Platinum Found in Women With Breast Implants
Friday, April 7, 2006
Researchers have found a new reason for possible concern about the safety of silicone gel breast implants: high and potentially hazardous levels of the metal platinum in some women who had silicone implants in their bodies for many years.
With the Food and Drug Administration poised to allow silicone implants back on the market for unrestricted sale, two researchers reported this week in a journal of the American Chemical Society that they found high levels of platinum salts in the urine, hair and breast milk of 16 women with silicone gel implants.
The platinum, they concluded, was in a form that made it a potential source of severe allergic or toxic reactions. Their findings were immediately challenged by chemists associated with implant makers and are at odds with the longtime conclusions of the FDA, which has determined that the platinum used to make silicone gel implants is inactive and unable to cause harm.
Although the possibility that some silicone implants might release a harmful form of platinum has been debated since the early 1990s, the metal has not been at the center of the long and contentious debate over the safety of the implants. And the possible health problems that could come from platinum -- severe allergies, asthma, nerve damage and reduced immune responses -- have not been the focus of the many lawsuits against implant makers.
The FDA deemed two applications to sell silicone gel implants to be "approvable" last year, although the agency has yet to give the final go-ahead to the companies -- Mentor Corp. and Inamed Corp., which is now a division of Allergan Inc. Some implants are used by women who have had mastectomies, but most of the more than 250,000 sold each year are for breast enhancement. That number is expected to rise if the more popular silicone implants are fully allowed back on the market along with saline-filled versions.
FDA spokeswoman Susan Cruzan said yesterday that the agency is "carefully reviewing the article, and we don't know how long that will take."
In their paper in Analytical Chemistry, considered a top journal of the field, researchers Ernest Lykissa and Susan Maharaj reported finding the highest platinum levels to date in women who had implants. They also wrote that for the first time, they found the platinum -- which had leached out of the implants -- in a transformed, oxidized state that makes it potentially more harmful.
"Implant manufacturers have said for years that their platinum is not harmful, and when the device is manufactured, they are correct," said Lykissa, a forensic toxicologist with the firm ExperTox in Deer Park, Tex. "But in the body, we know that the implants degrade and the platinum can disperse and take on a more reactive form."
Most of the women in the study, which was funded in part by a nonprofit group that has argued to keep silicone implants off the market, had their enlargements implanted in the 1980s. The women had them for an average of 14 years, and many had had them removed, generally because of health problems.
The study was quickly and aggressively attacked by other chemists, especially those with connections to breast implant makers.
Michael Brook, a chemist and silicone manufacturing expert at McMaster University in Hamilton, Ontario, said the new study contained some data and conclusions about platinum that he said were very hard, if not impossible, to accept. He said, for instance, that the researchers reported finding platinum in a highly unstable form never before known to exist in the presence of air or water, as existing in the human body.
"Because that finding seems so questionable, it's hard to know how to read other findings presented," said Brook, who has worked as a consultant to Inamed.
"I'm personally disappointed that [the journal] chose to feature this article because the facts are just not right," said Thomas Lane, a senior chemist with Dow Corning Corp. and a silicone expert who presented information to a panel of the federally chartered Institute of Medicine that studied silicone gel implants and, in 1999, found them to be largely harmless.
"This is an issue that has been well-studied, and results are clear -- that the platinum is not in a harmful form," he said.
Platinum is used as a catalyst to transform the silicone into a harder, gel-like form.
The new data were embraced as vindication by Marlene Keeling, president of Chemically Associated Neurological Disorders, a small Houston nonprofit group that does education and research and helped fund the new work.
"This is the first time the research has found platinum in this possibly harmful form in implanted women," she said. "With this now published in a peer-reviewed journal, they'll all have to take it more seriously than they have in the past. We've presented preliminary information to the FDA, and they've basically dismissed it before."
Based on the new study, Keeling filed a citizen's petition yesterday with the FDA, asking that any action on the Mentor and Inamed applications be delayed until the platinum issue can be further researched.
Keeling and her group filed an earlier citizen's petition regarding platinum and silicone implants in 2000, which was rejected a year later by the agency. In that decision, the FDA relied heavily on the work of the IOM, which concluded that the available evidence showed that platinum was present only in its harmless and nonreactive state. "Evidence does not suggest there are high concentrations in implants, significant diffusion of platinum out of implants or platinum toxicity in humans," the IOM said.
As part of its review, the IOM studied some early work by Lykissa and concluded that it came to unsupported conclusions about platinum in implanted women.
Maharaj, co-author of the new study and founder of the Center for Research on Environmental Medicine, said her work with Lykissa expands on preliminary work done by both of them. She said their work was the first to find platinum in the more risky, oxidized state because they were the first to systematically look for it in women and in removed implants.