Perhaps I can start, Member.
There are a couple of things. As you know, these products have been available in Europe for many years. It was Canada and the U.S. that had not licensed these products in the late 1990s and early 2000.
We conducted a very extensive review of these products, as did the U.S. FDA, and we were satisfied that they met the safety, effectiveness, and quality criteria that we meet. Now, those reviews, done by ourselves and the FDA, were done independently. We arrived at the same conclusion, a conclusion that Europe reached many years ago, I would just say.
So there are two things. One is that for all of the products that we deal with, right across the spectrum, for drugs and medical devices, there are risks of some kind, and we're always measuring the risks versus the benefits, what the appropriate use is. That's something we do every day. That's the nature of our work. So none of these products is risk-free. In the case of these devices, we have quite an extensive post-market follow-up strategy that's being undertaken, and as with any other medical device or drug, if there's new information that comes to light that requires a modification of the approval that's been given in terms of its use, or even if it's necessary, as occurs from time to time, that a product be withdrawn from the market, that's what we will do.
But the point we reached after extensive review was that it was appropriate to release these products to market, but the work will continue.