Silicone implant incompatibility syndrome (SIIS): a frequent cause of ASIA (Shoenfeld's syndrome)

Our plain-English summary of Silicone implant incompatibility syndrome (SIIS): a frequent cause of ASIA (Shoenfeld's syndrome), by J.W. Cohen Tervaert, R.M. Kappel (Immunologic Research, 2013).

The study

• Authors: J.W. Cohen Tervaert, R.M. Kappel
• Journal: Immunologic Research
• Published: 2013;56(2-3):293-8
• Cited by: 96 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Silicon has a molecular mass of 28 daltons. In nature, silicon is found as silicon dioxide (silica) or in a variety of silicates (e.g., in talc or asbestos). Furthermore, silicon is present in silicones, polymerized siloxanes, which are often used as medical silicones in breast implants. Silicon exposure is associated with different systemic autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, progressive systemic sclerosis, and vasculitis. Remarkably, silicon in silicone-filled breast implants is considered to be safe, not increasing the risk of developing autoimmune diseases. We analyzed the impact of silicone-filled breast implants on the immune system in 32 consecutive patients attending a specialized autoimmunity clinic. All 32 patients had silicone implant incompatibility syndrome and complaints fulfilling the diagnostic criteria of ASIA (autoimmune/inflammatory syndrome induced by adjuvants). Furthermore, in 17 of the 32 patients, a systemic autoimmune disease was diagnosed, and 15 of the 32 patients had an impaired humoral immune system. Patients developed symptoms and signs after long-term follow-up, suggesting that these symptoms and signs started after implant aging and/or rupture. We postulate that silicon in silicone-filled breast implants may increase the risk of developing (auto) immune diseases and immune deficiencies.

In plain English

This article reported a series of 32 women with silicone-gel-filled breast implants seen at a clinical immunology clinic in Maastricht, the Netherlands, between January 2008 and January 2012. It concerned implants, not asbestos, which appeared only as background. All 32 women had what the authors called silicone implant incompatibility syndrome, and all met the diagnostic criteria for ASIA (autoimmune/inflammatory syndrome induced by adjuvants). The median time from implant to the start of complaints was 10 years (range 2 to 24 years). Seventeen had a systemic autoimmune disease, including 6 with a connective tissue disease and 6 with systemic necrotizing vasculitis. Seven had an organ-specific autoimmune disease. Fifteen of the 32 had an immunodeficiency. Of 10 women whose enlarged lymph nodes were removed, 2 had a non-Hodgkin lymphoma. The authors postulated that silicon in these implants increases the risk of (auto) immune diseases, but stated that the association does not mean a causal relationship. They noted that the women were referred with complaints, and the number of women with implants and no complaints was unknown.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Case series of consecutive patients with breast implants referred to a clinical immunology clinic
• Who was studied: 32 women with breast implants, aged 18 to 64 years (median 49) at evaluation. They were found among approximately 600 patients referred to the Clinical Immunology Clinic of Maastricht University Medical Center, the Netherlands, between January 2008 and January 2012.
• Exposure: Silicone-gel-filled breast implants; none of the patients had saline-filled or mixed saline-hydrocellulose-filled implants. Asbestos is mentioned only in the introduction, as background from another study.
• Main results:
  • All 32 patients fulfilled the diagnostic criteria for ASIA.
  • Median time from breast implant to start of complaints was 10 years (2 to 24 years). 20% of patients reported signs and symptoms within 2 years, 33% between 2 and 10 years, 28% between 10 and 20 years, and 19% more than 20 years after the operation.
  • Median time from breast implant to diagnosis of ASIA was 16 years (2 to 40 years).
  • In 10 patients, enlarged lymph nodes were removed. 2 of the 10 had a non-Hodgkin lymphoma. In the other 8, a foreign body reaction with granulomatous inflammation was found, which the authors described as suggestive of biopsy-proven silicosis.
  • 17 of the 32 patients were classified as having a systemic autoimmune disease and 7 as having an organ-specific autoimmune disease.
  • Among the 17 with a systemic autoimmune disease: 6 had a connective tissue disease (1 systemic sclerosis, 1 systemic lupus erythematosus, 2 Sjogren's syndrome, 2 anti-phospholipid syndrome). 6 had a systemic necrotizing vasculitis, 1 had multiple sclerosis, and 4 had a systemic granulomatous disease (3 sarcoidosis, 1 Crohn's disease).
  • The 7 organ-specific autoimmune diseases were 4 cases of pernicious anemia and 3 of autoimmune thyreoiditis.
  • 15 of the 32 patients had an immunodeficiency. 8 had hypogammaglobulinemia (total IgG below 6.0 g/L). 7 had an IgG subclass deficiency: 1 IgG1, 2 IgG2 and 4 IgG3.
• The authors' conclusion: The authors postulated that silicon in silicone-filled breast implants increases the risk of developing (auto) immune diseases; the abstract says 'may increase'. They called for prospective long-term follow-up studies of women with silicone-filled breast implants.
• Limitations the authors state:
  • The patients were referred to an autoimmunity clinic with complaints. The number of women who had such implants without any complaints is unknown.
  • IgG levels were not measured before the implant operation, so immunodeficiencies may already have been present beforehand.
  • The authors stated that the association between autoimmunity and silicone breast implants does not mean a causal relationship.

Topics

Medical terms in this study, explained in our Lexicon: Silicate, Talc.

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