No test to detect silicone in body, according to FDA

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Is there a test to detect silicone in the body or to determine

whether an individual is sensitive to silicone?

There is no FDA-approved, standardized test to detect silicone in

the body. Determining that silicon or silicone is present in body

fluids does not indicate whether a person is sensitive to these

substances or at risk for any specific disease. (Silicon is an

element that is one component of silicone and is one of the most

abundant elements on the earth. Everyone is exposed to silicone.)

Some researchers reportedly have developed a test that can detect

antibodies to silicone in blood. However, the validity of the test

is controversial. Even if such antibodies were detected, the

significance would be unclear. Antibodies to silicone would not

necessarily indicate that silicone is harmful, or that a person

would necessarily have an adverse reaction to it. Some researchers

have also reportedly developed a test to detect if a woman's immune

system is sensitive to silica, a constituent of silicone breast

implants and reportedly a breakdown product of silicone gel. The

validity of this test also has been questioned, and it is not clear

at this time whether the results of this test have clinical

significance. FDA has not approved for general marketing any tests

to determine silicone in the body, or to determine whether a woman's

immune system is sensitized to any constituent of silicone breast

implants.

Even if simple techniques to detect silicone were available, they

might not be useful in detecting a rupture, because small amounts of

silicone ordinarily bleed even from intact implants. Further, since

silicone is found in food and many other products, including

commonly used medicines and cosmetics, the tests would not easily

determine whether the silicone came from the implant or another

source.

Some researchers have also reported that a test called the Anti-

Polymer Antibody Assay may be used to distinguish among women with

implants who have signs and symptoms of disease ranging from mild to

severe. However, the biologic basis for the assay has not been

established. The test remains to be validated by additional studies

and, at this time, the clinical significance of the test results

remains unclear.

Should a woman have her breast implants removed?

If a woman is experiencing symptoms that may be related to her

implants, she should contact her physician or surgeon in order to

discuss the best course of action. This discussion should include

the recognition that the cosmetic results of explantation may be

unsatisfactory to some women.

Source: US Food and Drug Administration, revised/posted 9/8/99.