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Tuesday, 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.

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