Anna E. Mazzucco, PhD and Diana Zuckerman, PhD, National Center for Health Research
In March, 2017, the U.S. Food and Drug Administration (FDA) updated its website to officially report that breast implants could cause a type of cancer of the immune system called anaplastic large cell lymphoma (ALCL). They stated they have received 359 reports of ALCL among women with breast implants.
The FDA’s announcement came 10 months after the disease was named breast implant associated ALCL (BIA-ALCL) in a World Health Organization publication in 2016, and a few months after the National Comprehensive Cancer Network (NCCN) released the first worldwide oncology standard for the disease. NCCN includes a guided algorithm for surgeons and oncologists to test for and diagnose the disease. They concluded that any abnormal accumulation of fluid or a mass that develops near the breasts months after breast implants were implanted must be evaluated.
The oncologists also state that even if the BIA-ALCL is confined to the scar capsule that surrounds the implant and even if that capsule is totally removed through proper explant surgery, the patient must be followed for 2 years. Here is the link to their guidelines: https://www.nccn.org/professionals/physician_gls/pdf/t-cell.pdf#page17
Although rare, it seems that BIA-ALCL is not “very rare.” In Australia, which can track medical problems from any kind of implants better than the tracking of implants in the U.S., they estimate that BIA-ALCL affects one woman per 1,000 with breast implants. The estimates were much lower in the U.S., but there is no reason to think BIA-ALCL is less likely to develop in women in the U.S. Given the dramatic increase in diagnoses, it is clear that BIA-ALCL was under-diagnosed and under-reported for many years.
The sooner ALCL is diagnosed, the more likely it can be treated easily and effectively by removing the implants and capsule. At later stages, treatment includes chemo and is less likely to be successful, as specified by researchers at the well-respected MD Anderson Cancer Center in a medical journal in 2013. Their study followed women for 5 years and found that ALCL related to breast implants sometimes requires chemotherapy, and approximately 25% of the implant patients with the more serious type of ALCL died during the 5 years following their diagnosis.1 Dr. Anna Mazzucco published a response to this study, urging physicians to respond quickly and to check patients who have swelling near their implants for ALCL.2 This would require cytology testing rather than testing for bacteria. The authors of the original study also published a response to Dr. Mazzucco’s article, expressing similar concerns. 3
For more information, see our summary of that study here.
ALCL caused by breast implants can result in swelling, which is often mistaken for an infection and treated with antibiotics. Antibiotics are ineffective against ALCL and the delay in timely and appropriate treatment for ALCL is dangerous.
Unfortunately, some health insurance companies have traditionally not covered the cost of medical tests or treatment for women with breast problems related to cosmetic breast implants. The published articles on ALCL clearly indicate that this can result in undetected cancer of the immune system (ALCL), which can be fatal. In addition, delays in treatment for ALCL can be extremely expensive for patients and their insurance companies; the companies would be required to pay for treatment for ALCL when it is eventually diagnosed at a later stage.
Read the FDA’s report on the risks of ALCL here
All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.
- Miranda RN, Aladily TN, Prince HM, et al: Breast implant–associated anaplastic large-cell lymphoma: Long-term follow-up of 60 patients. J Clin Oncol 32:114-120, 2014. ▲
- Mazzucco, AE. Next Steps for Breast Implant-Associated Anaplastic Large-Cell Lymphoma. J Clin Oncol, 2014. ▲
- Miranda RN. Reply to AE Mazzucco. J Clin Oncol, 2014. Early Release publication. June 16, 2014. ▲