The most recent investigation into unsafe and inadequately tested implantable medical devices on patients warrants the implementation of robust regulation of the medical device industry in Ireland
The results of an international investigation, entitled the ‘Implant Files’, led by the International Consortium of Investigative Journalists (ICIJ) comprising of 58 media organisations around the world including The Irish Times, looked into the dangers of medical devices, that have been tested inadequately, or not at all, in some cases.
According to the ICIJ’s website, the medical device industry is built upon a web of corporate and political influence. The organisation has described their ‘Implant Files’ investigation as a story of the pain behind the gain of devices rushed to market, aggressively sold, then implanted in people.
The ICIJ has established a publicly searchable international Medical Device Database https://medicaldevices.icij.org that tracks faulty versions of medical devices across the globe, for which there have been special warnings or alerts.
The worldwide investigation includes such medical devices as nerve stimulators, cardiac defibrillators, hip implants, breast implants and surgical meshes, to name a few.
Connected to the Implant Files investigation, a BBC Panorama exposé aired on the 26th November 2018, follows the Netflix Bleeding Edge documentary in July of this year, where they allege some medical device products are rushed to the market by manufacturers, without adequate testing to ensure patient safety. These investigations have also highlighted questionable regulatory systems in Europe and the U.S. that continue to allow medical devices that are unsafe and not fully tested to end up on the market and then inside patients’ bodies. Despite the medical device industry being worth billions, it appears shortcuts are allowed to be taken to get these products to the market quickly (taking advantage of weak regulation) and it is the patients’ health and in some cases, patient lives who are being put at risk in this way.
In Ireland there have been ongoing concerns regarding certain medical devices including vaginal/pelvic mesh products. As recently as the 21st November 2018, the Chief Medical Officer (CMO) reported to the Minister for Health, Simon Harris amid growing concerns about the frequency and severity of complications associated with the use of mesh devices in the surgical treatment of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) in women in Ireland. The 61 one-page report makes 19 recommendations, some of which are to improve the regulation of this medical device, including mandatory reporting of ‘serious adverse events’ and mandatory registration of implants used in the treatment in POP and SUI on a national register. The Department of Health states, it will be writing to the HSE to request that it prepare a detailed Implementation Plan for the complete set of recommendations set out in the Report, working in conjunction with other stakeholders. A pause remains on the use of mesh procedures.
The Health Product Regulatory Authority (HPRA) is responsible for the regulation of medical devices and for the monitoring of the safety of medical devices on the Irish market. It states on its website it is also designated as the Competent Authority (CA) for medical devices in Ireland. However, the HPRA is dependent on stakeholders such as patients and clinicians to make voluntary disclosures to it on adverse events pertaining to medical devices.
In September 2018, the Irish Times reported eleven incidents where medical devices are suspected of having played a role in the deaths of patients in Ireland in just three years. These incidents are under investigation by the HPRA.
In light of the results of the ‘Implant Files’ investigations, there have been enough reported incidents of concern now about some medical devices on the Irish market, to warrant the requirement for strong regulation of the industry in Ireland. The regulatory recommendations in the CMO’s report on mesh products (mandatory reporting of adverse events and mandatory registration) ought to be rolled out to all medical devices in the Irish market to minimise patients suffering from avoidable injuries.
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