FDA Dismisses Two Breast Implant Petitions

December 22, 2003

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Mon Dec 22, 4:40 PM ET

SANTA BARBARA, Calif. - Inamed Corp. Monday said the Food and Drug

Administration (news - web sites) 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 (news - web sites), 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 (news - web sites)'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.

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