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Silicone breast implants & autoimmune disease

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By Brown SL, Langone JJ, Brinton LA • www.ProHealth.com • January 3, 1998


In 1992, the Food and Drug Administration requested a voluntary
moratorium on the scale and implantation of
silicone-gel-filled breast implants because of growing concern
over the lack of scientific and clinical data supporting their
safety and effectiveness. Breast implants had been reported to
cause serious local complications, and new questions about
breast implants and increased risk for autoimmune disease,
including the rare but sometimes fatal connective tissue
disease scleroderma, were also raised. Since that time,
clinical studies have focused on the adjuvant effect of
silicone and of potential autoantibody production.
Epidemiologic studies have ruled out a large increased risk
for connective tissue disease overall in women with breast
implants, but samples were too small to rule out an increase
in rare connective tissue diseases. Nor were studies properly
designed to address whether an atypical syndrome might develop
in women with breast implants. Meta-analyses of these studies
cannot remedy their underlying methodologic weaknesses. While
the question of whether rare connective tissue disease is
associated with breast implants may never be answered
definitively, recent progress in identifying new syndromes
such as fibromyalgia and chronic fatigue syndrome may provide
an insight into methodology for evaluating the existence of a
silicone-related syndrome in women with breast implants.




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