Only Relevant Issue Is Trust and Integrity : A shaken Dow Corning exits the breast-implant business

Dow Corning’s decision last week to quit the silicone breast implant business came as little surprise. The announcement, by corporation chairman Keith R. McKennon, renders the Food and Drug Administration’s expected final decision on the use of the devices an anti-climax to what has become another cautionary tale for American business about public trust.

In January, the FDA imposed a voluntary moratorium on the sale and use of silicone implants; an advisory panel, convened by FDA Commissioner David A. Kessler, was troubled by the more than 2,500 reports of implant leakage or rupture. The panel’s action was also prompted by disclosure of internal documents indicating that Dow Corning may have ignored warnings of other health risks associated with silicone. Last month, the panel recommended that Kessler substantially restrict the use of silicone implants for cosmetic purposes while new clinical trials were conducted. Saline breast implants are unaffected by the recommendations.

AN EARLY DENIAL: Kessler has until April 20 to act on the recommendations, but the damage has already been done. Dow Corning’s early denial of the risks of silicone implants, and its stalling after the FDA asked it to release internal documents on the integrity of its testing process, sowed serious doubts in the minds of many women. At the same time, new lawsuits brought by women with implants added to the company’s financial and public relations woes.

So Dow Corning bowed out, promising to fund implant safety research and help pay for removing some implants. Dow Corning is the third--and the largest--silicone implant manufacturer to abandon the market, leaving only two other companies.

Dow Corning’s story evokes inevitable, tragic comparisons with the Dalkon Shield saga. A. H. Robins Co., maker of the Shield, also dismissed early reports of problems with the intrauterine device, first sold in 1968 and eventually worn by an estimated 2 million American women. Some of Robins’ own scientists even warned, to no avail, that the IUD’s unique string could cause pelvic infection that could lead to sterility and possibly death. Robins continued to insist that the device was safe, slamming its critics, until in 1974 it voluntarily took the Shield off the market in the face of mounting evidence of risk and an avalanche of adverse publicity.

The lesson that U.S. manufacturers, particularly those who make pharmaceuticals and medical devices, should take from the experiences of Dow Corning and A. H. Robins is not about the sometimes pernicious effect of government regulation and the tort liability system on American economic competitiveness. These are real issues, of course, but in these cases the lesson is about public trust: how to keep it, and how to lose it.

The FDA acted as it should on silicone implants; the agency’s mission is to guard the public’s health and safety by approving products for use or, sometimes, withholding them from the market. The FDA acts as a gatekeeper; sometimes, as appears to be happening with silicone implants, the gate should swing shut.

AN INEVITABLE FALL: The FDA was not co-opted by hysterical implant users or greedy trial lawyers. Instead, Dow Corning stumbled all by itself, just as A. H. Robins failed, because it lost the confidence of its customers. Dow Corning could not address the reasonable concerns of the estimated 1 million women with silicone implants or of countless other women considering implants. The company could not pursuade them that it had adequately tested its product. It failed initially to openly address risks associated with implants, and, when asked, it dallied before producing internal documents that only raised further questions.

The experiences of Dow Corning and A. H. Robins should at last teach manufacturers that they toy with public trust at their peril.