Breast Implants and Cancer of the Immune System (ALCL): A History of Who Knew What When

Other Cancers
Maura Duffy, Cancer Prevention & Treatment Fund

Experts now agree that breast implants can cause a type of cancer of the immune system.  The FDA finally admitted this risk of cancer in 2017, but other experts – including plastic surgeons — were aware of the risk years before.  Why did it take so long for FDA, the media, and women with implants to find out that choosing breast implants could increase their chances of developing a potentially fatal disease?

Anaplastic large cell lymphoma (ALCL) is a rare type of cancer of the immune system that usually develops in the lymph nodes, skin, lungs, or liver. However, ALCL sometimes develops in the breast area of women with breast implants.

In 2008 Dutch researchers published a report of 11 women with breast implants and ALCL, and concluded that the implants seemed to be associated with ALCL.[3]  Although published in the Journal of the American Medical Association (JAMA), this information was not widely reported.

The link between ALCL and breast implants was first reported by the FDA in January of 2011. In 2013, researchers at MD Anderson Cancer Center studied 60 women with breast implants who were diagnosed with ALCL in the breast. Since ALCL was thought to be diagnosed in only 1 woman in half a million, this was much higher than would be expected.[4]  In 2016, the World Health Organization (WHO) officially recognized BIA-ALCL.[5]  In 2017, the National Comprehensive Cancer Network (NCCN), a nonprofit network of cancer experts, released a worldwide oncology standard for surgeons and oncologists to test for and diagnose “breast implant associated ALCL (BIA-ALCL).” 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 in women with breast implants must be evaluated.

And yet, it was not until March 2017 that the FDA finally updated its website to officially report that breast implants could cause ALCL. At the time of the FDA announcement, the agency reported that they had received 359 reports of ALCL among women with breast implants. Reports to the FDA of problems from medical devices are acknowledged to be the “tip of the iceberg” since surgeons frequently do not do these online reports.

How did women find out they had ALCL before the official announcement of BIA-ALCL was made? 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. It has been reported in women both with and without capsular contracture, as well as women with silicone gel or saline breast implants.[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 BIA-ALCL found that all nine were disease free when they were studied 3.5 years later, and they did not require chemotherapy nor radiation treatment. However, some types of ALCL are more aggressive and need to be treated with chemotherapy or radiation. [6]

In December 2013, the study of 60 patients with breast implants and ALCL reported 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. Patients with solid ALCL tumors had a 50% recurrence rate.[7]

Longer studies with more patients are needed to determine if certain kinds of breast implants are more likely to cause ALCL.  Preliminary data indicate that most, but not all, women with BIA-ALCL had textured breast implants at some point.  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 the implants, and every two years after that.[8]

Although plastic surgeons and breast implant manufacturers admit that breast implants can cause ALCL, they claimed it was very rare.  For example, Allergan, a manufacturer of many different types of breast implants, claimed that “A woman is more likely to be struck by lightning than to get this condition.”[9]   However, 400 people are injured or killed by lightning every year,[10] which is why most people avoid situations where lightening can harm them.

In fact, the Australian version of the FDA now estimates that 1 in 1,000 women with breast implants will develop BIA-ALCL, [11] which is not nearly as rare as plastic surgeons and manufacturers have claimed.

Many women would not want to take the chance of developing cancer as a result of breast implants, and this is especially true for women who underwent mastectomies that were not medically necessary in an effort to reduce their chances of cancer returning.

It is also important to note that the link between breast implants and autoimmune diseases has been hotly debated for two decades, with many women reporting serious autoimmune symptoms that went away when their implants were removed.[11]  The scientific evidence regarding ALCL and implants 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 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.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

  1. Mazzucco, AE. Next Steps for Breast Implant-Associated Anaplastic Large-Cell Lymphoma. J Clin Oncol, 2014. Early release publication. June 16, 2014.
  2. 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
  11. Mazzucco, Anna, Ph.D and Zuckerman, Diana, Ph.D. “ALCL and Breast Implants: 2017 Update.” Breast Implant Information. Web. March 14, 2017. <http://www.breastimplantinfo.org/implantalcl/>