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November Newsletter

U.S. Advisory Panel Heads Appeals for Silicone Implant Rejection

WASHINGTON, November 5 , 2003 - Dr. Thomas Whalen, head of a U.S. advisory panel to the FDA, is urging regulators to reject the previous approved application by Inamed Corp.'s to resume the sale of silicone gel breast implants.

In a letter , Whalen, reported "very strong reservations" about the advisory panel's 9-6 vote in favor of resuming silicone gel implant sales. Silicone gel implants were banned in 1992 due to mounting safety and health concerns.

Whalen further suggested that too many long-term implant safety questions were as yet unanswered. "Long-term safety, the concern that prompted the removal from the market eleven years ago, was clearly not demonstrated, and to approve this device poses threats to women that are clearly unknown," wrote Whalen, professor of surgery and pediatrics at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School.

"I regret that the final chapter of my FDA experience was this one and implore you ... not to approve this (application)," Whalen wrote.

As the panel chair, Whalen¹s vote was not cast during the committee meeting. The chair¹s vote is required only in the case of a tie.

FDA officials were not available for comment.

Inamed Corp. are awaiting a final decision. Meanwhile, company stocks fell by 6%.

Source: Reuters


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