Silicone Breast Implants and Lupus

Evidence suggests silicone breast implants may be linked to autoimmune diseases

Breast implants have been associated with health issues, including immune disorders and cancer. Currently, the Food and Drug Administration (FDA) states that in addition to the standard risk of surgical complications and implant rupture, breast implants are also associated with breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), which is a type of cancer and with systemic symptoms that are described as breast implant illness (BII).

This article discusses the health issues that have been associated with silicone breast implants. 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?

Autoimmune diseases include disorders that occur when the body's immune system attacks its own tissue, causing a variety of symptoms that can include a rash, swelling, aching, fatigue, organ failure, and more. They can occur due to hereditary or environmental factors.

Lupus is a commonly recognized autoimmune disease that had been associated with breast implants in the past. However, recent studies suggest that people who have had breast implants are not at a higher than average risk of lupus.

Lupus 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, they were classified as a Class II product. 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, the U.S. Food and Drug Administration (FDA) banned silicone breast implants over concerns that ruptured implants could lead to serious health conditions. In 1999, the IOM declared that breast implants are safe and not linked to cancers or autoimmune diseases and the ban was lifted in 2006.

Currently, the FDA considers breast implants to be Class III products.

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 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 and it may stimulate an autoimmune response.

Breast Implants and Autoimmune Disease

According to the FDA, joint pain, muscle aches, confusion, chronic fatigue, and reproductive or breastfeeding problems have been reported with breast implants, but the evidence does not support an association between breast implants and these issues, and the risk for developing these problems is not well established.

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.


Breast implant illness is a newly defined condition that causes symptoms often associated with autoimmune disease—including joint pain, fatigue, hair loss, and brain fog. The exact risk of this condition is not known.

Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)

Breast implant-associated-anaplastic large cell lymphoma (BIA-ALCL) is an immune system cancer that starts as a lump near the implant and then may spread to other areas of the body.

Symptoms can include:

  • Swelling or lumps in the breast
  • Redness
  • Rash

The condition is diagnosed with breast imaging and biopsy. Treatment includes removal of the tumor and systemic cancer treatment that's used for other types of T-cell lymphoma if the cancer has spread.

Breast Implant Removal

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.


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

Women with these implants should mention autoimmune symptoms to their doctor.


Silicone breast implants have raised many health concerns over the years. 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

If you are considering having breast implant surgery, it's important that you think about the health aspects of your decision. Ask your doctor about the risks and benefits and what to expect if you decide to have them removed someday.

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By Jeri Jewett-Tennant, MPH
Jeri Jewett-Tennant, MPH, is a medical writer and program development manager at the Center for Reducing Health Disparities.