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Implants likely to be much tougher to get

An advisory panel's recommendation on silicone gel breast implants is only a framework of principles. The true effect of the action will come after the Food and Drug Administration (FDA) fills in details and defines who can get the devices.

After three days of testimony, the nine-member committee recommended that the implants be made available to women who want them, but only if the women meet criteria for strictly controlled clinical trials.

Each of the trials may have its own set of requirements.

It was a decision that completely pleased no one because the panel attempted to serve both the needs of science and the demands of women.

It did, however, provide some reassurance to the 1-million American women who have received silicone gel implants over the last 30 years.

The committee said, in effect, that the implants are important to the psychological health of many women and that the devices pose no clear and provable disease hazard for most patients.

On the other hand, the panel said there are women who have been harmed by the devices and there should be more research to precisely determine the risk.

Given the options of restricting access for everyone and accommodating the needs of women disfigured by surgery, the committee chose a middle ground.

Women recovering from breast surgery for cancer, burns or congenital defects were recommended for liberal access to the implants. But for women who want the implants just to make their breasts bigger, the committee said the implants should be more difficult to obtain.

Eighty percent of the devices have been installed to augment breast size.

The FDA enacted a moratorium on the implants last month. Technically, the moratorium is voluntary, observed by plastic surgeons at the request of FDA commissioner David Kessler.

However, plastic surgeons are bound to go along with the moratorium or face increased risk of malpractice suits in the event of complications.

The FDA is not required to follow the advisory committee's guidelines, but is expected to _ in its fashion. Kessler said a decision will be made within 60 days.

If the FDA designs clinical trials with highly specific criteria, the number of women who qualify for cosmetic breast implants could be severely limited.

"The number of augmentation patients to be studied will be determined by the nature of the scientific questions being asked" in the trials, the FDA said Friday.

Age, shape, size, stature and general health could all be factors that would exclude women from clinical trials. It's also likely that a woman's choice of doctor would be limited.

Rules will be less strict for breast-reconstruction patients. This will assure, as the panel wished, that virtually any woman disfigured by disease or accident will be allowed to get the implants.

Both types of patients probably will be required to undergo close scrutiny and periodic detailed examination for months or even years after surgery.

In some trials, researchers may look for changes in the immune system that could require frequent blood and urine tests, and perhaps even biopsies.

As one doctor said:

"Women will still get the implants, but it's going to be a lot more hassle. They'll have to be determined."

Because of the demands of scientific precision and patient follow-up, the committee said the implant trials should be controlled by institutional review boards.

These are organizations of supervising scientists that usually are present only in large teaching or research hospitals.

As a result, geography alone may limit the number of women getting implants. A woman wanting larger breasts, but who lives 200 miles from the nearest research center, may decide it's not worth the effort.

The committee, however, wanted to make sure that reconstruction patients were not harmed because of limited research centers. So, for them, neighborhood cosmetic surgery clinics may still be able to perform the implant operations and the detailed follow-up.


Information from Cox News Service was used in this report.