In case anyone didn’t notice, the ongoing dispute – which is likely to keep on going – concerning the commercialization of silicone gel breast implants isn’t just about this one type of product.

Rather, it clearly shines a spotlight on the larger issue that the FDA increasingly is attempting to grapple with, one that medicine will be debating for years, perhaps even centuries, to come.

It is simply this: that the “First, do no harm” rubric is out-of-date, pass , as dead as the dinosaur.

In a word, over.

Given the advances of modern technology in medicine, the current strategy is to evaluate products, whether devices or drugs, according to an analysis of their risks vs. their benefits. Risk/benefit analysis is medicine’s new mantra.

More broadly, it goes something like this: Sure, just about every new medical therapy or procedure may injure, or even kill, some (or even many) people, but such risks are greatly outweighed by the benefits of the therapy/procedure to a large number of others. The greater the benefits, the more likely the risks will be pushed to the background.

This type of analysis is most clearly applied, on the non-medical side, to the automobile.

In modern medicine, the approach is applied to medicines ranging from Aspirin to Viagra to Celebrex (to cite the most recent FDA decision) – or even to an athlete’s use of steroids.

And it is an analysis used for considering the commercialization of medical devices, from a simple injection needle to an advanced form of pacemaker.

In these cases, the analysis often may be relatively muddy, and it becomes progressively less clear when we’re talking issues of aesthetics, or in this case cosmetics – the use of a device in an elective procedure with outcomes very much more difficult to assess than the activity of skin infection or a failing heart.

It is an analysis implied in the recent release by Mentor (Santa Barbara, California) of an Internet survey indicating a 90% rate of “satisfaction” by women with the company’s implants – and 10% not-so-satisfied (not surprisingly, less highlighted by Mentor) (Medical Device Daily, April 7, 2005).

We hasten to note that those responding were what the survey crowd calls “self-selected.” In this case, it probably means that the 90% reporting satisfaction were happy with their choice and perhaps eager to say so – and those dissatisfied women perhaps less likely to respond; after all, they had made a bad choice. And so it is rather likely that the true figure of “dissatisfieds” is probably significantly higher than the 10% reported on this survey.

But, for argument, let’s grant Mentor its 90%/10% benefit/risk ratio. And if applied to a drug or device, wouldn’t 10%, considered as a failure rate, be large enough to say that a drug or medical device should be held from the market?

Such a question is made significantly more complicated, of course, given a variety of other questions – those questions facing the FDA in making final decisions concerning the applications by Mentor and Inamed to get their gel implants approved for U.S. marketing.

Such as:

  • How to consider last week’s starkly contradictory votes of its General and Plastic Surgery Devices Panel?
  • How to weigh the traditional statistical studies indicating no harm by implants against the wealth of anecdotal reports by women, ranging from breast-feeding difficulties to leaks and ruptures – perhaps even serious disease?
  • How to evaluate this conflicting evidence in the context of the emotionally overwrought pleas both for and against implant commercialization?
  • How to rationalize approving a device type that, apart from the risks of serious disease, obviously leads to increased use of already highly rationed medical resources, ranging from the panel’s requirements of regular MRIs and more frequent mammograms to the general increased use of medical care required by women with implants?
  • And finally, how to compute the wisdom of approving a device that clearly may offer large downside risks for many women but with those risks pitted against a media-driven culture that continually aggrandizes the benefits of outward appearance?