Weather | Sports | Forums | Comics | Classifieds | Calendar | Movies
WASHINGTON - Dozens of women and critics who blamed silicone gel breast implants for damaging health effects, including scarring and silicone leeching into organs, urged the Food and Drug Administration on Tuesday not to lift its 11-year ban.
But then a line of women pleaded for access to the implants, calling them the most natural-feeling option to rebuild cancer-ravaged breasts or to enlarge small ones.
The FDA panel opened the two-day hearing to seek advice on whether Inamed Corp. should be allowed to again sell silicone gel-filled breast implants here, like it does in Europe. The two key issues being debated are:
Inamed's own research found 46 percent of breast cancer patients getting silicone implants needed additional breast surgery within three years - as did one in five otherwise healthy women who had breast enlargements.
Whether Inamed has tracked women's health for a long enough period after implantation. Its key study covered just three years. FDA's own research suggests implants often break after seven years.
Inamed argues that short-term complications like painful scarring and extra surgery are comparable to today's main option - implants filled with saltwater.
Advisers plan to issue their recommendation today.