April 12, 2005

"Strings of silicone started coming out of her eyes and ears."

From the NYT report on FDA hearings about silicone breast implants:
Carolyn Wolfe, 74, of Manassas, Va., told the panel that after her silicone implants had ruptured, strings of silicone started coming out of her eyes and ears. Her nipples seeped silicone, she said, and she developed rheumatoid arthritis and a goiter.

Horrid, it's true, but can't people make their own decisions about the risks:
Michele Colombo, 35, of Lake Worth, Fla., said her silicone implants had helped her "to feel whole." Ms. Colombo said opponents of implants were "making a moral judgment, not a medical one."

UPDATE: And the panel rejects the broader use of silicone implants. Although I find it a little hard to see why cancer patients are treated differently from others who want implants -- none have a medical need, only a cosmetic one -- I found this persuasive:
In its own presentation, Inamed assumed that implants were like stereo equipment and were no more likely to break in their 10th year of use than in their first. With this assumption, it concluded that 14 percent of implants would have ruptured after 10 years.

The drug agency suggested that implants might be like cars or tires, which wear out with age. Under this theory, the agency found that as many as 95 percent of patients who got silicone breast implants for reconstructive surgery would experience a rupture by the end of 10 years. Still, it admitted that it had little idea whether this assumption was accurate.

"In fact, we really don't know," said Dr. Pablo Bonangelino of the agency.

ANOTHER UPDATE: One day later, the FDA [panel] approves a different company's silicone implants. That seems a bit strange, but Mentor had better evidence than Inamed. It's all about rupture rates, by the way, not any serious diseases of the sort you may remember reading about years ago.

3 comments:

Dean said...

Horrid, it's true, but can't people make their own decisions about the risks

As long as we have people who think government should be a nanny? Doubtful. But aren't they looking at the medical problems and not the moral ones? It seems Ms. Colombo would be confused.

Tim said...

What is wrong with making a mroal judgement?

Pogo said...

Re: "But aren't they looking at the medical problems and not the moral ones? It seems Ms. Colombo would be confused."

That would be true if the side effects were being discussed in a scientific format, such as in a medical journal. Where, in fact, science concluded long ago that the auto-immune claims against silicone were simply invalid.

But this is a government panel, and the scientific truth is of little importance. Stands must be taken, heads must roll. FDA hearings, like their congressional counterparts are about politics, not truth, not morals, not science.

The whole point, as Jouvenel pointed out in 1951, is the accrual of power. The attempts to satisfy certain social needs (here, the overblown concern about silicone implants) is a sham. The growth of public services such as the FDA, which increasingly intervenes into our lives, is portrayed as "for our own good", but is simply the relentless extension of power.

The topic here, silicone implants, is not important to this end. Next week, it will be Vioxx. Or Viagra. Or some othe Clear And Present Danger that the FDA Must Address For Our Own Good.