Panel Recommends Continues Limited Use of Breast ImplantsBy Marlene Cimons
Los Angeles Times
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 controversial 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.
The implants have been the focus of a painful and emotional national debate that has pitted woman against woman and raised soul-searching questions about the values of a breast-conscious society.
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."
Dr. Norman Cole, president of the American Society for Plastic and Reconstructive Surgery, said he believed the plan would make it difficult for women seeking augmentation, since they "will need to make a significant investment of time and effort to be part of the (study) group."