Monday, Dec. 14, 1998

Burst Balloon

By MICHAEL D. LEMONICK

The question of whether silicone breast implants are dangerous is essentially a scientific one. Yet in more than a decade of claims and counter-claims, lawsuits by the thousand and cash settlements in the millions of dollars, actual science has played an almost insignificant role. Women who say they've been harmed insist there's a cause-and-effect relationship between leaky implants and major immune-system disorders; manufacturers swear their implants are safe. But even though the FDA finally ordered the devices off the market in 1992, neither side has offered much proof for its position.

Now comes a report that at last casts some scientific light on the issue. Four distinguished medical experts announced last week that a review of all the existing evidence shows no strong link between implants and serious disease. The four, who have no ties to either side in the dispute, had been appointed by a federal judge overseeing nearly 9,000 implant lawsuits across the country.

Does that prove that the implants are safe? Not necessarily: the lack of evidence may just mean not enough research has been done, and some link between implants and illness could still turn up. The largest study on that relationship is currently under way and should be published early next year. Plaintiffs' attorneys are hoping it will support their cases, and so are advocacy groups that have been pushing the idea that silicone implants can make you sick.

But last week's report certainly isn't good news for women who are suing implant makers, especially since the experts' videotaped testimony will now be played before judges and juries hearing their cases. Suddenly, the offer made last month by bankrupt implant maker Dow Corning to pay settlements of $12,000 to $300,000 in exchange for dropping the lawsuits may look a lot more appealing.

--By Michael D. Lemonick