As I said, they've been around for a long time, and it's easy enough to say, “Let's do some research to prove their safety.” That was done in a half-assed fashion after the withdrawal of gel implants in the U.S.
The bottom line is numbers. To really understand these things, you have to look at huge numbers, not 20 or 30 patients, which has classically been done in the typical studies that were done by the implant companies and their consultants. You need thousands of patients, so that's where the data comes in.
It's not a question of trying to reinvent the wheel. They have a registry in the U.S. that is collecting data. As Dr. Lennox mentioned, the data is okay, but we need to tweak the data to get better information, because it's really with large numbers that we're going to be able to figure things out. The implant companies have pushed these implants forward over the past six years with different variations like texturing, which was meant to decrease contracture rates.
To take that as an example, they figured out that if they texture an implant, it's going to decrease contracture rates. Then we find out, unfortunately, seven or eight years later, that they were introduced in the 1990s, so we ended up not even recognizing it until about 2011, and it took 20 years, give or take, before they started recognizing the lymphoma. Now, the numbers tell us that the lymphoma typically develops around seven or eight years after, so yes, a number of people died unnecessarily because of that lag time, because we didn't have a registry to pick these things up.