Putting faith in the facts

October 17, 2003|By John Meroney and Patricia Beauchamp

WASHINGTON -- When the Food and Drug Administration is deciding if a medical device is safe, should it be swayed more by scientific studies or anecdotal evidence? That's the issue confronting the FDA as it weighs whether to follow an advisory panel's advice and allow silicone breast implants to be reintroduced into the marketplace.

This week, a special FDA advisory panel convened in Gaithersburg to consider if a new implant made by the California-based Inamed Corp. should be available to consumers. Plastic surgeons say silicone gel-filled implants look more natural than ones with saline, and Inamed argues that its clinical trials, coupled with existing science, prove its product's safety. The FDA event, where dozens of people testified, is causing a major stir.

Groups such as the National Organization for Women are campaigning coast to coast, trumpeting the message that implants are harmful and additional study is needed. Public Citizen is sponsoring an advertising blitz depicting a silicone implant as a ticking time bomb.

Last week, women who believe there's a conspiracy between implant makers and the government picketed the Department of Health and Human Services, which supervises the FDA, and shouted, "Hey, hey, FDA! Corporate greed is not OK!" The women also carried protest signs reading: "Industry Wealth Over Women's Health."

Earlier this month, Senators Dianne Feinstein and Barbara Boxer, California Democrats, announced their opposition to FDA approval.

It's not surprising that this issue is the focus of so much passion. Breast augmentation is the most popular form of plastic surgery, and implants have always been politically incorrect to some feminists because implants represent an emphasis on the body parts men find sexually attractive.

Plus, silicone breast implants caused one of the most emotional legal and scientific debates of the 1990s. They generated horror stories and thousands of lawsuits. But no matter how controversial something may be, hysteria shouldn't be allowed to drive government policy, especially when it comes to public health.

That's precisely what happened in 1992 when the FDA restricted silicone implants for general use and ruled that only women who'd had mastectomies or were participating in scientific studies could use them. Silicone implants, though, had been around since 1962, and until the early 1990s, studies showed that 90 percent of women were satisfied with them.

Trial lawyers, however, began to realize that women who thought their implants were to blame for illness had great potential for litigation. As with any medical device, there are risks of breaking or wearing out. But silicone implants were being blamed for devastating illnesses such as rheumatoid arthritis, chronic fatigue syndrome, lupus and depression.

Plaintiffs' lawyers exploited their implant clients using junk science. In many instances, media coverage bought into such claims. The reality is that scores of scientific studies and medical research by the likes of Harvard and the Mayo Clinic show there isn't any connection between implants and disease.

Experts found that silicone, which is also used in artificial joints, pacemakers and heart valves, poses no increased risk of illness. Women who didn't have them suffered from illnesses at about the same rate as those who did. In 1999, the Institute of Medicine released a comprehensive report about more than 2,000 studies that said while there is a chance implants may rupture and cause scar tissue to form, the silicone isn't toxic to humans, as had been alleged.

Marcia Angell, former editor of The New England Journal of Medicine and author of the book Science on Trial, about the implant controversy, told us that the breast implant case still stands as an astonishing example of how the courts, government officials and the public fell victim to a myth.

Dr. Elizabeth Connell, a pioneer in women's health who chaired the FDA's 1992 panel on silicone implants, echoed this sentiment in interviews Wednesday.

"There are no serious health risks," she said. "Women like implants and want to use them."

When the FDA took silicone breast implants off the market in 1992, it was reacting to pressure from the media, tort lawyers, feminist groups and advocates of extreme government regulation. Today, after more than a decade's worth of science saying that there's no connection between silicone breast implants and disease, a woman who wants silicone implants should have that option. After all, it's one that's always been available to women who've had reconstructive surgery.

Even more important, the FDA now has a chance to make a powerful statement that it won't put emotional testimony over scientific fact and will let women themselves make informed decisions about their own health and appearance.

John Meroney is associate editor of The American Enterprise. Patricia Beauchamp is a contributor to that magazine.

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