Fw: Comments on: Silicone injections are not approved by the FDAfor anything.

[Guest guest]

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

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

<Recipient List Suppressed:;>

Sent: Wednesday, May 08, 2002 9:31 PM

Subject: Comments on: " Silicone injections are not approved by the FDAfor

anything. "

Date: Wed, 08 May 2002 17:15:39 -0700

From: smoochs <smoochs

Subject: Silicone injections not " approved " , but " legal "

Hi, Silicone injections are not " approved " by the FDA, however ( here is the

loophole) a physician has, at his/her discretion, the right to use a product

that is FDA approved for another use. Legally the FDA approved pure liquid

silicone for injection into the eye as a means of retinal stabilization, to

hold

the retina in place until it could reattach( around 1994). This is one of

the

few treatment options people with retinal detachment have, and it does help

stabilize their condition and in a significant portion, prevents blindness.

The

oil is not recommended to stay in the eye permanently though..it is to be

removed within a year after surgery. In the US the name of the opthalmic

silicone prep is ADATOSIL 5000. Although I am a victim of silicone facial

injections and very opposed to them cosmetically, the eye injections seem to

offer hope where , without them, there really is none...retinal detachment

leads

to blindness. Because it is quite legal for a physician, at their

discretion, to

use a regulated product for an unspecified use( the name for this escapes

me),

silicone injections are now quite " legal " , even though not " approved " . If

you

notice in the FDA's response to you she said they were not " approved " ,

however

they are quite " legal " . Swell, huh?

~~~~

From: VANIQUE

Date: Wed, 8 May 2002 12:16:52 EDT

Subject: Re: From the FDA ... " Silicone injections are not approved by the

FDA for anything. "

I has silicone injected into my lips last year. It was from a doctor on

Park

Ave. He never told me that it wasn't legal.

~~~~

ÿFrom: bhickey@

Date: Wed, 8 May 2002 14:37:24 EDT

Ilena:

Interesting how injections are not approved but ruptured silicone gel

implants have been acceptable for many years....

~~~~

~~~ Thanks much to Dr. Zuckerman and Rogene for getting the " official " word

from the FDA on this important matter. ~~~

From: " Leonard, M. " <NML@...>

" '' " <dz@...>; " Leonard, M. " <NML@...>

Cc: " Rogene " <saxony01@...>

Sent: Tuesday, May 07, 2002 1:35 PM

Subject: RE: silicone injections

> Silicone injections are not approved by the FDA for anything.

>

> M. Leonard

> Public Health Advisor

> Consumer Staff (HFZ-210)

> Division of Small Manufacturers, International and Consumer Assistance

> (DSMICA)

> Office of Health and Industry Programs

> Center for Devices and Radiological Health, FDA

> Phone: 1-800-638-2041 ext. 141

> Fax: 1-301-443-9535

>

> THANK YOU!

>

> Your 100% satisfaction is our #1 goal and your feedback is important to

us.

>

> If for any reason you are not completely satisfied or have a comment to

> make, please contact us toll-free at:

> 1-800-638-2041, ext. 136 or email us at:

> dsmica@...

>

> Division of Small Manufacturers, International and Consumer Assistance

> Center for Devices and Radiological Health

> Food and Drug Administration

> Department of Health and Human Services

>

>

>

>

> -----Original Message-----

> From: [mailto:dz@...]

> Sent: Tuesday, May 07, 2002 2:43 PM

> Leonard, M.

> Cc: Rogene

> Subject: Re: silicone injections

>

>

> Dear ,

>

> Thanks for your response to Rogene.

>

> It was my impression that silicone injections are now legal. Please

update

> us on the current restrictions on silicone injections.

>

> Sincerely,

> Zuckerman, Ph.D.

> President

> National Center for Policy Research for Women & Families

> 1901 Pennsylvania Avenue, NW, Suite 901

> Washington, DC 20006

> 202 223-4000

> www.center4policy.org