FDA Says 'Yes' to Silicone Breasts

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After 14 years, silicone breast implants will once again be available to women in the United States.

The decision by the Food and Drug Administration makes silicone implants available to all breast reconstruction and revision patients, as well as women 22 years of age and older seeking cosmetic breast enhancement.

Critics were quick to respond to the announcement, saying the FDA has not fully examined all of the facts surrounding the dangers of silicone.

A number of conditions come attached to the approval, including studies and follow-up of a projected 40,000 women over the next 10 years, says the director of FDA's Center for Devices and Radiological Health Dan Schultz.

The move comes less than a month after health officials in Canada allowed such implants back onto the market after the country's moratorium, which began in 1999.

The decision has big implications for the industry, as breast augmentation is the second most-popular cosmetic surgery procedure in the United States today. According to statistics from the American Society for Aesthetic Plastic Surgery, nearly 365,000 women had breast augmentation surgery in 2005 -- a number topped only by that for liposuction.

Since the 1992 moratorium, only saline-filled implants have been allowed on the general market, and silicone implants had been available only to special patients through FDA-approved trials.

"The moratorium was put in place in 1992 by the FDA because they felt that there was insufficient evidence to determine if [silicone implants] were safe," said Dr. Michael Olding, chief of the division of plastic surgery at George Washington University Medical Center in Washington, and a member of the FDA's General and Plastic Surgery Devices Panel.

"This does not mean that they were unsafe," he said, "but rather that more information was necessary, so they pulled them from the market temporarily."

Olding said scientific studies conducted since the moratorium have concluded that there is no scientific link between silicone implants and the systemic diseases many believed were connected to their use.

"It's sort of a vindication because we all knew there was no scientific evidence back in 1992 that necessitated the moratorium," said Dr. David Song, chief of plastic surgery at the University of Chicago Pritzker School of Medicine in Chicago. "Since 1992, there have been several landmark studies, two of which were in the New England Journal of Medicine, that showed there was no correlation between silicone leakage and all the health conditions that were being described.

"I think this is a huge victory for women," Song said, "not just for those seeking cosmetic surgery but also for many reconstructive patients after breast cancer surgery."

Not all see the development as a victory for women.

"We find it shocking that the FDA would make such a move at this time, as more and more evidence has accumulated that critical information has been withheld by the manufacturers that would clearly demonstrate that these implants are not safe," Kim Gandy, president of the National Organization for Women, wrote in a letter sent to members of Congress this morning. "The FDA should not approve silicone-gel breast implants at this time, and Congress should examine these and other instances where FDA is not requiring sound science before making approval decisions."

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