FDA study shows silicone breast implants rupture more than previously thought.

Silicone gel breast implants had ruptured in over two-thirds of the women who participated in a recent study by the U.S. Food and Drug Administration.

FDA researchers looked at rupture rates among 907 women who had breast implants and had participated in a National Cancer Institute study. Until the recent litigation, breast implant manufacturers claimed the rupture rate of implants was less than one percent.

"In the past, breast implant rupture was thought to be rare, but the FDA study indicates that rupture of silicone gel implants is much more common than previously thought," the agency said in a statement. Though there have not yet been enough studies to determine fully the effect of silicone gel in body tissue, if the substance does get into the body, it is difficult to remove and causes local complications, according to agency reports.

In the first part of the study, 907 women --a majority of whom had silicone-gel-filled implants--were interviewed about whether they had had surgery to remove one or more of the implants. Researchers reported that one-third of the women interviewed had had at least one surgery in which an implant was removed and replaced.

The most common reason for the surgery was problems with the implant that affected the breast, including suspected rupture, pain, or infection. The second most common reason was concern over the safety of silicone.

In the second part of the study, 344 women received MRI examinations to detect possible implant rupture. The FDA found that 69 percent had at least one ruptured breast implant. In 21 percent, the silicone gel had leaked out and traveled to other parts of the body.

"This study confirms the results of other recent studies into the rupture rate of breast implants, which can occur in up to 70 percent of women who have the implants," said Ralph Knowles of Atlanta, cochair of the Plaintiffs' Steering Committee in the long-running multidistrict litigation that women have brought against implant manufacturers.

"This is just the most recent study to show the reality of the problems with the silicone implants. Another study into the long-term disease effects of silicone is expected to be completed next year. We expect that this study will also confirm these problems."

In 1992, the FDA removed silicone-gel implants from the general market, saying the manufacturer had not proven they were safe and effective. These implants are still available, however, to some women, including breast cancer patients who have undergone mastectomy and women with congenital breast deformities.

More information on the study can be found on the FDA's Web site at http://www.fda.gov/cdrh/breastimplants.

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