By Malcolm Gladwell
The Washington Post
Washington
Dow Corning Corp. on Monday released internal memos, letters,
and documents that revealed a history of worries that the
company's silicone breast implants could rupture under certain
circumstances and that the silicone could "bleed"
through the outer shell of the prosthesis into the patient.
The company also announced
Monday that it was replacing its chairman, John S. Ludington.
He will be succeeded by Keith R. McKennon,
formerly a vice president of Dow Chemical Co., which is a shareholder
in Dow Corning.
"
The McKennon appointment reflects the seriousness of the
breast implant controversy," said Scott Seeburger,
a spokesman for the company. "McKennon has broad executive
management experience in public policy and government affairs.
That background
is very pertinent to a meaningful resolution of the mammary
issue."
The company made the 800-page package, which
included 27 scientific studies and numerous internal company
documents
spanning 25
years, available to the public Monday at the request of the
Food and
Drug Administration.
Among the contents was a 1987 letter
that a Las Vegas plastic surgeon wrote to Dow Corning complaining
that while removing
an implant from a patient, the silicone inside it "literally
ran to the floor" with the "consistency of 50
weight motor oil."
In an internal company memo, dated
1980, a salesman complained that Dow Corning's decision
to put a "questionable" lot
of saline-silicone "mammaries" on the market "has
to rank right up there with the Pinto gas tank."
Dow
Corning officials said Monday that the memos contained
isolated complaints from a long and overwhelmingly favorable
product history,
and stressed that all of the scientific studies already
had been reviewed by the FDA.
There also was no information
in the package to confirm or deny allegations made by some
physicians and product
liability
lawyers
that leaky implants could cause autoimmune diseases.
"
There isn't anything new here," said Robert LeVier,
technical director of Dow Corning.
But the material contained
in the more than 80 company
documents in the package offer, for the first time, some
clues as to
why FDA Commissioner David A. Kessler ordered a moratorium
on the
use of all silicone implants last month, after reviewing
the documents himself.
Public concern about the safety
of breast implants increased in the past year as the FDA
for the first time required
manufacturers to provide evidence that their products
were safe, and as
a number of women successfully sued those manufacturers,
arguing
that
the implants caused a variety of adverse health effects.
Both
the FDA and the implant manufacturers agree that more research
is needed into the question of what kinds
of effect,
if any,
silicone implants have on human health. FDA officials
believe implants pose little or no risk of cancer,
but they want
further investigation of a puzzling series of anecdotal
reports of
women with implants suffering from autoimmune disorders
such as rheumatoid
arthritis or the skin disease scleroderma.
Neither
ailment is uncommon in middle-aged women, who make up a large
part of the implant market. Federal
health officials
want to find out whether it is a coincidence that
certain
autoimmune diseases show up in those women. Dow
Corning is now conducting
a major epidemiological study of that question
in Michigan.
Many of the questions raised by the documents
released Monday, however, involve not autoimmune diseases
but the quality
of the product.
One issue is rupture. Implants
consist of an outer shell filled with liquid silicone gel.
When the
shell is damaged,
the gel
can leak out. This happens most often during
the operation to insert the implant, when the
surgeon
accidentally
punctures it
or squeezes it too tightly. It can also happen
if the device is subject to some trauma after
implantation.
Another concern is whether or
not some amount of gel can "bleed" through
the implant shell into the body.
FDA officials
said that after reading the internal company documents in
January, they
became concerned
that they
did not have an adequate
idea how often and under what circumstances
rupture and bleeding occurred. Agency officials
were
also alarmed, they said,
by the extent to which those concerns were
shared by people within
Dow
Corning itself.
For example:* In a 1976
memo, Dow Corning engineer Tom Talcott wrote of his disappointment
that
at a symposium
for plastic
surgeons the company "ended
up saying the envelopes were `good enough'
while looking at gross thin spots and flaws
in the form of significant bubbles. ...
When will we learn at Dow Corning that
making a product `just good enough' almost
always
leads to products that are `not quite
good enough.' "
* In a 1978 memo,
a company salesman in the Detroit area
reported that four plastic
surgeons
were
experiencing ruptures about
15 percent of the time while implanting
what was then a new kind
of silicone implant.
Dow Corning Bankruptcy Filing Impedes Silicone Implant Cases
By Jay Mathews
The Washington Post
NEW YORK
Dow Corning Corp., stuck in a massive legal swamp over
allegedly harmful silicone breast implants, forced cancellation
of hundreds
of trials and threatened a $4.2 billion settlement Monday
by filing for federal bankruptcy court protection.
The Midland,
Mich.-based silicone material manufacturer said the bankruptcy
filing, which shields it from creditors while
it gets its financial affairs in order, was the only way
to avoid being overwhelmed by soaring legal costs.
Some
of the 400,000 women who expect to draw money from the settlement
fund or who decided to pursue separate legal
claims
against the company accused Dow Corning of stretching
out the process to avoid bad publicity and perhaps force women
who
need the money urgently to settle for smaller amounts.
"
A lot of women were relying on the money to have their breast
implants removed and now that money will not be forthcoming," said
Sybil Goldrich, a woman suing for damages after her implants
failed.
Dow Corning officials denied the charges, and
said their plight underlined the need for Congress's
current effort
to overhaul
product liability law. "We had to take this action
now to preserve both the fundamental strength of our
business operations
and our ability to fairly compensate all women with breast
implant claims," said Dow Corning Chairman Richard
A. Hazelton.
The Dow Corning decision leaves in doubt
the future of the settlement reached last year that
would have paid
participating women from $140,000 to $1.4 million each,
depending on
the
nature and severity of their symptoms.
Dow Corning officials
said they hope the financial reorganization plan they file
will still include the
$2 billion they
promised to contribute to the settlement fund. Three
other companies
involved in silicone implant production - Bristol-Myers
Squibb Co., 3M Co. and Baxter Intl. Inc. - have promised
to give
money to the fund, although a rush of new claims
led a federal judge
to conclude that $4.2 billion will not be enough.
Although
about 400,000 women agreed to accept the fund's restrictions,
at least 11,000 others did not.
Their
individual lawsuits created
an unpredictable element that Dow Corning - the
smallest of the four companies - said it could not handle.
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