The controversy around PIP breast implants highlights the need for robust systems to track and monitor quality across all surgical devices, says Andy Gordon Jones.
While in the short term the most pressing issue for the 40,000 women who received PIP implants is the funding of their removal, in the longer term the safety of these implants should be our top priority. The most effective way to do this is through a national database where information can be stored in one place and easily accessed by clinicians.
Such databases already exist. The National Joint Registry (NJR), managed by Northgate Public Services since 2006 on behalf of Healthcare Quality Improvement Partnership, is the biggest register of its kind in the world.
Established by the Department of Health and Welsh Assembly in 2002, it collects information on all hip, knee and ankle replacement operations and monitors the performance of hip knee and ankle implants. It is funded through a small annual levy on a single component used in each procedure, paid for by the purchaser.
Since its inception the NJR has collected information on more than a million procedures carried out on 850,000 patients, providing an invaluable resource on the safety, effectiveness and performance of artificial joints. The NJR provides information on implant performance to regulatory authorities as well as to the suppliers themselves. It also gives feedback to orthopaedic surgeons and teams to help maintain high clinical standards.
In the event of a recall a comprehensive patient database is essential for fast and effective follow-up. Since 2007, the NJR has been undertaking analysis of its data to identify outlier performance of implants. The results of this analysis are passed to the NJR’s Implant Performance Sub-Committee who will, if necessary, notify the Medicines and Healthcare products Regulatory Authority.
The NJR’s involvement has led to the MHRA publishing one device alert with instructions not to use a specific hip replacement, and its data, along with data from other sources, has contributed to suppliers withdrawing four other products from the UK market.
Through the NJR we were not only able to identify the problem, but were able to immediately contact the trusts that had carried out the operations. The trusts involved reviewed the records of the patients that had been fitted with these devices and were able to quickly make contact with them to reassure them and take action if required. This process used to take up to ten weeks but now it can be done in 48 hours.
From April this year the NJR will start collecting data on elbow and shoulder replacements and there is no reason why it can’t continue to expand. There is also no reason why similar registries could not be established in other surgical areas – if there is the collective will to do so.
Professor Norman Williams, president of the Royal College of Surgeons, recently called on the government to look at this as a matter of urgency. And professional bodies in other countries, such as the Australian Society of Plastic Surgeons are looking at recording the information of every breast implant patient, their surgeon and the type of operation recorded.
We strongly believe a national implant database should be established as a matter of urgency. Until then patients will continue to be at risk.