MN Star Tribune: Si Breast Implants w/Platinum Immunization
Gary.Greenberg at Duke.edu
Sat Dec 30 10:40:32 EST 2000
Published Saturday, December 23, 2000
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
But the proposal by Raymond 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.
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
manufacturing 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 John 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.
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.
Omar Henderson, 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. Henderson 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.
Published Monday, December 18, 2000
Breast-implant debate may shift focus to effects of platinum leakage
Greg Gordon / Star Tribune
WASHINGTON, D.C. -- A National Academy of Sciences panel last year found
no basis for concerns that silicone-gelbreastimplants 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-gelimplants and the now
more widely sold saline breastimplants -- 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.
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 Raymond 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 siliconeimplants 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
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 breastimplants 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
"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.
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-gelbreastimplants 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 Douglas 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
breastimplants," he said.
The only companies still selling siliconeimplants 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 also
said that at least one company uses platinum in the process of hardening
silicone shells for saline-filled breastimplants.
3M spokeswoman Mary Auvin said the company no longer employs scientists
who could answer questions about breastimplants -- 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. Michael Jackson 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 Omar Henderson, 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
Lykissa said he has received about $40,000 in funding from a group of
breast-implant recipients headed by Marlene Keeling, a Houston woman who
submitted one of the petitions before the FDA.
The second petition was submitted by Dr. Michael 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
Greg Gordon can be contacted at ggordon at mcclatchydc.com
Gary N. Greenberg, MD MPH Sysop / Moderator Occ-Env-Med-L MailList
gary.greenberg at duke.edu Duke Occupat, Environ, Int & Fam Medicine
OEM-L Maillist Website: http://occhealthnews.com
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