by Maura Duffy, BA
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. The bad news for women with breast implants is that there is growing evidence that the implants can cause a very rare cancer of the immune system.
Anaplastic large cell lymphoma (ALCL) is a rare type of cancer of the immune system that is estimated to affect 1 in 500,000 women.1 It typically appears in the lymph nodes, skin, soft tissue, lungs, or liver. However, ALCL has been found to sometimes develop in the breast area of women with breast implants. So far, there have been 60 reported cases worldwide of women diagnosed with ALCL in the breast. Even though the total number of documented cases of “breast implant-associated ALCL” is very low, it is much higher than would be expected for the general population of women of the same age.2 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 natural response for most women is for their body to form 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 physicians are usually only concerned if the scar tissue 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.3
Most women were diagnosed with implant-associated ALCL by testing the fluid that collects around the implant, called a seroma.4 Seroma is a potential complication of breast implants and is usually not caused by ALCL. It is important to note 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 are called “effusions”, because the cancer cells are within the fluid which has collected inside the scar capsule. Women with ALCL in the scar tissue surrounding the breast can be treated by removing the implant and the surrounding scar tissue. This surgery is known as a capsulectomy.
Although there have been few studies of ALCL among women with breast implants, one clinical follow-up 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 no chemotherapy or radiation treatment was necessary.5 However, there have been case studies reported of women with breast implants who went to their doctors because their breasts were swollen, and the doctors found a tumor near the breast implants. These women with tumors had a more aggressive form of ALCL that recurred after a capsulectomy and needed to be treated with chemotherapy or radiation.5 Although earlier studies reported shorter-term results, a recent long-term follow-up 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 effusions (cancer cells in the surrounding fluid).6 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. The effusion-type ALCL tumors were also less likely to recur after treatment, returning in only 14% of patients, compared to 50% recurrence ofsolid ALCL tumors.6 Longer studies with more patients are needed to determine the best treatments for both types of breast implant-associated ALCL.
So far, there are not enough data to show if there is more risk for ALCL among women with silicone gel implants compared to saline implants or for women who get implants for reconstruction rather than augmentation purposes.2 Since it is impossible at this time to tell which women are most at risk for ALCL, it is crucial for women with all types of implants to have routine follow-ups. 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.7 Women with saline implants should have regular clinical breast exams by an OB/GYN or other physician.
Implant companies and plastic surgeons have been quick to dismiss the FDA’s findings, as they have with most claims about the safety of implants. 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.”8 Four hundred people are injured or killed by lightning every year.9 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. In addition, it is possible that there may be more cases of ALCL than have been reported. It is not standard practice to examine the scar capsule after a woman has had her breast implants removed, and it is possible that among the many women who get their implants removed every year, some have slow-growing ALCL in the scar capsule that they were not aware of.5 The FDA is in the process of establishing a registry to monitor the number of breast implant-associated ALCL cases and plans to continue 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.
- U.S. Food and Drug Administration. 26 January 2011. Web. June 25, 2012, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm241090.htm target=”_blank”>http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm241090.htm> ▲
- “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 target=”_blank”>http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm> ▲
- “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 target=”_blank”>http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm241086.htm> ▲
- 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. ▲
- 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). ▲
- Miranda, et al. Breast Implant–Associated Anaplastic Large-Cell Lymphoma: Long-Term Follow-Up of 60 Patients. J Clin Oncol. 9 December 2013. ▲
- 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> ▲
- 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/ ▲
- Cooper, Mary Ann, MD. “Medical Aspects of Lightning.” National Weather Service. Web. 25 June 2012. http://www.lightningsafety.noaa.gov/medical.htm target=”_blank”>http://www.lightningsafety.noaa.gov/medical.htm ▲