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Interpreting FDA Statements: It's Easy to Get a Distorted View

Jan. 21, 2000 (Washington) -- One of the most misunderstood decisions made by the FDA in the 1990s related to breast implants. I'll bet you were misled into misunderstanding what the FDA was really trying to say. If so, you weren't the only one.

You may remember the controversy: In 1991 and again in 1992, pronouncements came out of the FDA that seemed to say that breast implants were unsafe. FDA's announcements led many women to seek to have their implants removed, and discouraged others from undergoing the cosmetic surgery. The announcements also led to massive billion-dollar lawsuits in which women sued the implant manufacturers for marketing an unsafe product. It led to the bankruptcy of one manufacturer, Dow Corning.

Would it surprise you to learn that the FDA never said that breast implants were unsafe? It happens to be the truth. The FDA never concluded that breast implants were unsafe. And that basic misunderstanding about what the FDA said is repeated in other situations.

Instead of concluding that implants were unsafe, the FDA actually said that there was not enough evidence to conclude that they were safe. There's a big difference between those two statements.

The FDA must base its assessment of a product's safety on the evidence presented by the manufacturer. In some cases, the evidence leads the FDA to conclude that a product is unsafe.

For example, in banning the phen-fen diet drug combination, the FDA believed that the evidence indicated that the product could cause heart valve problems in some patients. The FDA decided that this risk was not offset by the benefit offered by the drugs. Phen-fen, the combination of phentermine ( Fastin, Adipex P) and fenfluramine (Pondimin), was an extremely popular weight loss method in the 1990s.

However, in most situations in which the FDA appears to conclude that a product is unsafe, in reality it is saying that there is not enough evidence to conclude that it is safe. What the FDA is really saying is: 'We don't know whether the product is safe or not. We need more testing.'

That's what the FDA was saying about breast implants.

If you were led to believe that breast implants were unsafe -- rather than lacking in evidence -- it's hardly your fault. There are factors at work that contribute to your confusion.

First, the media often oversimplifies statements from the FDA. It's hard to write a headline that says, "FDA Finds Breast Implants Lacking in Evidence." It's easier to write: "FDA Finds Breast Implants Unsafe." The nuance of difference between those two headlines is lost on most headline writers and, indeed, on many reporters.

Second, the plaintiffs' attorneys -- lawyers who sue companies on behalf of consumers (usually for a huge fee that dwarfs what their clients receive) -- are experts at distorting the FDA's statements. They help the media "interpret" the FDA's statements to suit their purposes. In the breast implant situation, for example, such distortions led to millions of dollars in fees paid to the lawyers.

So the next time you see a headline that attributes to the FDA the view that a product is unsafe, read carefully. The message might actually be that there is not enough evidence to prove safety. Better yet, access the FDA's Web site (www.fda.gov) and read its statements yourself, unfiltered by media or lawyers. That's the best way to understand what's really going on.