russell Rian, a University of Texas spokesman, said the university doesn't comment on specific patients.
"I walked in to that hospital, and I expected to walk out," Mr. Greenwood says. "Getting paralyzed didn't even cross my mind at all."
Deirdre Murphy alleged in a 2011 lawsuit that she was paralyzed after an Albuquerque, N.M., spine surgeon named Douglas Slaughter implanted her with a stimulator made by St. Jude Medical that he hadn't been trained to use. Dr. Slaughter was negligent in failing to obtain proper training, the suit alleged. St. Jude Medical, the suit alleged, was negligent in selling the device to Dr. Slaughter without providing training, according to court documents.
The parties settled out of court in 2012, resulting in a cash settlement for Ms. Murphy, she and her attorney say.
St. Jude Medical declined to comment on Ms. Murphy's suit. Through his lawyer, Dr. Slaughter declined to comment.
Write to Joseph Walker at joseph.walker@wsj.com
WHY WOULD ANYONE RISK A SPINAL STIM WHEN THEY COULD TRY CALMARE. IT'S MUCH LESS RISKY AND A FRACTION OF THE COST AND WORKS BETTER.
