It’s not just women who are the losers following the latest TGA announcement. People with all types of medical devices need better regulatory protection.
The proposed Australian ban of some types of breast implants is too little, too late. It also reveals regulatory failures that need to be fixed if Australian consumers are to be protected.
Nearly all medical product recalls are voluntarily issued by firms, instead of mandated by the FDA.
Every year, thousands of medical devices and drugs are recalled in the US. But the decision to recall a flawed product is often left up to the manufacturer.
At last count, 11% of Australian women used long-acting reversible contraception methods.
Unlike condoms, which need to be used every time with sex, or the pill, which must be taken every day, LARC doesn’t require any action after placement in the body and is immediately reversible.
Advances in technology mean it’s now possible to 3D print everything from prosthetic limbs to skin, bones and organs.
Who should be legally responsible when 3D printed devices fail? Proposed changes to the Therapeutic Goods Administration's regulatory framework have the potential to settle that question.
Australia’s medical regulator needs to do more about cybersecurity.
Australia's Therapeutic Goods Administration must learn to deal with software rather than simply bits of metal and plastic.
Embedded medical devices will continue to be vulnerable to cybersecurity threats. The pacemaker depicted is not made by Abbott’s.
Pacemakers are Internet of Things devices for the human body, but they're still not particularly secure.
One day doctors could instantly diagnose your illness with a handheld device.
Hundreds of women have complained of adverse reactions from transvaginal mesh implants.
Regulatory bodies approved some medical devices to treat pelvic organ prolapse and urinary incontinence before having data to prove their safety and efficacy.
Advertisements for complementary medicines don’t always reflect what’s in the bottle.
Consumers can't always be confident claims for complementary medicines stack up. Here's how to foster truth in advertising.
A hydro-responsive thread can be used with sensors to monitor body functions.
Alonso Nichols, Tufts University
Flexible, easy to make, inexpensive, stretchable and simple to coat with nanomaterials, threads are also very commonly used by doctors already.
The Medical Technology Association of Australia is quietly influential.
If your health practitioner has used a syringe, pacemaker, dental filling or joint implant to treat you, you've encountered a product from the medical technology industry.
Preterm babies are at significant risk of health and development problems, highlighting the need to get prevention strategies right.
New research has found a commonly used method of preventing early or pre-term birth (delivery of a baby before 37 weeks) may in fact be causing more to occur, and leading to further problems.
The brain implant sends signals to anything from a bionic prosthetic limb, to a full body ‘exoskeleton’
A 3cm-long stent containing 12 electrodes could one day help people living with spinal cord injury to walk with the power of thought.
We’ll soon have you fighting those Klingons again.
A handheld ultrasound device could cut wound recovery times by 30% by reawakening the body's natural healing powers.
Ron Barnes, Doug Cope, Eileen Webber and Bob Lugton feature in ABC TV’s 4 Corners documentary The Walking Wounded.
The Walking Wounded, Four Corners
Starting with Karl Marx, many thinkers have pointed out that the creative potential of the capitalist economic system comes at a cost – the lack of inherent ethical scruples to limit the inexorable logic…
Saving the heart with a plastic coat.
Every year thousands of people are fitted with artificial heart valves to replace their own malfunctioning valve. Many of these patients, however, have to remain on drugs that stop blood clotting on these…
The Odon device in action.
Flickr/Ministerio de Ciencia
There are three ways a baby can be born: a spontaneous vaginal birth where the mother pushes the baby out herself, an instrumental vaginal birth where forceps or vacuum extractors are used to pull the…
A handheld device for diagnosing the early signs of osteoporosis could be available for clinical use within five years. Unlike…
The class action against the implant manufacturer has fallen over and despite the TGA’s failings, victims can’t sue the regulator.
The announcement this week by plaintiff law firm Tindall Gask Bentley that it was abandoning a class action against the Australian distributors of Poly Implant Prosthese (PIP) breast implants illustrates…
Medical device manufacturers sometimes engage in unconscionable behaviour to secure sales to private hospitals.
Image from Shutterstock.com
Australian public interest regulators usually have a very imperfect picture of how much anti-competitive or fraudulent activity is occurring in areas such as health care. But there’s a better approach…