Breast-implant debate may shift focus to effects of platinum leakage ~ Greg Gordon ~ Star Tribune... 12/18/2000

[Guest guest]

" He said platinum is so potent that it also appears to

cause people to become allergic to an array of other

substances. "

Date: Mon, 18 Dec 2000

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Breast-implant debate may shift focus to effects of

platinum leakage

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Greg Gordon

Star Tribune

WASHINGTON, D.C. -- A National Academy of Sciences

panel last year found no basis for concerns that

silicone-gel breast implants cause health damage, but

debate on their safety persists with a new focus.

Several researchers are trying to persuade the U.S.

Food and Drug Administration (FDA) that implant safety

reviews have focused too much on the effects of

silicone and too little on whether toxic platinum

leaked into women's bodies from some of the devices.

During the past 15 years, the FDA has received more

than 193,000 reports of adverse health effects from

users of silicone-gel implants and the now more widely

sold saline breast implants -- ailments that run from

connective tissue disorders to skin rashes and memory

loss.

Despite scores of scientific studies and mammoth legal

battles surrounding the implants, the causes of the

illnesses remain a mystery.

FDA officials are trying to determine whether the

platinum issue represents a smoking gun, or just more

smoke.

Lorri Ferraro, a psychotherapist from Forest Lake,

Minn., is watching the developments with keen

interest. She is among about 500,000 women who filed

claims alleging that implants harmed their health and,

in many cases, wrecked the quality of their lives.

Ferraro and other women assert that some of their

ailments could be consistent with common effects of

platinum exposure, such as asthmalike breathing

problems, itchy or burning skin, joint pain, hives and

possible nerve damage.

Present and former makers of the implants, including

Maplewood-based 3M, which manufactured the devices

from 1977-84, say no research has proved that platinum

used during manufacturing caused adverse health

effects.

Dow Corning Corp., 3M, Bristol Myers Squibb Corp. and

other former silicone implant makers that have put up

more than $6 billion to settle about 370,000 of the

claims filed by U.S. and foreign implant recipients,

dismiss attacks on the devices' safety as " junk

science. "

They cite the conclusions last year of the Academy's

Institute of Medicine and of a court-appointed science

panel in 1998 that there is no basis for health

concerns among the estimated 1 million to 2 million

U.S. women who had silicone implants. The institute

not only found insufficient evidence to implicate

leaking silicone, but also said " evidence is lacking

for an association between platinum ... and local or

systemic health effects. "

Langone, an FDA molecular biology official who

has monitored the platinum issue for more than five

years, said agency scientists " cannot draw conclusive

results from the data we've seen so far. "

Potent allergen

Platinum is a heavy metal probably best known for its

use in jewelry, in which it is harmless. But in

certain ionized or reactive compounds, it may be " the

most potent chemical allergen on the planet, " said a

leading platinum expert Biagini, a research

toxicologist at the National Institute for

Occupational Safety and Health (NIOSH). He said

platinum is so potent that it also appears to cause

people to become allergic to an array of other

substances.

Researchers found in the early 1900s that 50 to 60

percent of platinum refinery workers developed asthma

and other severe allergies after breathing platinum

dust. Recent studies suggest that reactive platinum is

a neurotoxin that might damage brain cells or attack

the nerves in fingers, toes and limbs -- ailments

similar to those described by some implant recipients.

However, neurological effects were not noticed in the

studies of platinum workers.

When silicone implants went on the market in the

1960s, no FDA approval was needed: The agency lacked

authority to regulate medical devices until 1976.

Citing unresolved safety questions, the FDA got a

voluntary moratorium on the sale of silicone implants

in 1992, limiting their use to clinical trials on

women undergoing reconstructive surgery.

Now, with overseas sales of the implants rising, the

FDA is considering two petitions seeking tougher

regulatory action based mainly on platinum concerns.

The agency has heard from physicians and researchers

who cite small-scale studies that they say implicate

platinum as a likely cause of immunological and

neurological effects in implant recipients. These

researchers argue that scientific review panels, as

well as lawyers scrambling to recover damages from

aggrieved women, focused too narrowly on connective

tissue diseases.

* The most dramatic evidence comes from Texas

researcher Ernest Lykissa, who operates a Houston

drug-testing laboratory. Lykissa first reported

identifying reactive platinum compounds leaking from

breast implants that had been removed from women's

bodies.

More recently, he tested samples of hair, fingernails,

sweat, blood and urine from eight women who had had

their implants removed and complained of physical

ailments. He said he found elevated levels of various

reactive platinum compounds in six of them, declaring

that he has established " a public health issue that

.... warrants the attention of the federal government. "

The FDA's Langone said, however, that Lykissa's

yet-to-be-submitted findings are too limited to prove

that the platinum came from the implants.

" We need bona fide, valid studies to determine what

platinum species are present [in implanted women], how

much is there, how much leaches out, where it goes and

what it does, " Langone said.

Strict threshold

Platinum is considered such a health hazard that the

U.S. Occupational Safety and Health Administration has

set one of its strictest workplace exposure thresholds

for the toxin: 2 parts per billion.

Makers of silicone-gel breast implants have advised

the FDA that they used as much as 1,500 parts per

billion of hexachloroplatinate, a highly reactive

platinum " salt, " during manufacturing. The issue is

how much platinum, if any, remained in the implants in

a reactive form.

Scientists for Dow Corning, once the principal implant

maker, say the company used " platinum salts " from 1969

until it quit making the implants in 1992, but only to

produce a different compound that served as a

catalyst. The catalyst caused the silicone oil to

thicken into a gel and, when more platinum was added,

to harden some gel into the devices' outer shells.

Tom Lane, a senior Dow research scientist, said that

an " exceedingly small " amount of platinum was used and

that any that remained after those chemical reactions

was in a harmless " zero oxidation " state. He said this

conclusion is supported by a " huge body of literature "

dating back 50 years.

" There's no harm here. There's no risk here, " said

Schoettinger, chief trial lawyer for Dow

Corning, which is under Chapter 11 bankruptcy

protection in the face of 170,000 implant suits.

But NIOSH's Biagini said that however the platinum is

used, not all of it is neutralized. " There is going to

be a certain amount ... in breast implants, " he said.

The only companies still selling silicone implants in

the United States under the FDA's current restrictions

are Mentor Corp. and Inamed Corp., which acquired the

implant business that 3M exited in 1984.

Bobby Purkait, a vice president for Mentor, which is

based in Santa Barbara, Calif., said his company uses

platinum salts in a process similar to Dow Corning's.

He said the company tests of its implants have not

found dangerous salt levels.

Inamed spokesman Ilan Reich declined to discuss the

company's use of platinum, calling it " an issue

between us and the FDA. "

Langone said he does not know whether Inamed's implant

subsidiary, McGhan Medical Corp., still uses a

platinum compound. FDA officials said, however, that

both companies use platinum in the process of

hardening silicone shells for saline-filled breast

implants.

3M spokeswoman Auvin said the company no longer

employs scientists who could answer questions about

breast implants -- a business it shed because " we had

such a small market share, and there were indications

that litigation was coming. "

Pointing to the Institute of Medicine's report, she

said, platinum " is not an issue. "

* Dow Corning spokesman T. said the

company would wait to see Lykissa's new study, but

criticized his earlier work as " dubious. "

* While Lykissa's methodology in a previous implant

study has drawn skepticism, his conclusion that

platinum leaked from the implants largely mirrored the

results of two other studies, including one about six

years ago by , a supervisory research

chemist at the federal Centers for Disease Control and

Prevention. Studies, some by the FDA, also have found

that about 70 percent of the devices eventually

ruptured.

* Lykissa said he has received about $40,000 in

funding from a group of breast-implant recipients

headed by Keeling, a Houston woman who

submitted one of the petitions before the FDA.

Keeling, who reached an out-of-court settlement with

3M over her implant complaints, blames the devices she

carried for 16 years for a host of ailments, including

nervous system disorders that numbed her fingers and

toes and affected her speech and memory.

Her petition seeks a ban on the sale of all

silicone-gel implants.

* The second petition was submitted by Dr.

Harbut, an occupational health specialist in

Southfield, Mich., who said that implanted recipients

he has examined have had symptoms consistent with

platinum exposure and that several of them have

platinum allergies. He wants the FDA to issue a health

warning about platinum risks to all recipients of any

implanted device made with a platinum catalyst.

Ferraro says she's sure her implants made her sick.

She said she began experiencing aching joints, burning

and itching skin and numbness in her fingers and toes

not long after she chose to have Dow Corning implants

following a double mastectomy in 1984. She said she

was too fatigued to work from 1992 until the implants

were removed five years later.

" I used to be a really active person, " Ferraro said.

" Now I have no energy. "

Greg Gordon can be contacted at

ggordon@...