For anyone reading the April 16, 2014 edition of The Wall Street Journal and contemplating implant surgery for a spinal-cord stimulator, the news was frightening. The headline set the stage: “When Spine Implants Cause Paralysis, Who is to Blame?”
According the newspaper’s analysis of adverse-event reports submitted to the U.S. Food and Drug Administration and a review of malpractice lawsuits, more than 100 patients have experienced partial or permanent paralysis in recent years after having spinal-cord stimulators inserted in their backs. The article went on to note, “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.
Since this procedure was pioneered and has been performed by the skilled surgeons at Texas Back Institute more than 10,000 times since its introduction, it’s logical to ask two of these spine specialists about this story. Dr. Michael Hisey and Dr. Ralph Rashbaum, in separate interviews, both agreed the facts presented by the Journal about this procedure are not wrong. They also agree with the conclusions drawn by the experts interviewed by the newspaper – the problem is not with the spine stimulator device.
“It’s ‘pilot error,’” said Dr. Rashbaum. “The article rightfully pointed to the real problem of this procedure and that’s a lack of training for some of the physicians who are performing the surgery.” More on this later.
How the Spine Stimulator Relieves Chronic Pain
The spine stimulator devices are made by several companies, including Medtronic, Inc., St. Jude Medical, Inc. and Boston Scientific Corp. Each uses electrical signals, which emanate from the implanted device and is then transmitted through electrodes connected to the spinal cord to block the pain signal before it is received by the Thalamus portion of the brain.
When properly placed in the back, these stimulators have an overwhelmingly high success rate. As one can imagine, for someone who has suffered chronic back pain for decades, this device is a god-send.
“I was one of the early adaptors of this technology,” said Dr. Rashbaum. “I’ve been performing this procedure for more than 37 years, more than 5,000 times and I’ve worked with all of the medical device companies who manufacture them. I have testified as an expert witness in cases related to these devices and have even invented devices from which I receive royalties from one of the companies – Medtronic, Inc.”
By any metric or criteria, Dr. Rashbaum is one of the internationally-recognized experts on spinal cord stimulators and it’s telling that he has serious concerns about the (lack of) training some physicians receive before performing this surgery.
Training is Inadequate
“Two days, which is the standard amount of time manufacturers allocate to explaining this procedure, is not nearly enough,” Dr. Rashbaum said. “Our doctors at Texas Back Institute must go through a full year of training, mentoring from other physicians and operate under close supervision before being allowed to perform this procedure. Why? Unforeseen factors arise in surgery and you never want these factors to occur when someone is only just learning the procedure.”
“The real problem we see and that which the Journal rightfully pointed out is a lack of training in the proper implantation of these devices,” said Dr. Hisey. “The devices are sound. However, when you have physicians who have never had surgical training and proper mentoring by more experienced doctors certified to perform this surgery two days of training is not enough. Unfavorable outcomes will occur.”
What Can Go Wrong?
What are the types of physician errors which might cause paralysis in a patient undergoing this type of spine stimulator procedure? Dr. Rashbaum, who after performing more than 5,000 of these procedures has never had a patient failure resulting in paralysis, notes several.
“When implanting the device, an inexperienced surgeon will sometimes put too much pressure on the spinal cord causing a bruise or contusion,” he notes. “If this pressure is severe, it could cause damage to the spinal cord and paralysis.”
“The electrode leads can also be pushed too far in this procedure,” Rashbaum notes. “And this is often difficult to determine, especially if the patient is under anesthesia. My experience has taught me to keep the patient awake through the procedure, monitor their progress electronically and listen to the patient.”
“Another problem which might cause paralysis is an epidural hematoma,” he said.
“Infections can occur even with good technique. However, a good team using appropriate technique can significantly decrease the number of infections.”
“Epidural hematomas (blood collection) are another possible cause of cord injury. These can occur when the epidural veins (the veins around the cord) are torn by the electrode lead. Bleeding in the epidural space causes pressure on the cord and it can be significantly injured.”
“All of these errors are preventable with proper and extensive training,” Dr. Rashbaum concluded.
Training Future Spine Specialists
How does Texas Back Institute prepare its physicians for spine stimulator implant surgery and the other ground-breaking procedures such as artificial disc replacement, SI joint fusion, herniated disc surgery and any number of other specialized procedures? It’s the same way a concert pianist gets to Carnegie Hall. Practice. Practice. Practice!
“Every year we offer fellowships to 2 to 5 physicians who have graduated a residency and want to learn more about the specialized surgery Texas Back Institute is known for,” said Dr. Hisey. “It is extremely rare for a private practice such as ours to offer this year-long training to future doctors who will not necessarily join our practice.”
He continued, “We do this because we believe in the benefits of mentoring young surgeons. After successfully completing our fellowship program, they have participated and observed hundreds of procedures such as the spine stimulator implant surgery. Some of them are asked to join our practice and some go on to other practices. However, they are all better doctors when they leave.”
“For the physicians who join the Texas Back Institute, we require a one-year period of specialized training (Fellowship) in spinal surgery during which they will typically supervised by senior physicians for about 500 to 600 cases before they graduate,” Dr. Hisey said. “After joining TBI, each will have their cases reviewed and will be supervised over the first several months before they operate independently.”
What Questions Should a Patient Ask?
Every doctor hopes to avoid the tragedy of permanent paralysis noted in the “Journal” article and every patient should take some responsibility. What are the questions a person who is considering this spinal stimulator surgery? Dr. Rashbaum offers a few.
“A patient should ask their physician about the number of cases, complication rates and outcomes they have had related to the spine stimulator device,” he said. “In my practice my trial-to-implant ratio is higher than 90 percent. This is due to my extensive screening and evaluation of each client. If a physician performs a large number of trials and his permanent implant rate is low, this could be a red flag. For example, the pain reduction ratio should be at least 50 percent in the trial before the final procedure is attempted.
Let’s face it. Some physicians perform this procedure better than others,” Dr. Rashbaum said. “Just because a pain-management doctor or anesthesiologist goes through two-day training for spine stimulator implants does not mean he or she is qualified for this type of surgery. Errors can occur and the damage to the patient can be permanent.”
Dr. Hisey adds, “A two-day course might be adequate to learn the nuances of a modification of a technique which the surgeon is already proficient in but it does not replace surgical training or practicing a procedure in a supervised setting.”
Dr. Rashbaum reminds us, “We physicians must live by the oath we take – ‘Primum non nocere.’ First do no harm.”