Initially it was banned for most women in 1992 amid a controversy over their safety. Now the findings represent the latest concern to be raised about silicone breast implants. Two makers are trying to return the implants to general use. Researchers said that they studied samples from 16 women who had implants for about 14 years on average and compared them with five women who had no implants. Platinum in nails, hair, urine and breast milk was higher in women who had the silicone implants than others who did not have implants. Levels were 100 times higher in breast milk, and as much as 1,700 times higher in urine.
Agency spokeswoman Susan Cruzan said that FDA will conduct a thorough review of this study. Marlene Keeling, the group's president said that the leaking implant in the mother's body is dangerous for both herself and for her kids who still breast feed. Silicone implants made by Mentor Corp and Inamed Corp, which was acquired by Allergan Inc, have been deemed approvable by the FDA. But now it was unclear how the new study would affect the agency's ongoing review. Both companies dismissed the latest findings, saying similar information was presented before the FDA made its initial decision.