Fw: Q and A regarding implant materials

[Guest guest]

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

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

Sent: Monday, July 22, 2002 4:22 PM

Subject: Q and A regarding implant materials

> Thank you Rogene for this !

>

> Q & A regarding implant materials . . .

>

> Rogene

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

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

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

> " 'Rogene' " <saxony01@...>

> Cc: " CDRH Small Manu. Assistance " <DSMA@...>

> Sent: Monday, July 22, 2002 12:26 PM

> Subject: RE: Implant materials

>

>

> > This is in response to your email to the Food and Drug Administration

> (FDA),

> > regarding breast implants and platinum.

> >

> > Platinum is used as a catalyst in silicone gel-filled implants in the

> cross

> > linking process of both the shell and gel filler for some

> manufacturers.

> >

> > While there are analytical methods that can detect low levels of

> platinum,

> > especially in urine, there is no FDA-approved test for

> measuring/detecting

> > platinum. Furthermore, some results using the analytical methods

> indicate

> > that the platinum levels in urine of women with breast implants do not

>

> > exceed levels found in urine of women with no know exposure to

> platinum.

> >

> > At present, there is insufficient evidence that platinum in breast

> implants

> > presents a defined health hazard. However, FDA will continue to

> evaluate

> > the results of new scientific and clinical studies to determine if a

> change

> > in this view is justified. Therefore, while the FDA believes that the

>

> issue

> > warrants watchful waiting, we believe it is premature to disseminate

> > information to manufacturers, physicians, and/or consumers on this

> issue

> at

> > this time.

> >

> > I hope the information I've provided is helpful.

> >

> > 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: Rogene [mailto:saxony01@...]

> > Sent: Thursday, July 18, 2002 4:17 PM

> > Leonard, M.

> > Subject: Re: Implant materials

> >

> >

> > Ms. Leonard,

> >

> > Thank you.

> >

> > Isn't platinum highly toxic?

> >

> > What level of platinum does the FDA considered harmful to a human?

> >

> > The tests of some implant women are showing alarmingly high levels of

> > platinum.

> >

> > Rogene Schorer

> >

> >

> >

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

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

> > " 'Rogene' " <saxony01@...>

> > Cc: " CDRH Small Manu. Assistance " <DSMA@...>

> > Sent: Thursday, July 18, 2002 1:01 PM

> > Subject: RE: Implant materials

> >

> >

> > > This is in response to your email to the Food and Drug

> Administration

> > (FDA),

> > > regarding a general list of breast implant ingredients.

> > >

> > > The following is what is in a silicone or saline-filled breast

> implant

> > > shell:

> > >

> > > 1. 80% highly cured, high molecular weight silicones

> > > 2. 20% finely powered silica

> > > 3. catalyst: small amounts (50-100 parts per million) of a tin or

> > platinum

> > > 4. impurities:

> > >

> > > - small amounts of (1-500 parts per million) of various smaller

> > > silicones

> > > - trace amounts of (<5 parts per million) of volatile (readily

> > > evaporating) materials like xylene and other organic compounds

> > (impurities_

> > > - trace amounts (<5 parts per million) of metals (impurities)

> > >

> > > I hope the information I've provided is helpful.

> > >

> > > 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: Rogene [mailto:saxony01@...]

> > > Sent: Tuesday, July 16, 2002 10:11 AM

> > > Leonard

> > > Subject: Implant materials

> > >

> > >

> > > Dear Ms. Leonard,

> > >

> > > Would you send me a document number or an URL for the FDA's list of

> > silicone

> > > gel implant ingredients including shell material?

> > >

> > > Thanks,

> > >

> > > Rogene Schorer

>

>

>