Fw: Public Citizen on Inamed's Rush to get FDA approval on silicone gel

August 23, 2003

----- Original Message -----

From: " ilena rose " <ilena2000@...>

<ilena@...>

Sent: Saturday, August 23, 2003 8:38 AM

Subject: Public Citizen on Inamed's Rush to get FDA approval on silicone gel

> At the bottom of this message are addresses to write the FDA:

>

> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

>

> Subject: Public Citizen on Inamed's Rush to get FDA approval on silicone

gel

> implants

>

> ~~~~ Thanks KKJ of Toxic Discovery Network ~~~

>

> HEALTH, 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 lift

> 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.

>

> ~~~~~~~~~~~~~~~~

>

> 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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September 5, 2003