Journal Issues Caution About Implant Study

A study that spurred concern about high concentrations of platinum in women with silicone breast implants seems to contain flaws and should be viewed "with caution," the scientific journal that published the work warned Monday.

Questions about platinum, a heavy metal that is a fairly common pollutant, come as the Food and Drug Administration nears a final decision on whether to allow the sale of silicone breast implants.

The FDA maintains on its Web site that while small amounts of platinum can leak from implants, it is in an inert state that doesn't pose any significant risk.

A study published this spring in the American Chemical Society's journal, Analytical Chemistry, came to the opposite view. Those researchers reported high concentrations of platinum in the hair, nails, urine and breast milk of about 18 implant recipients _ and called it a highly reactive form of platinum that has been associated with allergic responses.

On Monday, the editors of Analytical Chemistry stopped short of calling those results wrong, but concluded the evidence "falls short of this journal's standards."

"We firmly believe that journal editors act in the proper interests of science when they allow the publication of work that may prove to be controversial, provided that the science behind the results appears to be solid. In this case, at least some of the science may not meet that mark," wrote editor Royce Murray of the University of North Carolina, Chapel Hill, and associate editor Catherine Fenselau of the University of Maryland.

At issue are questions about how the platinum's reactivity was analyzed, including whether the researchers properly avoided contamination of the samples they tested _ questions raised in two letters from industry-affiliated scientists also published Monday.

The original researcher, Ernest Lykissa of the testing laboratory ExperTox Inc., didn't return a call seeking comment.

The FDA banned sale of silicone-gel implants in 1992 because of safety concerns. Since then, they have been available only in strictly controlled research studies. They have been largely exonerated of causing such serious illnesses as cancer or lupus, but remain contentious because, among other issues, they frequently break and require removal, and can form painful scar tissue.

___

On the Net:

Food and Drug Administration: http://www.fda.gov

American Chemical Society: http://www.acs.org/

Analytical Chemistry: http://www.pubs.acs.org/ac