Give Me a Crash Course In . . . Medical implants
What’s this fuss about medical devices?
The International Consortium of Investigative Journalists (ICIJ) this week published a new project, the Implant Files, which consisted of a series of stories about implanted medical devices that have gone wrong, or may be causing problems, or were not properly tested before they were allowed on to the market for implantation into people’s bodies.
What type of medical devices?
Metal hips that shed ions, causing people’s flesh and bones to soften and die; a permanent contraceptive, Essure, that doctors say in some cases turn into a “calcified nail”; vaginal meshes that cut through internal walls; breast implants that may be linked to rare cancers; and pacemakers that turn faulty. The devices are very difficult to remove, and patients can be left with a device inside their bodies that is causing serious pain and may even be a threat to their lives, but which is too risky to take out, or “explant”.
Who broke the story?
The Irish Times took part in the ICIJ project, along with the Guardian, the BBC, Le Monde, Süddeutsche Zeitung and media organisations around the globe. Irish coverage concentrated on the DePuy metal hip, which on a per capita basis was more popular here than in any other market. The device was withdrawn in 2010 and since then more than 1,000 Irish people have initiated High Court proceedings against DePuy, seeking damages.
The ICIJ, which has previously produced projects based on leaked data, such as Luxleaks and the Panama Papers, decided to have an intensive look at medical devices because of their increasing importance in healthcare, the size and power of some of the multinationals involved, and concerns about the adequacy of the sector’s regulation.
Is regulation that bad?
Maybe not any more. Arising from the metal hip controversy and a scandal involving industrial silicone being used in breast implants, the EU decided some years ago to reform its medical device regulation regime, with the new arrangement now being rolled out. In the US there is some concern that the political regime there, as part of its generally anti-regulation philosophy, may be softening the role played by the Food and Drug Administration.
So, should we avoid medical devices?
No. Medical devices have transformed healthcare in recent decades and the pace of innovation shows little sign of letting up. Conditions that were untreatable or involved major, risky surgery two decades ago, can now be substantially addressed using ingenious devices, many of which can be implanted with relative ease. All around the globe people are living active, pain-free lives because of the wonders produced by the medical device sector. It is because of the sector’s importance to people’s lives that it requires best-in-class regulation, something many observers believe is not currently the case.
The sector is also of enormous importance to the Irish economy, making up almost 10 per cent of our exports. Eight out of every 10 stents produced in the world, are produced in Ireland.
What can be done to make things better?
The DePuy metal hip was withdrawn from the world market when it was discovered that it was not performing as well as other types of hip. Key data came from the UK’s National Joint Register, which monitors the performance of all orthopaedic implants. A similar registry has since been established in Ireland and this week the Royal College of Surgeons in Ireland (RCSI), and the National Office for Clinical Audit, which operates the registry, responded to the Implant Files by suggesting that funding be provided so that the registry would monitor the performance of all implants, and not just orthopaedics.
An X-ray image shows the DePuy ASR replacement hip system. PHOTOGRAPH: BRYAN O’BRIEN