It will surely have startled most readers of our joint investigation of medical implants to learn that devices such as surgical mesh, pacemakers, replacement hip joints and contraceptive coils are not subjected to the same stringent tests as medicines. It can take pharmaceutical companies more than a decade to get a new drug through the three phases of clinical trials that are standard practice before it is approved for use in humans. By contrast, the regulation of medical items classed as devices, a category that includes some diet pills, has evolved in such a way that some new products undergo no formal testing at all – because they resemble another item already on sale.
Earlier this year we reported that about one in 15 women fitted with vaginal mesh implants in the UK went on to have it removed as a result of complications including chronic pain. This week’s investigation, carried out in partnership with media organisations around the world, reveals that vaginal mesh is far from the only implant to have caused harm as well as good. Examples of what appears to be a global regulatory failure include thousands of serious incidents linked to breast implants, which have also been linked to a rare form of cancer; the voluntary recall of metal-on-metal hips due to high levels of follow-up surgery; and the withdrawal of the permanent contraceptive Essure (used to block fallopian tubes) in the US and Europe.
In the UK, regulators received 62,000 “adverse incident” reports linked to medical devices between 2015 and 2018; 1,004 of these resulted in death. But worryingly, the proportion of reports leading to an investigation overseen by the Medicines and Healthcare Products Regulatory Agency (MHRA) has fallen sharply, while freedom of information requests, including one relating to the contraceptive Essure, were turned down on grounds of commercial confidentiality. New rules are due to come into force across the EU in 2020, but these fall short of the mandatory national registers called for by senior doctors we spoke to. They point to the influence of lobbyists in a European industry worth €110bn (£98bn) a year. Due to Brexit, there can in any case be no guarantee that the UK will remain part of the European system.
Around 160,000 hip and knee replacements are carried out in England and Wales each year. Most are successful, and the role played by companies that manufacture and market items such as artificial joints is key. But they must also be regulated, which is another way of saying that patients must be protected. The former secretary of state for health, Jeremy Hunt, made patient safety one of the themes of his tenure. His successor, Matt Hancock, should now set out how the government plans to increase transparency around medical devices, and ensure that mistakes such as those made with vaginal mesh can never happen again. The current regime gives manufacturers too much control over information – such as the number of devices in use – that should be in the public domain.
These are technical matters to which most people would not give much thought unless they or someone they knew was directly affected. In this, they have something in common with buildings regulation. Only when such a system fails catastrophically, as construction rules appear to have done at Grenfell Tower, is there a demand for action. There are obvious differences between healthcare and building. But both examples illustrate the folly of denigrating regulation. Used wisely, red tape saves lives.
