Oireachtas Joint and Select Committees
Thursday, 11 November 2021
Joint Oireachtas Committee on Health
Delays in Accessing Scoliosis Treatment and Surgery: Discussion
Professor Damian McCormack:
Yes. It is an American implant. The problem with surgical implants in this country is they are not regulated. Medical regulation is very strict in this country and the people doing it do a superb job. Surgical regulation is based on market activity. In other words, individual regulators look at how well something is selling; if it is selling well, it is a "good" implant, which is ridiculous.
That particular implant was tested and invented by a surgeon. The surgeon sent it to his friend in Hong Kong and it was tested on two patients. That was absolutely not sufficient to get Food and Drug Administration approval in the United States, where it was made, but the Americans were quite happy to let it be used in Europe. Having been tested on two patients, a paper was written to say it was great, and that was ridiculous. It got European CE approval and it was used in Europe. With marketing, it became-----
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