Fw: What They Already Knew In 1993

[Guest guest]

From: " by way of ilena rose " <janmarh@...>

Sent: Friday, May 18, 2001 9:42 PM

Subject: What They Already Knew In 1993

> Ilena,

> In light of the latest studies, i thought that this little re-post would

> remind all of us what we had already known, and had taken scientists years

to

> figure out. What is it that Freud, AKA " Sigmund " said? something like:

>

> " Science sometimes overlooks the obvious. " (not a direct quote)

>

> My addition to that would be: " and some overlook it 'for profit' " .>

>

> T93-15 Cruzan

> March 22, l993 (301) 443-3285

>

> IMMUNOLOGY STUDIES ON SILICONE GEL

>

> Two recent animal studies have shown that silicone gel of the type

used

>

> in breast implants can act as an antibody adjuvant -- that is, it can

enhance

>

> the ability of the animals' immune systems to produce antibodies to an

antigen

>

> (a substance that stimulates the body to produce antibodies). These

studies

>

> in rats used a cow's blood protein, bovine albumen, as the antigen. The

>

> following can be used to answer questions.

> FDA believes that these studies help provide a scientific

understanding

>

> for the possible link between silicone gel-filled breast implants and

>

> autoimmune-like disorders. However, the studies do not 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 will be needed before the relevance of these

>

> studies to women with breast implants can be established. Some of this

>

> research is already under way.

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

Naim

>

> and his colleagues and the other by Dow Corning Corporation, a supplier of

>

> silicone gel for implants, silicone gel was blended with liquid silicone

> -MORE-

>

> Page 2, T93-15, Silicone Gel

Studies

> and a known antigen 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 adjuvant, however, it produced

a

>

> strong antibody response. The study by Dr. Naim is being published on

March

>

> 22 in the journal Immunological Investigations.

> FDA has been concerned for a long time that silicone gel might

provoke an

>

> immune response in at least some women. That is one of the reasons the

agency

>

> decided to restrict the availability of these devices. These new studies

are

>

> consistent with this concern, although they certainly do not prove the

>

> implants cause immune-related disorders.

> Based on these studies, FDA will require 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

>

> breast implants under clinical studies.

> The symptoms of the immune system disorders 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;

and

>

> unusual hair loss. Many women with or without breast implants have one or

>

> more of these symptoms from time to time. However, people who have

>

> immune-related disorders, which are relatively rare, generally experience

a

>

> combination of these and other symptoms that don't go away as they do for

>

> those without such disorders.

> The advice to women who already have the implants remains the same as

in

>

> the past. The agency recommends that any woman with implants be alert to

the

>

> symptoms of these disorders, and that she consult her doctor if the

symptoms

>

> don't subside. These complaints could be indicators of a variety of

health

> -MORE-

>

> Page 3, T93-15, Silicone Gel Studies

> problems, not just immune-related disorders. Depending on the situation,

a

>

> woman's doctor may refer her to a rheumatologist or other

> type of specialist for further evaluation.

> Questions have also been raised about whether the new studies

addressed

>

> the safety of other types of implants made with silicone. There are many

>

> different materials known as " silicone. " Most of the silicone used in a

>

> variety of implanted devices, such as shunts, catheters, artificial joints

and

>

> facial implants, consists of relatively hard silicone elastomer ( " silicone

>

> rubber " ) rather than gel. Silicone rubber was not investigated in these

>

> studies, and there is no evidence to date that it has immune system

adjuvant

>

> properties.

>

>