New Concern About Resuming Breast Implant Sales

November 5, 2003

http://cbs2.comNew Concern About Resuming Breast Implant SalesNov 4, 2003 8:15

pm US/Pacific

In a highly unusual move, the chairman of a government advisory panel that

reluctantly backed resuming sales of silicone gel breast implants now is urging

federal health officials and lawmakers to disregard that advice.

" 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. " I felt morally compelled -- it sounds corny, but morally

compelled -- to do something about it. "

Silicone gel implants were highly popular until 1992, when fears that leaking

silicone caused serious diseases prompted the Food and Drug Administration to

end routine sales. Now one manufacturer is seeking an end to the ban, arguing

that silicone implants have been exonerated of causing serious diseases like

cancer or lupus.

Last month, the FDA asked outside scientists for advice. In a two-day meeting,

dozens of women blamed silicone implants for permanent disfigurement and dozens

more begged for access to them.

The advisers recommended, on a 9-6 vote, the sale again of implants but only

under very 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 Tuesday by The Associated Press, he wrote 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 broken or painful implants. " This

is a public health issue of no small import that must be addressed should the

FDA second this misguided panel decision, " Whalen said.

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

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