According to Inamed, Silicone is safe!

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From Inamed site Breast Implants

What is Silicone? H A T I I L I C O N E

CAUTION: Silicone-Filled breast implants are limited

distribution

devices, and are only available by or on the order of

a licensed physician as part of a McGhan Medical

Clinical Study.

The purpose of this brochure is to provide answers to

some of your

questions about silicones and breast implants, and to

provide an

overview of silicones, their common uses, and why they

are chosen by medical professionals. The reference

numbers throughout the text indicate the sources of

information discussed in this brochure.

Please refer to the " Reference " section for more

information. As with any medical device or drug, the

risk of possible adverse effects must always be

weighed against the ability to provide benefits. If

you have any questions, please be sure to ask your

physician. Please note, this brochure is not meant to

supplement or replace product labeling or medical

advice regarding risks and benefits associated with

implantable devices.

INTRODUCTION WHAT IS SILICONE?

Silicones are a family of chemical compounds. They are

made from

silicon, a naturally occurring element found in sand,

quartz, and

rock. Next to oxygen, silicon is the most common

element in the

earth's crust, and becomes silicone when it is

combined with oxygen, carbon, and hydrogen. Depending

on the arrangement of the molecules, silicones can be

manufactured in a variety of forms, including oils,

gels, and solids.1

CONSUMER AND MEDICAL PRODUCTS

Silicones have been part of the consumer industry for

over 50 years. Because they can be manufactured in

various ways, silicones appear in a wide variety of

products that most of us use everyday. Hairsprays,

suntan lotions, and moisturizing creams are just some

of the consumer products that contain one form of

silicone called dimethicone. The applications of

silicone, whether used as an oil, gel, or solid, are

equally extensive in the medical field. For example,

the lubricating qualities of silicones make them ideal

for coating surgical needles and suture thread, as

well as the inside of syringes and bottles used for

the storage of blood and intravenous medicines.

Protective silicone coatings have also been used in

pacemakers and heart valves. Other medical devices

utilizing silicones include: artificial joints,

catheters, drainage systems, facial implants, tissue

expanders, and breast implants. Silicone products have

been shown to be biocompatible, reliable, flexible,

and easy to sterilize, making them an ideal choice for

both implantable and non-implantable medical devices.

SAFETY ISSUES

Safety issues concerning the use of silicone in

medical devices have primarily focused on the possible

link between breast implants (both saline-filled and

gel-filled) and certain illnesses, including breast

cancer and connective tissue disorders (also referred

to as autoimmune diseases such as lupus, scleroderma,

and rheumatoid arthritis). Silicone materials have

been tested extensively in laboratory studies, as well

as clinical studies (those that study human health).

Of the one to two million women who have received

breast implants, much scientific evidence has already

been gathered. The following is a summary of current

published scientific information concerning silicone

breast implants, breast cancer, and connective tissue

disorders (CTDs).

SILICONE BREAST IMPLANTS AND BREAST CANCER

Breast cancer occurs in tissues dense with ducts and

glands, and may spread throughout the body. About one

in every eight women in North America develops breast

cancer in her lifetime.2 Because of the safety issues

surrounding silicone in medical devices and the

incidence rate of breast cancer in the human

population, questions concerning increased risks of

developing breast cancer for women with breast

implants have been raised. As the following clinical

studies indicate, the likelihood of developing breast

cancer does not seem to increase with the use of

silicone breast implants.

A 1986 University of Southern California study

published in Plastic and Reconstructive Surgery

investigated over 3,000 women in the Los Angeles area

who received silicone breast implants between 1959 and

1980. Results found no increased risk of breast

cancer following breast implant surgery compared to

standard incidence ratios.3 A 1992 five year update of

this study followed the same group and confirmed the

original findings.4

A 1992 University of Calgary study published in the

New England

Journal of Medicine investigated over 11,000 women in

Alberta, Canada who received silicone breast implants

between 1973 and 1986. This study, " did not find an

increased risk of cancer among women who had received

breast implants, although the length of follow-up, the

completeness of follow-up, and the size of the cohort

would have allowed the detection of such a risk. " 5

A 1996 Georgia, New Jersey, and Washington study

published in Plastic and Reconstructive Surgery,

investigated over 2,000 women with breast implants.

The results of this study are consistent with those of

the Los Angeles and Alberta studies, finding no

association between silicone breast implants and

breast cancer.6

A 2000 brochure published by the Institute of

Medicine, Information for Women About the Safety of

Silicone Breast Implants reports " Evidence clearly

shows that silicone breast implants do not cause

breast cancer or the recurrence of breast cancer. In

fact, some studies suggest that women with breast

implants have fewer new or recurring cancers. " 14

SILICONE BREAST IMPLANTS AND BREAST CANCER DETECTION

Most studies using standard mammography have shown no

difference in the average time to detect breast cancer

between women with and

without breast implants, nor have they shown a

difference in the stage of disease detected. However,

because implants may interfere with standard

mammography by obscuring some underlying tissue and/or

by compressing overlying tissue, you should inform

your radiologist about your implants and request

diagnostic mammography. Specifically, your radiologist

should be experienced with current mammographic

displacement techniques (such as the Eklund technique)

for imaging the breast tissue around the implants and

should provide you with multiple mammographic views.

Diagnostic mammography may facilitate early diagnosis

of small masses that may be difficult to see with

standard mammography.3

SILICONE BREAST IMPLANTS AND CONNECTIVE TISSUE

DISORDERS

Connective tissue disorders (CTDs) are described as a

group of

generalized disorders affecting the connective tissues

(i.e., fat, bone, and mucous). It has been theorized

that silicone breast implants may increase the risk of

developing a CTD. As the following clinical studies

indicate, actual statistical information has provided

no significant evidence that silicone breast implants

greatly increase the risk of developing CTDs.

A 1993 University of Texas, Houston study published in

the ls of Plastic Surgery investigated 603 women

undergoing reconstructive breast surgery between 1986

and 1992. In this study 250 women had breast

reconstruction with silicone gel-filled breast

implants and 353 women had breast reconstruction

utilizing their own tissue. Results of this

preliminary report found that " the incidence of

autoimmune diseases in mastectomy patients receiving

silicone gel implants is not different than in

patients who had reconstruction with autogenous

[patient's own] tissue. " 7

A 1994 Mayo Clinic study published in the New England

Journal of

Medicine compared 749 women who had breast implant

surgery between

1964 and 1991, with 1,498 women who did not have

breast implant

surgery. Study results showed " no association between

breast implants and the connective tissue diseases and

other disorders that were studied. " 8

A 1995 Harvard/Brigham's Hospital study published in

the New England

Journal of Medicine analyzed 14 years of follow-up

data from the

Nurses Health Study Cohort. This resulted in the

review of over 87,000 women, with and without breast

implants. Results found no " association between

silicone breast implants and connective tissue

diseases. " 9

A 1994 ish study published in Plastic and

Reconstructive Surgery compared 317 women with

silicone-filled breast implants over a 10 period with

women who did not have breast implants. The average

follow-up time was 68 months. This study concluded,

" no differences were found in the symptoms or physical

signs of connective tissue diseases between the study

patients and their controls. This study has failed to

find any case for a link between silicone gel-filled

breast implants and connective tissue diseases. " 10

A 1996 Canadian study published in The Journal of

Rheumatology was a retrospective study in Alberta that

recruited 1,576 women including 1,112 who had received

silicone breast implants between 1978 to 10 1986.

Post-surgical diagnoses of the principal targeted

conditions of rheumatoid arthritis, systemic lupus

erythematosus, scleroderma and Sjögren's syndrome did

not indicate an increased incidence of typical or

atypical CTD. " The results of this study do not

support the hypothesis that silicone gel-filled

implants induce or promote CTD. " 11

A 2000 brochure published by the Institute of

Medicine, Information for Women About the Safety of

Silicone Breast Implants states " there is no evidence

that silicone breast implants contribute to an

increase in autoimmune (connective tissue) diseases. A

review of 17 separate studies of the occurrence of

connective tissue disease in the population was

remarkable for the consistent finding of no elevated

risk or no indication of an association of implants

with disease. Evidence suggests that such diseases are

no more common in women with breast implants than in

women without them. " 14

A published statement prepared by the American College

of Rheumatology (ACR) - a task force of plastic

surgeons, rheumatologist specialists, and the American

Medical Association - advises that while a theoretical

risk for CTDs might exist, especially for a patient

with a CTD, there is " no reason to discourage women

from considering breast [implant surgery] on the basis

of acquiring or exacerbating a connective tissue

disorder. " 12

TESTING FOR SILICONE IN THE BODY

Recently researchers have developed tests to detect

silicone in the body. These tests have become a factor

regarding the safety issues of silicone breast

implants and the human body & #8217;s response to the

silicone found in these products. The FDA, at this

time, has not approved any of these detection tests,

and has indicated that the results of these tests

should be viewed cautiously. Further, the FDA has

indicated that " determining silicone is present in

body fluids does not indicate whether a person is

sensitive to these substances or at risk for any

specific disease...[and] the significance [of silicone

detection] would be unclear. " 13

CONCLUSION

A number of clinical studies have indicated that there

is no conclusive scientific evidence that silicone

materials in breast implants greatly increase the risk

of developing breast cancer or CTDs. We hope this

brochure has given you a better understanding of the

issues surrounding silicones, especially silicone

breast implants. If you have any further questions

about silicones and breast implants, ask your

physician about the following brochures: " Breast

Implant Information Package " provided by the FDA

(1-888-INFO-FDA). " Making an Informed Decision:

Saline-Filled Breast Implant Surgery - provided by

INAMED Aesthetics (800-624-4261). " Breast

Augmentation: A Woman's Choice " provided by INAMED

Aesthetics

(800-624-4261). " Choices in Breast Reconstruction: A

Guide to Breast Implants and Surgical Options "

provided by INAMED Aesthetics (800-624-4261).