When I'm talking about the marketplace, I'm talking about the way it's being used by patients. Whether it's a drug or a medical device, we receive a wide range of information once that product is in the market. It can come from voluntary reports from patients; it can come from the mandatory reports from the manufacturers.
We're going to be coming forward very soon with a regulatory proposal under Vanessa's law that will require mandatory reporting by hospitals of these sorts of incidents, so mandatory reports will be coming in. Also, signals can come in from foreign regulators, such as the European Medicines Agency discovering an issue, or the FDA.
There are a whole variety of signals that can come in, and the response on what to do is very much dependent on the situation. If the signals coming in indicate that there's a very serious problem, we might swing into action immediately and there could be a recall.