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FDA study shows silicone breast implants rupture

May 18, 2000
Web posted at: 7:36 p.m. EDT (2336 GMT)

WASHINGTON (CNN) -- Silicone breast implants leaked in two-thirds of women who participated in a study carried out by the U.S. Food and Drug Administration, the agency announced Thursday.

In the study, 67 percent of 344 women who had reported no symptoms of illness or problems with their implants were found to have at least one ruptured implant, as determined by magnetic-resonance imaging.

Diana Zuckerman, of the National Center for Policy Research for Women and Families, said the finding is important because previous studies looked only at women who had reported problems with their implants.

The study found younger implants more likely to have ruptured. Two-thirds of the implants that were more than 26 years old had ruptured, versus 79 percent of implants 11 to 15 years old.

Older implants were made of a thicker gel, but manufacturers switched to a thinner, more natural-feeling product that proved more likely to leak, Zuckerman said.

In 21 percent of the cases studied, the gel leaked outside the breast capsule and traveled to other parts of the body.

Zuckerman expressed concern over that finding. Before the advent of breast implants, doctors injected liquefied silicone into women who wanted larger breasts. That practice was banned after the silicone was found to have migrated to some women's lungs and other organs, which sometimes proved fatal.

"These things are breaking at a high rate," Zuckerman said. "Based on the previous problems with silicone gel, this is very dangerous and particularly worrisome."

A call to a silicone-gel manufacturer was not immediately returned.

About 1 million U.S. women have silicone-gel implants. In 1992, then-FDA Commissioner David Kessler said the manufacturers had not proven silicone-filled implants safe and effective, and ordered them removed from the general market.

They have remained available for certain women, including breast cancer patients who had undergone mastectomy and were seeking reconstructive surgery, women with congenital breast deformities and women who had ruptured implants but could not use saline-filled devices.

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Breast Implants Information
Food and Drug Administration
The American Society for Aesthetic Plastic Surgery

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