Selling Out Silicone: The Real Story Behind the FDA's Silicone Implant Ban

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After a nearly 15-year ban, the U.S. Food & Drug Administration announced on November 17, 2006 that silicone gel-filled breast implants would be available without restrictions for women who choose them. Yet despite the fact that no medical device has ever undergone more intensive testing and evaluation, myths and misconceptions about their safety persist. How did the safety questions arise in the first place?

The controversy dates to 1991, when concerns about an alleged connection between silicone and an array of poorly defined diseases prompted severe restrictions on the use of the implants. A crescendo of lawsuits ensued, although there was no evidence of such a link, and in the seminal cases the disease symptoms even pre-dated exposure to silicone. The obviously flawed logic of a device causing a disease that already exists notwithstanding, a class-action lawsuit against implant manufacturers soon followed, and the FDA came under enormous pressure to address the issue. (Silicone implants were already on the market, but had not yet been reviewed by the FDA.) The ban removed the option of using silicone implants for most augmentation patients, though they remained available for breast reconstruction and other limited indications.

The FDA’s action only added fuel to the litigation fire. A steady stream of research papers vindicating implants from a scientific perspective began to appear however, and while this was reassuring to women with implants it was hardly welcome news for the trial lawyers who stood to gain billions. The lawsuit was predicated on what is known as “junk science” in the first place, meaning that it was based on anecdote and opinion rather than verifiable and objective research.

This is where the so-called “activists” enter the picture. When the FDA finally convened hearings to consider approval of silicone implants in 2003, all of the scare tactics used to provoke the ban were again trotted out. The Wall Street Journal had an article that essentially pulled the curtain back to reveal the machinations behind the media spin. One example is an organization dramatically titled “Command Trust Network” which issued press releases calling for the FDA to slow down the approval process. But the contact person was a publicist who worked for a company with ties to a public relations firm called Fenton Communications, whose clients included the very lawyers standing to line their pockets with implant settlement money. Command Trust turns out to be one person, Sybil Goldrich, after the other founding partner reportedly quit in disgust when she realized they were working more for the lawyers than for women.

Another so-called women’s advocate is Diana Zuckerman, president of what is called the “National Center for Policy Research for Women & Families.” It turns out that the Center is funded by a foundation also tied to Fenton Communications. It appears that all roads lead back to the trial lawyers, still trying to make hay by frightening the very women whose well-being they purport to represent.

The PR firms that work on behalf of these lawyers are very good at what they do, so arming one’s self against the propaganda barrage takes some effort. They have even defined the language of the debate; for example, we all talk in terms of “rupture” rates, which implies that the implants sort of explode. (When the implant shell develops a tear or an area wears out, most often nothing at all happens.) We continue to see the same story about a whistleblower formerly employed by one of the manufacturers, who sounded alarm bells about falsification of data. (This has been reported and thoroughly investigated—and discredited—several times.) We hear stories about high implant failure rates, based on old studies not relevant to currently used implants. And of course there is always the anecdotal story, an implant “victim” with some awful disease,