Panel Confirms No Major Illness Tied to Breast Implants
[Yet, Dow Corning was driven bankrupt by politically astute plaintiffs' attorneys who argued otherwise. -- RR]
By GINA KOLATA -- June 21, 1999
In independent panel of 13 scientists convened by
the Institute of Medicine at the request of
Congress has concluded that silicone breast implants
do not cause any major diseases.
"Some women with breast implants are indeed very
ill and the IOM committee is very sympathetic to
their distress," the group wrote in a report to be made
public on Tuesday. "However, it can find no
evidence that these women are ill because of their
implants."
The report, more than 400 pages long, says that the
"primary safety issue" with implants is their tendency
to rupture or deflate and to lead to infections or
hardening or scarring of the breast tissue. There is
little argument about these localized problems,
which can be painful and disfiguring and which often
lead women to have additional surgery.
But the report asserts in forceful terms that there is
no reason to believe that the implants cause
rheumatoid arthritis, lupus, or any other systemic
disease. Women who say their implants have caused
them to suffer these or related problems have turned
breast implants into a leading source of liability
litigation.
The report was provided to The New York Times by
an organization that consults in the breast implant
matter and, a spokesman said, that "is pleased with
the report's conclusions." The report is the latest in a
series of evaluations that have concluded there is no
scientific evidence to support the lawsuits.
Because it comes from the Institute of Medicine, the
medical arm of the National Academy of Sciences,
the nation's most prestigious scientific organization,
it is expected to be influential in setting scientific
agendas and encouraging women to accept
settlements from implant makers rather than take
their cases to court.
In preparing the report, panel members held public
hearings, met in private and evaluated more than a
thousand research reports. The Institute panel did not
conduct any original research. Rather, the panel
relied primarily on research reported by other
scientists. But the report said that since lawsuits
were first filed in the late 1980s and early 1990s,
there have been many scientific studies upon which
to make an evaluation.
Last December, scientists appointed by the judge
overseeing implant liability litigation, Sam C.
Pointer Jr., of U.S. District Court in Alabama, came
to a similar conclusion as the Institute panel and a
report issued last July by scientists in Britain who
had been charged by the British minister of health to
review implant safety.
Scientists appointed by Judge Robert E. Jones of
U.S. District Court in Oregon, reached a comparable
conclusion.
Meanwhile, the Dow Corning Corp., which filed for
bankruptcy citing the burden of its breast implant
litigation, has agreed to pay women $3.2 billion to
settle their claims. Other implant manufacturers,
Baxter International, Bristol-Myers Squibb, and
Minnesota Mining and Manufacturing, have agreed
to a settlement estimated at $3 billion combined.
In addition, thousands of women have settled their
cases in private agreements with implant makers or
gone to trial and won awards that reached millions of
dollars.
The Institute of Medicine committee estimated that
about 1.5 million to 1.8 million American women
have had silicone breast implants, about 70 percent
for breast enlargement, the rest as reconstruction
after mastectomy.
Members of the committee, headed by Dr. Stuart
Bondurant, a professor of medicine at the University
of North Carolina at Chapel Hill, and Dr. Virginia
Ernster, a professor of epidemiology at the
University of California in San Francisco, were
prohibited from discussing the report until it is
officially made public.
Sybil Goldrich, founder of Command Trust
Network, an information clearing house for women
with silicone problems, said, "I find it extremely
difficult to accept what the Institute of Medicine says
because those studies are paid for by the
manufacturers. They have not convinced me that
their review is correct. It is as simple as that."
Tommy Jacks, a lawyer in Austin, Tex., whose firm
has represented 425 women with implants, said he
doubts that the report will be the last word on the
matter.
"This report is simply a review of the literature by a
committee that's reached some conclusion," Jacks
said. "It is premature to conclude that reports like
this are the last word that scientists and physicians
will have about the safety of breast implants," he
said.
But medical experts informed of the committee's
conclusions, applauded them.
Dr. Shaun Ruddy, the chairman of the rheumatology,
allergy, and immunology division at Virginia
Commonwealth University's Medical College of
Virginia in Richmond, said that the conclusions were
"very forthright and outspoken" and that he was glad
the group was attempting to put the disease
hypotheses to rest. Ruddy, a past president of the
American College of Rheumatology, said he has had
no part in any of the litigation.
The Institute of Medicine committee was set up at
the behest of Congress. It's work began with a public
hearing on July 24, 1997, when almost 700 people
filled an auditorium at the National Academy of
Sciences in Washington.
Representatives of medical professional associations
made statements, scientists spoke about their
research, and women with implants spoke of how
their lives had been ruined by them. Some said that
they were so ill that they needed canes or wheelchairs
to get around, conditions they blamed on the
implants. Others testified that after they breast fed
their babies, their children developed the same
debilitating symptoms.
Examining more than 1,200 references, the group
addressed the major questions about implants: Do
they cause established connective tissue diseases,
like arthritis or lupus? Do they cause breast cancer,
nerve diseases, like multiple sclerosis, or new
diseases with symptoms like aches and pains and
overwhelming fatigue? Are children of women with
breast implants at risk for disease because of silicone
transmitted across the placenta or in breast milk? Do
breast implants produce immunological reactions
that could cause disease?
In every case, the committee concluded, there was no
convincing evidence that implants were at fault.
When lawsuits were filed in the late 1980s and early
1990s there was a lack of research on the topic.
Since then, according to the report, "a number of
strong, well-designed epidemiological studies
involving large numbers of women and clear results
have been published."
For example, the group wrote, the evidence is
"insufficient or flawed." that implants cause "atypical
disease," a term covering signs and symptoms like
weakness, fatigue, and diffuse muscle pain. But the
group said that evidence on the other side is strong.
"Controlled epidemiologic studies cited" led the
committee to conclude that "there is no novel
syndrome."
On the question of established connective tissue
diseases, like lupus and rheumatoid arthritis, the
group reviewed 17 epidemiological studies and
concluded that they were "remarkable for the
consistency of finding no elevated risk or odds for an
association of implants with disease."
After hearing a description of the report, David
Bernstein, a law professor and adviser for the
American Tort Reform Foundation, a
business-sponsored group, said that, coming as it
does in the wake of similar reports, the report "might
have a dramatic effect in hastening the end of the
litigation."
"It is a very strong statement," Bernstein said. But he
added that it was a shame that the legal system went
ahead on the litigation in the absence of science, with
companies paying billions to compensate women
with implants. "It would have been nice to have had
this $7 billion ago," Bernstein said.
Copyright 1999 The New York Times Company |
