Platinum may leak from breast implants

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Last update: August 27, 2004 at 7:06 AM

Platinum may leak from breast implants

http://www.startribune.com/stories/1556/4950348.html

Greg Gordon, Star Tribune Washington Bureau

Correspondent

August 27, 2004 IMPLANT0827

WASHINGTON, D.C. -- New research presented Thursday

could lend credence to allegations that silicone gel

breast implants have leaked toxic forms of platinum

into the bodies of women and then reached their

breast-fed children.

The reactive platinum, unlike other inert platinum in

the body, can cause various forms of neurological

damage and asthma-like allergic reactions, said Ernest

Lykissa, a Houston clinical toxicologist who

co-authored the paper.

Maharaj, a chemist at American University,

detailed the findings to an American Chemical Society

meeting in Philadelphia.

Lykissa, who four years ago disclosed some of his

preliminary research to the Star Tribune, said the

paper presented Thursday reported sharply higher

levels of reactive platinum in the blood and urine of

10 women who had implants than in five control

subjects. While the sample size is small, he said in a

phone interview, the results reflect those in similar

tests he has since performed on hundreds of women.

Lykissa said that his research also has been confirmed

by a group of German scientists and that it offers an

explanation for many of the illnesses alleged by

hundreds of thousands of women who received silicone

gel implants.

Kathleen Quinn, a spokeswoman for the Food and Drug

Administration (FDA), said the agency " is not able to

comment ... at this time " on the paper. The FDA

declined last winter to lift a 12-year-old moratorium

and allow Santa Barbara, Calif.-based INAMED Corp. to

put silicone breast implants back on the U.S. market.

INAMED grew from a former subsidiary of

Maplewood-based 3M, which got out of the breast

implant business in 1984 and has paid more than $1

billion to settle suits over its products.

Dan Cohen, INAMED's vice president for global

government affairs, said he would not " dismiss [the

new study] until I've had the chance to have our

scientists review it. "

But, he said, the company has seen " no peer-reviewed,

credible data that would support Mr. Lykissa's claim. "

Cohen said the FDA's letter rejecting INAMED's

petition to fully market its silicone breast implants

included " no discussion of the platinum issue. "

Page 53

A catalyst

INAMED and the California-based Mentor Corp. continue

to sell silicone gel implants for use in

reconstructive surgery for breast cancer victims or

for women volunteering for clinical studies.

Silicone implant makers have used platinum for decades

to produce a catalyst. The catalyst causes silicone

oil to thicken into a gel.

At issue is whether platinum left over from those

reactions is inert or reactive and whether it leaks

into women's bloodstreams if the implants rupture.

Some government scientists have expressed concern that

not all of the platinum from the manufacturing process

would be neutralized.

Lykissa said reactive platinum " is notorious for

attacking nerve endings and interfering with the nerve

impulses to the brain. " Women he has examined, he

said, suffer from pain in their fingers and toes, have

ticks in their eyes, memory lapses and equilibrium or

eyesight imbalances.

" The children that we tested that I have seen have all

suffered from hearing and eye problems " after being

breast fed. " There were platinums detected in the

breast milk of those mothers,' " Lykissa said.

Greg Gordon is at ggordon@....