Breast Implants Linked to Fibromyalgia

By Marc Kaufman
Washington Post Staff Writer
Tuesday, May 1, 2001; Page A12

Women with ruptured silicone gel breast implants may be at increased risk
of the painful condition fibromyalgia, according to the first study of
women whose implants were known to have burst.

The study, conducted by researchers from the Food and Drug Administration
and the National Institutes of Health, found that when silicone gel
spreads outside the border of scar tissue around the breast area, reports
of fibromyalgia increased significantly.

"We found an association between fibromyalgia reports and women who had
silicone gel found outside the breast capsule," said Lori Brown, a senior
researcher with the FDA's Center for Medical Devices and Radiological
Health. "This doesn't mean there is a cause and effect relationship
between the two, but that there might be."

Her paper, published in the Journal of Rheumatology, concludes by saying
that if the findings are confirmed in later studies, a screening of all
women with silicone implants should be considered to determine if their
devices had ruptured.

The finding is the latest in a long scientific debate over the safety of
silicone gel and saline breast implants. The FDA took silicone gel
implants off the market in the early 1990s because of concerns they might
cause health problems. But they were returned to the market for medical
uses mostly for reconstruction after breast cancer surgery after
researchers concluded they were safe.

Two implant companies have announced they hope to resume use of silicone
gel implants for cosmetic surgery, and are working with the FDA to
demonstrate their safety. An official of McGhan Medical of Santa Barbara
said his company already has one large study underway and is now working
with the FDA to design a second for an improved silicone gel now widely
used in Europe.

The new study included 344 women from Birmingham who had undergone
cosmetic breast augmentation before 1988. The women had their breasts
examined with magnetic resonance imaging (MRI) to determine whether the
implants had ruptured and whether the gel had spread beyond the breast
area. The study found that about two-thirds of the implants had some
rupture and that gel had spread in about one-quarter of the women. (Some
companies, such as McGhan, had much better records on ruptures.)

While the study found a significant association between that spread and
reports of fibromyalgia, it showed no increase in risk for other major
connective tissue diseases. Fibromyalgia is a syndrome with no clear
biological cause that results in generalized pain and tenderness, sleep
disturbance and complaints of mental loss.

Diana Zuckerman, director of the National Center for Policy Research for
Women and Families, a Washington-based nonprofit group, said the new study
was important because it was the first to focus on women with ruptured

"There is every reason logically to think these women might have different
experiences, but there has been an obvious lack of research," she said.
"People concerned about breast implants have long said the women with
ruptured implants are the ones showing up very sick."

Another recent study of breast implants conducted by the National Cancer
Institute found that although women were not at increased risk for most
cancers, they appear to suffer from brain and lung cancer at a higher rate
than other women who undergo plastic surgery.

2001 The Washington Post Company