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Spinal Cord Stimulators – high complication rates and serious adverse events

spinal cord stimulator

Spinal cord stimulators are implanted devices designed to relieve pain by sending low level electrical signals directly to the spinal cord.  This signal interrupts the pain messages and therefore reduces pain. 

Or that’s the theory. In practice, the devices often leave patients in more pain and the devices are often removed.

Pain patients are being forced into trying a spinal cord stimulator in a misguided attempt to reduce their opioid pain medications when these spinal cord stimulators are often ineffective and have a very high complication rate, leaving patients in MORE pain, not less.

From the article :

“A $35,000 treatment at the forefront of medical technology which pumps electric pulses into the spine of patients with chronic back pain is leaving some incontinent, unable to walk or, in a few cases, dead.”

The number of operations in Australia has more than trebled from 1355 operations in 2008-2009 to 4433 in 2016-17.  Why?  It’s a lucrative industry projected to be worth $AU7 BILLION globally by 2030.

The Therapeutic Goods Administration received 520 reports of serious injuries linked to spinal cord stimulators.  Seventy-nine percent were “severe” and 13 percent were “life-threatening”.  Eighty-three percent required further surgery to correct.

Yet the Neuromodulation Society of Australia states they deliver 80% pain control or more and come with only “minor risks”.

Clearly the statistics do not bear that out.  Serious incidents reported to the TGA include:

  • Patients lost the use of their legs, which was only partially regained after the device was removed
  • Lost feeling in limbs
  • Incontinence
  • Tears and punctures in the spinal cord
  • Spinal fluid leaks
  • Infection and death

More common, less serious issues include:

  • Overstimulation and constantly being shocked by the device
  • The device not reducing pain
  • Headaches
  • Infections
  • Pain at the surgical site
  • Leads detaching from the spine and moving around the body or protruding through the skin

Statistics show 83% required further surgery to resolve the problems, and four out of ten spinal cord stimulators are subsequently removed due to malfunction and complications. 

Their use remains deeply controversial. A Cochrane review in September 2021 found that “a stimulator probably did not provide clinically important improvements in pain compared to a placebo, although the overall evidence was of very-low-quality.”  Cochrane reviews are generally considered the gold standard evidence.

Read the full article:

https://www.smh.com.au/national/to-hell-and-back-devices-meant-to-ease-pain-are-causing-trauma-20220203-p59tf3.html

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