I guess that's over to me. Thank you for the question.
We take our role to review health products extremely seriously. Our role is to do pre-market reviews. If we feel that the risk profile of a product is such that the risks outweigh the benefits, we will not approve it. That's what we do every day.
We may decide that we need to impose certain conditions on a product—that is the case with silicone breast implants—do follow-up studies, and so on. As you will recall from earlier this week, we also took four years to do that review. So we feel we did an extremely thorough job of that. We take the time we feel is necessary to do a proper and thorough review of the product submissions that are made to us. They are not allowed on the market until that review has been completed.