As her body lay rotting in the grave, her perfect silicone breasts pointed at the stars forever. Except, maybe not.

In documents made public on Wednesday, health regulators estimated that up to 93 percent of silicone breast implants ruptured within 10 years.

Silicone breast implants have been banned for some thirteen years because they can rupture or leak. The manufacturers have been pressing for the ban to be lifted. The debate will come to a head next week.

The panel voted, 9 to 6, in October 2003 to approve silicone implants. In an unusual move, its chairman later wrote a letter to the F.D.A. urging that it reject the recommendation. The agency sided with the chairman and ruled that more information was needed about long-term safety.
An expert committee of scientists found in 1999 that there was little evidence that silicone implants caused such diseases. Instead, the primary safety concern, the panel found, was the tendency of silicone implants to cause local complications like infections, pain and scarring.
All emphasis mine.

“Infections, pain and scarring”? That’s not enough to keep these things off the market?
How often do they fail?

Inamed studied its implants for four years and found that 9 percent a year rupture. Those numbers are fraught, however, because most patients have no idea when their implants rupture, and imaging tests are accurate in assessing failures only about two-thirds of the time.

Projecting the numbers over 10 years called for even more guesses. If one assumes that implants are no more likely to fail in their 10th year as they are in their first, just 21 percent of a cross-section of women will see their implants fail in 10 years.

But in comments posted on Wednesday on the agency’s Web site, reviewers wrote that implants, like cars and hearts, are more likely to fail as they age. Adjusting for the increasing risks that come with age, the agency estimated that 74 percent of a cross-section of women would suffer implant failures in 10 years. For women undergoing reconstructive surgery, mostly breast cancer survivors , the failure rate is 93 percent.

One percent over the lifetime of the implant would be too high a failure rate. “Just 21 percent”? What do they mean, just? One fifth will fail over a decade. That’s acceptable? Brain explodes, just as it did with this final quote:

Dr. Mark Jewell, president elect of the American Society of Aesthetic Plastic Surgery, said he was surprised that the agency had estimated that silicone implants failed so often.

“That’s certainly news and does need to be addressed,” said Dr. Jewell, who has consulted for Inamed and Mentor. “But I feel that the devices should be approved.”

The companies can track the safety of the devices after they are approved, he said. Women often find that silicone implants feel more natural than saline, Dr. Jewell said.

“Silicone implants feel more natural“? I don’t know about you but I would rather look at and feel the breasts of a marble statue than a silicone-inflated pair.

I also have to question whether any medical device aimed at men would even be considered with such a failure rate.

The first sentence is a paraphrase from a poem. Anyone remember it?
Update [2005-4-7 18:15:8 by Athenian]: As I mention in comments below, I was reminded of the full quote:

But she will not surrender to these voracious guests
inviolate forever, her perfect plastic breasts.
Possibly by Eleanor Brown

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