No safety in these implant numbers

Chicago Tribune, June 5, 1998

The Tribune editorial "seeking shelter from a legal storm" (May 22) on Dow Corning's decision to file for bankruptcy is misleading in the extreme. The Tribune implies that women are lying about health problems they have suffered from silicone-gel breast implants and openly ignores efforts by Dow Corning to suppress its own evidence on the cancer risks of implants.

In a routine, August 1987 inspection, the Food and Drug Administration discovered the previously unreported results of a Dow Corning carcinogenicity test on the silicone gel used in its implants. Injection under the skin of rats induced a high incidence of malignant tumors. While Dow attempted to trivialize these findings by claiming that these cancers were non-specific "solid state tumors," this claim was dismissed by an FDA task force on grounds that these cancers were highly lethal, invaded distant organs and showed no variation in the incidence between male and female rates.

On the basis of these findings, a senior task-force scientist urged that Aa medical alert be issued to warn the public of the possibility of malignancy developing in humans following long-term implants or silicone breast protheses. A July 1994 report by a National Cancer Institute investigator subsequently confirmed that silicone gel is also carcinogenic in mice.

At still higher risk of cancer are some 350,000 women with silicone implants wrapped in industrial-grade polyurethane foam. Evidence on the carcinogenicity of polyurethane was clearly demonstrated in the early 1960's. Subsequent studies showed that the foam breaks down in the breast to other carcinogens, toluene diisocyanate (TDI) and toluene diamine (TDA), which also induce breast cancer in rodents. (TDA was removed from hair dyes by the cosmetic industry in 1971 on the grounds of its carcinogenicity.)

Population studies, claimed as proof of safety by Dow and other implant manufacturers, are too short-term and otherwise flawed to negate the risk of cancer in some 2 million implanted women. Indeed, such studies would have exculpated asbestos in addition to most other recognized carcinogens, which have latencies extending over three decades. The study cited most often by industry as evidence of implants' safety was largely funded by plastic surgeons, who clearly have a vested interest in breast implants.

Rather than persisting in its egregious cover-up of the cancer risk of breast implants, apart from recent efforts to file for Chapter 11 to escape liability in breast-implant litigation, Dow Corning should immediately warn all implant women of their cancer risks, offer to remove their implants and develop long-term cancer surveillance at its own expense.