Platinum in women with implants

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Platinum in women with implants

MARC KAUFMAN

Washington, April 9: 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 US Food and Drug Administration (FDA) 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 long-time 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 centre 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.

Some implants are used by women who have had

mastectomies, but most of the more than 2,50,000 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 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, oxidised 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, Texas. “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 non-profit group that has argued to keep

silicone implants off the market, had their

enlargements implanted in the 1980s.

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, said the study contained some data and

conclusions that were hard to accept.

LOS ANGELES TIMES-WASHINGTON POST NEWS SERVICE