Withdrawal of Medical Devices from Irish Market
Looking at the Medical Device Sector in Ireland
Figures from the Health Products Regulatory Authority (HPRA) which regulates the medical device sector of the health care market in Ireland show that in 2017 there were 519 field safety corrective actions undertaken in Ireland.
A total of 178 involved medical products being recalled. Typically more than 150 medical devices are being withdrawn from the Irish market every year. Hundreds more require revised advice for medics to address concerns about risk of death or serious injury according to new data. Currently there is no register for medical devices in Ireland. The market for such products is believed to number at least 500,000 products ranging from tubes and catheters to sophisticated electronic medical devices.
It has been reported that the International Consortium of Investigative Journalists has collected in excess of 4700 safety notices and other warnings from the HPRA’s website. They then uploaded them in to an international searchable data base being built by the consortium. Recent recalls of devices include staplers used by colorectal Surgeons which had a defect that could trigger serious post-operative complications including haemorrhage or haemorrhagic shock.
There has also been recalls of inter-ocular lens which have been used for the treatment of cataracts in patients. Some of these inter-ocular lenses have opacified resulting in deterioration of a patient’s vision and require to be replaced as a result. The recall of the DePuy metal on metal hip replacement devices resulted in hundreds of proceedings being issued in the High Court seeking to recovery compensation for the patients who received the defective hip replacement device, most of which have been successfully settled at this stage.
If you have been affected by the recall of a medical device and you require legal advice as a result, please feel free to contact Gearoid Howard of Crimmins Howard Solicitors who would be happy to assist you in exploring your legal options.