According to an article that appeared in the Washington Post, the peer-reviewed journal Analytical Chemistry will soon publish the results of a study by researchers Ernest Lykissa, Ph.D., and Susan Maharaj, Ph.D., reporting elevated levels of platinum salts in urine, hair and breast milk samples from women who had silicone breast implants in their bodies for many years.
According to Drs. Lykissa and Maharaj the platinum found in these samples was in a highly oxidized form, making it a potential source of severe allergic or toxic reactions.Dr. Lykissa is a forensic toxicologist with ExperTox Inc., Deer Park, Texas. Dr. Maharaj is professor of chemistry at American University, Washington.
Opponents of silicone breast implants have been quick to applaud this study which was funded, in part, by the non-profit group, Chemically Associated Neurological Disorders (CANDO).
This Texas-based education and research group has been at the forefront of the fight to remove silicone breast implants from the market for years. Because the results of the Lykissa/ Maharaj study have found their way to the pages of a peer-reviewed journal, CANDO has petitioned the Food and Drug Administration (FDA) to delay any action allowing the return of the devices to the market until the findings can be investigated in greater detail.
Chemists and physicians acknowledge that platinum is used in the manufacturing process to transform silicone into the gel-like consistency that gives these implants a more natural feel than their saline counterparts. But they also voice serious questions over Drs. Lykissa and Maharaj's study and the conclusions drawn from the data.
Same old song?
He cites his own questions about the study's limited sample size, the controls that were referenced and the techniques used which, he suggests, may have actually contributed to the levels of harmful platinum described. In his opinion, the study is "not credible science."
Dr. D'Amico is a plastic surgeon in private practice in Englewood, N.J., and assistant clinical professor of the department of plastic surgery at Mount Sinai School of Medicine in New York City. He is also vice-president of the American Society of Plastic Surgeons (ASPS) and chairman of that organization's Breast Implant Task Force.
He acknowledges that, "For political reasons the FDA may have to spend time with this, but this is what they have to do."
However he does not think that this study will make any difference to his patients seeking breast surgery.
"It hasn't so far," he says. "Most patients know that there have been allegations and issues, and they have a good sense of what the issues have been. If you address them, most patients have a pretty good sense of comfort."
He reports that while few patients question him specifically about platinum, his patients are not ignorant of the ongoing arguments. If they don't bring up these questions, he says that he does.
"I would rather they hear about it from me," he continues. "I don't want my patients unnecessarily panicked. If you level with them I think that's all they're asking for."