Breast implant companies were required to complete safety studies before they could sell their implants in the United States. Although the Food and Drug Administration (FDA) approved breast implants, they admitted that women using breast implants for reconstruction had more complications than healthy women with cosmetic breast implants, and that “studies would need to be larger and longer” to find out if implants could cause the kinds of diseases many women were reporting.1
Since many women reported problems with autoimmune symptoms such as joint pain, breast implant companies did not study the safety of implants in women who had a family history or personal history of autoimmune disease before getting implants. They intentionally excluded those women because they were concerned that 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 disease is a condition where immune cells attack your body. Immune cells usually help our bodies fight off infections and foreign substances. However, these immune cells see silicone as a foreign substance, and that can cause the body to start an immune response.
Cancer treatments can harm a patient’s immune system, but not in the same way as an autoimmune disease.
In some cases, the immune system launches a big enough attack that it starts attacking the body. This could lead to symptoms like joint pain, fatigue, mental confusion, dry eyes, and hair loss. Some women with breast implants report a wide range of symptoms that do not fit into one specific condition. Over time, some women develop a pattern of symptoms that are diagnosed as lupus, scleroderma, or other conditions. Autoimmune diseases can target specific organs, like the brain or liver. They can also involve many tissues, like muscles or blood.3
It is important to know that not all people who get breast implants develop immune problems. Those who develop autoimmune symptoms may have other risk factors, such as allergies or a family history of autoimmune disease3,4. In addition, women who already had autoimmune symptoms can get worse symptoms or new symptoms 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. In addition, women who already had autoimmune symptoms can get worse symptoms or new symptoms after getting breast implants.
Silicone-related complaints and diagnoses (modified from DeBoer et al, 2011) 4
- Muscle aches
- Aching and painful joints
- Fever/elevated body temperature
- Dry eyes, dry mouth (sicca)
- Poor memory, concentration, or sleep
- Numbness, weakness, dizziness, vision changes (Multiple sclerosis)
- Raynaud’s disease (painful cold, pale, or purplish fingers and toes)
- Irritable bowel syndrome (diarrhea, constipation)
- Allergies (food allergies, metal allergies, multiple sensitivities, etc.)
- Immunodeficiencies (recurrent infections, e.g., pneumonia, sinus infections, diarrhea)
- Autoimmune diseases (Scleroderma, Lupus, Sjogren’s, etc.)
How “good” is the evidence?
There is conflicting evidence from studies that examined whether breast implants cause autoimmune disease or symptoms. Most studies were funded by implant companies or plastic surgery associations, and they tend to focus on narrowly defined diagnoses, with numerous studies based on hospital records rather than medical records. However, many women with breast implants have reported the same complaints over the last few decades, and many women report that their symptoms greatly improved or completely disappeared after their implants were removed.3, 4, 6
In 2001, FDA scientists reported that women with leaking silicone gel implants were nearly 3 times more likely to have fibromyalgia. 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.3
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 research was needed to determine if breast implants caused specific symptoms or diseases.5
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.
The Bottom Line
Although well-designed large, long-term studies are lacking, women with implants and autoimmune symptoms have reported for decades that their symptoms improved when their implants were removed. A Dutch study found that among 52 women who had their implants removed, 36 (69%) reported that they felt better, and 9 of the 36 reported that their symptoms were gone.6 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.4
However, the prognosis might be better for women with autoimmune symptoms who have their implants removed than for women with a diagnosed autoimmune disease.4
Treatments and Alternatives 3,4
Here are some symptoms that many women have reported to have developed after getting breast implants. Some of these symptoms developed almost immediately, but others developed years later.
- I have achy, sore, or weak muscles.
- I have achy or stiff joints.
- I wake up every morning feeling tired or un-refreshed, and no matter how much I sleep, I never feel well-rested.
- I feel like my head is in a “fog.” I have difficulty concentrating, finding the right word to say, or remembering things.
- I feel warm or hot even when it’s cold outside.
- I have dry skin, dry eyes, or hair loss.
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 the silicone implant. If you already have breast implants and have any of the above symptoms, here are some steps to consider:
- See a rheumatologist. A rheumatologist is a specialist of joint and immune system conditions. The rheumatologist can examine you and order tests if necessary to potentially diagnose any conditions. See a provider you trust and don’t be afraid to get a second opinion. This is your right as a patient!
- Your doctor may offer you medications to treat your symptoms. For example, he/she may offer you artificial tears to help with dry eyes or suggest medications to decrease inflammation in your body.
- 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
- 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
- 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.
- 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
- 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.
- 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