Government hasn't pursued suggestions to test silicone breast implants

[Guest guest]

Date: Sat, 30 Dec 2000 10:39:29 -0500

Sender: Occupational & Environmental Medicine for

Clinicians & Public

From: Greenberg

Subject: MN Star Tribune: Si Breast Implants

w/Platinum Immunization

Published Saturday, December 23, 2000

http://webserv3.startribune.com/stOnLine/cgi-bin/article?thisSlug=IMP23 & date=23-\

Dec-2000 & word=platinum

Government hasn't pursued suggestions to test silicone

breast implants

Greg Gordon / Star Tribune

WASHINGTON, D.C. -- A government scientist proposed a

study four years ago to explore whether silicone gel

breast implants could have leaked toxic forms of

platinum into women's bodies, as some health

professionals feared.

But the proposal by Biagini, a research

toxicologist at the National Institute for

Occupational Safety and Health who is a leading

platinum expert, went nowhere.

Now, the Food and Drug Administration (FDA) says it

needs more data to determine whether platinum may be a

culprit in the illnesses of some of the half-million

women who have sued implant manufacturers.

The issue underscores a handicap routinely confronting

the FDA: It lacks the money to perform research that

might settle many of the scientific questions on which

its regulatory decisions hinge. In an interview this

month, FDA Commissioner Jane Henney acknowledged the

problem and said Congress should consider " at least

doubling " her agency's $1.3 billion budget. The annual

budget for laboratory research at the FDA's National

Center for Toxicological Research in Jefferson, Ark.,

has been in the $40 million to $50 million range.

To the frustration of some scientists and a number of

women who think their silicone breast implants made

them ill, no government studies are underway into the

possible effects of platinum, small amounts of which

were used during manufacturing.

Potent allergen

In certain reactive forms, platinum is one of the most

potent allergens known to humans. Scientists have yet

to establish what level of exposure causes

sensitization, but once a person is sensitized,

exposure to the tiniest amounts of the substance can

cause allergic reactions ranging from asthma-like

breathing problems to hives, skin rashes and joint

pain. Some studies suggest platinum may also cause

neurological problems, such as numbness in fingers and

toes.

Silicone implant manufacturers, including former

makers Dow Corning Corp. and Maplewood-based 3M Co.,

stress that two national science panels have found no

basis for health concerns with regard to the implants.

Scientists at Dow Corning, the leading manufacturer of

silicone implants before most were removed from the

market in 1992, say they used platinum only to make a

catalyst at the beginning of their process and that

any platinum left in the implants was in a harmless

form.

But a Houston researcher, Ernest Lykissa, says he has

detected elevated levels of reactive platinum in the

hair, fingernails and body fluids of a number of women

who had the implants for years and blame them for a

variety of ailments.

Lykissa's findings have aroused the interest of

Langone, an FDA molecular biology official who is

monitoring the platinum issue. But Langone said the

agency needs more extensive studies to determine

whether reactive forms of platinum are in the implant,

how much leaches out and what, if any, health effects

it may produce.

....

Platinum leaking

Several researchers and health professionals have

urged the FDA and the National Institutes of Health to

conduct studies into the platinum in implants since

1993.

, a supervisory research chemist at the

Centers for Disease Control and Prevention, reported

in the mid-1990s that he had found platinum leaking

from 15 of 20 implants he tested after they were

removed from women's bodies. said he

proposed further study, but got no response.

Biagini, the toxicologist, wrote the FDA suggesting a

study in which gel from silicone implants would be

applied to the skin of platinum refinery workers known

to have been sensitized to the substance and to women

with implants. A pattern of skin reactions would be a

strong signal of a problem, he contended. He also got

no response.

Later, Biagini said, he wrote to a federal judge in

Alabama overseeing breast implant litigation, offering

his assistance if a court-appointed science panel

wanted to investigate the platinum issue. He said he

received no reply.