Breast Implants and Cancer of the Immune System (ALCL): What We Knew in 2014

by Maura Duffy

There is growing evidence that breast implants can cause a cancer of the immune system.  But in 2014 there was already very clear evidence that women with breast implants were more likely to develop that type of cancer than other women, and that women with breast implants need immediate access to medical care if there are any signs of a problem with their breasts.1

Anaplastic large cell lymphoma (ALCL) is a rare type of cancer of the immune system that was estimated to affect 1 in half a million women.2 It usually develops in the lymph nodes, skin, lungs, or liver. However, ALCL sometimes develops in the breast area of women with breast implants. In an article published in an oncology journal in 2013, researchers at MD Anderson Cancer Center studied 60 women with breast implants who were diagnosed with ALCL in the breast. This is much higher than would be expected.3 This link between ALCL and breast implants (“breast implant-associated ALCL”) was first reported by the FDA in January of 2011.

How did the women find out they had ALCL? Most of them approached their doctors with symptoms such as pain, lumps, swelling, or asymmetry in their breasts years after getting implants.  Since breast implants are a “foreign body,” the body forms scar tissue around the implant to protect their body from this “foreign invader.”  The scar tissue surrounding the implant is known as the scar capsule. It is natural for the body to form scar tissue, and the scar tissue is only a problem if it tightens or hardens around the implants, causing pain and hardness known as “capsular contracture.”  Breast implant-associated ALCL is almost always found in the scar capsule surrounding the implant, not the breast tissue itself, and has been reported in women both with and without capsular contracture.4

ALCL is diagnosed by testing the fluid that collects around the implant, called a seroma.5 Seroma is usually not caused by ALCL.  It is important to understand that even when ALCL is in the breast, it is not breast cancer, but rather a cancer of the immune system.  Most breast implant-associated ALCL has cancer cells within the fluid inside the scar capsule. That ALCL can be treated by removing the implant and the surrounding scar tissue. This surgery is known as a capsulectomy.

One study of nine women who had a capsulectomy after being diagnosed with breast implant-associated ALCL found that all nine were healthy and disease free when they were studied 3.5 years later, and neither chemotherapy nor radiation treatment was necessary. However, some types of ALCL are more aggressive and need to be treated with chemotherapy or radiation. 6

In December 2013, a study of 60 patients with breast implant-associated ALCL showed that the ALCL was more likely to be fatal for women who had a solid ALCL tumor than for women who had ALCL cancer cells in the surrounding fluid (known as effusion ALCL). All of the patients with effusion-type ALCL were still alive 5 years after their diagnosis, compared to only 75% of the patients with solid ALCL tumors. ALCL returned in only 14% of patients with effusion-type ALCL, compared to 50% recurrence of solid ALCL tumors.7

Longer studies with more patients are needed to determine if some kinds of breast implants are more likely to cause ALCL.  Meanwhile, women with all types of implants should have routine follow-ups and should immediately see a doctor if one or both of their breasts become swollen. For women with silicone implants, FDA recommends getting a breast coil MRI three years after getting silicone gel implants, and every two years after that.8

A statement on ALCL from Allergan, a manufacturer of both silicone and saline breast implants, said, “A woman is more likely to be struck by lightning than to get this condition.”9 Four hundred people are injured or killed by lightning every year.10 ALCL may strike fewer women but it is an avoidable risk that most of us would choose to steer clear of, just as we do not go swimming during a thunderstorm.

Even more worrisome, it is possible that ALCL is more common than has been reported, since most doctors don’t even think to consider testing for ALCL. The FDA is establishing a registry to monitor the number of breast implant-associated ALCL cases and is studying the link between breast implants and ALCL.

While the risk of ALCL appears to be very small, many women would not want to take the chance of developing cancer as a result of breast implants. In addition, the link between breast implants and autoimmune diseases has been hotly debated for two decades, and the evidence regarding ALCL once again raises questions about the possible impact of breast implants on autoimmune disease or symptoms such as joint pain, body pain, memory loss, and chronic fatigue.

For many years, women with breast implants were assured by implant companies, plastic surgeons, and the FDA that breast implants did not cause breast cancer or any other type of cancer. Evidence of a link to some types of cancer and to autoimmune diseases, including studies conducted by researchers at FDA and the National Cancer Institute, was dismissed. However, as everyone knows from data on lung cancer, emphysema, and smoking, it can take decades to determine if an exposure causes cancer or other serious diseases. Even a very strong carcinogen, such as tobacco, is very unlikely to cause lung cancer for at least 30 years.  For this reason, it is essential that physicians and researchers take a closer look at the link between breast implants and cancer of the immune system, as well as other immune disorders.

  1. Mazzucco, AE. Next Steps for Breast Implant-Associated Anaplastic Large-Cell Lymphoma. J Clin Oncol, 2014. Early release publication. June 16, 2014.  
  2. U.S. Food and Drug Administration. 26 January 2011. Web. June 25, 2012, <http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm241090.htm>  
  3. “Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses.” January 2011. Center for Devices and Radiological Health. U.S. Food and Drug Administration. Web. June 25, 2012, <http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm>  
  4. “FDA Questions and Answers about Anaplastic Large Cell Lymphoma (ALCL).” U.S. Food and Drug Administration. 26 January 2011. Web. June 25, 2012, <http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm241086.htm>  
  5. Kim B, Roth C, Young VL, Chung KC, van Busum K, et al. Anaplastic large cell lymphoma and breast implants: results from a structured expert consultation process. Plastic and Reconstructive Surgery. 2011 Sep;128(3):629-39.  
  6. Aladily TN, Medeiros JL, Amin, MB, Haideri N, et al. Anaplastic Large Cell Lymphoma Associated with Breast Implants: A Report of 13 Cases. Am J Surg Pathol. 2012 June 36(6).  
  7. end Miranda, et al. Breast Implant–Associated Anaplastic Large-Cell Lymphoma: Long-Term Follow-Up of 60 Patients. J Clin Oncol. 9 December 2013.  
  8. FDA Update on the Safety of Gel-Filled Breast Implants.” June 2011. Center for Devices and Radiological Health. U.S. Food and Drug Administration. Web. June 25, 2012, http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260090.pdf target=”_blank”>http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260090.pdf>  
  9. Edwards, Jim. “Breast Implant Maker Challenges FDA on Cancer Link.” CBS Money Watch. 27 January 2011. Web. 25 June http://www.cbsnews.com/8301-505123_162-42847224/breast-implant-maker-challenges-fda-on-cancer-link/ target=”_blank”>http://www.cbsnews.com/8301-505123_162-42847224/breast-implant-maker-challenges-fda-on-cancer-link/  
  10. Cooper, Mary Ann, MD. “Medical Aspects of Lightning.” National Weather Service. Web. 25 June 2012.http://www.lightningsafety.noaa.gov/medical.htm