Fw: Excellent News: FDA advisor: Ignore breast implant vote

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----- Original Message ----- From: ilena rose

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Sent: Wednesday, November 05, 2003 7:42 AM

Subject: Excellent News: FDA advisor: Ignore breast implant vote

Two Important Articles Below ... Your voices ARE being heard!

Thanks to all those who testified and who have written the FDA with their very real concerns!

It's not over yet!

Special thank always to Dr. Zuckerman and her indefatigable work on this issue for over a decade.

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FDA advisor: Ignore breast implant vote

WASHINGTON (AP) --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. Whalen of the University of Medicine and Dentistry of New Jersey- Wood 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.

Find this article at: http://www.cnn.com/2003/HEALTH/11/05/breast.implants.ap

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http://www.latimes.com/news/nationworld/nation/wire/ats-ap_health13nov04,1,1699738.story?coll=sns-ap-tophealth

Gel Implants a Concern for Advisory Panel

EXCERPT: "Long-term safety, the concern that prompted the removal from the market 11years ago, was clearly not demonstrated," Whalen wrote.WASHINGTON - In a highly unusual move, the chairman of a government advisorypanel that reluctantly backed resuming sales of silicone gel breast implants nowis urging federal health officials and lawmakers to disregard that advice."I really have a lot of angst" about the panel's vote, said Dr. Whalen ofthe University of Medicine and Dentistry of New Jersey- Wood Medical School. "I felt morally compelled -- it sounds corny, but morallycompelled -- to do something about it."Silicone gel implants were highly popular until 1992, when fears that leakingsilicone caused serious diseases prompted the Food and Drug Administration toend routine sales. Now one manufacturer is seeking an end to the ban, arguingthat silicone implants have been exonerated of caus ing serious diseases likecancer 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 dozensmore begged for access to them.The advisers recommended, on a 9-6 vote, the sale again of implants but onlyunder very strict conditions. These include additional safety tests and warningsto recipients about lingering safety questions and the frequent need forrepeated 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 aletter obtained Tuesday by The Associated Press, he wrote FDA Commissioner MarkMcClellan and five members of Congress about his "very strong reservationsconcerning this vote.""Long-term safety, the concern that prompted the removal from the market 11years ago, was clearly not demonstrated," Whalen wrote.Also "extraordinarily troubling," he added, is the enormous costs that womenface for additional surgeries and removal of broken or painful implants. "Thisis a public health issue of no small import that must be addressed should theFDA second this misguided panel decision," Whalen said.The FDA said it had received and would consider Whalen's comments.

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For info on Dr. Whalen:

http://www2.umdnj.edu/ethicweb/FacPhotos/BioWhalen.html

If you have input to give to the FDA, please write:Bernato, Laurie DEB@...Weinstein, Les S LSW@...Brady, MWB@...Leonard, NML@..., Samie Niver SXN@...To send to all together: DEB@...,LSW@...,NML@...,SXN@...Thanks Rogene for compiling these important email addresses

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For links to news articles, studies, etc., please visit:

www.BreastImplantAwareness.org

www.BreastImplantInfo.org (Dr. Zuckerman's site)