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David A. Kessler, M.D. - Washington, DC

Statement on Silicone Gel Breast Implants

by

David A. Kessler, M.D.
Commissioner of Food and Drugs

Washington, D.C.
January 6, 1992

Good day.

Today, I am requesting a moratorium on the further use of all silicone gel
breast implants until our advisory panel of outside experts can reconvene to
consider new information on the safety of these devices. The moratorium
will remain in effect until the FDA can review the advisory panel's new
recommendation and make a final decision.

Let me explain why we are taking this action.

Last November, an FDA advisory panel of outside experts agreed with our
evaluation that the data supplied by the manufacturers were insufficient to
establish that the implants are safe and effective.

Nonetheless, the panel recommended continued availability of the implants --
with certain conditions such as informed consent and a patient registry --
while the manufacturers collected additional data under a strict FDA-set
timetable.

However, since the last panel meeting, we have received new information
about the implants that amplifies our concerns about their safety.

Therefore, I am asking the panel to reassess its earlier recommendation.

The advisory panel will meet within the next 45 days. Until the panel
meets, and we have had an opportunity to review its recommendations, I am
asking that physicians cease using the silicone gel implants. As
physicians, our first obligation is to do no harm.

I am also asking manufacturers to stop distributing these products during
this period.

Given our heightened concern about the safety of the gel implants, I believe
the moratorium on further use is the most responsible action I can take.

Until we complete our own evaluation of the data, and until the advisory
panel has had time to give us its counsel on the new information, we cannot
support continued use of this product.

Our decision does not apply to saline-filled implants, which will continue
to be available during the moratorium.

Let me recap for you the original concerns about the gel implants that we
brought to the advisory panel last November and that remain unanswered:

* We still do not know how often the implants leak, and when they do, we
do not know exactly what materials get into the body.

* We still do not know how often the implants break, or how long they last.

* We still do not know how often women with the implants suffer adverse
effects. For example, there are reports that painful hardening of the
implant can occur in anywhere from 10 percent to 70 percent of patients.

* We still do not know to what extent the implants interfere with
mammography examinations. This is especially important because the implants
have been used in thousands of healthy women each year.

* We still do not know whether the implants can increase a woman's risk of
developing cancer.

* And we still do not know enough about the relationship between these
devices and autoimmune and connective tissue diseases.

Thirty years of use and we still don't know the answers to these questions.
Part of the problem is that, until 1976, there was no medical device law.

The information we've acquired since the last panel meeting, rather than
dispelling doubts, has increased our concerns about the safety of these
products.

For example, we've recently received reports from rheumatologists that they
are seeing an increasing number of autoimmune disorders among breast-implant
patients.

We are particularly concerned about this in view of new information that
some pre-1985 implants may not have been tested properly, and had
significant problems with leakage.

These kinds of quality-control problems have not been put to rest by the
manufacturers' recent submissions.

Over the last two weeks, we have also reviewed for the first time studies
bearing on the safety of gel implants that had not been seen by the advisory
panel prior to its November meeting. I want the panel to have the
opportunity to evaluate these studies.

Because of the limited information on the relationship between the implants
and immune disorders available at the time of the last panel meeting, FDA
did not stress this risk.

Given the new information, we intend to focus the panel's attention on this
question ant its implications for the future availability of the implants.

I know that many women who already have silicone gel breast implants will
have questions about possible harmful effects.

I want to take a moment to talk with them. This is a difficult issue. It
is highly emotional.

Over the next few days, you will probably hear a great number of disturbing
allegations about the safety of these products.

We are carefully reviewing all these allegations, and we'll present all
relevant information to the panel for its consideration.

If you are not experiencing any difficulties, there is no need to consider
removing the implants. However, if you are having symptoms you think may be
related to your implants, you should see your doctor.

And all women with implants should have periodic checkups for such problems
as rupture.

Nothing I have said today should deter women from seeking early detection
and treatment of breast cancer. There are other options available in the
absence of the silicone gel implants.

In closing, I want to stress that the FDA is not opposed to breast
implants. We recognize the value of these devices, particularly for women
who face a devastating and potentially disfiguring disease such as breast
cancer.

We want to see safe breast implants available for all women who need them.
But the manufacturers of silicone gel implants have failed thus far to
provide adequate evidence that they are marketing a safe product.

There remain troubling questions about the safety of the implants.

We owe it to the American public to see to it that these questions are
thoroughly investigated.