More than 1,000 adverse health episodes that might have been caused by medical devices were reported to the Irish regulator of such products last year, according to figures released to The Irish Times.
In the period from 2015 to the end of September of this year, 39 of the reports involved a patient death where it was initially suspected that the medical device was a contributing cause.
However, a spokeswoman for the regulator, the Health Products Regulatory Authority (HPRA), said that in all 22 of the 39 cases in which investigations had concluded, and based on the information available to date, “none of the incidents which involved a patient death were confirmed to be related to a device malfunction”.
The remaining outstanding 17 cases involving a death, of which eight were reported this year, continue to be investigated. “The HPRA considered that it is unlikely that many, or any of these would have been caused by the device.”
The Irish Times is part of a global investigation into the medical device sector which has been organised through the International Consortium of Investigative Journalists (ICIJ), and the results of which are being published from Sunday evening. The investigation is called the Implant Files.
Database
As part of the project an online database, the International Medical Devices Database, has been developed by the ICIJ. It allows easy public access to data on adverse events linked to, or potentially linked, to medical devices.
The database, which mostly involves US reports, can be searched by product name so that implant recipients can access information about their devices. However, it is not intended to be a substitute for medical advice.
While there is extensive information about possible medical device failures available publicly in the US, and less so in EU member states, the Implant Files investigation has found that fewer than 20 per cent of countries globally make data available to the public on device recalls and other safety issues.
In Ireland, data about safety notices and device recalls is published on the HPRA website.
The investigation has raised concerns about devices that have been withdrawn in one country for safety reasons still being available in others.
Orthopaedic, gastroenterological, urological and cardiovascular devices show the highest level of recalls for safety reasons in the US.
An examination of millions of US adverse event reports found almost 500,000 cases where patients with implanted medical devices were getting them removed, or “explanted”.
Figures given to The Irish Times by the HPRA for the period 2015-2018 show that last year there were 1,041 adverse "incidents" reported to the authority.
An adverse incident is an unexpected bad medical development that may be associated with a patient’s medical device, and is different from an “adverse event” which, in HPRA terminology, involves bad health episodes that would be expected with patients using the device concerned – for example, those with very weak hearts.
The adverse incident figure for 2016 was 859, while the figure for 2018 to the end of September was 838.
Of the 1,041 incidents reported in 2017, investigations have been completed in 594 cases and, of these, 156 were found to have been definitively linked to the patient’s medical device.
Overall, 80 per cent of the 2017 cases for which investigations have been concluded were found to be incidents which were caused, directly or partly, by the medical device, or which led to the manufacturer taking some type of corrective action. The rate was slightly less in other years.
Medical device manufacturers are obliged to report adverse health outcomes that might be linked to their devices to the HPRA. Medical practitioners and others are also urged to report suspected cases.
The figures supplied by the HPRA show that the bulk of the incident reports it receives come from manufacturers and that there has been a steady rise in the total number of reports over recent years, with the total in 2011 being just 112.
The head of medical device regulation with the HPRA, Dr Niall MacAleenan, said the increase was mostly due to the drive to encourage better reporting. The authority conducts audits on manufacturers to ensure they are complying with their obligations.
DePuy hip
There was a spike in reports in 2012, when the total jumped to 706 from the previous year’s 408. Dr MacAleenan said this was due to the DePuy metal hip device, which has since been removed from the market.
Globally DePuy, which is a subsidiary of Johnson & Johnson, is expected to pay out up to $4 billion (€3.53 billion) in damages and patient care costs arising from the withdrawn device.
Ireland had the largest per capita uptake of the DePuy hip in the world and an examination of how the product came to market is published today by The Irish Times. More than 1,000 people have lodged High Court proceedings against DePuy.
The DePuy hip controversy, and a scandal over industrial grade silicone being used in breast implants, led to the decision to reform the EU system of medical device regulation. The new structure is likely to see increased levels of clinical trials being conducted, according to Dr MacAleenan.
The reforms are also expected to lead to greater levels of information being put into the public domain.
Medical devices require a different type of regulation to that of pharmaceuticals, not least because they are often designed to be inside a patient’s body for years, according to Dr MacAleenan.
“Risk is inevitable with implanted devices. The question is if it is an acceptable level of risk.”
The Fine Gael MEP and vice-president of the European Parliament, Mairéad McGuinness, who played an important role in the negotiation of the new EU regime, said parts of the structure that were being replaced were “not fit for purpose”.
However, she said it was important that an industry that was constantly producing new products that save lives and address chronic medical conditions was not over-regulated.
"Activists and NGOs criticise the close links between academia and industry but it is the only way the sector can produce what it does," she told The Irish Times.
Ireland is a global hub for medical devices, which account for almost 10 per cent of its exports.
Vaginal mesh
Last Wednesday the Department of Health extended restrictions on the use of a medical device product, the vaginal mesh, in relation to some conditions. The mesh has caused severe complications in a number of women including damage caused by bits of the mesh breaking off and cutting through patients’ flesh. The product can be extremely difficult to explant as the body grows around and into it.
Josephine Kilroy (58), from Newport, Co Mayo, who received a mesh implant in 2007 to treat a bladder problem, is hoping that it can be removed early next year by a surgeon in London.
The former taxi operator said pain and other complications associated with the device had caused her to be all but confined to her home.
"I went from having everything, and being happy, to losing everything, all because of the mesh. It has taken my whole life from me," she told The Irish Times.
