"Coming up, some shocking information about breast implants." That's the way TV broadcaster Connie Chung introduced a 1990 segment on the horrors of implants, among them that they led women's immune systems in a gruesome revolt against the body, warring on joints, tissues and overall health.
Former Food and Drug Administration Commissioner David Kessler worried aloud about implants, saying, "We cannot assure the safety of this product." In 1992 he announced a near total ban on silicone gel-filled breast implants.
Today, six years later, there is more "shocking" news, at least to those who believed Ms. Chung and Mr. Kessler. A court-appointed, independent panel of scientific experts has found no evidence linking implants to diseases over which trial lawyers are suing and, in some cases, bankrupting implant manufacturers. Their choice of words leaves little room for misunderstanding.
Said the panel, which included experts in toxicology, epidemiology, immunology and rheumatology:
- There is no evidence that silicone breast implants precipitate novel immune responses or induce system inflammation.
- The preponderance of data indicates that silicone implants do not alter incidence or severity of autoimmune disease.
- There are no consistent data to suggest systemic inflammation or systemic induction of anti-silicone or autoreactive responses in women with silicone breast implants.
- No association was evident between breast implants and any of the individual connective tissue diseases, all connective diseases combined, or the other autoimmune/rheumatic conditions.
The authors of the findings -- professors at Oregon State, the University of North Carolina at Chapel Hill, Albert Einstein College of Medicine and the University of Ottawa -- did not claim theirs was the last word in the debate. They left open the possibility that someone, somewhere, sometime, could conceivably uncover links between implants and disease. But after two years of reviewing scientific material from both trial lawyers and manufacturers at the request of a federal judge in Birmingham, they couldn't find any.
The findings are significant because that judge, Sam Pointer, is overseeing some 9,000 implant cases in which the plaintiffs' bar is claiming that the devices harmed women. Defendants can now use this new research to contest the claims. In the meantime, attorneys from both sides will have an opportunity to depose the researchers and use their statements in trials.
Following release of the findings, Fenton Communications, which is best known for organizing the Alar scare but now represents plaintiffs in implant cases, quickly arranged a telephone press briefing to play down the research. An activist participating in the briefing, the New York Times reported, credited one of the researchers, saying, she had done a good job of answering the question she was asked which was, "Is there evidence of disease?" The question she didn't answer was, "Is there evidence these women were healthy?" And there, the activist said, the conclusion is, "We don't know."
She and others may not know, but it certainly hasn't stopped them from filing costly lawsuits that have forced the likes of Dow-Corning into bankruptcy. It certainly didn't stop them from setting off a panic among women with implants, many of whom rushed back to the surgeon's office to have them removed. One woman, unable to afford the removal fee, decided to undertake the job herself with a razor blade. A surgeon had to finish the job for her. And for what? "We don't know"?
The fact is that study after study has failed to find a link between implants and disease and the panic has continued anyway. "The breast implant controversy shows every sign of continuing on its irrational course for years," wrote Marcia Angle, executive editor of the New England Journal of Medicine, in her 1996 book, "Science on Trial." "Only an unyielding commitment to scientific evidence can stop it, and that does not seem very likely, given the money and passions involved."
Here's the place to make that commitment. No matter how shocking the expert panel's findings that there is no evidence linking implants and disease, the court, government officials, and everyone else should take them seriously.
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