Some patients chose to write directly to the TGA about their experiences. For every 10 stimulators implanted in Australia, four are removed. Of the reported events, 296 were for device malfunctions, with movement of the electrode wires the most common problem 83 per cent of problems required further surgery to fix. These include overstimulation, constantly being shocked, the stimulation not working, device malfunction, headaches, infection, pain at the surgical site, or the leads detaching from the spine and moving around in the body or protruding through the skin. In addition, there were more-common side effects. Another suffered a stroke due to spending a long time in the operating theatre, and died. One patient developed infection at the surgery site, which caused multiple organ failure or sepsis, killing them. It is only recently I’ve started processing what I went through. Mrs Iacobucci had six surgeries in total before she gave up and demanded the device be removed. It just kept opening up and the leads would just pop through my skin.” A month after that surgery, I had another surgery to fix them again. “I had surgery to fix the leads, and then they became displaced again. But then, after a fall, she felt the electrodes come out of her spine. Lauren Iacobucci did receive good relief from her stimulator at first. And none of these people had received an opinion from a spinal surgeon.” That’s a pretty substantial investment to just throw in the bin. “In the last year, I have operated on three people … and taken out a stimulator and thrown it in the bin. “I think there are a moderate number of stimulators being put in inappropriately,” he said. Michael Johnson, president of the Spine Society of Australia between 20, told The Age and Herald he was calling for the development of a spinal stimulation registry in Australia to monitor how well the devices were actually working, and how much harm they were causing.
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