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. Robert 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)