Spine Implants Meant to Treat Pain May Cause ParalysisApr 16, 2014
Spine implants manufactured by Medtronic, St. Jude Medical, Boston Scientific and other companies are meant to treat chronic back pain, but some patients have actually become paralyzed after receiving the device. According to a Wall Street Journal analysis of the U.S. Food and Drug Administration’s (FDA) adverse-event reports and a review of medical malpractice lawsuits, more than 100 patients have experienced partial or permanent paralysis after having a spinal-cord stimulator inserted into their backs.
The devices use stimulation therapy to help manage chronic pain; a small external remote is used to send low currents of electricity to the implanted generator and the electrical current from the leads creates a tingling sensation that it supposed to mask pain signals being sent to the brain, WSJ says.
According to researchers at Duke University Medical Center, nearly one in every 100 spinal stimulator patients experience spinal cord or spinal nerve-root damage at some level. Shivanand P. Lad, a Duke neurosurgeon and lead researcher of the study, said that the injuries range from muscle weakness to complete paraplegia.
This was the case for 66-year old Rick Greenwood, Wall Street Journal reports. Two years ago, Mr. Greenwood checked into a Dallas hospital in order to have a spinal-cord stimulator implanted after suffering from back pain for over 40 years. Hours after the procedure, he complained of numbness in his legs to nurses. It turns out that a blood clot was pressing on his spinal cord, and an emergency procedure was performed. Unfortunately, the damage was irreversible and he left the hospital one month later in a wheelchair, paralyzed from the waist down. "I walked in to that hospital, and I expected to walk out," Mr. Greenwood told WSJ. "Getting paralyzed didn't even cross my mind at all."
Doctors say the probability of paralysis often depend on the implanters’ skill levels and experience, WSJ reports. Although training standards and practice guidelines are usually implemented in medical societies, spinal stimulators can be implanted by several different types of doctors- including anesthesiologists, neurosurgeons and orthopedic spine surgeons- so no single medical society is responsible for guidelines.
In 2011, a lawsuit was filed over a stimulator that ultimately resulted in paralysis. Deirdre Murphy said that her spine surgeon implanted her with a St. Jude stimulator he had not been trained to use. The suit alleged that the doctor was negligent for failing to obtain proper training. It also accused St. Judge Medical of negligence in selling the device to the surgeon without proper training. According to WSJ, the case was settled out of court and led to a cash settlement for Murphy.