Fw: Silicone Implants are Back With FDA Approval

[Guest guest]

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

From: " Kathi " <pureheart@...>

Sent: Wednesday, September 18, 2002 7:00 AM

Subject: Fw: Silicone Implants are Back With FDA Approval

> Ms. Leonard,

>

> The following is an exchange of messages regarding Silimed's webpage

> statement that their silicone gel implants would ultimately be approved.

> Also, someone associated with

> Silimed was publicly saying their implants WOULD be approved back in

> May.

>

> My question is: How did they know something no one else did?

>

> After all the women and children who have gotten sick, after all the

> adverse MedWatch reports, after all the complications warned about by

> the FDA itself, after all the

> complications reported by the manufacturer's, HOW CAN SILICONE GEL

> BREAST IMPLANTS BE APPROVED?

>

> Who is willing to take a stand? . .. Not the FDA who has approved a

> device which carries serious warnings on their own website . .. Not the

> manufacturer's who never have to

> look the women or children in the eye when they become ill . . . Not the

> doctors who deny implants can cause the health problems those of us who

> have been there, done that,

> KNOW they can cause (After all they are FDA approved now, aren't they?)

> . . . Not the media who treat breast implants as a fashion statement . .

> .

>

> I guess that leaves the women who fall hook, line and sinker for the

> idea that they will have better self-esteem with bigger boobs! . . . A

> woman has a lot of self-esteem she is as

> sick as a dog and unable to work, when she can't take care of her own

> needs, let alone those of her family!

>

> For crying out loud . . . What is it going to take to stop this

> atrocity?

>

> Please, please, please!!!!!!

>

> Rogene Schorer

>

>

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

> From: " " <dz@...>

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

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

> Sent: Friday, May 31, 2002 4:33 PM

> Subject: Re: SILIMED

>

>

> > Dear ,

> >

> > It seems to me that an implant company can't legally say that their

> product

> > will be approved, even using the word " ultimately " approved. What

> will

> the

> > FDA do about that?

> >

> > 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

>

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

> > From: Rogene <saxony01@...>

> > Leonard, M. <NML@...>

> > Cc: Zuckerman <dz@...>

> > Date: Friday, May 31, 2002 4:19 PM

> > Subject: Re: SILIMED

> >

> >

> > >,

> > >

> > >Please check Silimed's webpage, specifically their Body Contour

> Implants

> at

> > >http://www.silimed.com/. Some implants they illustrate say they are

> not

> > >marketed in the U.S. . . . These don't.

> > >

> > >A quote from their webpage " The investigative studies for these four

> > devices

> > >have been submitted under an IDE and PMA for augmentation and

> > reconstruction

> > >and will ultimately result in pre-market approval by the FDA. " . . .

> > >Rerferring to " Mammary prosthetic devices from any of four

> substances:

> > >Polyurethane (exclusively by Silimed); Gel-Filled (cohesive);

> Pre-Filled

> > >Saline; Inflatable Saline "

> > >

> > >Do they know something no one else does?

> > >

> > >A -XXXXX- may be associated with Silimed . . . a Dallas

> > >company. Info was associated with his name.

> > >

> > >Rogene

> > >

> ==============================================

> In today's news:

> >

> > Silicone Implants are Back With FDA Approval

> >

> >

> > NEW YORK--(BUSINESS WIRE)--Sept. 17, 2002--On Monday, September 16,

> 2002, the

> > FDA gave approval to Silimed Corporation to begin clinical

> investigation of

> > their silicone implants for breast augmentation, reconstruction and

> revisions.

> >

> > New York City plastic surgeon, Dr. Herman, is medical director

> for one

> > of their programs. Dr. Herman says, " Silicone implants produce the

> best

> > cosmetic result and most natural feeling breasts. " Although used in

> many other

> > countries, the FDA halted use of the implants in 1991 for primary

> breast

> > augmentation when questions were raised about a possible connection

> with

> > autoimmune disease or breast cancer. Numerous studies since then have

> failed to

> > demonstrate a link with these diseases.

> >

> > This comes at an excellent time. Nothing better suggests this than the

> fact

> > that breast enlargement is now the most popular cosmetic procedure in

> the

> > country, after a decline in popularity throughout the 1990's. Last

> year, almost

> > a quarter million women nationwide opted for breast augmentation, far

> > surpassing the second most popular cosmetic surgery, liposuction,

> which was

> > performed on 180,000 patients.

> >

> > Dr. Herman states that there will be numerous sites throughout the

> United

> > States approved for the use of these implants. Each site is staffed by

> a board

> > certified plastic surgeon(s) very experienced in this type of surgery.

> The

> > results will be carefully monitored by the FDA.

> >

> > For further information, contact Diane Terman Public Relations at

> (212)

> > 744-6055.

> >

> > CONTACT:

> >

> > Diane Terman Public Relations

> >

> > Diane Terman, 212/744-6055

> >

> > DTAPublicity@...

> >

> > SOURCE: Silimed Corporation

> >

> > Today's News On The Net - Business Wire's full file on the Internet

> > with Hyperlinks to your home

> page. URL:

> > http://www.businesswire.com

> >

> > 09/17/2002 11:08 EASTERN

> >

> >

>