more about health risks and implants

[Guest guest]

Two studies yield new data on breast implants.

Title: Two studies yield new data on breast implants.

Citation: FDA Consumer, June 1993 v27 n5 p3(2)

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Subjects: Breast implants_Research

Reference #: A13823464

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

Abstract: Research conducted on laboratory rats to determine

the relationship between silicone gel and

immune-related disorders did elicit an antibody

response when the gel was mixed with an antibody

adjuvant. The nature of the study does not provide

conclusive results about the relationship.

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

Full Text COPYRIGHT U.S. Department of Health and Human

Services 1993

Two recent studies of laboratory rats may help provide a

scientific rationale for the possible link between silicone

gel-filled breast implants and autoimmune-like disorders. On

the basis of these studies, FDA is requiring breast implant

manufacturers to update information about the possible

connection between the implants and immune-related disorders

in the informed consent documents for women receiving these

breast implants under clinical studies.

The animal studies do not, however, establish the connection

with certainty, particularly since they were designed to

intentionally stimulate an antibody response by mixing a

known antigen with the silicone. More research, some now

under way, is needed to determine the relevance of the

studies to women with the implants.

In the two studies--one conducted in New York state by

Naim, Ph.D., and his colleagues and the other by Dow Corning

Corporation, a supplier of silicone gel for

implants--silicone gel was blended with liquid silicone and a

known antigen (bovine albumin) and injected into the rats.

Under these test conditions, the antigen alone would not have

been expected to produce an immune response. In the presence

of silicone gel or another antibody adjuvant (a substance

that stimulates antibody production), however, it produced a

strong antibody response. Naim's study appeared in the March

22 issue of Immunological Investigations.

FDA continues to advise women with silicone gel-filled

implants to be alert to symptoms of autoimmune disorders and

consult a doctor if the symptoms do not subside. They

include:

* pain and swelling of joints

* tightness, redness or swelling of the skin

* swollen glands or lymph nodes

* unusual and unexplained fatigue

* swelling of the hands and feet

* unusual hair loss.

Many women--with or without implants--may experience such

symptoms from time to time. But people with immune-related

disorders, which are relatively rare, generally experience a

combination of these and other symptoms that don't go away.

[Guest guest]

another good repost of a post

----- Original Message ----- From: Heer

Sent: Thursday, December 13, 2001 10:09 AM

Subject: more about health risks and implants

Two studies yield new data on breast implants.

Title: Two studies yield new data on breast implants.

Citation: FDA Consumer, June 1993 v27 n5 p3(2)

-------------------------------------------------------------

Subjects: Breast implants_Research

Reference #: A13823464

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

Abstract: Research conducted on laboratory rats to determine

the relationship between silicone gel and

immune-related disorders did elicit an antibody

response when the gel was mixed with an antibody

adjuvant. The nature of the study does not provide

conclusive results about the relationship.

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

Full Text COPYRIGHT U.S. Department of Health and Human

Services 1993

Two recent studies of laboratory rats may help provide a

scientific rationale for the possible link between silicone

gel-filled breast implants and autoimmune-like disorders. On

the basis of these studies, FDA is requiring breast implant

manufacturers to update information about the possible

connection between the implants and immune-related disorders

in the informed consent documents for women receiving these

breast implants under clinical studies.

The animal studies do not, however, establish the connection

with certainty, particularly since they were designed to

intentionally stimulate an antibody response by mixing a

known antigen with the silicone. More research, some now

under way, is needed to determine the relevance of the

studies to women with the implants.

In the two studies--one conducted in New York state by

Naim, Ph.D., and his colleagues and the other by Dow Corning

Corporation, a supplier of silicone gel for

implants--silicone gel was blended with liquid silicone and a

known antigen (bovine albumin) and injected into the rats.

Under these test conditions, the antigen alone would not have

been expected to produce an immune response. In the presence

of silicone gel or another antibody adjuvant (a substance

that stimulates antibody production), however, it produced a

strong antibody response. Naim's study appeared in the March

22 issue of Immunological Investigations.

FDA continues to advise women with silicone gel-filled

implants to be alert to symptoms of autoimmune disorders and

consult a doctor if the symptoms do not subside. They

include:

* pain and swelling of joints

* tightness, redness or swelling of the skin

* swollen glands or lymph nodes

* unusual and unexplained fatigue

* swelling of the hands and feet

* unusual hair loss.

Many women--with or without implants--may experience such

symptoms from time to time. But people with immune-related

disorders, which are relatively rare, generally experience a

combination of these and other symptoms that don't go away.