At the trial in San Francisco, lawyers for Mariann Hopkins, 48, maintained that the silicone gel that spilled from her implants had damaged her immune system. The jury agreed, finding Dow Corning guilty of fraud and malice in failing to disclose hazards it knew about. “The verdict sends a message to Dow Corning,” says Hopkins’s attorney, Dan C. Bolton, “that it cannot sacrifice the health and safety of women to enhance its balance sheet.” Among the exhibits the jury saw were internal memos showing that since 1970 some employees had expressed concerns about medical risks associated with implants. In one of the most damaging memos-reported by the San Jose Mercury News after being shown in open court-a company scientist wrote: “To my knowledge, we have no valid long-term implant data to substantiate the safety of gel for long-term implant use.” In another, a Dow Corning marketing executive said he had told a group of plastic surgeons, “with crossed fingers,” that the firm had a safety study in progress.
Dow Corning contends that it has never hidden any scientific data from the FDA. Says Robert Rylee, chairman of the firm’s health-care businesses: “We continue to be convinced of the safety of these products that has been established by a long history of bio-safety studies and clinical experience.” The memos, says another company spokesman, “were an airing of differences of opinion, not a consensus of scientists.”
The FDA has already called for additional safety studies from implant manufacturers. While that research is under way, Kessler could keep the implants on the market, as the American Medical Association and the American Society of Plastic and Reconstructive Surgeons have urged. Or he might decide to make them available only for clinical trials, with possible exceptions for women who have lost a breast through accidents or cancer surgery. Two million American women now have such implants, mostly for cosmetic reasons, and demand is growing. But if the implant manufacturers don’t make a firmer case for their safety than the one aired at the San Francisco trial, the great boom in breast augmentation may soon go bust.
