First clinical study of breast implants launched

Abstract

ON THE FIRST of this month, after three decades of widespread use, the first Stage 2 research protocol designed to ask basic questions about the safety of silicone gel-filled breast implants got under way. The Food and Drug Administration (FDA)-approved protocol, submitted by Mentor Corporation, Santa Barbara, Calif, is open to any woman who has a "medical need" for breast reconstruction and for whom saline-filled implants are considered medically unsatisfactory. This includes the following: Women who need reconstruction after mastectomy or other cancer treatments, or after therapeutic or prophylactic mastectomy for other medical reasons. This category includes cancer patients whose breasts were previously reconstructed with saline implants or autologous tissue techniques with unsatisfactory results. Women who need reconstruction because of severe breast or chest deformity unrelated to breast cancer or previous mastectomy. The deformity can result from congenital or developmental problems, trauma, or medical or surgical complication