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Approval of Silicone Gel Breast Implants Based on Only Three Years of Data Would Be Foolhardy, Public Citizen Tells FDA

Oct. 14, 2003

Approval of Silicone Gel Breast Implants Based on Only Three Years of Data Would Be Foolhardy, Public Citizen Tells FDA

As Many as Half of Women With Breast Reconstruction Require Implant Removal Within 10 Years

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should heed a series of red-flag warnings and not permit the return of silicone gel breast implants to the market, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, told an FDA advisory panel today.

In testimony before an FDA panel convened to address the Inamed application for approval of silicone gel breast implants, Wolfe said that because the company has submitted only three years of data from a study intended to run 10 years, the FDA cannot be reasonably assured of the implants’ safety.

Wolfe pointed out that the three-year data show similar complication rates evident in the three-year data from a previous Inamed study that continued for five years. At five years, the previous study showed that 26 percent of women had breast pain, 15 percent had asymmetrical breasts and 12 percent required implant removal or replacement.

“It is not unreasonable to hypothesize that in the current incomplete study, when the five-year data are collected, the risks will be as high or even higher than those found in the 1990 study,” Wolfe said.

Wolfe also presented data from an industry-funded study using National Cancer Institute data that showed that, among women receiving breast implants for reconstruction after cancer surgery, 21 percent had their implants removed within five years and 51 percent had theirs removed within 10 years.

Additionally, Inamed’s application includes a two-and-a-half-year shelf life for the implants. This is ironic, Wolfe said, because many women are led to believe that implants will last at least 10 years, if not a lifetime.

If the FDA proves unwilling to require implant manufacturers to provide longer-term data as a prerequisite for approval, serious questions will be raised about the agency’s enforcement of a 1976 medical device law that was enacted to protect patients, Wolfe said. The law was passed after the Dalkon Shield intrauterine device (IUD) caused the deaths of 17 women and made thousands of others sterile. Like breast implants, the device had not been tested for a long enough time.

To view a copy of Wolfe’s statement to the FDA, containing his analysis of the Inamed data, click here.