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David A. Kessler, M.D. - FDA General and Plastic Surgery Devices



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

FDA General and Plastic Surgery Devices Panel Meeting
Gaithersburg, Maryland
July 31, 1991

Good Morning.

I have asked to speak to you briefly today because the issues surrounding the
safety of breast implants are confusing to many people. We recognize that,
for those women who have implants in place, the confusion can be downright

Let me first discuss and put in context yesterday's seizure action by the FDA
against one brand of breast implant: Misti Gold. The U.S. attorney in
Minneapolis filed a seizure action against Misti Gold breast implants on
behalf of the FDA because the manufacturer of these implants was marketing an
unapproved breast implant, and because of unsubstantiated claims about that

The inappropriate marketing and promotion of these Misti Gold products is
illegal. Because the firm was illegally marketing the Misti Gold product, we
were left with no alternative but to act.

Unsubstantiated claims mislead the public. They will not be tolerated by
this agency. The many issues involving breast implants are difficult enough
for patients to understand, and misleading claims only add to the confusion.

It is important for the American public to recognize that our actions against
this one breast implant are based on unapproved marketing and misleading
claims, and not on any new evidence of risk about these products.

Second, let me comment on the purpose of today's meeting. It involves
discussion of the risks associated with polyurethane-coated breast implants
-- approximately ten percent of all breast implants. Because of actions
earlier this year, these products are no longer being marketed.

You are here today to address the concerns of women who have these
polyurethane-coated implants in place. You will review the findings of our
risk assessment group, and recommend what -- if anything -- should be done.

Third, let me move beyond the seizure action and the polyurethane-coated
breast implants and talk about silicone-filled breast implants in general.

Earlier this year, the agency called for the submission of data to establish
the safety and effectiveness of these medical devices.

Until this call, no definitive data base on safety and effectiveness had been
assembled for these silicone products, because they were on the market before
enactment of the Medical Device law in 1976.

Manufacturers have had until July 9 of this year to submit data to the FDA to
demonstrate that silicone-filled breast implants are safe and effective. We
have received more than 100,000 pages of data -- and a team of scientists is
in place to sift through and draw conclusions from this great mass of

Under the law, we have 180 days to review the data, and to decide on the
safety and effectiveness of these breast implants. The special team we have
assembled has already begun to evaluate the applications.

I will not prejudge the results.

But, as we analyze the data we have required manufacturers to submit,
American women must be aware that there are risks -- as well as benefits --
associated with these breast implants. These risks -- as best we know them
at present -- are generally found in the labeling that accompanies the
implants, as well as in educational materials available from the FDA.

The risks include but are not limited to contracture of the scar tissue
capsule that forms around the implant, causing hardening and pain; rupture of
the implant with release of the silicone gel; and infection.

Among the still-unanswered questions about silicone implants are their
possible implication in autoimmune disease and the possibility that they
could increase the risk of cancer. I should stress that we have no evidence
that these silicone implants are carcinogenic, but we must investigate the

In recent weeks I have been dismayed to learn that many women who have
undergone breast implant surgery did not recognize that these risks exist.

This situation has been brought home to the agency by our meetings with
women's support groups and the many calls we have received from women who
simply did not realize that there could beadverse effects with breast
implants. Many of the telephone calls we are getting come from women who
feel that they were lulled into believing that these devices are risk free.

When women feel that they have been lulled into believing that breast
implants are risk free, something is wrong.

Whether the risks were unexplained, played down, not heard, or simply not
known at the time, the fact remains that we must do a better job of
communicating the risks and unanswered questions associated with breast

I cannot overemphasize this point.

And yet, as women become more aware of these known and potential risks, it is
crucial that the risks are realistically understood -- and are not

A patient may desire reconstructive surgery; a patient may want cosmetic
changes. Whatever the reason for the surgery, the patient is entitled to
full disclosure of the risks involved. Of course, the benefits that accrue to
the patient will affect whether she is willing to accept the attendant risks.

While the issues are further investigated, we have an obligation to ensure
that each individual decision about breast implants is as informed as it can
possibly be at this time.

Women have to know that FDA is currently analyzing and evaluating the safety
of breast implants. Until these evaluations are complete, there can be no
definitive answers as to the safety of these devices.

It is important to understand that there are risks associated with breast
implants. The decision to use these implants is an important one, and it
should be carefully considered.

One of the most significant issues for women facing this decision involves
personal control. Women must be in a position to manage their health, and
that means they must have the accurate information that underlies any
informed choice.

Today, I urge all physicians to take additional care to explain in detail the
risks set out in the labeling of these devices -- as well as the existence of
unanswered questions
-- so that women can give truly informed consent before surgery.

It is appropriate for patients to ask physicians for a copy of the labeling
accompanying breast implants. Patients should talk openly to the surgeons
who will perform the operation. The surgeons should explain the known risks
-- such as hardening of thebreast and interference with mammography -- as
well as the unanswered questions and should put those risks into context.

If this labeling is unavailable, the FDA would be more than happy to send
information on the risks of breast implants to anyone who requests it.

FDA's job is to come to grips with the mountain of data we have received and
decide whether the risks associated with silicone-filled breast implants are
acceptable in light of the benefits. In the meantime, each woman -- with the
help of her doctor -- should carefully consider how the benefits and risks
apply in her own case.

Whatever the outcome of FDA's deliberation, American women must understand --
even if we conclude silicone-filled breast implants may remain on the market
-- that they are not risk free. No product ever is -- especially devices that
are implanted into our bodies.

Let me conclude by introducing two distinguished guests, each of whom will
bring a valuable point of view to your deliberations.

I am pleased to introduce Dr. Susan Honig, an Assistant Professor of Medicine
at the Georgetown University Medical Center. Dr. Honig's current research
focuses on clinical trials in breast cancer, treatment and prevention, and
she has also published on this subject.

We are also fortunate to have with us Ms. Susan Ann McKenney, a certified
oncology nurse and a certified adult Nurse Practitioner. A nursing
coordinator in the Breast Evaluation Center of the Dana-Farber Cancer
Institute, she has taught and lectured widely on the psycho-social aspects of
breast cancer.

Let me also introduce someone in our audience. Dr. Ruth Merkatz is a Ph.D.
nurse expert who is director of maternal-fetal nursing at the Albert Einstein
College of Medicine. She is an expert in women's health issues.

Dr. Merkatz will be joining the agency, beginning in September, as a Special
Assistant to the Commissioner on Women's Health Issues. She will join FDA's
team on women's health -- a team ably led by Dr. Mary Ann Danello and Ms. Pat

Ladies and Gentlemen, I look forward to having the results of your discussion.

Thank you for your efforts today.