Re: OTHER PEOPLE WITH SYPTOMS

May 3, 2005

Title: Less maligned, but cut from the same cloth, other silicone

implants also have adverse effects. (Medical News & Perspectives)

Authors: Randall, Teri

Citation: JAMA, The Journal of the American Medical Association,

July1,

1992 v268 n1 p12(2)

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

Abstract: The controversy over the health aspects of silicone breast

implants has alerted researchers to possible side effects of other

polymers used in medicine. These range from artificial lenses in the

eye

to artificial joints, pacemakers and catheters. Millions of people

have

received silicone implants, but the long-term safety of the devices

has

never been studied. Doctors knew that the body produces a fibrous

capsule around the implant, and they thought this capsule would

protect

the body. But researchers have found silicone particles in the

tissue

surrounding the implant, and even in lymph nodes near the implant.

The

body produces an immune response to the silicone particles, which

could

damage joints. Many surgeons say the body produces an immune

response to

any foreign object placed in the body, but the response is usually

benign. If use of these materials was restricted, orthopedic surgery

would cease to exist.

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

THE CURRENT controversy over silicone runs deeper than the problem

of

breast implants that rupture or bleed through their silicone shells

(JAMA. 1992;267:2439-2442). At the heart of the controversy is the

body's reaction to the polymer that for three decades has been

championed as inert, noncytotoxic, and biocompatible.

As a class of materials, silicone polymers are considered nontoxic

in

both animal and tissue culture studies. Millions of patients

worldwide

have received silicone implants, yet many researchers say that the

long-term biocompatibility of silicone has never been thoroughly

established scientifically. Only recently has the Food and Drug

Administration begun to require the manufacturers of silicone

breast,

penile, and testicular implants to submit data from rigorous trials

(JAMA. 1992;267:2578-2579).

However these scientific questions are resolved, the result is

likely to

influence the fate not only of breast implants, but also the entire

gamut of implants and devices that contain silicone.

Since the mid-1960s, medical device manufacturers have molded this

versatile material into a vast array of medical apparatuses. From

eye

lenses to bunions and almost every joint and private part in

between, a

silicone-based device has been made to repair what disease or time

has

taken away, or to augment what nature has never given.

These devices include silicone-based testicular implants (resembling

breast implants in fabrication) and penile prostheses of the

semirigid

rod and inflatable varieties. There also are implants for the

fingers,

thumbs, and wrists for patients with rheumatoid arthritis.

In addition, elbows, shoulders, temporomandibular joints (TMJs), and

middle ears now are fitted with silicone implants. And pacemaker

wires,

silk sutures, needles, and catheters are coated with silicone.

Some men now are seeking solid silicone implants for their calves

and

chests to achieve a more muscular look. The implants' early

recipients

were bodybuilders in Beverly Hills, Calif, but the procedure is

gaining

popularity throughout the country, plastic and reconstructive

surgeons

report.

For patients born with pectus excavatum, or funnel breast, plastic

surgeons place a solid silicone implant shaped like a breast implant

into the chest but with the rounded portion facing inward.

Isolating Self From Nonself

At least on the macroscopic level, the body appears to tolerate

these

foreign objects. Mammals and invertebrates alike, when implanted

with a

large, inert object, construct a natural barrier made of fibrous

scar

tissue around that object.

Once formed, this fibrous capsule separates self from nonself and,

from

the surgeon's point of view, provides the additional benefit of

helping

to stabilize the implant in the body. This reaction is not unique

tosilicone, but is observed with titanium, cement, plastic,

polyethylene, and many other materials.

For almost two decades, however, the response at the microscopic

level

has been troubling researchers from disciplines as diverse as hand

surgery, urology, and oral surgery, as well as plastic and

reconstructive surgery.

Microscopic examination of biopsy specimens reveals that silicone

implants shed microparticles of silicone (<100 [mu] m) into the

surrounding tissue. These particles are seen by the body as foreign,

and

they elicit an immune reaction that involves the local formation of

foreign-body granulomas by multinucleated giant cells.

X-ray microanalysis and electron microscopy have revealed this

immune

response in the tissue surrounding breast implants (Plast Reconstr

Surg.

1990;85: 38-41), urinary sphincteric implants and penile prostheses

(J

Urol. 1991;146:319-322), TMJ implants (Oral Surg Oral Med Oral

Pathol.

1985;59:449-452), and implants of the hand and wrist (J Hand Surg

Am.

1986;11:624-638), to name a few.

Of considerable concern to some but not all researchers is the

discovery

of silicone granulomas in the lymph nodes near these same implants

(Semin Arthritis Rheum. 1987;17:112-118; J Urol. 1991;146:319-322;

Oral

Surg Oral Med Oral Pathol. 1985;59:449-452; and J Hand Surg Am.

1988;13:411-412). Some of these investigators and others have also

reported lymphadenopathy and lymphadenitis after implantation with

silicone prostheses.

Around thumb and wrist silicone implants in humans, the local

inflammatory response is so aggressive, a recent study shows, that

it

lyses nearby bone and can result in pathologic fractures (J Hand

Surg

Am. 1991;16:835-843).

Recently, urologists at Mayo Clinic, Rochester, Minn, took biopsy

specimens from the fibrous sheath surrounding the penile prostheses

or

urinary sphincteric implants of 25 patients who were undergoing

repair

or replacement of their implants. They detected silicone particles,

and

usually the presence of foreign-body granulomas, in 72% of the

patients

(Figure).

The prostheses had been in place for 2 months to 5 years, but a

majority

had been in place less than 2 years. The study included most types

and

brands of prostheses (J Urol. 1991;146:319-322).

Granulomas in Lymph Nodes

These researchers also took biopsy specimens from clinically

enlarged

inguinal nodes in three patients and detected silicone particles and

foreign-body granulomas in all three. They also examined tissue from

the

periaortic node in one patient and found silicone particles.

Because biopsy specimens were taken from only four lymph nodes, the

study did not determine the overall rate of migration of silicone

particles to the lymph nodes. The researchers also did not determine

the

degree that silicone is disseminated throughout the lymph system,

because they did not examine tissue beyond the draining lymph node.

In their discussion, the authors suggest that " the presence of

silicone

in lymph nodes of itself is not important. " However, they

acknowledge

there is some controversy in the hand surgery literature as to

whether

there is increased incidence of malignant lymphoma in patients with

joint replacements and lymphadenopathy. A number of cases of

malignant

lymphoma have been reported in these patients who have silicone in

their

enlarged lymph nodes (Hand. 1982;14:326; and Diagn Histopathol.

1982;5:133).

M. Barrett, MD, professor and chair of the Department of

Urology

at the Mayo Clinic, and the study's first author, responds that " our

bodies come into contact with all kinds of particles over the years.

These undergo phagocytosis, granulomas are formed, some of the

particles

are broken down in the cells, and some of them are not. But this

doesn't

necessarily imply that this is a deleterious reaction in the

patient. "

The study concludes that there is no evidence that particle shedding

and

subsequent migration have either short-term or intermediate-term

deleterious effects on the host. Long-term assessment (20 years or

more)

is needed to ultimately determine the inherent risks, the authors

conclude.

In 1985, a group of oral surgeons observed a similar immune response

in

the parotid lymph node and tissue surrounding the TMJs of eight

patients

who received silicone disk implants (Oral Surg Oral Med Oral Pathol.

1985;59:449-452).

The authors, lin Dolwick, DMD, PhD, from the University of

Florida

College of Dentistry, Gainesville, and Aufdemorte, DDS, from

the

University of Texas Health Science Center, San , express

considerably more concern over the formation of foreign-body

granulomas

than the Mayo group.

The authors state, " it is most probable that associated pathologic

changes with resultant dysfunction and morbidity may coexist " with

the

foreign-body type of granulomatous inflammation. They also cite

reports

from the hand surgery literature of lymphadenopathy and inflammation

mimicking rheumatoid synovitis in sites adjacent to silicone implant

material.

" Thus, " they write, " the contention by some that the foreign-body

giant

cell response to this implant material is insignificant is not a

tenable

thesis in our view. Consequently, any material associated with such

a

response should receive full evaluation and study, particularly with

reference to the risk-benefits ratio attendant with its use. "

The Bigger Context

These oral surgeons stress that these cases must be viewed in the

overall context of the many TMJ silicone implants that have been

implanted during past years with no untoward effects. They add that,

although " silicone may not be a totally inert material and its

biomechanical properties are not ideal for use in the TMJ, " there

is, in

fact, " no ideal material available. "

It has been pointed out by many orthopedic surgeons that not only

silicone but all implant materials produce foreign-body giant cell

reactions. This includes stainless steel, titanium, ceramic,

polyethylene, Teflon, polypropylene, methyl methacrylate, and many

other

materials.

Alfred Swanson, MD, Grand Rapids, Mich, inventor of the silicone

finger

and wrist implants and an outspoken proponent of orthopedic implant

surgery, has written that " the foreign-body giant cell reaction is

among

the most benign of inflammatory reactions that human tissues can

mount

against an endless list of foreign materials. "

" It is specious to conclude, " he adds, " that any material that

provokes

a foreign-body giant cell reaction must, per se, be abandoned as an

implant material. If such views prevailed, orthopedic implant

surgery

would come to a precipitous halt [JAMA. 1983;250:1195-1198]. "

~~~~~~~~~

www.BreastImplantAwareness.org

May 3, 2005

Oh yes....

It boggles my mind that in spite of the suffering that occurs with the

use of silicone in other implants, the medical field is determined to

use this in the body. Perhaps they believe that admitting the harm it

does would ruin whole segments of medical specialties?

We have a folder on studies in our files section. Many of these

studies have shown indications that silicone implants of any kind

create a foreign body reaction that should be alarming. I know, for

instance, there was a study that discussed a little boy that had

gotten testicular implants and developed lupus; there is a study that

shows bone degeneration in people who have joint replacements; the

disgusting Norplant contraceptive device has had its own legal

entanglements due to the side effects (See

http://www.contracept.info/news/norplant0899.html

and there are the shunts, cheek implants, chin implants, calf

implants, penis implants, you name it, I don't doubt for a second that

many people out there who have gotten these things are suffering. 7

years ago when I first got involved in this issue, I remember talking

to a support group leader who had just gotten off the phone with a man

who had a penile implant, and was sicker than sick, like us. But where

are the guys going to go for help? You think they are going to form

support groups for men harmed by penile implants? You can hardly even

get them to go to the doctor, let alone form a support group! So, they

suffer in silence. The numbers may be too small to " make a story out

of it. " But women are getting breast implants by the busload! Maybe

we are the canary in the mine? Maybe it will be our loud voices that

bring the awareness that this issue needs. In my opinion, silicone is

not SAFE in the body, much as the medical field wants us to believe

it. Maybe they weigh the pros and cons, and decide that the pros

outweigh the suffering. What do they care? It isn't their body that

is suffering...but they get to practice their craft of body mechanics

regardless.

My own mother got knee replacements. I was very nervous about it, and

tried to talk her out of it when my dad told me they were using

titanium and plastic. That " plastic " is no doubt silicone. And guess

what? My mom went through with it and has developed autoimmune

disease of unknown variety. She is on plaquenil and God knows what

else--lots of drugs. She has fibromyalgia. She's got her new knees

alright....and a host of medical problems along with them.

Other people with symptoms are out there...there is no question in my

mind. But I think there are ALOT of people burying their heads in the

sand about it. Including the FDA, those most responsible for the

safety of the people of America from junk like this.

Patty

> I HAVE A QUESTION HAS ANYONE EVER LOOKED INTO IF ANYONE ELSE WITH

OTHER

> SILICONE IMPLANTS SUCH AS CHIN IMPLANTS OR PENIS IMPLANTS OR HEART

STINTS EVER BEEN

> STUDIED TO SEE IF THEY HAVE SIMILAR PROBLEMS I HAVE HAD SILICONE

IMPLANTS

> SINCE DEC 2003 AFTER BREAST CANCER NAD HAVE BEEN SICK SINCE MRI'S

(FOR AS GOOD AS

> THEY MIGHT BE) SHOW NO LEAK MAYO CLINIC EVEN DENIED TO LOOK INTO

SILICONE

> ALLERGIES BECAUSE THEY WERE IN THE STUDY BUT I WAS JUST WONDERING IF

ANY NORMAL

> PEOPLE HAVE THESE PROBLEMS NO ONE ONCE TO THINK WE HAVE THESE

SYPTOMS FROM

> SILICONE!!!!

May 4, 2005

> I HAVE A QUESTION HAS ANYONE EVER LOOKED INTO IF ANYONE ELSE WITH

OTHER

> SILICONE IMPLANTS SUCH AS CHIN IMPLANTS OR PENIS IMPLANTS OR HEART

STINTS EVER BEEN

> STUDIED TO SEE IF THEY HAVE SIMILAR PROBLEMS I HAVE HAD SILICONE

IMPLANTS

> SINCE DEC 2003 AFTER BREAST CANCER NAD HAVE BEEN SICK SINCE MRI'S

(FOR AS GOOD AS

> THEY MIGHT BE) SHOW NO LEAK MAYO CLINIC EVEN DENIED TO LOOK INTO

SILICONE

> ALLERGIES BECAUSE THEY WERE IN THE STUDY BUT I WAS JUST WONDERING

IF ANY NORMAL

> PEOPLE HAVE THESE PROBLEMS NO ONE ONCE TO THINK WE HAVE THESE

SYPTOMS FROM

> SILICONE!!!!

I had cheek implants for 9 years and had them taken out 13 months

ago by Dr. Kolb. The severe symptoms started with burning pain in

my face and I immediately thought of the implants. I developed all

of the same symptoms that women are complaining about with breast

implants. I had no idea that cheek implants weren't safe. In fact

when I had them put in, I asked the p.s. about the difference

between breast implants and cheek implants because I had heard about

the dangers of breast implants. He assured me that solid implants

don't leak and are perfectly safe. Then when I got sick, I had to

become a super sleuth because I went to several doctors who said

there was no link between my symptoms and my cheek implants even

with the severe pain around my cheeks. They were baffled as to what

was wrong with me. When I found the info on the internet, there

wasn't much about cheek implants, but I just inserted the word cheek

everytime women talked about their breast implants and realized that

I had the exact same illness. Dr. Kolb took them out over a year

ago, and while I am a lot better (I thought I was going to die) I

still have symptoms that scare me like tremors, heart racing,

chronic pain in throat, pain under ribs, burning tongue, etc. So, I

guess what I am saying is that it isn't relevant whether someone has

a rupture or not. Just having this in your body will make you sick,

there is no doubt in my mind. A lot of people are buying into the

idea put out by the manufacturers and the doctors that there is a

small chance of rupture or complication and maybe those people got

sick but I won't. I was 23 years old, great genes, extremely fit

and I developed a lot of the classic symptoms. In my opinion, if

you leave an implant in your body, you will eventually develop

debilitating symptoms. And it's not like a cold or the flu or a

headache; these symptoms are constant, painful, all encompassing

scary sh--. It may take years for someone to get very ill, Dr. Kolb

believes between 8-10 years, but if you pay attention, you will

notice some subtle things almost immediately. But because I thought

cheek implants were perfectly safe, I didn't attribute these things

to the implants. Things like hair loss, a little less energy,

intolerance to alcohol, some memory problems, skin not as clear or

supple, more headaches, etc. I would advise anyone and everyone to

never put anything into your body that isn't natural.

Ali

May 4, 2005

This in incredible. I am so sorry you have suffered so from your

cheek implants. We do not hear from people harmed by other silicone

implants that often, so THANK YOU for speaking up and letting us

know of your pain.

I pray you feel as good as before someday. I have no doubt Dr. Kolb

is helping you in a wonderful way. As you may have read from my

story, it took me 4 years to get rid of all of my symptoms...be

patient and stay ever hopeful of a better tomorrow, while enjoying

today to the fullest. There is always hope.

Love,

Patty

> > I HAVE A QUESTION HAS ANYONE EVER LOOKED INTO IF ANYONE ELSE

WITH

> OTHER

> > SILICONE IMPLANTS SUCH AS CHIN IMPLANTS OR PENIS IMPLANTS OR

HEART

> STINTS EVER BEEN

> > STUDIED TO SEE IF THEY HAVE SIMILAR PROBLEMS I HAVE HAD SILICONE

> IMPLANTS

> > SINCE DEC 2003 AFTER BREAST CANCER NAD HAVE BEEN SICK SINCE

MRI'S

> (FOR AS GOOD AS

> > THEY MIGHT BE) SHOW NO LEAK MAYO CLINIC EVEN DENIED TO LOOK INTO

> SILICONE

> > ALLERGIES BECAUSE THEY WERE IN THE STUDY BUT I WAS JUST

WONDERING

> IF ANY NORMAL

> > PEOPLE HAVE THESE PROBLEMS NO ONE ONCE TO THINK WE HAVE THESE

> SYPTOMS FROM

> > SILICONE!!!!

>

> I had cheek implants for 9 years and had them taken out 13 months

> ago by Dr. Kolb. The severe symptoms started with burning pain in

> my face and I immediately thought of the implants. I developed

all

> of the same symptoms that women are complaining about with breast

> implants. I had no idea that cheek implants weren't safe. In

fact

> when I had them put in, I asked the p.s. about the difference

> between breast implants and cheek implants because I had heard

about

> the dangers of breast implants. He assured me that solid implants

> don't leak and are perfectly safe. Then when I got sick, I had to

> become a super sleuth because I went to several doctors who said

> there was no link between my symptoms and my cheek implants even

> with the severe pain around my cheeks. They were baffled as to

what

> was wrong with me. When I found the info on the internet, there

> wasn't much about cheek implants, but I just inserted the word

cheek

> everytime women talked about their breast implants and realized

that

> I had the exact same illness. Dr. Kolb took them out over a year

> ago, and while I am a lot better (I thought I was going to die) I

> still have symptoms that scare me like tremors, heart racing,

> chronic pain in throat, pain under ribs, burning tongue, etc. So,

I

> guess what I am saying is that it isn't relevant whether someone

has

> a rupture or not. Just having this in your body will make you

sick,

> there is no doubt in my mind. A lot of people are buying into the

> idea put out by the manufacturers and the doctors that there is a

> small chance of rupture or complication and maybe those people got

> sick but I won't. I was 23 years old, great genes, extremely fit

> and I developed a lot of the classic symptoms. In my opinion, if

> you leave an implant in your body, you will eventually develop

> debilitating symptoms. And it's not like a cold or the flu or a

> headache; these symptoms are constant, painful, all encompassing

> scary sh--. It may take years for someone to get very ill, Dr.

Kolb

> believes between 8-10 years, but if you pay attention, you will

> notice some subtle things almost immediately. But because I

thought

> cheek implants were perfectly safe, I didn't attribute these

things

> to the implants. Things like hair loss, a little less energy,

> intolerance to alcohol, some memory problems, skin not as clear or

> supple, more headaches, etc. I would advise anyone and everyone

to

> never put anything into your body that isn't natural.

>

> Ali

May 6, 2005

-

That is really amazing. With all the controversy out there, her

father surely has to suspect that his daughters problems could be

from the implants. How could he put his livelihood above his

daughter's health? Unbelieveable.

kathy

-- In , jaylow2100@a... wrote:

> I read an article last year about McGhan which is now a different

name, but the daughter of the CEO got the same kind of implants I

had the double lumen and the same year. She was diagnosed with MS a

few years back and she said that it was definately NOT from the

implants because she beleived her father would never do that to her.

Do you beleive it??? her father is still telling her they are safe

and she still has them in?? What people will do for greed, I think

they convince themselves they are safe because they can't bear the

thought of injuring so many people or maybe not. Maybe they don't

want to know. They have built their whole lives around making money

from them and don't want to change or admit they're wrong. What goes

around comes around.

> Love

> Judi

July 3, 2005

This is worth posting again.....Lea

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~``

Re: OTHER PEOPLE WITH SYPTOMS

>

>> I HAVE A QUESTION HAS ANYONE EVER LOOKED INTO IF ANYONE ELSE WITH

> OTHER

>> SILICONE IMPLANTS SUCH AS CHIN IMPLANTS OR PENIS IMPLANTS OR HEART

> STINTS EVER BEEN

>> STUDIED TO SEE IF THEY HAVE SIMILAR PROBLEMS I HAVE HAD SILICONE

> IMPLANTS

>> SINCE DEC 2003 AFTER BREAST CANCER NAD HAVE BEEN SICK SINCE MRI'S

> (FOR AS GOOD AS

>> THEY MIGHT BE) SHOW NO LEAK MAYO CLINIC EVEN DENIED TO LOOK INTO

> SILICONE

>> ALLERGIES BECAUSE THEY WERE IN THE STUDY BUT I WAS JUST WONDERING

> IF ANY NORMAL

>> PEOPLE HAVE THESE PROBLEMS NO ONE ONCE TO THINK WE HAVE THESE

> SYPTOMS FROM

>> SILICONE!!!!

>

> I had cheek implants for 9 years and had them taken out 13 months

> ago by Dr. Kolb. The severe symptoms started with burning pain in

> my face and I immediately thought of the implants. I developed all

> of the same symptoms that women are complaining about with breast

> implants. I had no idea that cheek implants weren't safe. In fact

> when I had them put in, I asked the p.s. about the difference

> between breast implants and cheek implants because I had heard about

> the dangers of breast implants. He assured me that solid implants

> don't leak and are perfectly safe. Then when I got sick, I had to

> become a super sleuth because I went to several doctors who said

> there was no link between my symptoms and my cheek implants even

> with the severe pain around my cheeks. They were baffled as to what

> was wrong with me. When I found the info on the internet, there

> wasn't much about cheek implants, but I just inserted the word cheek

> everytime women talked about their breast implants and realized that

> I had the exact same illness. Dr. Kolb took them out over a year

> ago, and while I am a lot better (I thought I was going to die) I

> still have symptoms that scare me like tremors, heart racing,

> chronic pain in throat, pain under ribs, burning tongue, etc. So, I

> guess what I am saying is that it isn't relevant whether someone has

> a rupture or not. Just having this in your body will make you sick,