By Dr Rachel David
More than a million Australians each year receive a new body part, whether a hip, knee, ankle, heart valve or another implant designed to stay in the body for life. Many of these devices transform lives. But as new technologies race ahead, the rules designed to protect patients haven’t always kept pace.
This week’s 60 Minutes investigation into surgeon George Dimitroulis is a disturbing reminder of what can go wrong. Patients who received a jaw implant he helped design say they were left in chronic pain and with permanent complications. Some allege they didn’t even know their surgeon stood to profit from using it on them.
It’s a deeply distressing story. But it also exposes a broader problem most Australians don’t realise exists: not all medical implants are regulated the same way.
Most devices go through a rigorous safety assessment by the Therapeutic Goods Administration (TGA), which looks at how they’re made, the materials used, how long they last, and whether they work. But “custom-made” devices, including some 3D-printed implants, have historically skipped many of these checks. The TGA has acknowledged the risks and plans to tighten the rules, but not fully until 2029.
That leaves a window where personalised devices can be used with far less oversight, even though they stay in the body for life.
Then there’s the issue of conflict of interest. Surgeons are encouraged to disclose financial ties to device manufacturers to their patients, but many patients would never think to ask. If someone is putting a permanent device into your body, you deserve to know whether they designed it, patented it, or receive payments related to it.
Until reforms catch up, patients can and should protect themselves by asking questions. The TGA says you are entitled to know what is being implanted, why it’s being recommended, and what the risks are.
And please know this: you are not being difficult by asking. You are not challenging your surgeon’s skill or doubting their intentions. You are taking care of your body, and that is your absolute right.
Here are the five most important questions to ask:
- What exactly is being implanted?
Don’t accept vague descriptions like “a plate” or “a mesh.” Ask for the brand name, model and manufacturer. Ask how long the device has been in use and how many patients your surgeon has implanted it in. - Is it approved by the TGA?
Your surgeon should be able to explain its status and point you to independent, peer-reviewed research supporting its use for someone like you. There are almost always alternatives, including alternatives to surgical treatment. A trustworthy surgeon will explain the pros and cons of each without being threatened. - Does the surgeon have any financial ties to the device?
These include royalties, patents, training fees or consultancy payments. These relationships aren’t necessarily inappropriate, but they should be transparent and you deserve to know about them. - What are the long-term outcomes and known risks?
Even the best devices carry risks. New devices might have much less information available. Ask for data, not just anecdotes, about success rates and complications. - What happens if something goes wrong?
If the device fails or your body reacts badly, who will look after you and who pays for follow-up surgery?
Most surgeons in Australia are ethical, dedicated professionals who want patients to make informed decisions. If your questions are met with irritation or pressure, trust your instincts and seek a second opinion. Don’t sign anything you don’t understand. Never let yourself be rushed.
Health insurers see the consequences when devices fail: repeat surgeries, long recoveries, and avoidable suffering. Unlike medicines, which you can stop taking if they don’t work or have side effects, medical implants can be difficult or impossible to remove, so implant surgery should never be taken lightly. That’s why the sector supports stronger rules, better transparency and making sure new devices are backed by solid evidence before they’re widely used.
The 60 Minutes story is a wake-up call – not to fear surgery, but to be engaged and informed. Implants can change lives for the better. But they can also cause devastating harm when poorly tested, poorly chosen or shrouded in secrecy.
Until the rules catch up, your best protection is your own voice. Ask questions. Expect answers. Your health is too important to leave to chance.