The watchdog seeks a bigger say in the approval process.  When doctors finally operated to remove the troublesome device, they found his flesh had turned grey-black inside.

As Lugton is one of 5500 Australians and 93,000 patients worldwide fitted with the faulty hip – withdrawn from sale here in November 2009 – it’s little wonder a class action has been launched against the manufacturer by Shine Lawyers. But the case also raises serious questions about the operation of the nation’s medical watchdog, the Therapeutic Goods Administration.

A Senate inquiry is investigating and what it has learned already is worrisome: most of the one million medical devices used here are approved by the TGA without any local assessment or clinical trial. Further, there are just 100 people employed by the TGA to approve and monitor any side effects caused by medical devices.

It’s too late for Bob Lugton, but TGA national manager Rohan Hammett is pushing for changes to the way medical devices are regulated in Australia as well as globally.

“One of the challenges for us is Australia has a mutual recognition agreement with the European Commission that mandates that where a device has been approved in Europe, we have to include it on the Australian register within five days of receiving the necessary approval certificate,” he tells Weekend Health.

That European process was heavily criticised in the British Medical Journal recently because it doesn’t mandate clinical trials and usually checks devices only after they’re on the market.

The BMJ asked 192 manufacturers to provide evidence of the clinical data used to approve their devices but was denied the information because it was “company confidential”.

The European bodies in charge of the approvals process, some of which employ only two or three people, then refused to provide their scientific rationale for approving devices. The BMJ couldn’t get the information through a freedom-of-information request as a European Union directive keeps the information confidential.

Along with Australia, the EU, Britain and the US are reviewing their regulatory systems for medical devices, and there’s a push, to set up a new, more robust global approval framework.

It’s a move that has the support of medical device manufacturers in Australia, who are also backing efforts to set up more registries to track the post-market performance of medical devices.

According to Hammett, a gastroenterologist, it’s not possible to conduct clinical trials on medical devices because, unlike medicines, you can’t give someone a placebo hip replacement.

Instead, the watchdog relies on the company that sponsors the device or the doctor who inserted it to alert it when any problems emerge. The process has been criticised by the Consumers Health Forum. When Johnson & Johnson subsidiary DePuy withdrew the troubled ASR hips from sale in Australia in 2009, it offered the reason that it was “streamlining its hip portfolio to reduce costs and reallocate resources to ensure continued growth and expansion of its core hip platforms”.

There was no mention of the concerns raised by the TGA about its hip’s high revision rate, identified by the independent National Joint Replacement Registry.

While Australia was the first country to remove the DePuy ASR hip from use, the TGA became aware of problems in 2007. But it took two years to pull it from the market, and even then the TGA informed doctors but not consumers about the problems.

Hammett says he wants to give clinicians a bigger role in assessing devices before they are approved.

He also wants to implement a unique identification coding system so the TGA can track which medical devices are inserted into which patients, and notify patients when there’s a problem.