Revision and replacement procedures are a common experience for many spinal cord stimulator patients, rather than a rare complication. Published research indicates that nearly half of spinal cord stimulator (SCS) patients eventually experience loss of efficacy. These failures often occur within 1 to 2 years of implantation. When an SCS patient experiences a loss of effectiveness, it may require stimulator revision or replacement surgery. The need for replacement or revision surgery is well documented in the medical literature.
If you or a loved one underwent spinal cord stimulator revision or replacement surgery after a device failure, you may have questions about the recovery process, why the device failed, and whether the failure could have been prevented. Our firm can help you understand your legal options.
Understanding the Difference Between Revision and Replacement
When it comes to spinal cord stimulation, revision and replacement refer to two different procedures. Revision surgery addresses a specific problem. It may reposition a stimulator that has lost effectiveness or moved out of place, or re-anchor leads that have shifted. Other reasons for a revision include a broken lead or hardware that is failing to perform as intended.
Replacement surgery, on the other hand, swaps out a part of the spinal cord stimulator or the entire system. Most often, replacement surgery is necessary when the battery in the implantable pulse generator is depleted or when the device cannot be repaired.
In some circumstances, patients may undergo both a revision and a replacement procedure within the same surgery. For patients, understanding what was done during the surgery can help with recovery expectations. It is important to note that these procedures are common for SCS patients. Published research indicates that these surgeries are often the result of technical problems rather than the body rejecting the device.
Healing After Revision or Replacement Surgery
Spinal cord stimulator revision or replacement surgeries are commonly performed on an outpatient basis, meaning many patients return home the same day. However, each person’s recovery depends on the complexity of the procedure and their overall health. It can take a few days to a week for patients to resume light activities, depending on the recovery. Throughout recovery, patients will receive instructions on caring for the surgical wound. Patients experiencing new or worsening symptoms should always seek medical care as soon as possible to determine if there has been a complication.
Patients will often be given a follow-up appointment shortly after surgery to allow the provider to check the incision site and determine whether any leads have been repositioned. SCS revision or replacement patients are strongly encouraged to keep all follow-up appointments to ensure the wound is healing properly and to allow for device reprogramming as necessary.
Every recovery is different and depends significantly on the patient and the actual procedure. Some patients may need more follow-up than others to ensure the device is working properly. SCS patients should direct specific recovery questions to their healthcare provider.
What Happens When Problems Persist
In some instances, revision or replacement surgery may not fully resolve the problems a spinal cord stimulator patient experiences. While some patients may undergo one procedure, regain pain relief, and move on, others do not. In some cases, the surgery does little to correct the issue the patient was experiencing, or worse, causes them to develop new problems.
It is important for SCS replacement or revision patients to document any new or worsening symptoms and to report them to their healthcare provider.
Symptoms that may warrant a return visit to a provider include but are not limited to:
- Renewed loss of pain relief
- New or worsening pain at the implantation site
- Abnormal shocks or electronic pulses
- Signs of infection, including redness, warmth, or drainage
Any indication of a problem should be reviewed by a medical provider for prompt medical evaluation, diagnosis, and treatment.
Unfortunately, revision or replacement surgeries after spinal cord stimulator implantation are not always a permanent fix. Leads can still shift, scar tissue can form and alter how a device performs, or underlying pain patterns can change. Because of the potential for problems to return or new issues to arise, many patients have to undergo more than one procedure.
How Often Patients Need Repeat Procedures
Multiple studies indicate that spinal cord stimulators frequently need to be revised or removed. A systematic review of 25 studies covering over 13,000 patients between 1984 and 2024 found that explantation rates reached as high as 38%, with most occurring within the first year after implantation. The leading reasons for revision or removal were inadequate pain relief/loss of efficacy (38%), lead failure or migration (15%), or infection (14%), according to the study.
As the study shows, repeat surgery, repositioning, and battery replacements are common experiences for SCS patients across the country.
Whether Patients Were Adequately Warned About the Risks
Lawsuits filed nationwide allege that certain SCS manufacturers knew or should have known their devices were prone to failure and failed to adequately warn patients about the risks. Risks include the potential for lead migration, device malfunction, or a loss of effectiveness/pain relief.
A review of the FDA’s MAUDE database by Public Citizen found more than 220,000 adverse event reports associated with implanted spinal cord stimulators between 2004 and 2019, including more than 156,000 injury reports and 931 deaths.
Patient-reported injuries included:
- Loss of effective pain relief
Some legal claims allege that SCS manufacturers made extensive post-FDA-approval design changes without performing additional safety testing. Patients are encouraged to review spinal cord stimulator side effects and their causes. Any adverse symptoms should be reported immediately to a health care provider for medical evaluation.
Why Your Surgical Records Are Worth Keeping
Surgical records often prove critical in a legal claim. Keeping documentation from a revision or replacement surgery, such as operative reports, device identification cards, imaging, and other medical records that note the manufacturer and SCS model number, can help to strengthen a case. These records can establish what device was implanted and what complications occurred.
Considering Your Options Beyond the Operating Room
People who experienced complications from a spinal cord stimulator requiring revision or removal may be eligible to pursue a legal claim against the manufacturer. These claims generally rely on legal theories, such as design defect, failure to warn, and negligence. An attorney can help determine whether you or your loved one may be eligible to file a claim and how to proceed with the case.
Eligibility in SCS claims may depend on several factors, including the type of device implanted, the complications experienced by a patient, available medical documentation, and any applicable state-specific legal deadlines known as statutes of limitation. SCS patients who believe they have suffered harm are encouraged to seek legal consultation to determine whether they may meet the criteria necessary to file a lawsuit.
Wisner Baum offers free, confidential spinal cord stimulator case evaluation. Claims are accepted on a contingency basis, meaning clients pay no fees unless compensation is recovered on their behalf. Patients who have questions after having revision or replacement surgery may contact Wisner Baum at (310) 207-3233 to learn more.
