Sure.
These are two completely distinctive entities or two problems caused by implants. With BIA-ALCL it's proven, as I alluded to and as Dr. Lennox has just mentioned. It's accepted now that it's the texturing of the implants, as he said, that is leading to the ALCL. Now, the exact details of that are not yet 100% clear, but they're being understood more and more over time.
BII is breast implant illness, which refers to the autoimmune issues that you just mentioned. That's a constellation of symptoms that are very wide-ranging and that patients have been complaining about since, as I said, within a year of the introduction of breast implants. These BII can be caused by any kind of implant. There's a general feeling in the BII community that the gel implants are more problematic, but that has not been proven.
Once again, conflict of interest is a huge problem. We tried to get a good study going recently. Well, it was not “we”; it was the Americans. The study was performed by two breast implant consultants who skewed the data. It's a lousy study. Unfortunately, it's the only well-funded study we have so far on BII. It was done by two consultants who don't believe, frankly, in breast implant illness. It is, nevertheless, recognized by the FDA. As I said, if it weren't for the fact of the recognition of BIA-ALCL, a completely other entity, these patients with BII would still be told now that implants are perfectly benign and that it's all in their heads.
Just to be clear, BIA-ALCL, the lymphoma, is proven, and it's caused by textured implants, with a much higher incidence the more textured the implant is and the more rough it is on the outside. BII autoimmune illnesses are caused by any kind of implant, whether it be gel or saline.
Something we haven't addressed that is even newer is something called “BIA-SCC”, another cancer that was recognized only in September 2022. Just in brief and not to belabour the issue, the difference between it and BIA-ALCL is that this is a more aggressive cancer. It is presenting typically around 20 years after implantation, as opposed to ALCL, which presents about seven or eight years after. It occurs with any kind of implant—saline, gel, textured, smooth—it doesn't matter. It's more aggressive and felt to be very rare.
I'm curious to know what Dr. Lennox thinks, but I'm pretty sure that one will remain rare. We've had implants on the market since the 1960s, and I'm only hearing about this cancer for the first time in September 2022.