Silicone Gel Breast Implants: Secret Industry Studies

[Guest guest]

This document has been around for a while . . . I'm

sorry I don't have a date for it . . . Still, it's

interesting! - Rogene

========================================

Silicone Gel Breast Implants: Secret Industry Studies

Health Letter has reported the health risks associated

with the silicone gel breast prosthesis, implanted in

130,000 American women each year, in previous issues.

These complications include inflammation and scarring

of the breast and surrounding tissues, swollen lymph

glands draining the breast, and leakage and migration

of the silicone gel leading to allergic reactions

elsewhere in the body. Long-term hazards include the

development of immune diseases such as scleroderma,

with the development of thickened skin and internal

organ damage, or chronic arthritis, with stiff, aching

joints which may eventually become deformed. Finally,

silicone gel has been shown to cause a highly lethal

soft tissue cancer in laboratory animals, and the Food

and Drug Administrations (FDA) own staff felt that

there is considerable reason to suspect that silicone

can [cause cancer in humans].

The Dow Corning Corporation, the major manufacturer of

silicone gel, has amassed 30 years worth of research

on the biosafety of implanted materials, including

silicone and silicone gel. At an FDA hearing on

January 26, 1989, a company representative stated that

Dow Corning had submitted information to the FDA that

included, among other items, a summary list of 750

biosafety studies conducted by or on behalf of Dow

Corning; pooled reports on 39 toxicology studies; and

a final report on the two-year Industrial Biotest Labs

study conducted from 1976 to 1978 [a highly disputed

study which demonstrated that silicone gel produced

malignant tumors of the lymphatic system].

On January 27, the Public Citizen Health Research

Group requested access to all of the information

comprising Dow Cornings biosafety research, under the

Freedom of Information Act. When the FDA did not

respond within the 10 working days allowed, on

February 14, the Public Citizen Health Research Group

and the Public Citizen Litigation Group brought suit

against the agency in the United States District Court

for the District of Columbia and, subsequently, filed

a motion for a temporary restraining order to prevent

the FDA from returning some of these documents to Dow.

The Dow Corning Corporation has intervened in the

case, and is co-defendant (with the FDA) and the

defendants have until June 1 to file their motion for

summary judgment, that is, to demonstrate that there

is no dispute on matters of fact relevant to the suit.

We are prepared to argue this point, and to ask

questions of both the FDA and Dow Corning about these

documents.

[Guest guest]

Wow, great info. I have been sitting at the computer for 3 hours now!

I'm so excited to be learning this stuff and wish everyone strength and

wellness!

>

> This document has been around for a while . . . I'm

> sorry I don't have a date for it . . . Still, it's

> interesting! - Rogene

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

>

> Silicone Gel Breast Implants: Secret Industry Studies

>

> Health Letter has reported the health risks associated

> with the silicone gel breast prosthesis, implanted in

> 130,000 American women each year, in previous issues.

> These complications include inflammation and scarring

> of the breast and surrounding tissues, swollen lymph

> glands draining the breast, and leakage and migration

> of the silicone gel leading to allergic reactions

> elsewhere in the body. Long-term hazards include the

> development of immune diseases such as scleroderma,

> with the development of thickened skin and internal

> organ damage, or chronic arthritis, with stiff, aching

> joints which may eventually become deformed. Finally,

> silicone gel has been shown to cause a highly lethal

> soft tissue cancer in laboratory animals, and the Food

> and Drug Administrations (FDA) own staff felt that

> there is considerable reason to suspect that silicone

> can [cause cancer in humans].

>

> The Dow Corning Corporation, the major manufacturer of

> silicone gel, has amassed 30 years worth of research

> on the biosafety of implanted materials, including

> silicone and silicone gel. At an FDA hearing on

> January 26, 1989, a company representative stated that

> Dow Corning had submitted information to the FDA that

> included, among other items, a summary list of 750

> biosafety studies conducted by or on behalf of Dow

> Corning; pooled reports on 39 toxicology studies; and

> a final report on the two-year Industrial Biotest Labs

> study conducted from 1976 to 1978 [a highly disputed

> study which demonstrated that silicone gel produced

> malignant tumors of the lymphatic system].

>

> On January 27, the Public Citizen Health Research

> Group requested access to all of the information

> comprising Dow Cornings biosafety research, under the

> Freedom of Information Act. When the FDA did not

> respond within the 10 working days allowed, on

> February 14, the Public Citizen Health Research Group

> and the Public Citizen Litigation Group brought suit

> against the agency in the United States District Court

> for the District of Columbia and, subsequently, filed

> a motion for a temporary restraining order to prevent

> the FDA from returning some of these documents to Dow.

>

>

> The Dow Corning Corporation has intervened in the

> case, and is co-defendant (with the FDA) and the

> defendants have until June 1 to file their motion for

> summary judgment, that is, to demonstrate that there

> is no dispute on matters of fact relevant to the suit.

> We are prepared to argue this point, and to ask

> questions of both the FDA and Dow Corning about these

> documents.

>