DOW called on lies told to public

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DCCO17006752

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Services

Food and Drug Administration

CERTIFIED MAIL RETURN RECEIPT REQUESTED

WARNING LETTER

December 30, 1991

Dan M. , Jr.

President

DOW Corning

5677 Airline Road

Arlington, Tennessee 38002

Dear Mr. :

On September 26, 1991, the Food and Drug

Administration (PDA)

published a Federal Register notice on silicone

gel-filled and

silicon, inflatable breast prostheses (56 FR 49098)

that was designed to promote the dissemination of

accurate information on the risks associated with

breast implants to women considering implantation

while FDA had under review the application for these

implants. It included guidance for manufacturers and

physicians on the type of information FDA believes is

required. This notice stated that FDA would regard a

manufacturer as misbranding its breast prosthesis

under section 502(a) of the Federal Food, Drug and

Cosmetic Act if labeling does not provide adequate

written information to patients on the risks

associated with these devices.

As part of its efforts to ensure that consumers

receive accurate

information about the risks of breast implants, FDA

staff have made calls to the Dow Corning Implant

Information Center. The Center's toll free number has

appeared in newspaper advertisements directed at

consumers who wanted " Accurate information about

breast implants...based on 30 years of valid

scientific research. "

In responding to these calls, the Centers staff have

made verbal

statements which are not factual or have been used in

a confusing or misleading context. These statements

overstate the safety of breast implants and minimize

known or suspected side effects. The do not reflect a

balanced presentation of the safety issues which have

led to FDA'S requirement that premarket approval

applications be submitted for breast implants. FDA has

documented the following examples of false and/or

misleading statements:

- Regarding the safety of breast implants:

The FDA advisory panel that met on November 12, 13,

and 14, 1991 said that breast implants were safe.

Scientific data and research show that breast implants

are 100% safe. After thirty years of study conducted

with patients, there have never been health problems

with implants or silicone. Breast implants are safe.

- In response to questions regarding joint pain:

has been very sensationalized and never diagnosed by a

physician to be related to implants. It's rheumatoid

arthritis which many women get. It's never been proven

or linked to breast implants.

- Regarding gel bleed:

a minute amount of gel, less than half a teaspoon,

which doesn't go anywhere.

- Regarding rupture:

results from a traumatic incident, usually from an

accident, like a car accident. Results from an

incident such as being hit in the chest with a two by

four. (rupture) has happened less than 1% in 2 million

women.

- Regarding migration of silicone:

Extensive studies on women and animals reveal the

normal reaction is for the silicone to get to the

lymph glands and then form microfascia.

It means that the cell fingers move toward the lymph

glands. When it moves across the tissue point it is a

matter of years so don't worry, if you are thin this

can easily be detected and corrected by your

doctor...It is not possible for the silicone to go to

the internal organs because it is not scientifically

possible for the silicone to get into your spleen,

kidneys, etc.

- Regarding autoimmune disease:

The rate of connective tissue disease for women with

breast implants is the same as the general population.

of women...It must be a genetic glitch...Silicone

breast implants have never been linked to autoimmune

or connective tissue disease in. any studies ever

done.

- Regarding cancer:

There is no link to cancer at all - there is no

increase in breast cancer from implants, if anything

it is less.

- In discussing the known complication of capsular

contracture, an extremely misleading comparison was

made to childbirth:

But remember, you can have complications when you have

a baby, yet people do it all the time.

The above are offered as examples and may not

necessarily reflect all of the false or misleading

information being distributed through the Center.

These statements, and others that are not consistent

with the guidance FDA issued in its September Federal

Register notice, misrepresent the status of the

science and the advisory panel's actions. While Dow

Corning is not required to maintain this telephone

service, if it undertakes to do so, it must provide

accurate information. FDA expects that any information

provided will offer a proper balance of the known and

suspected risks as well as the

benefits of silicone gel filled breast prostheses.

You should take immediate action to eliminate

dissemination of false and/or misleading information

by Dow Corning . Please notifythis office in

writing by close of business. January 2, 1992, of the

specific corrective steps you have taken.

Your response should be sent to Watchko, office

of Compliance and Surveillance, Center for Devices and

Radiological Health, 1390 Piccard Drive, Rockville, MD

20850.

Sincerely yours,

(signed)

M.

Director

Office of Compliance and Surveillance

Center for Devices and Radiological Health

CC:

Lawrence A.

President

Dow Corning

P.O. Box 994

Midland, Michigan 48686-0994