He says his life improved when he chose to have the stimulator taken out. "All options are on the table to ensure that medical devices are properly regulated," he said. He also requested an urgent update on the TGA's review. Health Minister Mark Butler said he was "deeply concerned" by what was revealed by Four Corners and has asked his department to investigate. "We've seen the devastating impact of harmful surgery on Australians through the recent high-profile scandals involving use of hernia mesh for pelvic organ prolapse and metal-on-metal hip implants … We need urgent action to protect Australians with back pain from a similar experience." "Australians should be confident they are receiving safe, high-quality health care," Dr David said in a statement. The TGA launched a post-market review into spinal cord stimulators in 2022, but the results are yet to be published. They range from infections to recurring shocks, brain haemorrhage and paralysis - but the TGA notes the reports are not conclusive.Īfter a workplace accident left him with back pain, Gordon Myers got his first stimulator in 2013.įollowing Four Corners' investigation, Private Healthcare Australia is now calling for "the immediate recall and suspension of spinal cord stimulators to protect public safety", pending a review by the TGA. It told Four Corners it has received around 2,000 reports of adverse events relating to spinal cord stimulators since 2012. The Therapeutic Goods Administration (TGA), which regulates medical devices in Australia, runs a database that tracks harmful and negative patient outcomes. Others who have had the devices successfully implanted have gone on to suffer serious complications. She says she is now in more pain than before the surgery, requiring three times the amount of painkillers. Teresa was supplied with material outlining the risks of the stimulator surgery but says her specialist downplayed them. "You'll lose control of your proper bowel functions … bladder function, you'll lose sexual function. You won't feel any temperature … no touch, but all you'll feel is pain," she says. "Nobody tells you that paralysis means you won't feel anything.
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