Autoimmune Symptoms and “Breast Implant Illness”


Thousands of women have reported health problems after getting breast implants, including muscle and joint pain, chronic fatigue, mental confusion, rashes, dry eyes, and hair loss. These symptoms can suddenly develop right after getting breast implants, or they can develop gradually years later.

The Food and Drug Administration (FDA) approved breast implants more than a decade ago, but acknowledged that “studies would need to be larger and longer” to determine if implants could cause the symptoms and diseases many women are reporting.1 Many of the women refer to these symptoms and diseases as “breast implant illness,” although most physicians do not consider this term to be a medical diagnosis.

In their safety studies that were used for FDA approval, breast implant companies intentionally excluded women who had a family or personal history of autoimmune disease before getting implants. This is because those women might be more likely to have health problems from the implants. Breast implant companies recognize this as a shortcoming of their studies. For example, this is what Mentor says in their label for MemoryGel® implants:2

Safety and effectiveness have not been established in patients with the following:

Autoimmune diseases (for example, lupus and scleroderma)…”

Unfortunately, most physicians and most women considering implants are unaware of that warning.

What Is Autoimmune Disease?

Autoimmune diseases are conditions where immune cells attack your body. Immune cells usually help our bodies fight off infections and foreign substances. However, when immune cells react to silicone as a foreign substance, that can sometimes cause the body to start an immune response. In some cases, the immune system starts attacking the body. This can result in many different symptoms like joint pain, fatigue, mental confusion, dizziness, fever, and hair loss. Some women with breast implants report many different symptoms that do not fit with the diagnosis of one specific disease. Over time, some women develop a pattern of symptoms that are diagnosed as lupus, scleroderma, fibromyalgia, Sjogren’s Syndrome, Hashimoto’s, or other diseases.

Autoimmune diseases can target organs, such as the brain or liver. They can also involve many tissues, such as muscles or blood.3 In addition to autoimmune diseases, silicone-related diagnoses include raynaud’s disease, irritable bowel syndrome, and allergies.

Many autoimmune symptoms are also connective tissue symptoms, so the terms overlap.

Not all women with breast implants develop these health problems. It is possible that some women are more likely to develop autoimmune symptoms, such as those with a personal or family history of autoimmune disease, allergies, or a compromised immune system.4 Women who already had an autoimmune disease before getting breast implants may find that their symptoms got worse after getting breast implants. Certain genes may also increase the chances of developing autoimmune diseases or symptoms, sometimes as a reaction to silicone or other exposures.

How “Good” Is the Evidence?

There is conflicting evidence from studies that examined whether breast implants cause autoimmune disease or symptoms. Most of the existing studies were funded by implant companies or plastic surgery associations, and they tended to focus on narrowly defined disease diagnoses, rather than the symptoms that many women report. Some studies even relied on hospital or medical records. These types of studies do not accurately capture the magnitude of the issue because most women who experience symptoms are not hospitalized and do not receive specific diagnoses. Despite those challenges, there is a growing body of evidence that breast implants can cause autoimmune symptoms and connective tissue symptoms in some women.

In 2001, FDA scientists reported that women whose ruptured breast implants leaked silicone outside the scar tissue surrounding the implant were significantly more likely to have been diagnosed with fibromyalgia (a painful soft-tissue disease), pulmonary fibrosis, and connective-tissue diseases such as dermatomyositis.5 Fibromyalgia is a disorder that causes widespread pain in the body as well as fatigue. Little is known about how fibromyalgia develops, but researchers think it is an immune system problem.

In 2004, scientists from the National Cancer Institute reported that women with breast implants were more likely to have autoimmune symptoms. However, because symptoms were self-reported, the scientists concluded that more reliable research was needed to determine if breast implants caused specific symptoms or diseases.6

The National Center for Health Research reviewed dozens of research studies of the health problems of women with breast implants. This report points out the weaknesses in each study and highlights what we do and do not know about breast implant illness.

In 2018, researchers at the MD Anderson Cancer Center analyzed data that implant companies submitted to the FDA and published in a medical journal. The researchers found that “silicone implants are associated with an increased risk of certain rare harms.” For example, certain autoimmune diseases (such as Sjögren syndrome) increased by as much as 800%, among women with breast implants. However, the study had limitations because most of the women in the studies dropped out after just a few years.7

A study of more than 56,000 Israeli women, including more than 11,000 with breast implants, was published in 2018 in the International Journal of Epidemiology. They found that women with breast implants were significantly more likely to develop several autoimmune and rheumatic disorders, in particular sarcoidosis, systemic sclerosis, and Sjögren’s syndrome. 8

In recent years, the discovery that breast implants could cause cancer of the immune system (ALCL) supports the claim that breast implants can have a harmful impact on the immune system.

Treatment

If you already have breast implants and have any of the above symptoms that are not responding to other treatment options, research suggests that you may want to consider permanently removing your breast implants. Although there is no guarantee that removing your breast implants will improve your autoimmune symptoms, studies show that it is a very reasonable strategy. 

Many women with breast implants report that these symptoms greatly improved or completely disappeared after their breast implants were removed and not replaced. A study published in 2013, by researchers in the Netherlands, found that 69% of women with autoimmune symptoms who had their implants removed experienced reduction in symptoms and almost 20% experienced full recoveries after explantation.9 A meta-analysis, which is a type of study that combines the results from several studies, found that on average, 3 out of 4 women who removed their silicone breast implants saw improvement in their symptoms.10 The National Center for Health Research surveyed 449 women who had their breast implants removed, and more than 85% said their symptoms improved after explant.

For more information on removing your implants and finding a qualified surgeon, read our article here on explant.

The Bottom Line

Although well-designed large and long-term studies are lacking, for decades women with implants have reported developing autoimmune symptoms that later improved when their implants were removed.

If you already have an autoimmune disease, breast implants could make your symptoms worse. If autoimmune disease runs in your family, you may be at increased risk of developing an autoimmune reaction to breast implants.

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

  1. U.S. FDA. Medical Devices: Breast Implants: Risks of Breast Implants. (Apr. 4, 2017). Available Online: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064106.htm#Connective_Tissue_Disease.  
  2. Mentor. Mentor Silicone Gel-Filled Breast Implant Product Insert Data Sheet. (Nov. 2006). Available online: https://www.accessdata.fda.gov/cdrh_docs/pdf3/p030053c.pdf.  
  3. Cohen Tervaert JW, Colaris MJ, van der Hulst RR. Silicone breast implants and autoimmune rheumatic diseases: myth or reality. Curr Opin Rheumatol. 2017 Jul;29(4):348-354. doi: 10.1097/BOR.0000000000000391.  
  4. de Boer M, Colaris M, van der Hulst RRW, Cohen Tervaert JW.Is explantation of silicone breast implants useful in patients with complaints? Immunol Res. 2017 Feb;65(1):25-36. doi: 10.1007/s12026-016-8813-y.  
  5. Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. “Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women.” The Journal of Rheumatology 2001.  
  6. Brinton LA, Buckley LM, Dvorkina O et al. Risks of connective tissue disorders among breast implant patients. American Journal of Epidemiology. 2004; 180: 619-27.  
  7. Coroneos, Christopher J., et al. “US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients.” Annals of surgery (2018).  
  8. Watad, A., Rosenberg, V., Tiosano, S., Cohen Tervaert, J. W., Yavne, Y., Shoenfeld, Y., … & Amital, H. (2018). Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis. International journal of epidemiology, 47(6), 1846-1854.  
  9. Maijers MC, et al. Women with silicone breast implants and unexplained systemic symptoms: a descriptive cohort study. The Netherlands Journal of Medicine. 2013; 71(10): 534-540. Available online: http://www.njmonline.nl/getpdf.php?id=1392.  
  10. de Boer M, Colaris M, van der Hulst RRW, Cohen Tervaert JW.Is explantation of silicone breast implants useful in patients with complaints? Immunol Res. 2017 Feb;65(1):25-36. doi: 10.1007/s12026-016-8813-y.