Monday, December 11, 2006

Will FDA ruling bring back 'Silicone City'?

Interesting articles published in the Houston Chronicle

Say what you will about breast implants — and people have spoken volumes over the past three decades — they are as much a part of modern American culture as, well, Barbie, Marilyn Monroe, the Playmate of the Month and maybe even the Statue of Liberty, though we can only speculate on what the great lady is hiding beneath those robes.

Perhaps with that in mind, officials with the Food andDrug Administration have finally stepped away from the long battle over silicone, the main ingredient of the implant of choice, preferred by many women who say it looks and feels more like the real thing.

Lacking persuasive evidence that silicone is harmful to the human body, the FDA last month lifted a moratorium on silicone implants that dated to 1992, allowing it to be added without restriction to the cosmetic surgeon's arsenal. The ban was put in place after thousands of women complained that their implants had made them sick — an assertion that failed to find support in subsequent medical studies.

Some silicone opponents are decrying the decision, saying the agency didn't insist manufacturers prove the implants are safe.

Big news in Houston

The FDA's decision was big news not only to plastic surgeons, who hailed it as a triumph of science over hysteria, but to many women unhappy with what nature denied them. It was even bigger news in Houston, birthplace of the breast implant and home to more breast-enhancement operations per year than any city save Los Angeles.

Once dubbed "Silicone City" by Texas Monthly magazine, Houston has long embraced the notion of improving on nature. (See: the Astrodome.) If ambitious entrepreneurs could reinvent themselves here, why not modestly endowed women?

Save for a few years immediately after the ban, when news reports gave women considering artificial endowment pause, the demand for breast augmentation has steadily increased. Last year more than 290,000 women in the United States received implants to expand their bustline, and almost 60,000 more underwent breast reconstruction following mastectomies. That's up from 130,000 total in 1996.

"Something like 50 percent of American women are dissatisfied with the shape or size of their breasts," said Franklin Rose, a popular Houston plastic surgeon. "Some of it is cultural, but I believe some of it is innate. There is a certain attractiveness to the breast that goes back to antiquity. An attractive female form is mentioned in the Old Testament. I think many more would consider surgery than do if it were not cost-prohibitive for them."

The caricature of the implant seeker is a woman who wants to be noticed for the wrong reasons. Though Houston has its share of slender women who enjoy the attention an oversized chest may bring, the truth is that most who want enhancement want only to look closer to normal, Rose said.

More often than not, it's a young woman whose breasts never developed in proportion to the rest of her body. Other common patients are mothers who suffered breast-tissue loss after childbirth, women whose breasts did not develop equally or are oddly shaped and cancer patients.

"I just wanted to put my shirt on and have something there to fill my bra out," said 28-year-old Heidi Lancaster, who got her implants two years ago. "Every day when I put on my old clothes, they felt like new ones. I felt more confident. I achieved the look I personally wanted."

Lancaster's implants are filled with saline, which was true for most of the implants sold after 1992. Only a small number of surgeons were allowed to keep offering silicone implants, and then only if the woman was willing to participate in a long-term clinical trial.

Saline still cheaper

The widespread availability of silicone won't change that trend overnight. Saline implants remain significantly cheaper, about $900 instead of about $1,500. That makes a difference to some patients.

"The patients who are first getting breast augmentation are usually younger, and they are very price-sensitive," said Mark Schusterman, a longtime Houston plastic surgeon.

But the return of silicone is expected to spark escalating interest. Cosmetic surgeons across the country have already reported more calls from prospective patients and from those who had already scheduled surgery with saline. If price is taken out of the equation, silicone will win, especially as memories of the controversy around it fade.

"I wasn't happy with saline," said Stacy Thompkins, a Houston hairdresser who got implants about a dozen years ago and switched to silicone two years later. "They weren't as natural-looking or -feeling. I felt like I was carrying around melons on my chest. They were much harder and heavier."

Breast implants were first thought to be good for a lifetime. That's how they were promoted. In truth, they were rupturing in alarming numbers, which was the genesis for the hundreds of thousands of lawsuits that arose in the 1990s. Women feared the silicone that leaked into their bodies was leading to serious illness.

A spate of epidemiological studies could not link implants to any of the autoimmune disorders they were accused of causing. Though forced to acknowledge that the product they sold did not perform as intended, the implant manufacturers claimed a victory of sorts before walking away.

The billions of dollars they spent on settlements and legal costs drove most out of the implant business. For companies as large as 3M and Dow Corning, the small profits from implants were not worth the trouble.

The two smaller companies that persevered through the controversy, Mentor and Allergan (which acquired implant maker Inamed), set about redesigning the implant. The silicone mixture was made more viscous so that it would not migrate throughout the chest in the event of a rupture. The shell became thicker and much less likely to tear or split. The old implants were so thin that the silicone could "bleed" through them even if the shell was not compromised.

"It's like the difference between a car made 20 years ago and one today," Schusterman said. "The engineering leaps have been astronomical."

How well they perform will continue to be of interest to the FDA, which will monitor the products and is requiring the manufacturers to conduct follow-up studies. Implant recipients are advised to have MRIs to determine the integrity of the device, the first to be performed after three years, then every two years thereafter.

New guidelines

The new and improved implants will come with extensive caveats, including an explicit statement that they are not lifetime devices. Replacement is to be expected. That's good news for the manufacturers; they'll sell more implants, and many of the women who have saline now will "upgrade" to silicone when the time comes.

"When I decide to have them redone, I'm sure I will go with silicone," said Brandi Phillips, a 24-year-old administrative assistant who received implants two years ago. "If it were my choice, I would have picked silicone back then because it's the more natural look. It wasn't that easily available."

Phillips figures to wait about eight years before switching them out. She has no thoughts about going back to the way she was before.

"I'm a girl and in a bikini, if you don't fill up your top, it's kind of embarrassing," Phillips said. "I always knew I would get implants. Nobody told me to get them. It was what I wanted. It was a bit nerve-wracking when I was going through it, but then you see that you're perfectly normal, just a little bit tweaked. I'm 100 percent happy with them."

Manufacturers claim the breast implant is the most studied medical device in history, and if there was any association with illness it would have been discovered. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said the agency looked extensively at data for the past decade and determined that making silicone implants widely available is in the best interest of women.

'Simply unacceptable'

Many of the anti-silicone advocates remain skeptical. Sybil Goldrich, a longtime opponent and founder of the Command Trust Network support and advocacy group, called lifting the restrictions "simply unacceptable," saying the FDA decided to "approve now and collect safety data later." The National Women's Health Network said the agency failed to do its job because it did not demand the companies prove that implants are safe.

"They can't tell women how long these products last, when they will have to be replaced or what the effect on their health will be if the product fails," said Amy Allina, the group's program director. "Why did they do it? The best reason I can come up with is that they have been worn down and don't want to deal with the issue anymore."

Of that there is little doubt. The companies totaled a combined $464 million in implant sales last year. An expanded silicone line will boost that number. They were not going to give up because they know absolutely that the demand for the product will not go away.

"All I wanted was to be proportionate and look natural," Lancaster said. "I love my implants."


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