01.Joint replacement devices
Given the recall of faulty joints implanted in thousands of patients, we investigate the true price of prosthetics.
We look at:
If you’re waiting for hip or knee replacement surgery, you may end up serving as a guinea pig for prosthetic devices that haven’t been clinically tested. And the device fitted can differ depending on your surgeon and hospital and whether you are a private or public patient.
These issues were highlighted in a Senate inquiry in late 2011 that looked into a recent medical scandal. Between 2004 and 2009, 5500 Australian patients were implanted with two now-recalled DePuy hip replacement devices.
To date, up to 13% of those patients needed revision surgery to replace the faulty prosthesis, more than double than for hip replacement devices generally – and those figures are expected to go up.
For more information about therapies, see General health.
The Senate inquiry and several other regulatory reviews currently being implemented should go some way toward improving TGA processes.
However, several important issues, such as a lack of registries like the National Joint Replacement Registry (NJRR) for many other devices, have not yet been addressed. The effects of shortcomings can be seen in the recent case of the PIP breast implants where no registry like the NJRR exists.
CHOICE wants consumers to be given comprehensive information about the devices selected for them. Only then can you make an informed decision and know whether the device has any track record worth knowing about.
The need for clinical testing
Last year’s Senate inquiry into medical devices asked the Therapeutic Goods Administration (TGA) to change the way it lists new prostheses in Australia – and for good reason.
Currently, no clinical testing is needed for the TGA to list a hip or knee replacement device in Australia. In approving the DePuy devices, the TGA relied on British information, based on laboratory testing. In the US, one of the DePuy devices couldn’t be listed without clinical testing, but this trial was abandoned and DePuy subsequently withdrew its application for listing.
Between 2003 and 2007, 260 new devices for hip and knee replacement surgery were released in Australia, according to the National Joint Replacement Registry (NJRR), which tracks the performance of hip and knee prosthetics in this country.
Three-quarters of these were used on fewer than 100 of the roughly 80 000 hip and knee surgery patients per year and so their performance was difficult to assess. Of the rest, none performed better than what was already available, and 30% performed “significantly worse,” according to NJRR director Professor Stephen Graves.
The Australian Orthopaedic Association (AOA), which established the NJRR, recommends introducing two-year clinical testing before a new device can be listed.
The NJRR reveals that factors such as age, gender, individual diagnosis and the type of prosthesis and surgical techniques can determine the success of a hip or knee replacement surgery and longevity of the device. So it’s crucial that your surgeon takes your specific circumstances into account when deciding which devices to use.
Bob had a faulty hip prosthesis implanted in 2008 when he was 63 years old. After his revision surgery removed tumours and inserted bone grafts, he says he now lives in pain “24 hours a day, seven days a week”.
Patients with faulty devices can experience swelling, pain and problems with walking, which may be caused by the device loosening, the fracture of a bone around the device or dislocation of a part of the prosthesis.
The DePuy devices have metal ball-and-socket components that move against each other, and can release small particles of heavy metals such as cobalt and chromium that have been associated with a number of health problems.There is concern about the same problem happening with other metal-on-metal prostheses.
Two class actions against DePuy bare currently underway on behalf of affected patients.
- Early 2004 to early 2005 Two Johnson & Johnson (J&J) DePuy ASR devices approved by TGA for use in Australia
- 2007 to 2009 NJRR warns TGA and J&J 17 times about problems with the ASR devices
- Sep 2007 J&J agrees to supply one of the devices only to surgeons who undergo further training
- Dec 2009 Voluntary Australia recall of ASR devices
- Aug 2010 Voluntary worldwide recall of ASR devices