Cathal Crowe (Clare, Fianna Fail) | Oireachtas source

I will restart my question to Mr. Woods. There is a device that is manufactured in America. The FDA has in July of this year issued strong caution about it. It has alerted both patients and healthcare providers of the potential risk of this device. One of the key concerns it flagged is that the end caps of this device have a tendency to detach from the rest of the device. They detach from the rod itself while it is implanted. It has also been referenced that these have not been tested for biocompatibility. Basically, they detach when within the body of the person. We do not know what potential harm that causes. The scientific world is investigating this. Currently, however, there is a suspension of the sale of this device in all 33 countries that require a Conformitè Europëenne, CE, mark. On top of that, there is a voluntary hold on shipments of the device in other countries. I understand that the device is still used in Ireland in scoliosis surgery. I understand that 51 patients may already have this device implanted in them. It is continuing to be implanted on so-called compassionate grounds on the basis that the need for surgery and the need for this device outweighs potential risks that other regulatory bodies on the other side of the Atlantic have already flagged. I do not expect Mr. Woods to have all the answers. It is a bit of a curve ball question. If nothing else, I want it on record here today that we have major concerns about this device. The world’s scientific community has major concerns about it and surgeons have major concerns about it. The CE mark has been withdrawn from the device. The FDA has written cautionary notes to all in the sector. Yet, in Ireland, we still continue to implant this. It is essential that we slow down a little bit here and that we look at global scientific studies. If this device needs to be suspended, which other countries have done, we should follow suit in that and not become the outlier in potentially putting patients, particularly young people, at risk.