U.S. Food and Drug Administration documents show links to autoimmune disorders,
connective tissue disorders, genetic mutations, and cancer.
From http://www.fda.gov/cdrh/ost/rpt97/OST1997AR86.HTML
Autoimmune diseases have been reported in women with silicone breast implants.
The presence of autoantibodies in some of the women, as well as studies
in experimental animals, suggest that silicone may play a role in these
adverse effects on the immune system.
Our earlier studies have shown that silicone gel/oil can promote autoantibody
production against the connective tissue proteins, collagen, and can migrate
from the implant site to other parts of the body.
Serum samples of 180 women have been analyzed for autoantibodies to collagen,
a connective tissue protein. Patients included women with or without breast
implants, with or without autoimmune symptoms, and from normal controls.
Autoantibodies to collagen were detected in patients with connective tissue
disease + silicone breast implants, with connective tissue disease without
silicone breast implants, and with silicone breast implants without connective
tissue disease. Autoantibodies to collagen were not detected in control
sera from normal volunteers.
Published studies also have shown that animals with autoimmune disease
produce antibodies against their own DNA. We have found anti-DNA antibodies
in the serum of experimental animals injected with silicone gel/oil. Based
on these results we will determine if women with breast implants also produce
autoantibodies against DNA.
From http://www.fda.gov/opacom/backgrounders/collagen.html
Has liquid silicone been approved by FDA for injection?
No. FDA has not approved the marketing of liquid silicone for injection
for any cosmetic purpose, including the treatment of facial defects or wrinkles,
or enlarging the breasts. The adverse effects of liquid silicone injections
have included movement of the silicone to other parts of the body, inflammation
and discoloration of surrounding tissues, and the formation of granulomas
(nodules of granulated, inflamed tissue).
Can FDA prohibit doctors from promoting the injection of liquid silicone,
since its marketing has not been approved?
Yes. FDA prohibits manufacturers or doctors from marketing or promoting
unapproved products such as liquid silicone. This means that a doctor cannot
legally advertise or sell this material.
From http://vm.cfsan.fda.gov/~frf/forum97/97G14.htm
FDA on mutations and cancer (foreign body carcinogenesis):
After 12 months, fibrosarcoma in situ developed in 100% of rats implanted
with either silicone or cellulose.
The American Educational Gender Information Service (AEGIS) was an important
early TG advocate in the field of health issues. They put out a series of
articles, ads and pamphlets called Dangerous Curves Ahead, which remains an
important overview of injectable silicone's dangers.
Advisories against the procedure:
http://www.gender.org/resources/curves.html
http://www.gender.org/resources/bad_news.html
<-- highly recommended
http://www.gender.org/resources/malas_noticias.html
(traduccion en español)
