1990 report . . . How little has changed! . . . Soooo Sad!

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120/DCC017001260

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

Rockville, MD 20857

BACKGROUND INFORMATION ON THE POSSIBLE HEALTH RISKS OF

SILICONE BREAST IMPLANTS

(PREPARED DECEMBER 18, 1990)

Silicone gel-filled breast implants have been used for

approximately 20 years, and at present about 2 million

women in the U.S. have them.

When the medical device law-the statute that gives the

Food and Drug Administration (FDA) the authority to

regulate products such as implants was passed in 1976.

it " grandfathered devices that were already on the

market, including breast implants. This means that the

manufacturers of those products were not required to

provide FDA with scientific evidence of safety and

effectiveness, as they are with brand-new types of

devices. That stipulation in the law is based on the

premise that, generally speaking, more is known about

the safety of a device that has been in use for some

time than about one that is newly developed. But if

questions arise over time that cast any doubt about a

" grandfathered " device's safety, the law also gives

FDA the authority to go back and require that its

manufacturer provide us with evidence to demonstrate

that it is safe and effective.

That is what FDA has chosen to do with silicone breast

implants. Although it appears that most women with

these implants do not suffer serious adverse effects,

there are enough unanswered questions about possible

risks that FDA has decided to require manufacturers to

provide scientific data demonstrating their safety.

The possible risks of silicone breast implants fall

into two basic categories: those related directly to

the breast, and those that may involve distant parts

of the body. One breast-related risk is that the

implant may make it more difficult to see

abnormalities in the breast when mammographic x-ray

examinations are done, unless special adaptations are

made in the x-ray procedure. Another is the hardening,

discomfort and pain that occur in some patients,

resulting from fibrous tissue growing around the

implant. Still another is occasional breakage of the

implant's outer envelope, causing the gel filling to

be released.

Most of these breast-related effects are relatively

easy to observe, and they are not unexpected. All

implanted devices, from artificial hip joints to heart

valves, will fail to work or will have adverse effects

in a small proportion of patients -- no type of device

placed in the body for a long period of time can be

considered perfect, and etc surgical procedure is

without risk.

With breast implants, FDA needs more information on

what percentage of patients experience these

readily-observed, breast-related effects and how

severe they are.

The possible affects of silicone breast implants on

ocher parts of the body are far more uncertain and

difficult to measure. For example, it is known that

even in the absence of obvious leaks, minute

quantities of the gel filling can migrate out of an

intact breast implant over a long period of time and

can travel throughout the body.

It is not known whether this can be harmful over the

long run or not. It has been suggested that these tiny

amounts of silicone in the body could lead some people

to develop auto-immune diseases in later years, and

some scientists have raised the question of whether

the silicone could have an effect on a developing

fetus. But at this point there is no convincing

evidence that these effects actually occur.

The long-term effect of greatest concern to most

people is the possibility of cancer. That concern was

aroused several years ago by a study of laboratory

rats conducted by the Dow Corning Corporation, a

leading manufacturer of silicone breast implants. The

study showed an excess of a particular type of cancer

called sarcoma in rats who had been implanted with

silicone gel. FDA, too, was concerned about these

results, and presented them to cancer experts within

FDA and also at the National Institutes of Health

The experts noted two reassuring facts about the

study. First, sarcomas (the type of cancer produced in

the rats) occur very rarely in humans; the vast

majority of human breast cancers are of a distinctly

different type, called carcinomas. Secondly,

laboratory rats are extraordinarily susceptible to

sarcomas caused by implanting foreign objects in their

bodies; the experts pointed out, that these animals

develop sarcomas after the implantation of a wide

variety of materials, most of them innocuous in

humans. The experts concluded (a) that the results of

the rat study are unlikely to apply to humans; (

that although a risk from silicone breast implants

cannot be completely ruled out, there are at present

no convincing animal or human studies that point to

such a risk; and © that if a cancer risk did exist

from silicone breast implants, it would be very small.

To sum it up, FDA does not believe that there is cause

for alarm at present about the safety of silicone

breast implants. But answers are needed to the

questions outlined above in order to establish once

and for all just what the risks are. That is why FDA

is going to require the manufacturers of the implants

to supply scientific evidence of their safety.

Manufacturers will have until the summer of 1991 to

submit the data.

Silicone breast implants coated with polyurethane foam

may pose certain additional hazards. FDA is

particularly concerned that the polyurethane may break

down in the body, and is conducting laboratory

research to find out whether this is the case. Based

on the results of this research, FDA will shortly

decide whether or not to allow polyurethane-coated

breast implants to stay on the market.

What should a woman who is contemplating a silicone

breast implant do? For now, the best course or action

is to discuss the situation frankly with her

physician. (It is perfectly reasonable to ask the

physician to see the informational material that comes

with the implant, which describes possible adverse

effects.) She needs to talk over the known,

breast-related risks as well as the less

well-understood, non-breast related risks described

above, and to weigh these risks against the benefits

of the procedure. That way she can make an informed

decision about whether to proceed with the implant

surgery.

If a woman who already has a silicone breast implant

is concerned about the possible risks, she too should

ask her physician's advice.

Most of the readily-observed, breast-related adverse

effects discussed above are well known to physicians,

as are the ways to treat them. As to the possibility

of effects on other parts of the body (related to the

fetus, for example, or to autoimmune disease, or

cancer), at this point these are only hypothetical

questions. In weighing the possible long-term risks of

silicone breast implants, it is important to bear

in mind--and this applies to any number of substances

we encounter in everyday life--that not being able to

completely rule out a risk does not necessarily mean

there is onfiltered

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[Note from Pam Dowd on this document: While this

document states 2 million women had implants at this

time, documents from manufacturers from 91/92

acknowledge they could not prove that figure. It was

possibly used to dilute the appearance of risks. In

their own records, they were not able to prove more

than 700,000 women had implants from 1962-1992.]