New study of implants and platinum

[Guest guest]

--- Zuckerman <dz@...> wrote:

> From: " Zuckerman " <dz@...>

> <ifriends@...>

> Subject: new study of implants and platinum

> Date: Fri, 7 Apr 2006 09:21:45 -0400

>

> Congratulations to and Drs. Maharaj and

> Lykissa!

> I want to assure you that

> 1. The study found no platinum in women with saline

> breast implants (although it included only 2 women)

> 2. This doesn't mean that ALL women with silicone

> gel breast implants will have platinum in their

> bodies. But it does mean that it could happen and

> that the FDA needs to figure out what's going on!

>

>

>

> Platinum Found in Women With Breast Implants

>

> By Marc Kaufman

> Washington Post Staff Writer

> Friday, April 7, 2006; 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.

>

> © 2006 The Washington Post Company