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12/24/03 - FDA Dismisses Two Breast Implant Petitions - Associated Press

SANTA BARBARA, Calif. - Inamed Corp. Monday said the Food and Drug Administration denied two petitions by interest groups that sought to delay a review of its application to reintroduce silicone-gel breast implants.

The Santa Barbara company said the FDA denied both petitions on procedural grounds and the decision has no bearing on the review.

On Nov. 6, the National Organization for Women, Public Citizen's Health Research Group, and the National Women's Health Network filed a petition with the FDA seeking to block the application process.

Chemically Associated Neurological Disorders followed with another petition Nov. 19.

On Nov. 5, the head of a Food and Drug Administration advisery board, which voted in favor of allowing silicone implants back onto the market, urged the agency to reject Inamed's marketing application.

In a letter to FDA head Dr. Mark McClellan, advisery board chairman Dr. Thomas Whalen expressed "very strong reservations" concerning the mid-October 9-6 vote in favor of re-approving the implants, which were virtually taken off the market more than a decade ago over safety concerns.

Inamed continues to try to have its version of implants approved, and said it expects the administration to complete the current phase of its review in the next few weeks.

Earlier this month, the company said a model of its implants were certified as satisfying the European Union's most stringent safety and efficacy requirements.

In 1992, the FDA blocked general use of silicone implants. Then, a barrage of lawsuits drove the main manufacturer into bankruptcy. Saline implants, viewed by some as inferior in look and feel, took over the market.

Inamed shares closed Monday at $46.77, down 59 cents, or 1.2 percent, on the Nasdaq Stock Market.