IMPLANTS WILL BE AVAILABLE - BUT MORE DIFFICULT TO GET

                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: SATURDAY, February 22, 1992                   TAG: 9202220049
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-2   EDITION: METRO 
SOURCE: Associated Press
DATELINE: WASHINGTON                                LENGTH: Medium
IMPLANTS WILL BE AVAILABLE - BUT MORE DIFFICULT 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 fills in details and defines who can get the devices.
After three days of often heated and tearful testimony, a nine-member committee recommended to the FDA 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 Solomon-like 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 one 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 again 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, which put a moratorium on the silicone gel implants Jan. 6, is not required to follow the committee's guidelines, but is expected to - in its fashion.
FDA commissioner David Kessler said a decision will be made within 60 days. That decision will determine the impact of the committee findings.
If the FDA designs clinical trials with highly specific criteria, the number of women who qualify for cosmetic breast implants could be severely 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. Some experiments could possibly require a detailed review of life style, diet, family history and contacts with environmental chemicals.
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."

by Bhavesh Jinadra by CNB