Fw: FDA letter from House of Representatives

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----- Original Message ----- From: m keeling

keeling.m@...

Sent: Tuesday, November 25, 2003 10:38 AM

Subject: FDA letter from House of Representatives

The attached letter will be sent to the FDA at the end of today. Please call your representative and ask that they call Sharon Scribner in Rep. Gene Green's office at 202/225-1688 and sign onto this letter if their name does not appear below:

(Representatives who have already signed onto the letter)

Pete Stark D-CA

Lynch

Jan Schakowsky D-IL

Stepheanie Tubbs D-OH

Tammy Baldwin D-WI

Jim McDermott D-WA

Sam Farr D-CA

Delahunt D-MA

Rahm Emanuel

McCarthy D-MO

Neil Abercrombie D-HI

Virgil Goode D-VA

Burr R-NC

DeGette D-CO

Dutch Ruppersburger

Dale Kildee D-MI

Ackerman D-NY

DeLauro D-CT

Bart Gordan D-TN

Carolyn Maloney D-NY

Sherrod Brown D-OH

Jerry Nadler D-NY

Kaptur D-OH

, Jr. D-IL

Maurice Hinchey D-NY

Louise Slaughter D-NY

November 25, 2003

Dear Colleague:

I write to encourage you to sign onto the attached letter to Mark McClellan, urging him to reject the recommendations of the General and Plastic Surgery advisory panel meeting held on October 14 and 15, 2003, at the conclusion of which the panel recommended approval of silicone breast implants based on a 9-6 vote.

There has recently been a push to have silicone implants approved by the FDA. At least one manufacturer of silicone gel-filled breast implants has filed clinical data from an investigational device exemption (core) clinical trial based on only 2-3 years of patient follow-up. Clinical data based on only a few years of clinical patient follow-up will fail to address the long-term problems that can affect women's health. Local, regional and systemic complications of silicone gel-filled breast implants often don't develop until 8-10 years.

Additionally, the clinical data provided to the agency to support approval demonstrated high complication and reoperation rates even during the short duration of follow-up. More than 45 percent of breast cancer survivors had to undergo at least one additional surgery in the first three years after getting implants.

Given these concerns, I am sending Commissioner McClellan the attached letter to request that core clinical trials be extended to better assess long-term safety prior to approval. If you are interested in joining me, please contact Sharon Scribner at 5-1688.

Sincerely,

Gene Green

Member of Congress

Gel Implants a Concern for Advisory Panel

WASHINGTON - 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.