Re: No test to detect silicone in body, according to FDA

[Guest guest]

There are tests to detect silicone antibodies. You cannot have silicone

antibodies unless you are reacting to silicone.

Lynda

At 08:33 AM 7/24/2004, you wrote:

><http://www.theshawcenter.com/FAQimplants.htm>http://www.theshawcenter.com/FAQi\

mplants.htm

>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.

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