As a growing number of lawsuits are filed against Abbott, Boston Scientific, Medtronic, and Nevro over allegedly defective spinal cord stimulators, patients and their families across the U.S. are asking the same question: How do spinal cord stimulators fail?
Unlike many medical devices, these are sophisticated electronic systems. Since spinal cord stimulators have a combination of hardware, software, batteries, and wireless communication that must all be working properly to provide pain relief, there are several components that could malfunction.
As the technology evolved over the last two decades, so have the allegations surrounding device failures and what specifically caused them to fail and injure patients.
In June, we reported on the creation of the Boston Scientific multidistrict litigation (MDL). The MDL consolidated a group of cases alleging the company’s spinal cord stimulators malfunctioned and caused serious injuries.
But as awareness of the defective product lawsuits expand and more lawsuits are filed, attention has shifted to the technology of these implanted pain devices. Understandably, even patients with spinal cord stimulators that are working as intended are concerned about the potential of them failing – and how.
How Have Spinal Cord Stimulators Changed?
Spinal cord stimulators were first made available decades ago. They help patients with chronic pain that didn’t improve after other medical treatments were explored, such as surgery, physiotherapy, and medication.
While the earliest systems were relatively simple, spinal cord stimulators now have many features that weren’t available when they were first approved. For example, numerous popular devices are controlled with an app, like mySCS GO for WaveWriter systems, but there are many other differences.
Modern spinal cord stimulators function like implantable computers with several parts:
- Multiple stimulation settings
- Controllers or smartphone apps
- Bluetooth
- Programming software
- Rechargeable batteries
- Firmware updates
In general, these technological advances have helped countless patients with debilitating conditions, including nerve pain, failed back surgery syndrome, chronic back pain, and complex regional pain syndrome (CPRS). At the same time, their increasing complexity have introduced more ways they can fail.
Because of this, spinal cord stimulator lawsuits involve a range of alleged defects. Plaintiffs argue certain products failed because of design, manufacturing, or performance problems.
That doesn’t mean that every device is defective. For many patients, their implanted spinal cord stimulators have been lifechanging.
Hardware vs. Software: Spinal Cord Stimulators are More than Just an Implant
Spinal cord stimulator lawsuits against Boston Scientific, Abbott, and other manufacturers are complex because the devices themselves are complex. They include several components that must function together to work properly.
Placement of spinal cord stimulators involves electrical leads near the spinal cord, and a pulse generator (battery) is typically implanted near the upper buttock or abdomen. There’s charging equipment, external controllers, software used by physicians to adjust stimulation, and firmware that controls how the device operates.
If one component malfunctions, patients may experience:
- Loss of pain relief
- Lead migration or fractures
- Unexpected shocks or uncomfortable stimulation
- Charging failures
- Battery depletion
- Device communication errors
Given the numerous components that could fail, plaintiffs who filed spinal cord stimulator lawsuits have endured a range of complications; they required repeated surgeries, and experienced worsening pain, neurological injuries, and/ or permanent disability.
FDA Approvals and Spinal Cord Stimulators
With technological advances made all the time, it makes sense that medical devices like spinal cord stimulators have been improved since first developed. But do changes to spinal cord stimulators require approval by the U.S. Food and Drug Administration (FDA)?
Unfortunately, there isn’t a simple answer to that question. While all medical device changes require FDA oversight, not every software improvement, manufacturing change, or design modification involves the same level of regulatory review as new devices.
Major changes require certain steps, like clinical trials, whereas minor software updates and component modifications don’t. For these smaller changes, 510(k) clearances apply. Basically, manufacturers must show that the device is just as safe and effective as what was previously approved.
What Happens if a Spinal Cord Stimulator Fails?
Just like there are many reasons why a spinal cord stimulator could fail, there are different solutions too. Some involve a simple, non-invasive reprogramming to adjust the settings, but a lot of patients with a failed spinal cord stimulator require surgery.
Minor surgery may be needed for broken wires and depleted batteries. In other cases, explant surgery is required to remove spinal cord stimulators, which can be much more complicated than when the device was initially implanted.
While studies show the most common reason for spinal cord stimulator explantation is due to inadequate pain relief (it didn’t work as intended), lead failure and infection are the next most common causes.
When lead migration occurs, patients experience a tingling sensation, known as parathesias, in a different area of the body than where their pain is.
Then there are infections, which usually occur near the battery pack. Symptoms include swelling, pain or discharge and redness, and/ or fever or delirium.
Patients have also experienced unexpected, painful shocks, something several plaintiffs who filed spinal cord stimulator lawsuits allege were caused by a defective device.
What are the Spinal Cord Stimulator Lawsuits About?
Although individual allegations vary, plaintiffs generally claim that companies designed or manufactured defective spinal cord stimulators and/ or failed to adequately warn physicians and patients of the risks. Many plaintiffs had to undergo repeated – and costly – revision, explant, or replacement surgeries.
Some cases involve battery failures, while others are based on lead migration, electrical malfunctions, unexpected shocks, software problems, or loss of efficacy due to alleged defects.
What Makes Spinal Cord Stimulator Lawsuits Difficult?
Defective medical device lawsuits are rarely straightforward. Unlike being injured immediately after using a consumer product, spinal cord stimulator patients already had severe chronic pain before the device was implanted.
This complicates cases because if a patient’s pain worsens, it’s difficult to determine whether it’s caused by their underlying condition or a defective device. That’s why expert witnesses and medical records are crucial in spinal cord stimulator lawsuits.
What’s Next in the Spinal Cord Stimulator Lawsuits?
Individual cases are still being filed, and the federal spinal cord stimulator MDL involving Boston Scientific devices, including WaveWriter and Precision, is in its early stages. The next part of the MDL involves further organizing evidence, selecting cases for bellwether (test) trials, and scheduling expert testimony.
Early trials will not resolve every lawsuit, but they’re likely to provide valuable insight into how cases play out in court. They may also influence future spinal cord stimulator settlement discussions.
Individuals who had their SCS fail, required surgery, or suffered worsening injuries after implantation can learn their legal options by speaking with an experienced defective device attorney. Since statutes of limitations vary by state, waiting too long could affect eligibility to file a claim.
