![]() Common complications include lead migration, lead fracture, implant-related pain, infection, hematomas, seromas, and cerebrospinal fluid leakage. Overall complication rates for such stimulators documented in literature reviews were 30% to 40%.įDA data shows shocks, burns and spinal cord damage ranging from muscle weakness to paraplegia have been reported. Published literature reviews and an analysis of data from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database reveal that implanted spinal cord stimulators for pain relief can cause substantial harm. Only metal hip replacements and insulin pumps have logged more injuries. The FDA has flagged over 80,000 incidents caused by spinal cord stimulators since 2008. In fact, according to a recent Associated Press (AP) investigation, they account for the third highest number of medical device injury reports to the U.S. Spinal cord stimulators are more dangerous than many patients are led to believe. These devices rely upon a complex network that sends electrical currents through wires placed along the spine, using a battery implanted under the skin. Spinal cord stimulators use electrical current to block pain signals before they reach the brain. In practice, electrode placement and electrical stimulation dosing for spinal cord stimulators are done empirically. ![]() Theories, though plausible, still remain unproven. It is surmised that the devices block transmission of pain signals by nerve fibers in the spinal cord to the parts of the brain involved in pain perception. Sixty-thousand spinal cord stimulators are implanted annually.Īlthough the mechanism of the purported pain relief from inducing electrical stimulation of the spinal cord is yet unknown, several theories have been proposed. Manufacturers and doctors push these devices to patients who have injury resulting in chronic pain and to an aging population seeking chronic pain relief. Touted as an alternative to opioids, spinal cord stimulators have become one of the fastest growing sectors in a $400 billion medical device industry. Medical device companies and doctors prescribe spinal cord stimulators as a cure for millions of patients who suffer from pain disorders.
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