Blood Test Detects Silicone Immune Response

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Blood Test Detects Silicone Immune Response

NEW YORK, Feb 18 (Reuters) -- Silicone from breast

implants or other medical devices containing silicone

may cause individuals to produce antibodies that can

be detected by a newly developed laboratory test,

according to a study published in The Lancet.

" The test provides doctors with one of the first

objective measures of the most severe manifestations

of this disease, " said one of the study's authors, Dr.

Garry, professor of microbiology at Tulane

University School of Medicine in New Orleans.

Garry and his colleagues found that women with more

severe combinations of muscle pain, joint pain,

neurological dysfunction, and local complications

after receiving silicone gel-containing breast

implants (SBI) were " significantly more likely " to

test positive for antibodies to synthetic substances

-- such as silicone -- than women who had mild

symptoms.

" Definitely, the presence of these antibodies is liked

to the presence of silicone gel-containing breast

implants in the body, " said Garry. " The most logical

explanation is that the silicone is inducing these

antibodies, though it's also possible that it's

because of other natural polymers in the body. "

The researchers studied a total of 153 women at a

rheumatology clinic in Arizona, 110 of whom had

received SBI and were presenting with varying degrees

of complications. Of the remaining 43 women who did

not have silicone implants, 20 showed classic symptoms

of autoimmune disease, and 23 were recruited as

healthy controls among employees of the clinic.

After a history was taken and a physical examination

was done, the SBI recipients were classified into five

symptom groups: limited; mild; moderate; advanced; and

those with specific autoimmune diseases.

Positive antibody results were found in 1 (3%) of

those with limited symptoms, 2 (8%) of 26 with mild

symptoms, 7 (44%) of 16 with moderate symptoms, and 13

(68%) of 19 with advanced symptoms.

Some of the women who did not have silicone implants

also tested positive. Two (10%) of the women with

autoimmune diseases and 4 (17%) of the healthy control

group were found positive to the antibody test. The

study authors suggest that the " higher than expected "

numbers may be a result of the small size of the

sample, or other uncontrolled demographic factors.

" We believe the (antibody test) can objectively

contribute to distinguishing between SBI recipients

with limited or mild signs and symptoms, SBI

recipients with more severe manifestations, and

patients with specific autoimmune diseases, " the

authors wrote.

Although the authors recommend that " further studies

are needed to define the signs and symptoms associated

with exposure to SBI, " Garry believes the test may

prove useful for women with severe symptoms who are

considering having their implants removed. " A test

like this can help a doctor advise a patient one way

or the other on making this critical decision, " said

Garry.

Ultimately, Garry hopes the test will help researchers

better understand the disease process, and help

develop safer biomedical devices that would not induce

a similar immune response.

" There are a number of devices, including implants,

pacemakers, shunts, even artificial organs, that will

continue to play an important role in medical care, "

said Garry. " We'd like to be able to use these safely,

without making people sick in the process. "

SOURCE: The Lancet (1997;349:449-453)