The Food and Drug Administration (FDA) released a statement today that there may be a possible link connecting breast implants and a rare form of lymphoma, anaplastic large cell lymphoma (ALCL). This is a very rare type of lymphoma found in the breast in only 3 in 100,000,000 women without breast implants. In women with breast implants from 1997 to 2010 there have been approximately 30 to 60 cases of ALCL found worldwide (out of an estimated 5-10 million women with breast implants). The FDA report indicated that because of the rarity of this disorder they cannot confirm with statistical certainty that breast implants cause ALCL. It does appear more than coincidental, however.
Although the risk of ALCL is extremely low, it is certainly something I am very concerned about and will pay a great deal of attention to as further studies and reports are released. It is actually quite reassuring to me as a plastic surgeon that the FDA and collaborators are scrutinizing breast implants close enough to identify this association. There has never been a medical device that has gotten this degree of scrutiny.
Should I have my breast implants removed to avoid getting ALCL lymphoma?
My first advice to the woman with breast implants would be to avoid panic. We are talking about an extremely small risk. According to the FDA’s report, they do not recommend prophylactic breast implant removal. Women with ALCL lymphoma associated with breast implants had significant findings associated with their breasts. These include late-onset fluid collections around the implant (seroma), capsular contracture or a mass adjacent to the breast implant. Women with breast implants who are not having problems don’t need to do anything.
I have capsular contracture or other symptoms, does that mean I should be concerned about ALCL?
This is where it is going to get a little tricky. The breast symptoms associated with ALCL are not specific to ALCL. In fact, these symptoms are quite common with reports of capsular contracture as high as 36 – 81% for silicone implants and 8-41% for saline implants (Institute of Medicine, 2000). Late seroma is less common but still not a rare symptom. Breast lumps and bumps are very common. Hopefully there will be more specific symptoms and findings as the FDA continues to evaluate this. For now, they recommend “consider the possibility of ALCL when you have a patient with late onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant.” The only diagnostic tool currently involves analyzing the fluid and capsule under a microscope. That means surgery. There was no indication in the report that mammography, ultrasound or MRI was helpful in diagnosis.
From my standpoint, the patient with a seroma, breast mass near the implant, or significant capsular contracture should have surgery to correct the condition. During surgery the responsible plastic surgeon should send any fluid or unusual capsule for pathology examination. For the patient with mild capsular contracture who would not require surgery otherwise, I am not sure. Hopefully further data will clarify this risk.
What types of breast implants are associated with ALCL?
The FDA was able to identify 34 unique breast implant ALCL patients reported in the literature from 1997 to 2010. A few important findings are noted:
- ALCL was found in both cosmetic augmentation and breast reconstruction after cancer
- ALCL was associated with both silicone implants 24/31 andsaline implants 7/31
- Only 4 of the reports identified whether the implants were smooth or textured. Of these ALCL was found only withtextured implants.
The FDA has asked for the cooperation with the American Society of Plastic Surgeons, implant manufacturers, and other collaborators to gain more information regarding the association of ALCL and breast implants. Hopefully a better understanding of risk factors, diagnostic methods, and treatment options will result.
What is ALCL?
Anaplastic large cell lymphoma is a very rare type of non-Hodgkins lymphoma. It is characterized by an abnormal growth of T-lymphocytes, a type of blood cell. Research would suggest there is some indication that ALCL associated with breast implants may be a new clinical entity with non-aggressive behavior. A large majority of patients studied were found to be free of disease during the follow up period. Although comforting, the FDA has warned that it is premature to draw conclusions about the prognosis of women with ALCL associated with breast implants.
ALCL is rare. I will likely never see a single case in my career. In fact, odds are there may never be a single case here in Utah. To put this into perspective, one is much more likely to be struck and killed by lightening or while riding a roller coaster than ALCL.