Silicone Breast Implants and Lupus

Evidence suggests silicone breast implants may be linked to autoimmune diseases

In 1992, the U.S. Food and Drug Administration (FDA) banned silicone breast implants over concerns that ruptured implants could lead to serious health conditions, including the autoimmune disease lupus. Although the ban was lifted in 2006, health concerns remain.

This article discusses the relationship between silicone breast implants and lupus. It also explores the FDA's decision to allow the use of silicone breast implants and what that does (and does not) mean about potential health risks.

A silicone breast implants
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What Is Lupus?

Lupus is like other autoimmune diseases in that it occurs when your body mistakes your own healthy tissues for a foreign invader like a bacteria or virus.

Different autoimmune diseases affect different areas of the body. Lupus is unique in that it can affect any area of the body, causing chronic inflammation and pain.

Symptoms can overlap with those of many other autoimmune diseases and change from one flare-up to the next. This makes lupus especially complicated and difficult to diagnose.

Common symptoms of lupus include:

  • Fatigue and exhaustion no matter how much you sleep
  • Pain and swelling in your muscles and joints
  • Skin rashes
  • Hair loss
  • Mouth sores
  • Sensitivity to the sun
  • Lung, heart, or kidney problems
  • Trouble remembering things

Around 90% of people with lupus are women. While there is no cure, symptoms can be managed with early diagnosis and treatment.

There is no specific cause of lupus. It is believed to be triggered by an interplay of genetic, hormonal, and environmental factors (e.g., exposure to toxins).

History of Implant Concerns

Before a new medical product can be put on the market, the FDA carefully studies it to ensure it is safe. All new products are then classified according to the amount of risk associated with them.

Those classes are:

  • Class I: Low-risk products, like bandages or sunglasses
  • Class II: Medium-risk products, like X-rays or electric wheelchairs
  • Class III: High-risk products, like implantable pacemakers and other devices that could pose a risk to your life

Silicone breast implants first became available in 1962. At the time, the FDA considered them a Class II product. But in the 1980s, they were changed to Class III. This was prompted by concerns that breast implants could be linked to cancers, autoimmune diseases like lupus, and more.

In 1992, silicone breast implants were banned completely so that the FDA and the Institute of Medicine (IOM) could investigate those concerns. In 1999, the IOM declared that breast implants are safe and not linked to cancers or autoimmune disease.

Fast forward to 2006 when the ban was lifted: The FDA's decision to re-approve silicone breast implants was based on studies done by the breast implant manufacturers themselves. The FDA also recognized that the long-term risks of breast implants are unknown.

To this day, the FDA considers breast implants to be Class III products.This means they present a risk of illness or injury, and there is not enough information to assure they are safe.

Recap

The FDA's approval of silicone breast implants is not confirmation that they are 100% safe in the short- or long-term. It just indicates that they are reasonably safe for use as directed based on available data.

Saline vs. Silicone Implants

The FDA has approved two types of breast implants for breast implant surgery:

  • Saline-filled breast implants: Implants that are filled with sterile salt water (saline) and have a silicone outer shell.
  • Silicone-filled breast implants: Implants that are filled with silicone gel and have a silicone outer shell.

Both types of breast implants come with the risk that they will tear (e.g, due to wear and tear or trauma) and leak filling into your body. This is known as a rupture.

You will probably notice right away if your saline implant ruptures, because your breast will start to appear deflated within a few days. Any saline that leaks will be absorbed by the body, which poses no risk to your health.

Since silicone gel, on the other hand, is thicker and leaks much slower. It may take longer for you to realize your silicone-filled implant has ruptured, and some women may not realize it at all. Silicone gel does not absorb into the body like saline. Instead, it can travel to other areas, like lymph nodes, and stimulate an autoimmune response.

Breast Implants and Autoimmune Disease

Since 2006, studies have shown that silicone breast implants may, in fact, be associated with cancers and autoimmune diseases.

Researchers at the University of Texas MD Anderson Cancer Center found that the rate of autoimmune disease was two to eight times higher in women with silicone breast implants than in the general population.

In particular, they found that silicone breast implants are associated with the following autoimmune diseases:

  • Sjögren's syndrome: When the immune system attacks the glands that secrete substances in your body, resulting in a dry mouth, eyes, and vagina
  • Rheumatoid arthritis: When the immune system attacks joint tissues, resulting in painful, swollen joints.
  • Scleroderma: When the immune system attacks skin tissues, resulting in hard, thick skin, sores, and joint pain
  • Dermatomyositis: When the immune system attacks muscle tissues, resulting in muscle weakness, fatigue, and skin rashes.

Out of the nearly 100,000 women in this study, 500 cases of autoimmune disease were associated with silicone implants, while five were associated with saline implants.

Sjögren's syndrome, rheumatoid arthritis, and scleroderma were the most commonly reported autoimmune diseases. But the researchers also found a slightly higher rate of lupus in women with silicone breast implants compared to women without them.

That doesn't mean any direct link has been found, although it cannot be ruled out. More studies are needed to prove that silicone breast implants are a direct cause of autoimmune disease.

Recap

While experts cannot definitively say that silicone breast implants can cause lupus or other autoimmune diseases, research supports an association.

Breast Implant Removal

Symptoms of lupus may come and go, progress slowly over time, or happen all at once then go into remission. Because lupus is often vague and unpredictable, it takes an average of six years from appearance of the first symptoms for it to be diagnosed.

So far, there is no evidence that having your breast implants removed will prevent autoimmune symptoms from ever developing. However, multiple studies have shown that, when combined with immunosuppressive therapy, having implants removed may relieve early autoimmune symptoms that are already present.

In one study, researchers examined the cases of women who developed some autoimmune symptoms after getting breast implants. They found that 63% of women found relief from their symptoms within 14 months of having their breast implants removed.

This was not the case for women with fully-formed and diagnosed autoimmune diseases, though. For them, improvements were minimal. The researchers believe that once silicone particles reach the lymph nodes, the autoimmune response will continue even after the implants are removed.

Importance of Early Diagnosis

The most common causes of death in people with lupus are kidney failure, infection, and cardiovascular disease. Early diagnosis and treatment can reduce the risk of these complications.

Furthermore, according to one 2014 study, people who are diagnosed with lupus early have lower medical bills, require fewer doctor's visits, and have lupus flares less frequently compared to people diagnosed later on.

It's for these reasons that all women with breast implants should be aware of the symptoms of autoimmune diseases—lupus and others—and contact their doctor if they experience them. These include chronic fatigue, joint pain and swelling, skin rashes, digestive issues, a fever that keeps returning, or swollen glands.

Recap

Breast implant removal may reduce autoimmune symptoms when combined with treatment. More research is needed to determine if removing breast implants will stop lupus from developing in at-risk people.

Still, women with these implants should mention autoimmune symptoms to their doctor.

Summary

Silicone breast implants have raised many health concerns over the years. Today, there is strong evidence that silicone breast implants are associated with autoimmune diseases like lupus.

Although the FDA says that these implants "have a reasonable assurance of safety," they also note that there may be long-term risks that available data can't identify.

Silicone breast implant removal may relieve early autoimmune symptoms, but it will not cure an autoimmune disease that has already developed. The decision to have your breast implants removed is personal and one that should be made with your doctor.

A Word From Verywell

According to a survey by the Lupus Foundation of America, 23% of people with lupus were originally told by their doctor that their symptoms were psychological, not physical.

If you are at risk for autoimmune disease, it's critical that you educate yourself on the symptoms. Don't be afraid to get multiple opinions from multiple doctors until you are certain your needs are met.

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  1. Centers for Disease Control and Prevention. Lupus Awareness. Reviewed June 2020.

  2. Maidhof W, Hilas O. Lupus: an overview of the disease and management optionsPT. 2012 Apr;37(4):240-249.

  3. Jin J. FDA authorization of medical devices. JAMA. 2014 Jan;311(4):435. doi:10.1001/jama.2013.286274

  4. FDA Centers for Devices and Radiological Health. FDA update on the safety of silicone gel-filled breast implants. Published June 2011.

  5. U.S. Food and Drug Administration. Update on the Safety of Silicone Gel-Filled Breast Implants (2011)—Executive Summary. July 16, 2018.

  6. U.S. Food and Drug Administration. Types of breast implants. Updated October 2019.

  7. Tervaert JWC, Colaris M, van der Hulst R. Silicone breast implants and autoimmune rheumatic diseases: Myth or reality. Curr Opin Rheumatol. 2017 Jul;29(4):348-354. doi:10.1097/BOR.0000000000000391

  8. The University of Texas MD Anderson Cancer Center. Breast implant-associated anaplastic large cell lymphoma.

  9. Coroneos C, Selber J, Offodile 2nd A, Butler C, Clemens M. US FDA breast implant postapproval studies: Long-term outcomes in 99,993 patients. Ann Surg. 2019 Jan;269(1):30-36. doi:10.1097/SLA.0000000000002990

  10. Kaplan J, Rohrich R. Breast implant illness: a topic in reviewGland Surg. 2021 Jan;10(1):430-443. doi:10.21037/gs-20-231

  11. The University of Texas MD Anderson Cancer Center. Largest-ever study shows silicone breast implants associated with rare diseases. Published September 2018.

  12. Lupus Foundation of America. Lupus facts and statistics. Updated October 2016.

  13. de Boer M, Colaris M, van der Hulst RRWJ, Cohen Tervaert JW. Is explantation of silicone breast implants useful in patients with complaints?Immunol Res. 2017 Jul;65(1):25-36. doi:10.1007/s12026-016-8813-y

  14. Watad A, Rosenberg V, Tiosano S, et al. Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis. Int J Epidemiol. 2018 Oct;(47)6:1846-1854. doi:10.1093/ije/dyy217

  15. Centers for Disease Control and Prevention. Systemic lupus erythematosus. Reviewed October 2018.

  16. Oglesby A, Korves C, Laliberté F, et al. Impact of early versus late systemic lupus erythematosus diagnosis on clinical and economic outcomes. Appl Health Econ Health Policy. 2014 Feb;12(1):179-190. doi:10.1007/s40258-014-0085-x

  17. Johns Hopkins Medicine. What are common symptoms of autoimmune disease?.

  18. Lupus Foundation of America. Why it's difficult to determine exactly how many people are living with Lupus in the US. Updated February 2021.