BREAST IMPLANT BAN REJECTED

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

DATE: FRIDAY, February 21, 1992                   TAG: 9202210181
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A1   EDITION: METRO 
SOURCE: Los Angeles Times
DATELINE: WASHINGTON                                LENGTH: Medium
BREAST IMPLANT BAN REJECTED
A federal advisory panel Thursday rejected an outright ban on the use of silicone gel breast implants, recommending instead that certain women be allowed to obtain them under carefully prescribed conditions.
The recommendation by the Food and Drug Administration panel reflected an effort to reconcile concerns about the potential dangers of silicone with feelings that some women - particularly those who have had mastectomies - have a compelling psychological need for the implants.
Under the recommendation, women seeking the devices for cosmetic reasons - usually breast enlargement - would have limited access as part of carefully controlled scientific studies.
The panel said, however, that all women who need the implants for reconstruction purposes should have them, although they, too, would become part of a research program. These women would include breast cancer patients, women with congenital breast abnormalities, and those who have suffered some kind of trauma that deformed the breast.
This proposal "responds to science on the one hand and compassion on the other," said medical ethicist Nancy Dubler, a member of the panel.
Many women have argued that the implants made a profound difference in their lives, especially for reconstruction after breast cancer, while others have blamed the devices as the source of debilitating conditions that caused enormous suffering.
If the proposal is approved by the Food and Drug Administration, it would mean that the devices would no longer be available on the general market.
Furthermore, women who receive silicone gel implants would become participants in a large research program monitored by the federal government.
"This is wonderful for those women who will have access, but I am disappointed for those women who may be denied it in the future," said J. Kermit Campbell, group vice president for Dow Corning Corp., the leading manufacturer of the devices. "We hope it will not be so restrictive that women who truly have a need will not be able to get it."
The recommendation must still be approved by the FDA, although it rarely overrules an advisory committee. FDA Commissioner David Kessler has promised to announce a final decision within 60 days. Until then, a voluntary moratorium on the use of the devices, requested by Kessler on Jan. 6, is expected to remain in place.

by Bhavesh Jinadra by CNB