The Carlson Law Firm is investigating cases where spinal cord stimulators caused severe injuries or losses.
A nationwide lawsuit includes multiple defendants responsible for spinal stimulators that can cause permanent digestive disorders, permanent vertigo, permanent syncope or the loss of the option to seek a future back surgery. Abbott, Boston Scientific, Medtronic, St. Jude and Nevro failed to disclose the full extent of the risks associated with the permanent battery-powered devices intended to relieve pain. The damages caused by the spinal stimulators include the following:
- Burning caused by device
- Electric shock by device
- Lead wire fracture/migration
- Urinary incontinence or retention
- Gastroparesis
- Dysphagia
- Uncontrollable diarrhea (fecal incontinence)
- Dizziness/fainting (cognitive complications)
- Ineffective or worsening pain
- Cardiac Arrhythmia
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What are Spinal Cord Stimulators?
The first spinal cord stimulators (SCS) date back to the 1960s to help people with chronic back pain. The device has electrode wires that send low levels of electrical impulses to the spinal cord. A battery implanted under the skin provides the power to the leads.
Since the first SCS was developed by Medtronic in 1968, multiple advances have been made, and additional companies have developed other models. In the 1980s, long-lasting lithium batteries enabled spinal stimulators to become more sophisticated. Modern spinal cord stimulators are divided into three categories:
Current models of SCS’s can be prescribed for the following conditions:
- Arachnoiditis (inflammation of the membrane that covers the brain and spinal cord)
- Angina (heart pain)
- Chronic back pain
- Complex regional pain syndrome
- Peripheral vascular disease
- Post-amputation pain (phantom limb)
- Post-surgical pain
- Nerve-related pain (severe diabetic neuropathy and neuropathy caused by radiation, surgery, or chemotherapy)
- Spinal cord injuries
- Visceral abdominal pain and perineal pain
How Do Spinal Cord Stimulators Work?
Spinal cord stimulators have wires that connect the battery to nerve endings in the spinal cord. During surgery, the wire leads are implanted between the spinal cord and vertebrae. The battery is connected to the leads that send electrical impulses to the nerve endings that cause the pain. Patients receive a remote they can use to initiate and control the level of electrical impulses whenever pain ensues. The electrical impulses will interrupt the pain.
What’s wrong with the stimulators, and how does the lawsuit work?
Over the years, several issues have occurred with different SCS models. Some problems include non-compliance with FDA regulations related to electrical components, proper reporting of adverse events and manufacturing defects.
Electrical Issues
SCS Effect on Tissue
In order to make sure that tissue doesn’t burn or become damaged by the electrical impulses in medical devices, the FDA regulates based on how the body responds to the charges. The resistance that tissue has to changes in electric charge is called impedance and is measured in units called Ohms. The FDA requires that the lead wires remain below 18 Ohms. Some SCS models did not meet this standard, which could result in severe burns and permanent damage to nerves and other tissue.
SCS Temperature
The FDA also regulates the maximum temperature a device can reach inside the body. According to the FDA, the implantable pulse generators that power SCSs should not exceed 42°. Several SCSs did not comply with this requirement.
IPG Malfunction
Electrical malfunctions can cause misfiring of the electrical impulses leading to overstimulation and increased, even crippling, pain. Furthermore, electrical charge misfiring can also cause permanent nerve and tissue damage.
Failure to Report SCS Adverse Events
The FDA requires manufacturers of Class III medical devices like SCSs to report adverse events that occur during or as a result of the device’s use. However, SCS manufacturers have underreported severe adverse events to the FDA and MAUDE database, as required. Notwithstanding, an Associated Press investigation found that as of 2018, SCSs were the third-highest cause of medical device injuries.
Breach of Warranty
Manufacturers’ sales representatives had direct access to potential patients, during which they misrepresented the benefits and risks of the SCSs. Common sales points would focus on the permanency of the device without adequately underlining the risks of the implant. Potential patients were offered complete and permanent relief—something the devices could not deliver. Reps also failed to warn that the implant would prevent them from getting MRIs in the future and prevent them from being candidates for some other surgeries. Additionally, removal of the leads requires surgery that can often involve monumental risks such as paralysis and spinal cord injuries such as epidural hemorrhages that can affect neurological functions. Furthermore, SCS recipients are required to turn off their devices while they drive motor vehicles or operate heavy machinery.
Types of Defective Spinal Cord Stimulators
What to Do If You’ve Been Affected
If you suffered damages due to a defective spinal cord stimulator, the following steps will get you started on the road to seeking just compensation and holding the manufacturers accountable for the negligent practices:
- Gather medical records. This includes pre-op records, surgical records and post-op records. You should also preserve records of any additional care required by the injuries caused by the defective SCS, starting from the first time you mentioned any related discomfort and spanning to the most recent medical attention. Screenshots of telemedicine chats can also be a helpful addition to the official medical records.
- Meet with The Carlson Law Firm. Consultations are free, and there is no upfront change from our attorneys handling these lawsuits.
- Join the mass torts lawsuit. If you qualify for the defective medical device lawsuit, our team will help you through the legal process.
The FDA regulates the design of medical devices, providing guidelines that must be followed. When manufacturing companies deceptively produce and sell SCSs that do not comply with the electric pulse and maximum temperature parameters, they are putting people in danger for profit. Unethical practices from big companies must be brought to justice; your injuries deserve justice. Schedule a free consultation today.
Get Help With Your Defective Spinal Cord Stimulator Case at The Carlson Law Firm
Defective medical device lawsuits are complex undertakings that go against large companies. Lawsuits against large companies where there are multiple defendants and more than one damage pattern calls for a team of experienced and caring trial attorneys. Our defective device trial attorneys will fight for your due justice with tenacity. Your experience and your injuries matter, and seeking justice is what we do best. We care. We can help.