Study Clears Gel Implants of Some Ills
An independent scientific panel’s report that silicone gel breast implants appear not to cause chronic disease is likely to ratchet down the legal warfare over the devices while pressuring federal officials to lift the seven-year ban on their widespread use.
That conclusion is shared by scientists and lawyers on both sides of the controversy. At the same time, many stress that the 400-page Institute of Medicine report does not give the implants a completely clean bill of health.
The government-funded report, requested two years ago by Congress, emphasizes that implants frequently can cause serious--although not life-threatening--localized problems such as hardening and scarring of breast tissue, implant ruptures and infections. When implants rupture, the silicone can migrate elsewhere in the body, causing joint stiffness, pinched nerves and other complications. The implants can also interfere with mammography screening for breast cancer, the report says.
The report, scheduled to be released Wednesday, is the third independent scientific review in two years to conclude that there is no consistent evidence to support charges that silicone gel breast implants cause chronic diseases. The institute’s panel of scientists scrutinized 2,264 peer-reviewed scientific studies and 1,077 medical reviews, case reports, policy papers and other accounts. The report is broader than previous ones, especially in its emphasis on localized complications.
However, the report is not expected to change the terms of the pending $3.2-billion settlement that Dow Corning, once the leading implant maker, has offered to thousands of women whose lawsuits pushed the company into bankruptcy earlier this decade.
But it is likely to make the settlement more attractive for women who have not yet decided whether to accept it or pursue their individual claims in court.
Dr. David Feigal, director of the Food and Drug Administration’s center for medical devices and radiological health, predicted that the report’s chief impact will be to shift the emphasis away from long-term health consequences to the local complications, which turned out be “more common than previously asserted,” he said.
“We are calling for more data on local complication rates so we can better inform women of what the probabilities of these various [adverse] outcomes are,” said the vice chairwoman of the 13-member panel, Dr. Virginia Ernster, a UC San Francisco epidemiologist. “A woman who gets an implant should not have the impression that it will last forever.”
Despite those problems, however, Ernster said it was her personal opinion that the FDA moratorium on silicone gel implants may no longer be justified.
An estimated 1.5 million to 1.8 million U.S. women have received silicone gel breast implants. Roughly 70% have been for cosmetic augmentation and 30% for reconstruction after breast cancer surgery.
The FDA placed a moratorium on routine use of the devices in 1992, citing manufacturers’ repeated failures to provide the agency with safety data.
Meanwhile, thousands of women with implants sued manufacturers, sometimes winning multimillion-dollar damage awards and prompting leading implant makers to get out of the business. In addition to Dow Corning, three other former manufacturers have lawsuits consolidated against them in federal district court in Alabama.
At the heart of the controversy is the charge that the devices caused a range of chronic, debilitating diseases in many women. Those claims have included rheumatoid arthritis and other immune system disorders, lupus erythmetosis, breast cancer, scleroderma and a new “atypical connective tissue disease.”
On that question the institute report strongly agreed with previous analyses produced by the United Kingdom’s health ministry and the U.S. National Science Panel, which advised a federal judge overseeing implant lawsuits. But the institute’s findings on local complications surpassed those panels’ concerns.
The institute’s panel of physicians and scientists--who reportedly had no ties to either side of the debate--held two public hearings on the issues in addition to their reviews of the scientific and policy literature.
Firmly repudiating any link to chronic diseases, the report does not deny that thousands of women with implants are sick, but says that the evidence indicates that the implants did not cause their disease.
Consistent evidence does not support an association between silicone breast implants and connective tissue disease, breast cancer, neurological disorders or immune system disorders, the report says. Further, epidemiological evidence suggests there is no atypical disease at all in women with implants.
“Evidence suggests that such diseases or conditions are no more common in women with breast implants than in women without implants,” the report says.
The leading plastic surgery group hailed the panel’s findings. “We’re delighted because it reconfirms what we’ve been saying for a long time, which is that silicone gel breast implants are safe from the point of view of not causing systemic disease,” said Dr. Paul Schnur, president of the American Society of Plastic and Reconstructive Surgeons.
Lawyers on both sides of the dispute agreed that the conclusion was likely to encourage women considering suing implant makers to settle their cases rather than going forward to try their luck in court.
“I think the effect is going to be to force plaintiffs to lower their sights because it’s going to be harder than ever to get a judge to let the question of systemic disease go to a jury,” said plaintiffs lawyer Michael Williams, of Portland, Ore.
The managing trial attorney for Dow Corning agreed. “It should further discourage plaintiffs from opting out [of the settlement] to pursue litigation, for the reason that those claims are looking less viable in court,” Douglas Schoettinger said.
Less clear is the new report’s impact on the FDA ban on use of silicone gel implants other than for research purposes.
Feigal, of the FDA, said it was unlikely that the report would compel the agency to reconsider its moratorium, stressing that no manufacturer has applied to put them back on the market.
“I’m not sure how many [manufacturers] could point to the institute report and say: ‘This exonerates us,’ ” he said.
“The real issue of the moratorium was that there were a lot of things that should have been known that weren’t known” about complications such as how often implants break or leak, Feigal said. Manufacturers in the past told the FDA that they did not have data on those questions, he added.
Diana Zuckerman, head of the National Center for Policy Research for Women and Families, said the report’s emphasis on local complications “makes important strides” in educating women.
“The conventional wisdom has been that they’re safe, but women need to be told that ‘some women have problems and many women have to have the [implants] removed.’ ”
Plastic surgeons and defense attorneys denied that women have not been fully informed of the risk of local complications.
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Times staff writer Marlene Cimons in Washington contributed to this story.
