25 Years Ago, CBS & FDA Concoct Silicone Implant Scare

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Screen Shot 2015-12-09 at 12.43.44 PMOn this date 25 years ago, CBS News correspondent Connie Chung generated a shock wave of fear to all with known exposure to silicone polymers.

She began her Face to Face with Connie Chung broadcast with these words: "Most of us know little about breast implants we don't know anything about the dangers." She built her case on the complaints of three women, who had developed flu-like symptoms, mouth ulcers, general fatigue and an unexplained rash, which they attributed to their silicone breast implants. Linkage with silicone came from two "experts" devoid of clinical experience with implantable devices. CBS producers accepted their allegations at face value, but a federal judge later disqualified them from testifying in American courtrooms.

The impact of Chung's report was instantaneous and powerful.

Telephones rang in surgeons' offices nationwide, not only from women with breast implants but thousands more with myriad silicone devices which had been safely employed for multiple uses since the 1950s. Although Chung later boasted that, "It was one of the most important stories we have ever done," what she actually achieved was a new low in one-sided, fear-mongering journalism, a 60 Minutes-style of false-science reporting previously measured and exposed by the American Council on Science and Health (e.g. the alar scare in 1989).

When FDA Commissioner David Kessler later chose to ignore his own advisory panel recommendations and call for a moratorium on the use of breast implants, he set in motion a litigation frenzy that would not run its course for another decade. More than 200 diseases or symptoms were attributed to silicone exposure, not one of them supported by scientific evidence.

It was not until 1999 that breast implants, and all other medical uses for silicone, were granted a full pardon not by the FDA but instead by the National Academy of Science's Institute of Medicine. A panel of 13 medical scientists determined that all claims of teratogenic, mutagenic, carcinogenic, and immunologic influence were invalid, thus affirming the original toxicological findings conducted in the 1940s that apparently meant little to the misguided federal agency.

It was a reprieve that came too late for some medical device manufacturers forced into bankruptcy, while others expended $12 billion ($16 billion in today's dollars) to sustain their commercial viability and appease the demands of America's litigation industry.

Looking back, this might seem an insignificant transfer of resources when compared with the human cost of banning DDT, a known deterrent to malarial death; outlawing the sale of genetically engineered foods or resisting vaccination protocols. But the unwarranted attack on breast implants, and by implication all health applications of silicone, stands as a model for producing what legal scholar David Bernstein terms "phantom risk litigation."

He lists four requirements:

  • Politically-motivated individuals' (or government agencies') disregard for objective, scientific evidence
  • Sensationalistic media coverage
  • Public outrage at presumed corporate misconduct
  • Financial incentives to pursue legal claims based on dubious evidence

We need not be vulnerable to phantom risks; there is another choice. As is promoted by the Council each day, the information we require for health maintenance must be derived from use of accepted scientific methods. As citizens we deserve nothing less from our government: public policies based on science, instead of politics.


Jack Fisher, a renowned plastic surgeon prior to retirement, is a member of the Board of Trustees for the American Council on Science and Health. For a comprehensive description and assessment of the full impact of the Silicone Scare, see Dr. Fisher's book, Silicone On Trial: Breast Implants and the Politics of Risk.