FDA Dismisses Petitions Against Breast Implants

Inamed Corp. on Monday said the Food and Drug Administration had denied two petitions by interest groups that sought to delay a review of its application to reintroduce silicone-gel breast implants in the U.S.

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

The implants were taken off the market more than a decade ago over safety concerns.

In October, amid much debate and controversy, an FDA advisory panel voted 9 to 6 in favor of allowing silicone implants back onto the market. The FDA usually follows the advice of its panels.

But on Nov. 5, Dr. Thomas Whalen, head of the advisory panel, urged the agency to reject Inamed’s marketing application, expressing “very strong reservations” about the implants in a letter to FDA chief Dr. Mark McClellan.

One day later, 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 delay the application process. Chemically Associated Neurological Disorders followed with another petition Nov. 19.

All the groups are asking that additional safety studies be performed before the implants are allowed back onto the market.

Inamed continues to try to have its version of implants approved. It said it expected the FDA to complete the current phase of its review in a few weeks.

This month the company said a model of its implants was certified as satisfying the European Union’s most stringent safety and efficacy requirements.

In 1992, the FDA blocked general use of silicone-gel implants, ruling that they could be used only in research.

The move came after concerns were raised that leaks were causing women to suffer health problems and possibly autoimmune diseases such as lupus.

Saline implants, viewed by some as inferior in look and feel, took over the market.

Shares of Inamed closed Monday at $46.77, down 59 cents, or 1.25%, on the Nasdaq Stock Market.