Fw: For your information... FDA Advisory Panel hearings scheduled for Inamed application

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----- Original Message ----- From: Sybil Goldrich

Sent: Friday, August 22, 2003 10:06 AM

Subject: For your information... FDA Advisory Panel hearings scheduled for Inamed application

Late yesterday, Inamed Corporation announced the FDA advisory panelHearings have been scheduled for mid-October to consider approval of thecompany's silicone breast implants. Please see the enclosed press release for further information. Command Trust will be in contact with you in the near future regardingactions you take to influence this process. Thank you for your active participation on this important issue.Sybil Goldrich

Mike McGill

Senior Project Director

Strategies

1920 I Street, NW

Washington, DC 20006

P- (202) 466-7248

C- (301) 728-0674

CONTACT:

Mike McGill

(202) 466-7248 or (301) 728-0674

mike@...

HEALTH AND CONSUMER GROUPS CALL ON U.S. FDA

TO HALT BREAST IMPLANT APPROVAL PROCESS

Statement from Kim Gandy, President, National Organization for Women

and Dr. Sidney Wolfe, Director,

Public Citizen’s Health and Research Group

AUGUST 25: The National Organization for Women and Public Citizen call upon the U.S. Food and Drug Administration to suspend its consideration of lifting restrictions on the sale of silicone gel breast implants. Reuters reported August 21st that an FDA advisory panel will review, on October 14th and 15th, Inamed’s application to resume sales of the devices.

Inamed filed its application last December, including data from two years of clinical trials. The FDA is using this data for its review even though its own researchers have found that problems dramatically increase seven to ten years after implantation.[1]

On May 8th, NOW convened a panel of scientists and clinicians to review the latest research on the safety and efficacy of silicone gel breast implants. The panel included representatives of the National Institutes of Health, the Food and Drug Administration (FDA) and the Armed Forces Institute of Pathology. Among its conclusions was the fact that long-term safety has not been adequately addressed in past research, specifically regarding the integrity of devices over time. The panel agreed that little regard has been given to the varying physical and chemical properties of the implant materials over time.

Because silicone breast implants are widely available for augmentation and reconstruction under clinical trials, there is no reason to life restrictions on their sale until we are sure they are safe and effective.

NOW and Public Citizen will continue to fight the process and will get the hearings on behalf of the hundreds of thousands of women who deserve to have ALL of the facts about silicone breast implants.

[1] Brown et al. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. Journal of Rheumatology, 2001; 28: 996-1003.