Monday, April 16, 2007

Thru the looking glass - how a 15 year old editorial on silicone breast implants could have been written today

On this day April 16,1992 the FDA started the groundwork for what would ultimately be the reintroduction of silicone gel breast implants (SBI) when they relaxed the outright prohibition that had been hastily introduced shortly before and started some of the early clinical trials that would provide data for further review.

It was nearly 15 years later this past October when they finally (officially) concluded that they were likely mistaken and reintroduced SBI's. We're now part of the international consensus of over 60 countries where this has been the decision by the respective health regulatory agencies overseeing this in other countries.

I found this January 1992 editorial from Reason Magazine (click to read) which is an interesting window into the mindset and arguments flying around at that time. Many of the philosophical issues are the same now as then. It's interesting that the author of this was spot on in warning that (at that time) pending epidemiological studies might not corroberate the claims being asserted in lawsuits. Since then an avalanche of literature has done just that.

In its letter to the Food and Drug Administration requesting a ban on the implants, the advocacy group Public Citizen repeatedly emphasized the frivolous nature of cosmetic surgery: "Because approximately 80 percent of these devices have been used for breast augmentation, as opposed to reconstructive purposes, the overwhelming 'public need,' not the public health need, for these devices is the psychological benefit of having more perfect or larger breasts . . . . We do not accept that the psychological needs of women, who seek breast augmentation, are legitimate public health needs within the meaning of the {Food, Drug and Cosmetic} Act."

The notion that breast augmentation is simply wrong undergirds much of the hostility to the procedure. In her widely discussed book, "The Beauty Myth," Naomi Wolf characterizes breast augmentation as "sexual mutilation." And Public Citizen declares in a press release, "The widespread use of silicone gel implants for surgery that is purely cosmetic is a particularly egregious aspect of the issue."

Take the claim that silicone breast implants cause scleroderma, a connective-tissue disorder that leads to a painful tightening of the skin. To lead in to its program on the implant controversy, "Nightline" featured a woman who had had a breast implant and who had later developed scleroderma. Reporter Judy Muller told viewers that the woman's doctor "believes the disease was caused by silicone leaking from the breast implants."

Muller did not inform viewers that there is no epidemiological evidence to back up that diagnosis. To tell whether there is indeed a connection between implants and scleroderma-like disorders would require a large sample of women who had received implants, whose medical histories were well-documented and whose symptoms were unambiguous. Such evidence may be forthcoming, although a May 1991 literature search under the auspices of the American Medical Association turned up only 28 women who had developed connective-tissue disorders after receiving silicone gel implants. For now, it is scientifically incorrect to say that implants cause such auto-immune diseases.

To such arguments, implant opponents reply by pointing to scleroderma victims. See, they say, it happened to this woman. She had an implant and now she has a disease. Post hoc, ergo propter hoc. The statistical standards of proof on which epidemiologists rely do not make for powerful journalism. And they run counter to the case-oriented culture of clinical practice.

In evaluating the safety of breast implants, the FDA and the courts should view the evidence rationally, with an eye toward real epidemiological proof rather than emotional claims. Regulators should seek to inform women of risks, not deprive them of choices. And those women who do want the freedom to make informed choices must take responsibility for the consequences, rather than going to court later to demand compensation for bad outcomes. Above all, the FDA should avoid taking refuge in extremist, paternalistic views of what women should be and what women should want.

A couple of other Reason Magazine articles about breast implants can be read here, here, and here


health watch center said...

Hello Dr. Rob,

Informative blog on Plastic surgery... I came across to your blog while was searching for health and plastic surgery on the net...and found very informative, wanted to say Hi.

Skin Care Beauty Zone

Dr. Rob Oliver said...

Thanks! Stay tuned for updates which I try to do 2-3 times a week.

rob oliver

health watch center said...

Hello Dr. Rob,

Thank you for the welcome..