Spinal Cord Stimulator Complications: What Are Your Legal Options?

Chronic pain can be debilitating, impacting every aspect of your life. When conservative treatments fail, a spinal cord stimulator (SCS) may seem like a beacon of hope. These devices, implanted to disrupt pain signals, can offer relief for many. However, like any medical procedure, SCS implantation carries risks. According to the American Society of Regional Anesthesia and Pain Medicine, complications from spinal cord stimulator implantation are estimated to range from 30% to 40%. If you’ve experienced complications, understanding your legal options is crucial. This article will guide you through the potential issues and how to seek recourse.

Understanding Spinal Cord Stimulators

A spinal cord stimulator is a device that sends electrical pulses to the spinal cord to block pain signals from reaching the brain. It involves implanting electrodes near the spinal cord and a pulse generator, usually under the skin. While SCS can be effective, it’s not without risks.

Common Complications of Spinal Cord Stimulators

Complications from spinal cord stimulators can be broadly categorized into device-related and biological issues. Here’s a breakdown:

Device-Related Complications:

Lead Migration: This is one of the most common issues, where the electrodes move from their intended position, reducing the device’s effectiveness. A study in the journal Pain Physician found lead migration rates ranging from 20% to 22.6%.
Lead Breakage: The wires can fracture or disconnect, interrupting the electrical signals.
Hardware Malfunction: The pulse generator or other components can fail, requiring repair or replacement.
Battery Failure: The generator’s battery has a limited lifespan and may need replacement.
Over or Under Stimulation: The device may deliver too much or too little stimulation, causing discomfort or inadequate pain relief.
Intermittent Stimulation: The device may not consistently deliver the electrical pulses.

Biological Complications:

Infection: Because the procedure involves implanting a device, there is a risk of infection at the surgical site. Infections can range from superficial to deep and may require additional surgery to treat, and in some cases, the device may need to be removed. Infection rates range from 2% to 10%.
Epidural Hemorrhage: Bleeding in the epidural space can cause pain and other complications.
Seroma: Fluid accumulation around the implanted device can lead to infection and pain.
Dural Puncture: If the dura mater (the membrane surrounding the spinal cord) is punctured during the procedure, it can cause severe headaches.
Neurological Injury: Though rare, nerve damage or paralysis can occur during implantation.
Pain Over Implant Site: Some patients experience pain at the site of the implanted device.
Allergic Reaction: An allergic reaction to the device materials is possible.
Skin Breakdown: The skin over the implant site can break down.
Spinal Cord Trauma: In extremely rare cases, the insertion of the stimulator can cause nerve injury and paralysis.

When Complications Arise: What Are Your Legal Options?

If you’ve experienced complications from a spinal cord stimulator, you may have legal recourse. Here are some avenues to explore:

Medical Malpractice: If your complications resulted from negligence during the implantation procedure, you might have a medical malpractice claim. This could include:
- Improper Implantation: Errors during surgery, such as damaging nerves or other structures in the spine.
- Inadequate Pre-operative Planning: Failure to properly assess the patient’s condition before surgery.
- Failure to Monitor: Not adequately monitoring the patient after surgery for complications.
- Unnecessary Surgery: Implanting the device when it was not medically necessary.
- Failure to Remove Leads: Not removing the leads promptly when complications arise.
Product Liability: If the device itself is defective, you may have a product liability claim against the manufacturer. This could include:
- Design Defects: Flaws in the device’s design that make it inherently dangerous.
- Manufacturing Defects: Errors during the manufacturing process that result in a faulty product.
- Failure to Warn: Inadequate warnings about the risks associated with the device.
- Inadequate Testing: Failure to conduct sufficient safety testing before releasing the device to the market.
Defective Medical Device Lawsuit: These lawsuits often involve allegations of device malfunction, inadequate testing, failure to warn patients of risks, and non-compliance with FDA requirements.

What Damages Can You Recover?

If you have a valid claim, you may be able to recover compensation for:

Medical Expenses: Costs related to treating the complications, including additional surgeries, hospital stays, and medications.
Lost Wages: Reimbursement for time away from work due to the injury.
Pain and Suffering: Compensation for the physical and emotional distress caused by the faulty device.
Corrective Treatments: Compensation to replace or correct the defective device.
Punitive Damages: In some cases, additional damages may be awarded to punish the manufacturer for particularly egregious negligence or misconduct.
Loss of Consortium: Compensation for the impact on relationships with family members.

Taking Action: What You Should Do

If you believe you have a case, here are the steps you should take:

Seek Immediate Medical Attention: If you experience any complications, seek medical care promptly.
Document Everything: Keep detailed records of your symptoms, medical treatments, and any expenses related to your complications.
Consult a Lawyer: Contact a personal injury attorney experienced in medical device litigation. They can evaluate your case, advise you on your legal options, and help you navigate the complex legal process.
Gather Information: Identify the device, including its model and manufacturer. This information can usually be found on the device or in your medical records.
Stay Updated: Check the FDA’s database for details on any recalls or safety alerts related to your device.

Why You Need an Experienced Attorney

Navigating the legal landscape of medical device complications can be challenging. An experienced attorney can:

Evaluate Your Case: Determine if you have a valid claim and what legal options are available.
Gather Evidence: Collect medical records, expert opinions, and other evidence to support your case.
Negotiate with Insurance Companies: Deal with insurance companies on your behalf to ensure you receive fair compensation.
Represent You in Court: If necessary, represent you in court to fight for your rights.
Maximize Your Compensation: Work to ensure you receive the maximum compensation you deserve.

Conclusion

Spinal cord stimulators can offer significant pain relief, but they are not without risks. If you’ve experienced complications, understanding your legal options is essential. By taking the necessary steps and seeking the help of an experienced attorney, you can protect your rights and pursue the compensation you deserve. Don’t let the burden of medical device complications weigh you down. Contact us today for a free consultation to discuss your case and explore your legal options.