FDA hears women on breast implants

Some tearfully describe silicone-related ailments

others want ban lifted

April 12, 2005|By Ricardo Alonso-Zaldivar | Ricardo Alonso-Zaldivar,LOS ANGELES TIMES

WASHINGTON - Pamela Dowd drove her 20-year-old motor home 2,500 miles from Boise, Idaho, to tell a government panel how her silicone breast implants led to health problems that have sapped her vitality and made her medically uninsurable.

Terry Heide took time off from her Pentagon job to urge just as forcefully that women be allowed to make their own decisions about the risks and benefits of silicone gel implants, which many believe have a more natural look and feel than the available saline-filled ones.

The two women, both breast cancer survivors, were among the dozens who testified yesterday, often tearfully, before a Food and Drug Administration advisory panel that was to hear more than 180 witnesses on the first of three days of deliberations on making silicone breast implants available to anyone who wants them.

Two Santa Barbara, Calif., companies, Inamed Aesthetics and Mentor Corp., are asking the FDA to lift restrictions imposed in 1992 that largely limited silicone implants to women seeking breast reconstruction after cancer surgery. The restrictions were put in place after the FDA determined that manufacturers had not shown the devices to be safe.

The FDA is already under heightened congressional scrutiny because of the way it has dealt with safety concerns that have arisen after drugs were approved for sale, and yesterday's testimony exemplified the wide gap between those who believe that silicone implants can cause severe problems and should be kept off the market and those who contend that women should be able to make an informed decision on the implants after studying the potential risks.

"If there is no connection between implants and health problems, why the insurance denial?" said Dowd, who is unable to work. "What is the toxic secret insurance companies know about but aren't sharing?"

Heide, who works as a congressional liaison for the Army, described how she researched the risks before choosing silicone for her breast reconstruction in 2003.

"Silicone is widely used in medical devices," she said. "If it had all these terrible side effects, we would be seeing worldwide outrage."

At stake are tens of millions of dollars for the two companies and an improved market for plastic surgeons, who perform more than 250,000 cosmetic breast augmentations a year - most of which use implants filled with saline solution.

Like many surgically implanted medical devices, silicone implants can be expected to wear out, and some women may have to replace them. One of the main issues before the panel is whether women can be harmed by silicone gel leaking from ruptured implants.

The hearing marks the second time in as many years that an FDA advisory panel has considered the issue. In 2003, Inamed applied for approval of its silicone implants and a panel recommended that they be allowed on the market. But that decision was overridden by the agency, which said it needed more information. Mentor did not seek approval for its product in 2003.

Agency reviewers remain skeptical that the two companies have settled the issue. In preliminary analyses released last week, FDA scientists estimated that three-quarters of the gel-filled devices could break and leak within 10 years of implantation, requiring additional surgery to remove or replace them. Inamed and Mentor, the analyses noted, submitted studies tracking rupture rates for just three or four years.

The advisory panel is to vote today on Inamed's application and tomorrow on Mentor's, but the final decision is the FDA's.

The Los Angeles Times is a Tribune Publishing newspaper. The Associated Press contributed to this article.

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