Free Consultation
(310) 207-3233
Thousands of spinal cord stimulators are implanted each year. The medical device is commonly prescribed to help manage chronic pain. It is surgically implanted and emits an electrical current into the spinal cord. Recently, however, spinal cord stimulators have come under scrutiny. These developments have caused many patients to worry about potential side effects before receiving the device.
The attorneys at Wisner Baum can explain what a spinal cord stimulator (SCS) is, potential long-term and short-term side effects attributed to the device, and what someone can do if they are negatively impacted by an SCS after it is implanted.
A spinal cord stimulator is a medical device that is implanted in the area near the spinal cord in patients with chronic pain. It emits an electrical current into the spinal cord that can help to block pain signals. Spinal cord stimulators are often used in patients with chronic back or leg pain and in cases where other, non-surgical methods have failed. The device may also be used in patients with failed back surgery syndrome or complex regional pain syndrome.
Trial vs. permanent spinal cord stimulators:
Spinal cord stimulators may be implanted on a trial or permanent basis. A healthcare provider may recommend a trial of one week or more to determine if the therapy will be effective. During the trial phase, the device is worn externally and does not require any incisions. If the trial is successful, or in cases involving severe chronic pain, the SCS may be permanently implanted for long-term use. In both instances, the device may be used in conjunction with pain medication.
Spinal cord stimulators have been associated with a number of side effects. These side effects may be short- or long-term. Any new or worsening symptoms after SCS implantation should be discussed immediately with a healthcare provider. Spinal cord stimulator side effects may be normal but could be a sign of a serious problem from infection to device malfunction.
Spinal cord stimulators have a number of known short-term side effects. Some are common and some are more rare. Any side effects of a spinal cord stimulator should be discussed with a healthcare professional who can determine whether there is additional treatment that may be necessary.
Common short-term side effects of spinal cord stimulators:
More rare short-term side effects of spinal cord stimulators may include signs of infection such as redness, swelling, or a fever. The device may also cause stomach pain or bowel discomfort in some situations.
In addition to short-term side effects, there have been some long-term side effects reported with spinal cord stimulators, according to legal documents.
Long-term spinal cord stimulator implant side effects:
Most long-term side effects of spinal cord stimulators are rare, but there have been a significant number reported. Lawsuits have been filed nationwide against SCS manufacturers alleging that they knew or should have known about the risk of injury and failed to warn consumers.
Yes, spinal cord stimulator side effects may vary by brand.
Spinal cord stimulator brand specific side effects:
Nevro spinal cord stimulator side effects: Patients filing lawsuits against Nevro allege the HFX spinal cord stimulator caused vagus nerve overstimulation, leading to cardiac arrhythmias, bowel dysfunction, dysmotility, incontinence, and syncopal episodes. Lawsuits further allege that these autonomic injuries can become functionally permanent even after device removal, and that Nevro failed to adequately warn patients and physicians about these risks.
Medtronic spinal cord stimulator side effects: Patients filing lawsuits against Medtronic allege its spinal cord stimulators caused unintentional electric shocks, burning pain worse than before implantation, lead migration, rapid battery loss and charging failure, device non-function, worsening pain, and urinary incontinence. Lawsuits further allege that Medtronic dismissed patient complaints and made over 400 post-approval design changes to the device without conducting new clinical safety trials.
Boston Scientific spinal cord stimulator side effects: Patients filing lawsuits against Boston Scientific allege its WaveWriter Alpha and related SCS devices caused unpredictable shocking sensations, nerve pain, lead migration, and battery displacement requiring revision surgery. Lawsuits further allege the devices caused stimulation-induced autonomic dysfunction, including urinary incontinence, orthostatic hypotension, and cardiac arrhythmia.
Abbott spinal cord stimulator side effects: Patients filing lawsuits against Abbott allege its Proclaim and related SCS devices caused painful electric jolts, burning and overheating at the device site, nerve damage, excruciating cold pain, and battery failure. Lawsuits further allege Abbott concealed a broader set of serious complications, including cardiac arrhythmias, bowel and bladder incontinence, dysphagia, cognitive disturbances, and lower extremity weakness.
The US Food and Drug Administration (FDA) received 107,728 medical device reports related to spinal cord stimulators between July 2016 and July 2020, including reports of 428 patient deaths. The FDA cautioned that these reports do not contain enough information to establish that the devices caused or contributed to the deaths.
A study published in Current Pain and Headache Reports found that while implantation of an SCS device is less invasive than other procedures, complications may still arise. The most common are hardware complications. However, less common complications may include neurological injuries, infections, and biological complications that can cause serious injuries.
Any new or worsening symptoms that develop after the implantation of a spinal cord stimulator should be reported to a health care provider as soon as possible. Emergency medical treatment may be needed if there are signs of infection, including fever, redness, or swelling. Patients should also seek emergency treatment if they experience increased pain, paralysis, extreme headaches, or burning sensations.
Reporting complications immediately can help to ensure a prompt diagnosis and treatment, and may also be important in any legal action taken against the manufacturer. Medical records often prove pivotal in cases against medical device manufacturers.
If you are experiencing any complications after having a spinal cord stimulator implanted, you should immediately report them to a healthcare provider. While some side effects are common, others may be a warning sign of something more serious. Depending on the case, a patient may also be eligible to file a lawsuit against a manufacturer. Contacting a spinal cord stimulator lawyer as early in the process as possible may prove critical.
Individuals experiencing side effects from a spinal cord stimulator may qualify for a lawsuit. The best way to determine whether you or a loved one meets the criteria for taking legal action is by consulting with an attorney.
Qualifying factors for a spinal cord stimulator lawsuit:
Individuals who have suffered harm from a spinal cord stimulator are encouraged to contact a lawyer as soon as possible. A spinal cord stimulator lawyer can help to seek justice by holding manufacturers accountable for their alleged negligence or wrongdoing. The attorneys at Wisner Baum will help to determine eligibility, secure necessary evidence, and file a claim against all potentially liable parties.
Contact the spinal cord stimulator lawyers at Wisner Baum today at (310) 207-3233 for a free and confidential case evaluation.
