Silicone Breast Implants Would Be Carefully Monitored

Approval dependent on follow-up safety reports

By Janice Billingsley
HealthDay Reporter

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FRIDAY, Oct. 17 (HealthDayNews) -- Despite Wednesday's recommendation for their approval, silicone gel breast implants face several hurdles before they're back on the American market.

A U.S. Food and Drug Administration advisory panel voted 9-6 to approve the devices after a two-day hearing. But the panel couched its OK with a long list of follow-up procedures for the implants' manufacturer, Inamed Inc. of Santa Barbara, Calif., to implement that would monitor the risk of the popular yet controversial devices.

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Even then, the FDA, which must ultimately rule on the panel's recommendation, is not making any promises for approval.

"We are in the process of reviewing Inamed's application for the safety and effectiveness of the device, and will take the panel's recommendations into consideration as we continue in our review of the company," said an FDA spokesperson, who would not give a time frame for the decision.

Most of the recommended procedures are in response to the fact that the data presented by Inamed included two-year follow-ups on 26,000 women who got the implants. While this is the standard time frame for data required by the FDA for applying for approval of a medical device, those who oppose the gel implants are not convinced this was enough.

"There is no data on the safety of the [implants] for more than two years," said Diana Zuckerman, president of National Center for Policy Research for Women and Families in Washington, D.C., who testified against approving the gel implants at the hearing. "We need at least 10 years."

Joann Kuhne, who is the senior director for regulatory and clinical affairs for Inamed and testified at the hearing about the study results, feels strongly that the implants are safe.

"These implants have probably been tested more than any other medical device," she said. However, she added that the company would work closely with the FDA on follow-up procedures to make sure the implants are safe in the longer term.

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