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Silicone breast implants have been used for augmentation or reconstructive breast surgeries since the 1960s. However, as their popularity skyrocketed, concerns began to arise regarding a potential link between the implants and autoimmune or connective tissue diseases. Numerous studies were conducted on this issue in the 1980s and beyond, yielding mixed results. In 1992, the FDA issued a moratorium on silicone implants for safety assessment, and this ban remained in effect until 2006. Today, silicone implants are used in 84% of breast augmentation surgeries. According to the American Society of Plastic Surgeons, there were approximately 243,600 silicone breast augmentations in 2016.

During the FDA's moratorium, in 2000, a meta-analysis was conducted that examined 20 studies between 1984 and 1999. This analysis found no association between silicone breast implants and autoimmune disease. Since then, tools for autoimmune disease diagnosis have improved. Subsequent studies utilizing these tools found positive associations in previously unexamined cohorts, which demonstrated a need for an updated meta-analysis to quantitatively measure any association between silicone implants and autoimmune disease.

In 2016, Cardno ChemRisk conducted a meta-analysis of the results of 20 cohort and nine case control studies. Silicone breast implants were associated with a non-statistically significant decreased risk for all connective tissue diseases, meta-RR 0.87 (95% CI: 0.62-1.21). When stratified by disease, silicone breast implants were associated with a non-statistically significant increased risk of sclerosis, meta-RR 1.14 (0.75-1.74), and a non-statistically significant decreased risk of rheumatoid arthritis, meta-RR 0.75 (95% CI: 0.52-1.08), and systemic lupus erythematosus, meta-RR 0.90 (95% CI: 0.43-1.87). These findings suggest that silicone breast implant exposure is not associated with autoimmune disease among women.

If you would like to receive more information on this topic, please contact Dr. Andrew Monnot.