Weighing in on one of the biggest health controversies of the decade, a court-appointed scientific panel concluded this week that, based on the available evidence, silicone breast implants do not appear to cause immune diseases such as lupus.
Judge Sam J. Pointer of the U.S. District Court in Alabama appointed the panel in October 1996 to review the scientific evidence in lawsuits by women claiming their implants caused debilitating symptoms ranging from fatigue to sore joints. Pointer asked the panelists--a toxicologist, an immunologist, an epidemiologist, and a rheumatologist--to consider whether the plaintiffs' expert testimony "provide[s] a reliable and reasonable scientific basis" for concluding that silicone breast implants "cause or exacerbate" systemic diseases, such as lupus or connective tissue disease, that might account for the reported symptoms. The panel also examined the evidence for "atypical" connective tissue and immune diseases, according to the report, which was released on 30 November.
After scrutinizing 40 studies in their fields and hearing scientific witnesses, the panelists concluded that they could find no links between implants and disease. For example, the report's toxicology summary says "the preponderance of data ... indicate ... that implants do not alter incidence or severity of autoimmune disease." And analyses of data pooled from many epidemiology studies found "no association" between implants and connective or immune disease, the report says.
"We're pleased," says Doug Schoettinger, managing trial counsel for Dow Corning, one implant manufacturer. "I think this is going to help bring an end to this controversy." But not everyone reads the report that way. "Nowhere in there do they say breast implants are safe," says Robert Garry, an immunologist at Tulane University in New Orleans who studies women with breast implants. "They found flaws in basically all the science," he says. "They leave the door pretty wide open for new research."
Dow Corning, which is in bankruptcy, proposed a $3.2 billion settlement of its lawsuits 3 weeks ago, although plaintiffs can still opt to go to trial. The panel's report "will certainly have an impact" on those and thousands of other pending cases, says Brooklyn Law School professor Margaret Berger. First, however, the judge will question the panel, and he could end up including some evidence in his ruling; then lower court judges will decide whether to follow the decision in their own cases. "It's going to take a while to see what the fallout is," Berger says.