Disadvantages and Risks of Spinal Cord Stimulation

One of the most significant drawbacks of spinal cord stimulation (SCS) is the failure to provide effective pain relief.

Additionally, as with any surgical implant procedure, there is a potential for implant-related complications and surgical risks, such as infection, bleeding, or pain at the implantation site.

Side Effects and Risks of Spinal Cord Stimulators

People with implanted stimulators may experience temporary discomfort, face certain permanent restrictions, or develop rare risks, which include but are not limited to:

• Difficulty adapting to the electric impulses. Some individuals find the tingling sensation of the stimulator to be bothersome and intrusive. 
• Difficulty adapting to the implanted device. Less commonly, the implanted device may cause discomfort and irritation in the skin or surrounding areas.
• Discomfort in the stomach and bowels. In rare cases, stomach pain, abdominal distension, and constipation may occur when a higher setting or electric frequency is used.¹La Grua M. Rare Side-effects during Spinal Cord Stimulation: Gastrointestinal Symptoms. Neuromodulation. 2009;12(2):161-163. doi:10.1111/j.1525-1403.2009.00202.x
• Permanent activity restrictions. Activities that add pressure to the body, such as scuba diving more than 10 meters below the surface, are permanently restricted for those with implanted stimulators. Patients are also advised to inform a healthcare professional before entering a hyperbaric chamber (a small, closed space with high air pressure intended for medical use).
• Electromagnetic interference. Strong interference, such as from a magnetic resonance imaging (MRI) machine, can damage the stimulator and/or leads if the device is not MRI-compatible, causing severe burns, serious injury, or other adverse outcomes. This risk applies to any test or procedure involving electromagnetic fields. 
• Device-related complications. The leads (wires) responsible for delivering electric impulses to the nerves in the spinal cord can displace, move, or migrate, resulting in stimulation in unintended areas and reducing the effectiveness of the treatment.²Hasoon J. Lead migration in spinal cord stimulation with loss of pain coverage in a CRPS patient. Saudi J Anaesth. 2020;14(2):280-281. Available from: www.ncbi.nlm.nih.gov/pmc/articles/PMC7164436/
  It is also possible for the leads to break, bend, or malfunction. Migration or breakage of the leads requires additional procedures to fix the problem. 
• Fluctuations in stimulation or “overstimulation.” Rarely, malfunctioning of the stimulator may cause erratic firing of electric impulses, which may injure nearby nerves or soft tissues. 
• Headaches and migraines. Stimulator wires in the neck (cervical spine) for treating neck pain and arm pain may sometimes cause nerve inflammation and altered nerve activity near the head and neck region, causing migraines and headaches.³Ward TN, Levin M. Case reports: headache caused by a spinal cord stimulator in the upper cervical spine. Headache. 2000;40(8):689-691. doi:10.1046/j.1526-4610.2000.040008689.x
• Surgical risks. Both the trial period and permanent implantation of a stimulator involve minimally invasive procedures. As with any such procedure, there are certain risks and potential complications, such as: 
  • Leaking of spinal fluid if the spinal cord’s outer layer (dura mater) becomes punctured 
  • Lung collapse (pneumothorax) due to accidental lung injury from a needle in the upper back 
  • Neurological damage caused by an injury to the nerve root or spinal cord – including permanent nerve damage or paralysis
  • Excessive bleeding (hemorrhage) in the epidural space
  • Collection of fluid (seroma) around the implanted device leading to infection and pain
• Surgery to replace the stimulator. While most implanted stimulators can be used for several years, the battery would need to be replaced at some point, necessitating another surgery to remove and replace the stimulator.

Patients considering spinal cord stimulation should discuss the potential benefits, risks, and treatment alternatives in detail with their physician before committing to the procedure. 

When to See a Doctor

If one or more of the following signs or symptoms are experienced, a doctor must be consulted immediately:

• Inadequate pain relief despite changing the frequency or settings of the stimulator
• Abnormal tingling when the stimulator is turned on, which feels different from the regular tingling sensation 
• A jolting or shocking sensation that comes on randomly during the day or while turning on the device
• Pain, swelling, redness, fluid discharge, and/or irritation around the implantation site 
• Fever above 101 F
• Headaches that are constant or worsen with certain positions, such as while leaning forward 
• Severe pain, numbness, muscle weakness, and/or loss of sensation in the arm(s) or leg(s)
• Inability to control bowel and/or bladder function
• Sexual dysfunction (inability to get or maintain an erection or loss of sensation in the genital area)

These signs and symptoms indicate a serious problem with the stimulator and/or leads, severe nerve or spinal cord damage, or infection and require urgent medical care to prevent serious complications.