Consumers needing a hip, shoulder or knee replacement can take comfort in new data that shows revision rates for joint replacement surgery are down, thanks in part to increased clinical testing and monitoring requirements by the Therapeutic Goods Administration.
Joint replacement surgery in Australia
An ageing population means increasing numbers of Australians are undergoing joint replacement surgery, with a total of 107,740 hip, knee and shoulder replacements in 2015. Most people having this surgery do so largely due to pain and disability caused by osteoarthritis.
By and large the replacements are successful, and can be expected to last 10–15 years. Factors that can determine the success of a hip or knee replacement surgery and the longevity of the device include:
- the patient's age and gender
- individual diagnosis
- the type of prosthesis
- surgical techniques.
In 2009, two DePuy-brand hip replacement prosthetics were taken off the market when it was found that an unacceptably high number of people with the implants required revision surgery. The device was recalled in 2010, and more than 13% of people given the implants required revision surgery.
Part of the fallout was a 2011 senate inquiry into the scandal, which considered the approvals process for joint replacement prosthetics. As a result:
- joint replacement prosthetic devices were reclassified by the Therapeutic Goods Administration such that more clinical testing was required before they could be placed on the market, taking effect in July 2012 for new devices, with devices already on the market given two years to comply
- there was to be increased monitoring of the implants once the product was on the market.
"Prior to these changes," explained the Australian Orthopaedic Association (AOA) President, Ian Incol, "the principle basis for approval was what is referred to as substantial equivalence. This meant that a new device, if it was similar to other joint replacement prostheses, was approved on the basis of equivalence rather than the requirement for specific testing of that device."
Revision surgeries are down
In its recently released annual report, the AOA reported a decrease in the number of hip replacement revisions in the 12 months to December 2015 to 9.6%, from a high of 12.9% in 2003. In addition, the number of prostheses on the market that are associated with higher than expected rates of revision has also decreased, and most of those that are problematic are not new ones.
"This is particularly pleasing and confirms that decisions made by the government a number of years ago to increase clinical evidence requirements before new joint replacement devices are approved has had a beneficial effect," says AOA president Andreas Loefler.
The annual report notes that 92% of all total hip and 92.3% of all total knee replacements devices implanted in patients at the turn of the century are still providing the patients with a quality of life they may not otherwise have enjoyed.
Contemplating joint replacement surgery?
Our article on joint replacement surgery has more information about the problem with the two DePuy implants, and includes questions you should ask your doctor if you're contemplating joint replacement.