Medical malpractice attorneys alerted patients about a year ago of an FDA Class I recall of defective Medtronic Deep Brain Stimulation (DBS) leads due to twisting of parts during the surgical implantation. A year later, a Wall Street Journal analysis of adverse events reported to the Food and Drug Administration (FDA) states that more than 100 recipients of spinal cord stimulators in the last few years, many of which manufactured by Medtronic, have experienced partial or permanent paralysis. The FDA’s database contains 48 reports of injury in 2012 and 58 reports in 2013 regarding spinal stimulators. According to a number of medical malpractice claims regarding partial and permanent paralysis, injuries occur when spinal cords are punctured and/or compressed by the device’s electrodes, which are surgically implanted in the epidural space, a narrow spinal cavity outside the spinal cord but inside the vertebral canal.
Experts have discovered that a leading cause of paralysis events resulting from the implantation procedure is the lack of awareness that many physicians have of the risks of operating near the spinal cord. This lack of awareness is due, in large part, to the lack of training standards or practice guidelines surrounding the spinal stimulator devices. Medical societies and device manufacturers themselves often hold training seminars or classes for physicians planning on using a medical device that may require additional training. However, no such program exists for spinal stimulators manufactured by Medtronic, Boston Scientific, or St. Jude Medical.
According to Gilbert G. Fanicullo, the Director of Pain Medicine at the Dartmouth-Hitchcock Medical Center in New Hampshire, the procedure is seemingly simple and therefore attractive. “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.”
Spine stimulators are implanted by anesthesiologists, neurosurgeons, and orthopedic spine surgeons and no one medical society has claimed responsibility for issuing the appropriate guide lines to help prevent injury as a result of this procedure.
The Philadelphia medical malpractice lawyers at Messa & Associates are experienced at handling medical malpractice cases involving medical devices. Our extremely skilled team of medical malpractice lawyers and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you or a loved one have suffered partial or permanent paralysis after a spinal stimulator implantation procedure, contact the medical malpractice lawyers of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.
The information in this post was based on conclusions drawn by Joseph Walker, author of When Spine Implants Cause Paralysis, Who Is to Blame?, a Wall Street Journal business article.
Joseph L. Messa, Jr. is the founding partner of Messa & Associates, P.C. He is an AV-rated attorney (highest rating available), listed in the Bar Register of Preeminent Lawyers. Read More