Spinal Stimulator Device Migration with Injury: Device and Doctor

Spinal cord stimulators are linked to over 80,000 injuries, with lead migration and hematomas causing severe harm

SANTA BARBARA , CA, UNITED STATES, January 13, 2025 /EINPresswire.com/ -- “The Food and Drug Administration has flagged over 80,000 injuries caused by spinal cord stimulator (SCS), making them the 3rd most flagged medical device," states Dr. Wayne K. Cheng, MD, Loma Linda Orthopedics Spine.

Greg Vigna, MD, JD, national product liability attorney and neurological injury attorney, comments, “Lead migrations cause neurological injury or injuries to organs or structures impacted by the leads. Injuries are generally caused by direct trauma from the migration of the leads but also can be caused by hematomas that may cause spinal cord compression and paralysis.”

Dr. Vigna continues, “Interestingly, spinal cord stimulator hematomas associated with spinal cord compression are 300% higher than what is observed with non-spinal cord stimulator laminectomies, which is a real risk with these devices.”

What was reported in “Analysis of reasons for medical malpractice litigation due to spinal cord stimulator” published in Interventional Pain Medicine 2(2023) 100376?:

“Case outcomes (settlement, plaintiff or defendant ruling) did not statistically vary based on the SCS (spinal cord stimulator) manufacturer type—St. Jude, Boston Scientific Corp., or Medtronic.

Claims due to SCS infection were more likely to result in a defendant verdict, whereas claims filed due to hematoma and resultant paralysis were more likely to result in a plaintiff verdict.

Six (13.33 %) cases were filed in Georgia, 4 (8.89 %) in Delaware, 4 (8.89 %) in Louisiana, 4 (8.89 %) in Ohio, 4 (8.89 %) in Texas, 3 (6.67 %) in California, 3 (6.67 %) in Florida, 3 (6.67 %) in Indiana, 2 (4.44 %) in Michigan, 2 (4.44 %) in Mississippi, 2 (4.44 %) in New York, 2 (4.44 %) in Oklahoma, 2 (4.44 %) in Virginia, 1 (2.22 %) in Illinois, 1 (2.22 %) in Oregon, 1 (2.22 %) in Pennsylvania, and 1 (2.22 %) in Utah."

Read Dr. Cheng’s study: https://www.sciencedirect.com/science/article/pii/S277259442300208X

Dr. Vigna adds, “We understand that device manufacturers will consistently point the finger at implanting physicians when faced with a product liability lawsuit. It is important for physicians to understand what the manufacturers knew or should have known prior to the physician selecting the device to be implanted in their patient.”

Read "Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters", published in the Annals of Internal Medicine, Volume 177, Number 12: https://www.acpjournals.org/doi/abs/10.7326/ANNALS-24-00089

Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic pain syndromes caused by mini-slings such as the Coloplast Altis sling and Boston Scientific Solyx sling that include pudendal neuralgia and obturator neuralgia. He represents clients with both medical malpractice and product liability claims across the country. He litigates these cases with the Ben Martin Law Group, a national pharmaceutical injury law firm in Dallas, Texas.

Click here for a FREE BOOK on Vaginal Mesh Pain.

Read Dr. Vigna’s book "Mother's Guide to Birth Injury"

Greg Vigna, MD, JD
Vigna Law Group
+1 817-809-9023
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