There are some criticisms that have been raised about a registry. Specifically, there are some criticisms around consent—in the medical world, if it's a quality registry, you don't actually have to have patient consent—and how you collect the data. An opt-out registry is the one that's most effective, meaning patients have to specifically ask not to be included, as opposed to asking to be included.
One of the other criticisms is on what they do with the data. Any registry or research tool is only as good as the data put into it. You have to maintain a registry, keep track and make sure the data is updated.
The bottom line, I think, is that there is no downside to having a registry. It will hopefully allow us to see these things developing in real time, as opposed to, as Dr. Nicolaidis said, having to react and scramble to provide appropriate care and notify patients. That was one of the hardest things with the ALCL issue—tracking down patients who had textured implants, because there was no repository. Even the implant manufacturer companies, which were supposed to track that data, didn't do it effectively.