Silicone Implants Generate Renewed Debate

Study finds lower rupture rate, but some say rate may be higher

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HealthDay Reporter

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THURSDAY, Aug. 21, 2003 (HealthDayNews) -- As federal health officials ready for hearings on whether silicone breast implants should be allowed back on the U.S. market, a new study offers evidence of a reduced rate of implant rupture.

The study, conducted by a group of Danish researchers, used magnetic resonance imaging (MRI) to study implant rupture rates in some 300 women for a period of three years. From that data, the researchers extrapolated a rupture rate of 15 percent to 17 percent 10 years after the women received the implants.

But not all experts agree with the accuracy of the projection.

Diana Zuckerman, a former member of the National Cancer Institute advisory committee on breast implants, says the study offers a gross underestimate of the implant rupture problem.

"If it were truly 15 percent at 10 years, that would be an improvement, but I do not believe for a minute that it is 15 percent. It's an estimate based on an assumption that I don't believe this study supports," says Zuckerman, executive director of the National Center for Policy Research for Women and Families.

Zuckerman notes the new research, published in a recent issue of the Archives of Surgery, only studied women for three years. And without specific 10-year data, there's no real way to accurately project the rate of rupture across an entire decade, she says.

A study published in 2000 by the U.S. Food and Drug Administration (FDA) found a silicone implant rupture rate as high as 55 percent, with up to 69 percent of all women likely to experience a rupture in at least one breast.

However, some plastic surgeons agree with the new study results. And one, Dr. Barry Zide of New York University, remains unconvinced that silicone implants pose any significant health problems even if a rupture does occur.

He believes the number of implant ruptures is probably lower than 15 percent.

"First, I object to the use of the term rupture, because in reality we are mostly talking about small and very slow leaks, which more often than not, you would not even notice unless you had an MRI. We are talking about a very small amount of silicone leaving the implant," says Zide, a professor of surgery at New York University School of Medicine.

But more important, he says, there is no direct evidence that silicone that does leave the implant has any ill effects on a woman's health.

"It's been studied over and over and there is just no proof that it is linked to any major health problems. So I don't see the leakage as any major concern, regardless of what the percentage is," says Zide.

Not surprisingly, Zuckerman believes otherwise.

"Up until two years ago there were no specific studies done on the health problems of women whose implants ruptured. And when this research was finally conducted, in one study by the FDA and two by the NCI (National Cancer Institute), there was a significant increase in certain health problems in the women with the ruptured implants," Zuckerman says.

In the FDA study, researchers compared women who had silicone implants with no rupture to women with ruptured silicone implants. They found a statistically significant increase in the incidence of fibromyalgia and several other potentially debilitating autoimmune diseases among the women whose implants ruptured.

Zuckerman says the findings from the NCI studies were even more troubling. In this research, doctors compared women who had breast implants to other plastic surgery patients, and found the implant group (most of whom had silicone gel implants) were more than twice as likely to die from brain cancer, and three times as likely to die of lung cancer.

"If I were a woman contemplating silicone breast implants, this would sure scare me," Zuckerman says.

The new Danish study, which began in 1999, recruited 271 women who had received silicone implants at least three years before. Each woman received a baseline MRI exam to judge the integrity of the implant and document leakage. Two years later, 206 of these women had a second MRI.

The doctors also tracked the number of women found to have leaks on the first MRI, and who subsequently had their implants removed or replaced. All these women were included in the final calculations.

The result: The researchers found 33 definite ruptures (10 percent) and 23 possible ruptures (7 percent) in the implants between 1999 and 2001.

They concluded the overall rate of implant rupture is approximately 5.3 incidences for every 100 implants. However, they report the rupture rate significantly increased according to the age of the implant itself, with the newer, double-lumen type implant associated with a substantially lower risk profile than the older single-lumen implant.

For the most up-to-date implants, the Danish researchers estimate a rupture rate of about 15 percent to 17 percent at the 10-year mark.

The FDA has agreed to reexamine the possibility of bringing back silicone breast implants to the American market. The agency banned the implants in 1991 after numerous reports that ruptured implants could lead to health problems in women.

Saline-filled implants continue to be available to women seeking breast augmentation.

More information

For the latest data on silicone breast implants, check this 2003 U.S. Food and Drug Administration report. For more about other types of breast augmentation options, visit The American Society of Plastic Surgeons.

SOURCES: Barry Zide, M.D., plastic surgeon and professor, surgery, New York University School of Medicine, New York City; Diana Zuckerman, Ph.D., executive director, National Center for Policy Research for Women and Families, Washington, D.C.; July 2003 Archives of Surgery

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