On the recordMay 29, 1996
It wasn't on the approved list in the United States it was approved in Europe. And so the gentleman went to Italy and his surgeons, I believe, flew to Italy with him, and they had the operation, and it was a success and he went mountain climbing within 6 months after the operation. Had he stayed in the United States and waited for the FDA for approval, it is arguable that the gentleman would be dead today. He would not only not be mountain climbing, but he would not be breathing today. But because he did go overseas and was fortunate enough to have the money to go overseas, he is alive to tell the story today.
Source
govinfo.gov




