Panel Finds No Breast Implant Disease Risk
In the most definitive U.S. analysis yet of the safety of silicone-gel breast implants, a court-appointed panel of neutral scientists has concluded there is no credible evidence that the implants cause disease.
Assembled two years ago, the panel of three women and one man reviewed hundreds of studies at the behest of the U.S. District Court in Birmingham, Ala., which is overseeing consolidated federal lawsuits against three implant makers.
The National Science Panel’s long-awaited report, made public Tuesday, will guide Judge Samuel C. Pointer Jr. in deciding what scientific evidence to allow in the cases against Bristol-Myers Squibb, 3M Corp. and Baxter International.
Those companies have offered tens of thousands of implant recipients settlements of $5,000 to $100,000 each, depending on their illness. Although the report will not affect women accepting the offer, it is expected to make it much harder for others who refuse the offer to prove their case in court.
But the findings of the first study group to analyze scientific data at the heart of sweeping federal product-liability litigation are bound to affect implant lawsuits in other courtrooms as well.
The report appears likely to embolden judges to throw out sketchy plaintiffs evidence, make it easier for defendants to get cases against them dismissed, and reduce the dollar amount of settlements offered to women who sue companies on their own, legal scholars said.
Still, some plaintiffs attorneys played down the panel’s significance, even though the panel was formed in response to plaintiffs’ requests. They contend that future studies may yet find a link between implants and disease. Also, the panel did not address the consequences of gel implants that rupture.
“We have always viewed breast implants and continue to view them as a dangerously defective product simply because they break,” said Elizabeth Cabraser, a San Francisco plaintiffs attorney.
An activist for implant recipients and plaintiffs, Sybil Niden Goldrich of the Command Trust Network, criticized the report as incomplete. A “research gap” still exists, she said. “We need reliable government scientists to find trustworthy answers as to why thousands of women are sick.”
Predictably, implant makers interpreted the panel’s conclusion as a victory for their side. Conversely, the tens of thousands of women considering lawsuits may view it as a setback, perhaps inducing more of them than were previously expected to settle instead, lawyers on both sides agreed.
At the same time, defense lawyers and plastic surgeons suggested that the basic finding that implants do not appear to cause disease or disrupt the immune system may offer a measure of comfort to currently healthy implant recipients worried about their well-being.
A Decade of Controversy
The new information “should provide reassurance and relief” to women with the implants, said Dr. C. Lin Pucket, a University of Missouri plastic surgeon and president-elect of the American Society of Plastic and Reconstructive Surgeons.
The analysis caps nearly a decade of raging controversy over silicone gel implants, which the Food and Drug Administration banned in 1992 because of manufacturers’ failure to provide safety data after repeated agency requests.
More than a million American women have received silicone-gel implants since they were introduced in the 1960s. And hundreds of thousands have joined in class-action suits against implant makers that have cited a growing body of scientific studies appearing to show that the devices were associated with illness.
Among the health problems attributed to the implants have been lupus, arthritis, immune-system disorders and a newly described syndrome called atypical connective tissue disease.
Faced with conflicting data, Pointer asked the National Science Panel to determine whether existing data provided “a reliable and reasonable scientific basis” to conclude that silicone-gel implants cause or worsen conventional connective tissue diseases, atypical ones or immune system dysfunctions.
The panel members were chosen after a lengthy search by the court in cooperation with defense and plaintiffs attorneys. The four scientists--who have no ties to either side of the litigation--possess expertise in the key areas of epidemiology, toxicology, rheumatology and immunology.
The panel members, who are barred from speaking to the news media, are Dr. Betty Diamond, Albert Einstein College of Medicine, Bronx, N.Y.; Dr. Barbara Hulka, University of North Carolina; toxicologist Nancy Kerkvliet, Oregon State University; and Dr. Peter Tugwell, University of Ottawa.
Though the panelists said they “cannot anticipate what research findings may appear in the future,” they nonetheless reached conclusions that many viewed as surprisingly blunt.
Analyzing studies on lab animals given silicone, they found “no evidence that silicone breast implants precipitate novel immune responses or induce systemic inflammation.”
Regarding the claims made in dozens of previous studies that the implants cause conventional or atypical connective tissue disease, they said there was “no association between silicone gel-filled implants and any of the definite connective tissue diseases . . . or the other autoimmune/rheumatic conditions.”
And summarizing the data in 20 epidemiological studies that compared the health of women with and without implants, they said “there was no consistent or meaningful association” between the implants and health problems.
Defense attorneys view the report as vindication. “This is another in a long line of evidence proving the point that implants are safe,” said John McGoldrick, general counsel for Bristol-Myers Squibb, which was the second-largest silicone-gel implant maker before it quit selling the product in 1992. He said the report would bolster the company’s move to get some cases dismissed.
Dow Corning, the largest maker of silicone-gel implants, will apparently make use of the science panel’s findings. Now in bankruptcy court, the company proposed a $3.2-billion settlement offer last month. Attorney David Bernick of Chicago’s Kirkland & Ellis said the company will submit the panel report and other evidence to the judge overseeing the bankruptcy for a ruling on the issue of whether the plaintiffs’ evidence is admissible. A favorable ruling would be likely to encourage women to settle rather than pursue a trial.
He and other product liability lawyers said it was the first instance they were aware of in which a judge had utilized a court-appointed expert panel to help determine the state of science in a particular area for use in a trial. “This is a highly tailored and effective means of reconnecting law and science,” Bernick said.
As for the medical evidence, the panel’s report is consistent with some other recent independent scientific reviews, including one conducted for the British Ministry of Health and released last summer.
“The incidence of ill health in women implanted with silicone gel breast implants is no greater than in the general population,” the British group reported. “There is no evidence of an association with an abnormal immune response or typical or atypical connective tissue diseases or syndromes.”
Dr. Elizabeth Connell, who chaired the two FDA hearings leading up to the agency’s ban and has since consulted for 3M, said the report was a milestone in the debate. “It may not be the end of it, but it will be extremely helpful in putting the controversy to rest,” said the retired obstetrician and gynecologist.
But others say the debate goes on. Louise Brinton, chief environmental epidemiologist at the National Cancer Institute, said the panel’s findings would have little impact on a massive study of implant safety that the institute is conducting.
‘Unanswered Questions’
The ongoing study involves 13,500 women who received silicone-gel breast implants between 1960 and 1988. Their rates of cancer and connective tissue disease are being compared to those of 4,000 women who underwent plastic surgery but did not receive implants.
“I think there are still a lot of unanswered questions that could benefit from well focused and well designed epidemiological studies,” Brinton said. The panel’s work “won’t affect my analysis of the data.”
At a Houston news conference arranged by the Command Trust Network, Mike Lieberman, chairman of pathology at Baylor University College of Medicine, said the panel’s influence would be limited because it was instructed to examine data pertaining to just a few ailments previously associated with implants.
Plaintiffs’ attorney Rick Laminack said the report was simply “wrong.” His firm, O’Quinn and Laminack, has settled or litigated about 3,000 breast implant cases, with 1,500 more to go, he said.
Times staff writer Henry Weinstein in Los Angeles and researcher Lianne Hart in Houston contributed to this story.
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BACKGROUND
The National Science Panel, funded with $800,000 in federal grants, took nearly two years to produce its report, “Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunological Dysfunction.” The four members, agreed to by both plaintiffs and defendants, were appointed by U.S. Judge Samuel C. Pointer Jr. They are: Dr. Betty A. Diamond, immunologist, Albert Einstein College of Medicine, the Bronx, N.Y.; Dr. Barbara S. Hulka, epidemiologist, University of North Carolina, Chapel Hill; Nancy I. Kerkvliet, toxicologist, Oregon State University, Corvallis; Dr. Peter Tugwell, rheumatologist, University of Ottawa, Canada.
