Yesterday the FDA released an update on the link between ALCL, a rare cancer of the immune system, and breast implants. I have received several emails, calls and concerns from patients who have breast implants asking for my opinion on this which I am always happy to provide
ALCL, breast implant associated anaplastic large cell lymphoma is a rare cancer of the immune system. It is not breast cancer, it is different in presentation, diagnosis, treatment and prognosis. The cancer cells are most commonly found in fluid surrounding an implant. Although it can occur in women without breast implants, it has been found to be more common in women with breast implants than without.
How long have we known about ALCL?
Although the report was updated yesterday, this is not a new diagnosis or disease. In 2011, the FDA presented an association with this rarely seen cancer and breast implants. In a thorough literature review the FDA identified 34 patients throughout the world from 1997 – 2010 who were diagnosed with breast implant associated ALCL. Most of the patients presented with late onset fluid around the implant (seroma) and were treated by implant and capsule removal, a few had chemotherapy or radiation. The prognosis was generally very good with simply removing the implant and surrounding capsule. The recommendation by the FDA was to consider ALCL in any patient with a late onset seroma, sending fluid or tissue for pathological diagnosis. After writing this update, I remembered I wrote about the initial 2011 report here.
What new have we found out about ALCL with this FDA update?
There has been a lot of ongoing ALCL research and investigation over the past 6 years. There have been more cases identified, currently totaling 359, including 9 deaths associated with the disease. Being a world wide epidemic, the information available on many of the cases is scarce but in 231 cases there was information provided regarding the type of implant and surface characteristics. Of these, 203 were textured and 28 smooth, confirming the suspicion that textured implants are a higher risk factor. Regarding implant fill material, ALCL was found in both silicone and saline implant cases.
What are the FDA’s recommendations?
ALCL is a very rare condition and one that most plastic surgeons will not see in their career. That said, it needs to be taken seriously and the FDA is still recommending pathologic evaluation in the event of unexplained late onset seroma. They have also added to this previous recommendation that ALCL is found more often with textured implants and this should be considered, although there is no change in the FDA status of textured implants. The FDA does not recommend any change for women in their routine medical care or follow up. They do not recommend implant removal or exchange.
I have breast implants, how worried should I be about ALCL?
This is a very serious condition, all cancers are. I don’t mean to downplay the significance of this with what I am about to write but having received four panicked phone calls and emails today I feel like this needs to be put into perspective. Patients need logical advice, not the hysteria often portrayed in self-serving media outlets.
Firstly, ALCL is EXTREMELY rare. Of the 10-11 million women in the world with breast implants less than 10 patients are diagnosed a year, according to the American Society of Plastic Surgeons and the Plastic Surgeon Foundation. In one study it was determined that the incidence of ALCL was 1 in 300,000. Compare this to a 1 in 8 lifetime risk of women without implants developing breast cancer. Ordinary breast cancer is so common it is easy to forget that a women with breast implants is 37,000 x more likely to develop cancer unrelated to implants than that related to implants. A woman with breast implants is more likely do be struck and die from a lightening strike (1 in 174,000) than from ALCL. I find parallels to the book Freakonomics, wherein the author often discusses how the rare and unique tragedy is often given much more attention and concern than the ordinary (but MUCH more dangerous) tragedy.
Secondly, it is a type of cancer with a very favorable prognosis. Of the 359 cases identified world-side, there have been 9 deaths, a mortality rate of 2.5%. Put into perspective it is estimated that in excess of 300,000 women in the U.S. alone will develop non-implant related breast cancer this year with a mortality rate around 20%.
Thirdly, even in the event of seroma it is very unlikely that ALCL is the cause. I for one have seen 5 or 6 late onset seromas that I have sent for cytology without a single diagnosis of ALCL. Statistically, I am unlikely to see a single case in my career. Despite that, I’m always watching out for it.
My recommendation is that of the FDA. If you have implants, don’t pain, continue your normal screening breast exams and imaging and present to your doctor if there are breast changes particularly fluid build up.