If you’re like most people, you’ve never heard of ALCL. Well, you will now, because the FDA has just issued a bulletin, drawing attention to this exceptionally rare disease. ALCL is a subtype of non-Hodgkin’s lymphoma. ALCL is NOT breast cancer, but an entirely different disease. It can affect lymph nodes, skin or breast tissue.
About 3 people per 100 million will be diagnosed per year with ALCL of the breast, whether they have breast implants or not. It’s really rare. Most plastic surgeons will never see a case of ALCL during their lifetimes. You’re more likely to be hit by lightning and win a major lottery on the same day.
Why are we talking about this rare disease? Because there have been some early reports of ALCL occurring in women with breast implants, so the FDA is investigating whether there is any link between the two. There have been between 34 and 60 cases reported worldwide in women that also have breast implants. The FDA isn’t saying there is a definite link for sure, just that there might be a “possible association”.
So far, we don’t know that much from a tested, scientific point of view. Some of the reported cases happened in women after breast reconstruction, some after cosmetic use. Some have happened with saline implants, some with silicone.
Scientists aren’t even sure whether these cases really had “classic” ALCL, or whether it represents something new that happens to look like ALCL. Fortunately, the disease seems to respond well to treatment.
Phillip Haeck, MD, President of the American Society of Plastic Surgeons (ASPS) said “ASPS shares the FDA’s commitment to patient safety, but we also want to make certain this information does not raise false alarms with our patients. We’ve been down this path before. For nearly 20 years American women were denied access to their choice of breast implants because of false claims and unfounded science. We are determined this shouldn’t happen again.”
Women that have implants certainly don’t need to panic. There’s no need to have your implants removed.
The FDA is setting up a central registry to look at the reports in more detail, which is a good thing. I’ll keep my patients informed, as we learn more.
My advice: do what we’ve always advised our patients. Do your own breast self-examinations. Get mammograms and ultrasounds of the breast, following the normal schedule. If you notice something new, like swelling or a lump in the breast, let a doctor check you over. But otherwise, there’s no need to panic. The FDA’s actions are out of an extreme abundance of caution.