Silicone breast implants leak platinum into the body

Apr 10 2006

According to a new study high levels of platinum have been found in the hair, breast milk and other samples from women who had silicone gel-filled breast implants.

The study by researchers at the Texas-based firm EperTox and the Center for Research on Environmental Medicine is now being reviewed by the U.S. Food and Drug Administration (FDA).

The findings represent the latest concern to be raised about silicone breast implants, which were banned for most women in 1992 amid a controversy over their safety. Most concerns then centered around the effects of the silicone leaking out and not the platinum used in their manufacturing.

Two makers are currently trying to return the implants to general use.

The researchers say 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. They say the platinum levels found in nails, hair, urine and breast milk was higher in women who had the silicone implants than others who did not.

It seems the levels were 100 times higher in breast milk, and as much as 1,700 times higher in urine.

The study was funded by a nonprofit group, the Chemically Associated Neurological Disorders, who have filed a petition with the FDA asking for a delay on the decision on new silicone breast implants in view of this latest study.

The researchers say that the platinum salts found in the women's urine, hair and breast milk was in a dangerous form likely to cause allergic or toxic reactions,and women who may have leaking implants in their body need to know, as do those young women who are considering breast-feeding their children.

Silicone implants made by Mentor Corp. and Inamed Corp., have been deemed "approvable" by the FDA if certain, undisclosed conditions are met, but it is unclear how the new study will affect the agency's review process.

Both companies have dismissed the latest findings, saying similar information was presented before the FDA made its initial decision.

The report is published in Analytical Chemistry, a journal of the American Chemical Society.