Spinal Cord Stimulator Malpractice

Severe back pain is one of the most common debilitating conditions facing many Americans today. Back pain is generally of two types, one that comes on suddenly or acutely following an injury or fall, or pain that is more chronic in nature, coming on slowly but lasting for years. In many of these instances, the pain is either caused by degeneration of the spinal cord discs (gel-like spaces that occupy the spaces between the spinal cord vertebrae). As the discs weaken, they can bulge out of the normal disc space, or even rupture, which in turn, puts pressure on the spinal nerve roots that run through the back region. Bulging discs are often referred to as herniated discs. Herniated discs can cause intense back pain. In some instances, the pain radiates into the buttocks or down into the legs. In more severe cases, the herniation can result in loss of bowel/bladder control, leg weakness or paralysis.

Typically, back pain is treated initially with over-the-counter medications, muscle relaxers or prescription pain medications. If these conservative treatments fail, your physician may consider or recommend a spinal cord stimulator. A spinal cord stimulator is comprised of soft, think wires with electrical leads on their tips. The leads are placed through a needle in the back into the spinal canal just above the spinal cord. A small incision is then made in the upper buttock or abdomen and a programmable generator is placed, which in turn, emits electrical currents to the spinal column, thereby controlling the pain. Typically, a patient will undergo a brief trial period with a stimulator to see if pain levels can be diminished before a more permanent stimulator is implanted.

The implantation of the spinal cord stimulator leads is either accomplished via a percutaneous approach (utilizing a wide bore needle to insert the lead into the epidural space) or through a surgical laminectomy/laminotomy procedure (where the vertebrae at the affected level is temporarily removed so as to gain access to the epidural space through an incision in the ligament that protects the spinal cord). The leads are then sutured in place and affixed to the implanted generator.

Unfortunately, for a procedure that often times can be completed within 20-30 minutes, the implantation of spinal cord stimulators is fraught with significant peril as recent studies have documented the growing number of instances in which patients emerge from the surgery with mild to severe paralysis. There is no doubt that the cardinal rule for any health care provider who performs these procedures is to protect the spinal cord at all costs. The epidural space, however, is no more that a few millimeters wide with the spinal cord lying immediately below it. The cord itself is essentially the consistency of wet pasta, and therefore, can be injured easily if contacted by surgical instruments or the paddle leads themselves with any force. Many patients have what is called “scar tissue” in their epidural space. Scar tissue can result from a prior injury at the level of the cord or if a previous lead had been placed in the area and now needs to come out. Scar tissue often blocks the intended pathway for the paddle leads and makes their implantation difficult. In order to properly place the paddle leads, the surgeon must first free up the scar tissue or gently push the paddle leads through the scar tissue to reach the intended location. In many cases, the surgeon will negligently injure the spinal cord while attempting to free up the scar tissue (either by a surgical instrument) or by pushing the paddle lead into the cord itself (instead of the epidural space).

The Wall Street Journal reported that more than 100 recipients of spinal cord stimulators had experienced partial or permanent paralysis over a couple year period. Many experts have opined that a leading cause of paralysis events following spinal cord stimulator implantations is a general lack of awareness that many physicians have of the risks of operating near the spinal cord. This lack of awareness appears to stem, in large part, to lack of training standards or guidelines, and the fact that stimulators are implanted by a wide range of health care providers including anesthesiologists, neurosurgeons, orthopedic surgeons and pain management doctors. No uniform guidelines within any these professions exist.

As you might imagine, for patients who are expecting a quick and painless procedure to remedy chronic back pain, ending up with partial or total paralysis is an outcome that is generally not expected and, most assuredly, devastating. Because the vast majority of these paralytic events are preventable if the standards of care are adhered to, if you or a loved one has been paralyzed following the implantation of a SCS, call our lawyers for a free consultation.