I don't think I said that.
In the nineties, when the moratorium took place, silicone gel implants were taken off the market. When patients had need of further surgery, we could only offer saline-filled implants. As a result of that, we all have a lot of experience with patients having their implants done and everything going fine, and then they have a sudden deflation one to 20 years later. That was an issue because it's a sudden failure. It's a complete failure. It's a very obvious failure.
Circling back to the complications issue, when you hear a number.... I do an operation—deep inferior epigastric artery perforator flap from the abdomen to reconstruct the breast—that is the alternative. As we've heard, what are the alternatives to using an implant?
In a woman who has had a mastectomy, my options are an implant or tissue. The implant is a one-hour operation and the results are pretty good most of the time. The other option is a four-, six- or eight-hour highly invasive tissue transfer operation. I present that to them. There are pros and cons to both. Patients, for their own self, have the choice of not having a breast reconstruction after mastectomies—which some choose, and that's perfectly reasonable—or they'll decide to have an implant put in, with a full discussion of the risks of that procedure, or they'll have the bigger operation.
On the bigger operation that I do, from the abdomen, in studies it has a 50% complication rate, which.... What surgeon is ever going to do a 50% complication operation? That's crazy. The thing is that, in those studies, in that 50%, are little things like an abscess to a little stitch or suture lines that are a little thick or other things. When you hear numbers like 25%, that's not a 25% serious complication rate. We think the ALCL is higher than we initially thought. Maybe one in 300 is the highest estimate I've heard, which is 0.3%, still very alarmingly high for that complication, but the other serious complications are hard to pin down. like, for example, the autoimmune. We have one of the world's experts here, and he'll tell you that it comes in all kinds of forms.
On BII, we had a scientific director at our national meeting this year and we had a full session on BII. Basically, does it exist? What are the diagnostic criteria? What's the test for it? There is no consensus at all. The first question was, does it exist? Most people weren't sure that it actually exists. There were certainly no diagnostic criteria, and there is no test to confirm it.
When you're talking about a 20% complication rate, that's not a 25% serious complication rate. There's never been a study in the literature that has ever implied that.