Fw: FDA Response RE: Scleroderma

[Guest guest]

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

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

Sent: Sunday, December 29, 2002 11:43 AM

Subject: FDA Response RE: Scleroderma

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

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

> " 'Rogene' " <saxony01@...>; " Leonard, M. "

> <NML@...>

> Cc: " sey " <fuchsmorrissey@...>; " CDRH Small Manu.

> Assistance " <DSMA@...>

> Sent: Friday, December 27, 2002 8:19 AM

> Subject: RE: Scleroderma

>

>

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

> (FDA),

> > regarding breast implants and scleroderma patients.

> >

> > According to the Office of Device Evaluation (ODE), the office

> responsible

> > for conducting scientific reviews of medical devices, and the Office

> of

> > Surveillance Biometrics (OSB), they have no knowledge of a registry.

> >

> > Currently, the on-going IDE studies are not designed to study the

> effects

> of

> > implants on offspring. The studies do capture difficulties in

> pregnancy

> and

> > breastfeeding. Any manufacturer who is submitting a Premarket

> Approval

> > (PMA) to support the safety and effectiveness of their silicone gel

> breast

> > implants will need to provide, among other things, literature

> information

> on

> > the topic of offspring.

> >

> > 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: Friday, December 20, 2002 9:09 AM

> > Leonard

> > Cc: sey

> > Subject: Scleroderma

> >

> >

> > Ms. Leonard,

> >

> > Dr. Melmed, Dallas sent me a message that one of his early explant

> patients

> > had a child with juvenile diabetes . . . He didn't make the connection

>

> then.

> >

> > I suspect there are many, many such children out there . .. But no one

>

> asks

> > if their mother had implants before her child was born . . .

> >

> > Is there any registry for scleroderma patients, especially juvenile

> > patients? A way to track back from those patients to see if their

> mothers

> > had some form of implant? Who could do it?

> >

> > Somebody, somewhere, somehow must do something soon. . . According to

> what

> I

> > hear, silicone gel implants are ready to be put back on the market. .

> .

> and

> > still, no " good studies " on the children.

> >

> > Shouldn't the manufacturer's be required to pay for a study to " prove "

>

> > implants are really safe for children?

> >

> > Rogene Schorer

>

>

>