- The Washington Times - Thursday, March 15, 2001


Are French health care authorities irresponsible or are their American counterparts simply mired in red tape, ignorance and politics?
This is the question that springs to mind when one considers the news that French authorities have lifted the ban on silicone gel implants while here in America, the federal Food and Drug Administration continues to peddle the line that silicone gel is dangerous and to be avoided.
Either the French are crazy or the FDA has become politicized, using its regulatory clout to deny Americans treatment options and scare them with unscientific bogeymen about dangers that don't exist.
So, which is it?
If the exhaustive studies of the matter are any guide, the French are not crazy. Neither silicone gel nor implants using silicone are a threat to health. But this is not news or shouldn't be.
The most authoritative inquiry on the relationship, if any, between silicone gel and reported illnesses was conducted by the Institute of Medicine (IOM), an arm of the National Academy of Sciences, at the behest of Congress last year. It did not get anywhere near the attention it should have.
Perhaps this was because the IOM's findings regarding silicone gel were uniformly positive. The researchers found "no evidence that silicone implants are responsible for any major diseases of the whole body" including the so-called "auto-immune" diseases alleged by trial lawyers representing some women who had implants. Of the 1.5 million women who've had breast implant surgery, fully two-thirds have said they are "very satisfied" with their supposedly dangerous implants, according to the IOM.
Unfortunately, a false connection was established by the lawyers between the facts that some women who had implants later became ill in some way. Yet the fallacy becomes obvious when one considers that in any group of people, over a period of time, at least some will become ill or develop maladies. But are these facts related? Not necessarily.
The "cause" and "effect" are no more "connected" to one another than is the crowing of the rooster to the rising of the sun each morning.
It was this false relationship between silicone gel and serious diseases that the IOM report (and many previous studies, including one done by the New England Journal of Medicine) exposed. Those interested in reading the facts for themselves can download the full text of the IOM report at www.nap.edu on the Internet.
Still, silicone gel and silicone implants continue to suffer from a bad "rep" in the United States. There has been billion-dollar litigation, with huge monetary awards the lion's share of which has gone you guessed it straight into the alligator skin wallets of trial lawyers.
The bad "rep" is due in part to the media being spoon-fed false and alarming misinformation by those very same trial lawyers and also as a consequence of the overzealousness of former Food and Drug Administration (FDA) Administrator David Kessler. It was Mr. Kessler who peremptorily banned the gel implants back in 1992 on the same specious grounds as the courtroom rants of the trial lawyers and their paid "expert witnesses."
For Mr. Kessler, like other political appointees before him, the ginned-up hysteria enhanced his prestige as "protector of the public" just as other federal bureaucracies, such as the Environmental Protection Agency, often overstate or even manufacture "problems" that only more money and resources for the agency in question can solve. As regards the EPA, the bogeyman of "global warming" (a theory based on hypothetical scenarios using computer models, not actual data from the real world) is a prime example of science taking a back seat to politics and bureaucratic self-preservation.
As regards the FDA and Mr. Kessler, it never seemed to bother the man too very much that he needlessly terrified tens of thousands of women many of whom are breast cancer survivors who had the implant surgery done for reconstructive purposes following mastectomies or that he set in motion a legal feeding frenzy that established a dangerous precedent for future shakedowns of private business by government. The lawsuits against the tobacco and firearms industries being two cases in point.
We all pay for the explosion in spurious litigation and pseudo-science in terms of higher prices, decreased innovation and, in the case of medical products such as silicone gel implants, fewer treatment options. No one's interests are served except, of course, those of the trial bar.
The French, having reviewed the evidence, have wisely rethought the ban on silicone gel. The health interests of women won out over fear and hysteria. Hopefully U.S. health authorities will follow the example of their "crazy" colleagues overseas.


Eric Peters is an editorial writer for The Washington Times and a nationally syndicated columnist.


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