Spinal cord stimulators (SCS) offer a treatment option for individuals experiencing chronic pain that has not responded to other therapies. These devices aim to reduce pain perception and improve quality of life. Understanding the safety aspects of spinal cord stimulators is important for patients. This article provides an overview of SCS safety, addressing potential risks and long-term considerations.
Understanding Spinal Cord Stimulators
A spinal cord stimulator is a small, implantable medical device designed to alleviate chronic pain by delivering mild electrical impulses to the spinal cord. The system consists of two main components: an implantable pulse generator (IPG) and thin wires called leads. The IPG, similar to a pacemaker, is placed under the skin in the lower back or abdomen.
The leads are positioned in the epidural space, the area surrounding the spinal cord. Electrodes on the leads deliver electrical signals that interfere with pain signals traveling from the body to the brain. This process, known as neuromodulation, reduces pain sensation. Patients can control the stimulation levels using a handheld remote.
Common Side Effects and Potential Complications
Spinal cord stimulator implantation is generally considered minimally invasive, but potential side effects and complications can occur. Surgical risks include infection at the implant site, bleeding, and bruising. Infection is a notable concern, with rates of approximately 3.4% to 10%, making it a common reason for device removal.
Device-related issues are also possible, such as lead migration, where the wires move from their intended position, which is the most common device-related complication. Lead breakage or malfunction can also occur, sometimes requiring additional surgery for repair or replacement. Patients may also experience uncomfortable stimulation, described as jolting or sudden shocks, or stimulation that moves to unwanted areas.
Rare but serious neurological risks can arise, including nerve damage, which can lead to weakness or paralysis. Cerebrospinal fluid (CSF) leaks, occurring if the dura mater is punctured, can cause headaches that often improve with rest and hydration. Allergic reactions to the device materials are also a possibility.
Patient Selection and Minimizing Risks
Careful patient selection is important for maximizing benefits and minimizing risks associated with spinal cord stimulators. Healthcare professionals conduct a thorough evaluation, which includes a detailed medical history and a physical examination. A psychological assessment is also performed to ensure realistic expectations and identify any untreated psychological disorders that could affect outcomes.
A temporary trial stimulation period allows the patient to experience the therapy and determine if it provides adequate pain relief before permanent implantation. Certain conditions can make SCS unsafe or ineffective, such as active infections, bleeding disorders, or severe psychiatric conditions. Patients unable to operate the device or those with significant spinal deformities may also not be suitable candidates.
The medical team’s experience, particularly that of the surgeon and the pain management team, plays a role in minimizing complications. Patient adherence to post-operative care instructions, including wound care and activity restrictions, is important for a successful recovery. Following device programming recommendations and attending regular follow-up appointments further supports long-term safety and effectiveness.
Long-Term Considerations for Safety
Living with a spinal cord stimulator involves ongoing management and long-term safety considerations. The device’s longevity is a factor, as the battery in the implantable pulse generator (IPG) will eventually need replacement. Rechargeable IPGs generally offer longer battery life, but all will eventually require an outpatient procedure for replacement.
Magnetic Resonance Imaging (MRI) compatibility is an important consideration for patients with SCS devices. While older stimulators were often not MRI compatible, newer systems allow for safe MRI scans under specific conditions. Patients should confirm their device’s MRI compatibility with their healthcare provider, as some models may have restrictions on the type or strength of MRI scanner that can be used.
Regular monitoring and follow-up appointments with the pain management team are important for long-term safety. These visits allow for assessment of device function, adjustments to stimulation settings, and early detection of any emerging issues. While the risk of infection is highest immediately after surgery, a low, ongoing risk persists, making it important for patients to be aware of symptoms that could indicate an infection.