FDA's 15-year false alarm

December 04, 2006|By Steve Chapman | Steve Chapman,Chicago Tribune

CHICAGO -- When the panic about silicone breast implants erupted back in 1991, it was big news. But when the last chapter of that saga was closed a couple of weeks ago, hardly anyone noticed. Government regulators and journalists often find it tempting to set off loud, clanging alarms. They don't find it nearly so enjoyable to publicize when the alarms turn out to be false.

Last month, the Food and Drug Administration decided that the medical evidence was sufficiently positive to let these devices back on the market. The amazing thing is not that the agency reached this conclusion, but that it didn't reach it sooner. In the end, the truth - and personal freedom - prevailed. But only after a heck of a fight, and only after sustaining some serious wounds.

The reversal took so long that most people have probably forgotten the original scare, when Americans were inundated with lurid tales of how women in their prime had been struck down by this malignant invention. The family of a 27-year-old woman who suffered three strokes blamed the implants for her death. Another woman said they caused up to 10 episodes a day of anaphylactic shock.

The FDA decided that there couldn't be so much smoke without fire. Ignoring the recommendations of an expert advisory panel, the agency yanked the implants off the market, making an exception only for women undergoing reconstructive surgery in clinical studies. That decision facilitated a rash of litigation against the manufacturers, who wound up on the hook for billions of dollars.

The agency's action had the endorsement not only of liberal public-health activists but also of feminists who regarded the entire business as a greedy exploitation of women.

But even then, two things were clear. The first was that little data implicated silicone implants in serious disease. The second was that millions of women had undergone breast augmentation, and by far most of them were happy with the results.

The whole episode was a case study in the folly of policymaking by anecdote. Certainly, there were women who got ill or even died after getting silicone implants. But a coincidence is not a cause.

No one denied that recipients sometimes suffered breast pain, hardening around the implant and rupture of the device. (Those risks also exist for the less-popular saline implants, which were not banned.) But study after study came up empty on other problems. In 1999, a panel convened by the National Academy of Sciences found that implants did not raise the risk of connective tissue disease, breast cancer, immune disorders or other alleged harms.

So why did it take a decade and a half for the FDA to let these implants back on the market? One reason is that government regulators don't like admitting they were wrong. Another is that they prefer to err on the side of excessive caution. No one will get sick from an operation she is not allowed to have, which means no bureaucrat will be blamed.

But the FDA and other critics of implants also never regarded this as a serious matter of individual freedom. The alleged danger - illness and death - was obviously weighty. The benefit - an improved appearance for women unhappy with their natural endowment - was easy to dismiss as shallow, vain and foolish.

But in a free society, the important question about medical procedures is not: Do the benefits exceed the risks? It is: Who decides? As a rule, it should be patients, not the government. In countries that haven't imposed a ban, 90 percent of women getting implants choose silicone. Now, American women will be free to do that as well. But for those deprived of an option they valued, it comes 15 years late.

Steve Chapman is a columnist for the Chicago Tribune. His column appears Mondays and Wednesdays. His e-mail is schapman@tribune.com.

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