WASHPOST: Platinum Found in Women With Breast Implants

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http://www.washingtonpost.com/wp-

dyn/content/article/2006/04/06/AR2006040601917.html

Platinum Found in Women With Breast Implants

By Marc Kaufman

Washington Post Staff Writer

Friday, April 7, 2006; Page A06

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 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 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.

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

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 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.

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www.BreastImplantAwareness.org

Full study at:

www.BreastImplantAwareness.org/cando.htm