Stimulation therapy is a growing treatment intended to relieve chronic pain in the spinal cord by sending electrical pulses through an implant. In some patients, the procedure works well and pain is well-managed. In others, the operation turns dire, causing permanent paralysis. Medical device attorneys at Pintas & Mullins look into these implants and who is to blame when a patient is paralyzed.
Spinal stimulator devices are manufactured by a variety of companies, including Medtronic, Boston Scientific, and St. Jude Medical. The devices are implanted into patients near the spinal cord, where a pulse generator sends low currents of electricity into extension wires, which are placed on the spine. The leads then transmit an electrical current onto the spine that distracts the brain from recognizing - and therefore feeling - pain signals.
Patients are typically admitted to hospitals for overnight stays, and can return home shortly after implantation with, ideally, a pain-free life. For dozens of patients, the procedure goes too far, causing partial or permanent paralysis or motor weakness.
In most of these cases, the injury occurs after the spinal cord is punctured or compressed by the electrical conductors, which are inserted into a narrow cavity called the epidural space in the lower spine (this is where an epidural anesthesia is administered during childbirth).
According to the FDA's database, nearly 60 patients were paralyzed by spinal stimulators in 2013 - up from nearly 50 the year before. It is worth noting that the FDA's database is far from complete, and many assert that injuries are vastly underreported.
Who is to Blame?
Doctors highlight a potential cause of the problem - insufficient awareness by doctors on the true risks of operating around the spinal cord, and proper techniques for avoiding the most dangerous areas. Much of the blame, they assert, rests on insufficient training and lack of surgical guidelines that leave physicians unprepared.
Part of the reason for this is that spinal stimulation procedures are conducted by various types of doctors: orthopedic spine surgeons, neurosurgeons, or anesthesiologists. Thus, no one medical society (which are typically responsible for developing training standards and practice guidelines) is held responsible for issuing such standards and performance tracking.
It may sound trite to say that surgical outcomes largely rely on the experience and skills of the doctor - but in spinal stimulation implantations this is particularly true. A physician at the Dartmouth-Hitchcock Medical Center stated that the surgery initially seems straightforward and simple, which attracts doctors who are not familiar with how risky a spine procedure actually is.
Medical device manufacturers like Medtronic claim they monitor adverse event reports and update the product labelling to reflect new or increased risks. Among these include the possibility that scar tissue can form around the device electrodes and cause nerve damage (which is also the site of paralysis). Companies like Medtronic offer weekend-long training sessions, however, experts agree that these courses are not sufficient.
Stimulators can cost between $20,000 and $60,000 each, but about a third of patients experience complications because of the device within a year of implantation. Nearly one in four patients have to undergo additional surgeries to fix the adverse side effects.