Did you get a spinal cord stimulator to manage chronic pain?
You’re not alone. Tens of thousands of other patients just like you have had these devices implanted in the United States alone, all with the desire to end chronic back, nerve or joint pain. The problem is:
A growing number of these implants have been recalled. And patients are getting hurt.
The good news?
You have legal rights if you or a loved one have been injured by a defective pain implant. Here’s everything you need to know about your options and what to do.
In this guide:
- What Is A Pain Implant Recall?
- Why Lead Migration Injury Is So Common
- The Latest Recalls You Should Know About
- Patient Rights After A Recall
- Legal Options For Affected Patients
What Is A Pain Implant Recall?
A pain implant recall occurs when a company or FDA removes a device from the market due to safety concerns for patients.
They provide pain relief by sending mild electrical pulses to the nerve to stop pain signals. Conditions treated with these devices (sometimes referred to as spinal cord stimulators or SCS) include:
- Chronic back pain
- Failed back surgery syndrome
- Complex regional pain syndrome
- Diabetic neuropathy
Sounds great, right?
The issue is that too many of these implants are failing. Folks have faced problems ranging from faulty devices to severe bodily injury. Some of these patients were injured more severely by the device than their original pain.
Why Lead Migration Injury Is So Common
Lead migration occurs when the electrical leads within a spinal cord stimulator move from their original placement.
When the leads move, two things go wrong:
- The patient stops getting proper pain relief
- Unwanted stimulation can cause new pain or nerve damage
It is one of the most frequently encountered complications and the most common reason why patients return to surgery. Published literature cites migration rates of leads anywhere from 10% to 25% of patients with permanent implants.
If you or a loved one has suffered because of these failures, filing a spinal cord stimulator lawsuit may be your best option to seek recovery for the medical expenses, lost wages, and suffering caused by a lead migration injury. Numerous manufacturers have been named in these lawsuits for failing to properly warn both doctors and patients.
Here’s the kicker:
When you have a lead migration injury, you often need revision surgery. This translates to another operation, more anesthesia, more recovery time and even MORE risk to the patient. Some patients have had multiple operations just to correct one faulty device.
The Latest Recalls You Should Know About
The numbers are pretty shocking when you look at them.
The FDA says there were over 80,000 injuries reported from spinal cord stimulators in 10 years. This makes them the third leading cause of medical device injuries in the United States.
And it doesn’t stop there.
FDA has issued over 40 recalls of spinal cord stimulators since 2010 for major manufacturers such as:
- Abbott (St. Jude Medical)
- Boston Scientific
- Medtronic
- Nevro
In September 2023, Abbott issued a Class I recall of devices linked to 73 reported injuries. The recall affected more than 155,000 Proclaim and Infinity devices. Affected devices were unable to exit MRI mode, cutting off patients’ therapy and frequently requiring revision surgery.
Months later in July 2024, Boston Scientific issued a recall for almost 77,000 WaveWriter Alpha systems. This was due to a software issue that resulted in the product unexpectedly resetting while charging.
Both of these recalls are now part of major lawsuits.
Patient Rights After A Recall
If you have a recalled pain implant, you have rights.
Most patients don’t know this, but a recall is just the start.
Here’s what patients are entitled to:
- To be notified by the manufacturer about the recall
- To receive clear information about the risks
- To get proper medical care to manage the defect
- To pursue compensation through the legal system
The problem is that companies don’t always make that easy. Patients are often the first to learn of a recall through their own investigation. Or even worse, after they have been hurt. That is a huge disconnect.
And it gets worse…
Accusations have surfaced that device companies exploited loopholes in the FDA process to rush updates to market without safety checks. These devices were given to patients without safety reviews that would have ideally identified issues sooner.
Legal Options For Affected Patients
Ok but what can you DO about it? Plenty, as happens to be the case.
Product Liability Claims
This would be considered the most typical route legally. Product liability claims are brought against the manufacturer for:
- Defective design
- Manufacturing defects
- Failure to warn about known risks
- Misleading marketing
Patients may be able to receive compensation if they can prove that the device caused them harm and the manufacturer was negligent.
Joining A Multidistrict Litigation
Multidistrict litigation, better known as MDL, is when large groups of lawsuits are consolidated for efficiency. There are currently MDLs being organized against the large spinal cord stimulator manufacturers.
The benefit?
You are not alone against a large medical corporation. Your case is proceeding with hundreds of others just like it. Discovery is coordinated among the attorneys.
What Compensation Is Available?
It depends on the case but typically includes:
- Medical bills (past and future)
- Lost wages and lost earning capacity
- Pain and suffering
- Revision surgery costs
- Long-term care needs
Timing is critical. Every state has a statute of limitations for these claims. Waiting too long damages your case.
What Patients Will Need
To build a strong claim, patients should collect:
- All medical records
- Device model and serial number
- Any recall notices received
- A diary of symptoms and pain levels
The more documentation, the stronger the case will be.
Final Thoughts
Pain implant recalls are a serious problem — and patients are paying the price.
Have you had a spinal cord stimulator implanted and suffered injuries such as lead migration injury, shock felt or infections? Device failure? You do have options. You are not forced to accept the injuries and go on.
Patients now have actual avenues through the legal system to pursue accountability from manufacturers. This can be either through a product liability lawsuit or by becoming part of an MDL. Here’s how…
- Get medical care for the immediate issue
- Document everything (symptoms, surgeries, expenses)
- Talk to a qualified product liability lawyer
- File the claim within the legal deadline
Patients were just trying to cope with pain. Now it’s time for the makers to step up and do the right thing as well.
