A global investigation has found malfunctioning medical implants have been responsible for tens of thousands of deaths around the world.
Experts are demanding greater testing of medical devices before they're approved for use in Australia.
Melbourne woman Chantelle Karo had hoped a small medical pump implanted near her spine would change her life for the better.
"The last thing I want is to be needing a frame or a stick or even a wheelchair at a young age."
She has Hereditary Spastic Paraplegia and the implant was meant to dispense the drugs she needs to keep her mobile.
But soon after the operation, she says things went wrong.
"A couple of months after the operation I noticed my pump would rotate all the time. Now I'm having problems because the catheter might be kinked, stopping the medication going to where it's needed."
She later learned some models of her pump had been recalled in the United States.
A global investigation now reveals her story is just one of many when it comes to faulty medical devices.
Journalists from 36 countries have compiled data to reveal over the past decade almost 83,000 people have died, 170 of them in Australia, because of medical device malfunction.
Columbia University’s Dr Rita Redberg told the BBC patient safety needs to be prioritised.
"As a patient, I would be terrified not to know the adverse events. We're talking about people's lives - it's really important to know if these devices are safe or not."
The research says 1.7 million people have been injured by medical devices in the past decade, with more than 8,500 of them in Australia.
But experts like Wendy Bonython [[bon-EYE-thon]], from the University of Canberra, says there could be more.
"One of the things that we know is that it's an opt-in system for doctors, so we know that a lot of things probably aren't getting back to the regulator. I would guess that it's probably an under-representation of the true toll."
The Australian regulator, the Therapeutic Goods Administration, says it builds upon assessments made in Europe before approving devices for use.
But Wendy Bonython says questions have been raised about the quality of testing performed by privately operated European assessors.
"There has been documented evidence of people (manufacturers) forum-shopping and looking around for the easiest of the assessors in order to get their device approved for use in the market."
The approval process for medical device use has recently been discussed by a Senate inquiry, following a number of reported problems with a product used to treat prolapse and incontinence in women.
While reforms have been recommended, none have yet been put in place.
CEO of the Medical Technology Association of Australia, Ian Burgess, said in a statement that... “More can be done to ensure that all adverse events are reported to devise companies and the TGA. MTAA welcomes moves by the Commonwealth Government to more closely consult with the States and Territories to ensure this happens.”
It's a move Chantelle Karo supports.
Facing more surgery, she has one wish for the pump device in her body.
"That it would be secure and not moving and that I would have no problems with it for the rest of my life."
Indian Australian Arvind Jain is an orthopedic surgeon in Melbourne.
He says there are stringent regulations around orthopedic implants in Australia.
Dr Arvind told SBS Hindi, “Most of the technology comes with the short-term basis and the trails are done for 1-2 years, but sometimes after effects are only known when patients have used them for few years.”
