Study Claims to Link Disease, Breast Implants
While scientists and courts have recently dismissed women’s claims that silicone breast implants cause disease, a study released this week could nudge the pendulum in the other direction--presenting controversial new evidence that implants may cause unusual health problems.
The study, published in the widely cited international medical journal the Lancet, describes a newly developed blood test for antibodies that the researchers say are produced in response to leaking silicone. The researchers claim their study provides the first medical evidence to back contentions that silicone breast implants cause an unusual disease.
The researchers report that a survey of 95 women with implants found that the antibodies were much more common among women with serious illnesses than among those with just mild symptoms. Based on that, they conclude that the antibodies are “markers” for silicone-related disease.
If confirmed by other laboratories, the antibody test would constitute the first objective tool for telling whether a woman’s illness is related to her silicone implants, the researchers say. Though the researchers admit the test is not definitive--the antibodies were not found in 30% of the women with implants who reported major symptoms--it could nonetheless have a profound impact on pending litigation against silicone-gel implant manufacturers.
Groups that have insisted that there is a link between implants and disease hailed the study as vindication. “We’ve been told our sicknesses are in our heads, basically that we’re crazy,” Sybil Niden Goldrich, co-founder of the Beverly Hills-based advocacy group Command Trust Network, said in a statement.
“Now the scientific community is beginning to catch up and realize what we’ve known all along.”
But scientists familiar with the research urged caution, mindful that at least two widely publicized diagnostic tests for implant-related disease have collapsed under the weight of scientific scrutiny.
“It’s an interesting study but hardly conclusive,” said Dr. Elizabeth Connell, an Emory University obstetrician and gynecologist who chaired the Food and Drug Administration hearings on the safety of silicone-gel breast implants in 1991 and 1992. “I don’t see enough here to say that it will turn the whole situation around.”
“The test has not been validated” by outside scientists, said Dr. George Ehrlich, a University of Pennsylvania physician and chairman of the World Health Organization panel on chronic disease, who has not worked for either side in the long-running litigation over breast implants.
The mere presence of antibodies to the implant, he said, does not establish that either the antibodies or the implant “are associated with the disease.”
Casting a shadow over the new findings is the fact that some of the researchers have served as expert witnesses on behalf of plaintiffs suing implant makers for damages. The research team included Dr. Luis Espinoza, a Louisiana State University rheumatologist who has repeatedly worked with plaintiffs’ attorneys, and it was led by virologist Robert Garry of Tulane University.
Although Garry said in an interview that he was not affiliated with either side in the legal battle, his name does appear on a list of expert witnesses scheduled to appear on behalf of plaintiffs in a class-action suit next month in Louisiana. An attorney for defendant Dow Chemical Co., Kenneth Bass, said he took Garry’s deposition on Monday.
Of the 1 million to 2 million women in the United States who have received implants over the last three decades, more than 400,000 have reported illnesses that they attribute to the implants. FDA Commissioner David Kessler declared a moratorium on widespread use of silicone implants in 1992, pending further evidence from manufacturers on their safety. Dow Corning, the largest silicone-gel implant maker, filed bankruptcy after implant manufacturers set aside $4.25 billion to settle injury claims.
FDA spokeswoman Sharon Snider said agency scientists and regulators had not yet reviewed the study thoroughly enough to comment on it. The antibody test has not been submitted for FDA approval as a diagnostic measure, but is being made available to some physicians on a “research-only” basis. Last February, the Centers for Disease Control and Prevention alerted physicians that such experimental tests should not be used for routine diagnostic purposes.
At the core of the controversy over silicone implant safety is the question of whether prolonged exposure to the devices gives rise to a new immune system or connective tissue disease, sometimes called siliconosis.
Because the symptoms of that proposed new ailment often closely resemble highly subjective ailments such as fatigue and joint pain, medical researchers have struggled to show that illnesses reported by implant recipients are caused by the devices, not some other underlying problem.
Recently, major studies at Harvard Medical School and the Mayo Clinic found that women with implants were no more likely to suffer from immune system, connective tissue or other chronic diseases than women without implants. And last year, an Oregon judge overseeing breast implant litigation barred experts from testifying because the notion of a new disease was “at best a hypothesis.” That ruling was cited as a major victory for implant makers.
In the Lancet study, the researchers took blood samples from 95 women with silicone breast implants who attended a New Orleans rheumatology clinic with symptoms that fit no conventional medical diagnosis.
Like other women suspecting that they had implant-related disease, those in the study reported such symptoms as extreme fatigue, joint pain and even memory loss. Doctors assessed these women’s symptoms, rating them from mild to severe. To minimize skewing of the results, the researchers who conducted the antibody tests did not know the clinical status of individuals whose blood was being studied.
The researchers found serum antibodies to an unusual polymer, presumably derived from implants, in 68% of the women with severe symptoms, 44% of those with moderate symptoms and 5% with limited to mild symptoms.
That rough link between symptom and severity and presence of the “anti-polymer antibody,” the researchers said, shows “the existence of a laboratory marker that correlates with the severity of . . . complications in silicone breast implant recipients.”
“I think this is the first strong objective evidence that this disease exists in a subset of women with silicone implants,” Garry said in an interview. “There are some people who maintain that these atypical diseases don’t exist. The [study] goes directly counter to that.”
At the same time, though, Garry and colleagues found that even some healthy women who never had silicone breast implants sometimes had the anti-polymer antibody in their blood. They can’t explain that finding, but critics of the study took it as a clear sign that the researchers were not measuring what they claimed to be.
Still, Tulane scientists have licensed the antibody technique to a New Orleans firm, Autoimmune Technologies, which is hoping to commercialize it.
But controversy on this subject is certain to continue. Noting that one study cannot undermine many others that have come to an opposite conclusion, Emory’s Connell said, “One swallow doesn’t make a summer.”
