FDA panel chief challenges silicone-implant advice

By The Associated Press

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"I really have a lot of angst" about the panel's vote, said Dr. Thomas Whalen, of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School in New Brunswick. "I felt morally compelled — it sounds corny, but morally compelled — to do something about it."

Silicone-gel implants were popular until 1992, when fears that leaking silicone caused serious diseases prompted the Food and Drug Administration (FDA) to end routine sales, restricting them to breast-cancer patients in strictly controlled clinical trials. One manufacturer is seeking an end to the ban, saying silicone implants have been exonerated of causing diseases such as cancer or lupus.

Last month, the FDA asked outside scientists for advice. In a two-day hearing, dozens of women blamed silicone implants for permanent disfigurement while dozens more begged for access to them.

The advisers recommended, on a 9-6 vote, that sales of the implants be resumed under strict conditions. These include additional safety tests and warnings to recipients about lingering safety questions and the frequent need for repeated operations because of painful scar tissue and other problems.

As the panel's chairman, Whalen could not vote unless there was a tie. But in a letter obtained yesterday by The Associated Press, he wrote to FDA Commissioner Mark McClellan and five members of Congress about his "very strong reservations concerning this vote."

"Long-term safety, the concern that prompted the removal from the market 11 years ago, was clearly not demonstrated," Whalen wrote. Also "extraordinarily troubling," he added, is the enormous costs that women face for additional surgeries and removal of ruptured or painful implants.

The FDA said it had received and would consider Whalen's comments.

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