WASHINGTON (Jan. 9)—Going against the advice of its General and Plastic Surgery Advisory Panel, the Food and Drug Administration refused to lift a 12-year ban on the open sale of silicone-gel breast implants in the U.S.
Inamed Corp., which markets the devices in more than 60 countries, had petitioned the FDA to remove the ban, but the agency ruled there were too many unanswered questions about why some implants rupture and what the silicone gel does to women's bodies in the case of rupture. The agency also issued new testing guidelines defining the sort of information it seeks on silicone implants, but Inamed suggested it would take several years to complete the recommended testing.