FDA regulations are restricting women's choices
Published: Tuesday, October 21st, 2003
T he recommendation from a scientific adviso ry panel that the Food and Drug Administration allow silicone breast implants back on the market 11 years after the FDA banned them in 1992 highlights several extremely odd aspects of the way we have come to make medical decisions in this country. Unfortunately, scientific evidence plays little if any role in the deliberations. You might think that in a country in which officials constantly celebrate the virtues of freedom that the burden of proof would be on those who wanted to restrict the choices women have about what can be placed into their bodies. In this country, the burden is the other way around, which means the country is nowhere near as free as citizens think it is. Silicone breast implants were already available when Congress gave the Food and Drug Administration authority to regulate medical devices (which implants are considered to be) in 1976. So sales were allowed to continue. In the late 1980s some women complained that when implants leaked (as both silicone and saline implants tend to do after a few years), they caused medical problems beyond discomfort, pain and embarrassment. Based on these complaints the FDA took the implants off the market. As a 1999 Institute of Medicine review of the literature later confirmed, however, there was simply no evidence linking breast implants to serious illnesses beyond breaking and local complications. The original FDA decision was based on the contention that there were not systematic studies available proving they were completely safe and risk-free. That seems to be the standard now. New products with a relationship to medicine will be kept off the market — which means consumers and patients will be denied the opportunity to make their own choices — until long-term studies have proven there is virtually no detectable risk. It is virtually impossible to prove there is zero risk associated with something put into the body with a surgical procedure. So the institutional incentive for the FDA is to say “no” to innovations for a very long time. One patient harmed by a side effect is visible and likely to be publicized, while hundreds who might die prematurely because they are denied access to a new drug or product are effectively invisible. We recognize that medical products and drugs might require more regulation than, say, overcoats. But the level of regulation in this country, which is much more restrictive than in Western European and other economically developed countries, has become absurd.
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