A Confederacy of Boobs
How special interests, assorted ideologues, and a sensationalist
press torpedoed breast implants and now threaten other medical devices
By Michael Fumento
Reason, October 1995
Copyright 1995 by Reason Magazine
Not only are they abusing the judicial system, but they are emotionally
abusing the women." That's what one silicone breast implant recipient told
the Boston Herald following the decision of Dow Corning to file for bankruptcy.
Dow Corning had contributed about half of a $4.2 billion settlement --
the biggest ever -- for women claiming to suffer various illnesses from
their implants.
Earlier this year, however, it became clear that there were far more
women trying to get a piece of the pie than there were slices. Plaintiffs'
attorneys were saying that $74 billion might be needed to satisfy just
the first set of claims against the companies. Rather than close its doors
forever, Dow Corning chose to try to limit its losses.
Financially, it's unclear where the bankruptcy leaves implant claimants.
But what has become more and more certain since the settlement was reached
back in 1993 is that while both the judicial system and silicone implant
recipients have been terribly abused, the villain isn't Dow Corning or
any other implant maker.
Indeed, women with breast implants have been nothing more than pawns
in a bizarre game involving lawyers, feminists, headline hounds, and super-inflated
bureaucratic egos. The stakes, however, go beyond the physical and mental
health of women with implants to include the future health of millions
of Americans who will need insertable medical devices. Indeed, the multimillion
-dollar awards against silicone implant manufacturers have already triggered
a wave of suits against medical implants made of solid silicone and even
some containing no silicone at all.
"We have great concerns that any medical device with silicone in it
will not survive," says Elizabeth Connell, a professor of gynecology and
obstetrics at Emory University and head of two Food and Drug Administration
silicone breast implant panels that unsuccessfully recommended leaving
the devices on the market. Since June 1992, most uses of silicone breast
implants have been banned by the FDA. Annually, some 1.5 million patients
receive silicone eye lenses; another 670,000 get artificial silicone joints.
All told, about 7.5 million medical devices are implanted in Americans
each year. Many of these devicessuch as pacemakers, heart valves, and shunts
which draw fluid off the brain are life savers.
Hence, the misinformed campaign against silicone breast implants raises
issues that go far beyond the not insignificant question of whether women
should be able to change their appearance as they see fit. A strange alliance
of diverse interests, including FDA bureaucrats interested in broad ening
their powers, feminists who equate boob jobs with mutilation, and reporters
more interested in good copy than relevant medical research, worked together
to take implants off the market. The anti -implant campaign is nothing
less than a case study in how medical public policy is often driven by
anecdotal rather than epidemiological evidence, formulated by ideologues
who have little regard for what individuals might val-ue, and discussed
in a consistently one-sided manner.
The use of silicone implants to enlarge the size of the breast dates
back to 1963. Somewhere around one million American women have received
them. Implants may be used either for "augmen tation"making a healthy breast
or pair of breasts largeror to replace a breast removed during mastectomy.
It appears that about 60 percent of breast implants have been used for
augmentation.
While there has been mention of possible disease caused by implants
as far back as 1978, the kick-off point of the scare that ultimately prompted
the FDA to ban silicone implants may have been the airing of an implant
feature on CBS's Face to Face with Connie Chung in 1990. Chung's graphic
imagery she called silicone gel "an ooze of slimy gelatin that could be
poisoning" women spurred one stampede of women to have their implants removed
and another to file suits against implant makers.
As Chung herself later put it, the show "unleashed a torrent of protests
and investigations around the country." Soon, women were bombarded with
such stories as "Toxic Breasts," "The Hazards of Silicone," and "Time Bombs
in the Breasts." The height of hysteria may have been reached when, after
the FDA moratorium, two women removed their own implants with razor blades.
They said they had no success in getting doctors to remove them.
A new front opened up in December 1991, when a California jury awarded
a Marin County woman, Mariann Hopkins, $7.3 million from Dow Corning. She
alleged aches, pains, and fatigue caused by her implants without citing
any illness more specific than autoimmune disease, a catchall phrase for
a variety of connective- tissue diseases such as rheumatoid arthritis,
scleroderma, lupus, Sjogren's Syndrome, fibromyalgia, and Raynaud's Disease.
In January 1992, the FDA declared a voluntary (but strongly recommended)
moratorium on the sale and use of silicone breast implants pending review
of additional information, saying, "physi cians should cease using them
and manufacturers should stop shipping them." Four months later, the FDA
essentially converted this to a ban, although the agency did allow continued
use of the implants for women who had suffered mastectomies and permitted
a small number of women who wanted implants for cosmetic purposes to enroll
in long-term studies.
Like many health scares, the one over silicone implants is primarily
American. Only a few countries besides the United States forbid the devices
within their borders. One is Canada, even though the Canadian Independent
Advisory Committee review showed no causal link between silicone breast
implants and serious illness. While most countries haven't even seriously
considered removing silicone implants from use, some, such as the United
Kingdom, have reviewed the evidence and affirmatively stated that implants
should remain available. In June 1994, the 20-member European Committee
on Quality Assurance and Medical Devices in Plastic Surgery declared it
"does not support any restriction on the use of silicone-gel filled implants."
Because of the ban in the United States, American women have gone to
other countries, includ ing the United Kingdom, Mexico, France, and Germany,
to get implants. One popular package mixing implantation in an English
hospital with a trip to Shakespeare's birthplace is called "Boobs n' Bard."
Having to go abroad for implants, of course, prices some women out of the
market. Women who do travel for implants face different problems: If something
goes wrong with the surgery, the doctor is thousands of miles away. And
malpractice suits are difficult to pursue in much of the world and virtually
impossible in South and Central America.
The FDA seriously considered pulling saline-filled implants off the
market as well. But in late 1994, it decided to allow their continued use
pending approval applications due in 1998. Silicone is generally preferred
to saline because it gives the breast a more natural feel. To keep saline-filled
breasts from swishing like a waterbed, it is necessary to pack them tight
with the solution. In breasts that are quite small to begin with, wrinkles
or ripples in the implant surface are more easily visible through the skin
and the breast may not move or hang as naturally as it would with silicone
implants.
Whatever goes into the implant of the future, the silicone implants
of today are in the bodies of a million or more women who need to know
what risk, if any, these devices pose.
There are two ways that women can be exposed to silicone from an implant.
One is when microscopic droplets of silicone fluid "bleed" through the
envelope of a gel-filled implant. "Low -bleed" implants have been available
since the early 1980s and have reduced the amount of silicone that escapes
from the implant. In any event, because scar tissue quickly forms around
the implant, the gel usually goes no further than one or two millimeters
beyond the implant wall.
The other way women can be exposed is through rupture. According to
the FDA, about 4 percent to 6 percent of silicone implants have ruptured,
though studies in progress indicate this figure is probably too low.
Nonetheless, again the scar "capsule" that invariably grows around the
implant tends to hold any silicone even if it breaks, which explains why
so many ruptures are outwardly undetectable. While the gel has gone beyond
the pouch, it still usually remains in place, although it has been found
in the lymphatic system of some women.
That implants can cause physical problems is beyond doubt. It has long
been known, for instance, that the scar capsule can harden and constrict,
sometimes painfully so. This hardening can make necessary follow-up treatment
to remove the scar tissue. Makers of later model implants claim to have
reduced this problem, but it's too early to say what success they may have
had.
But when critics warn of the dangers of silicone implants, this usually
minor problem is seldom what they're talking about. According to Jack Fisher,
a San Diego plastic surgeon and outspoken defender of implants, more than
50 symptoms are alleged to be caused by implants, including memory loss,
dry mouth, cancer, bladder problems, difficulty swallowing, joint pain,
decreased sex drive, and a host of autoimmune diseases. Some have referred
to this broad constellation of symp toms as "silicone-gel syndrome." But
if it is a syndrome it appears the proper definition would have to be any
illness that any woman with implants ever contracts.
To sympathetic observers, such a wide array of symptoms must seem alarming.
But a general rule of epidemiology is that the more diverse the symptoms
allegedly related to a single cause are, the less likely it is that the
suspected cause is real. This basic precept is, in a sense, the mirror
image of snake-oil cures that promise to remedy all sorts of unrelated
symptoms. Many of the most com monly cited symptoms of silicone exposuresuch
as fatigue, headaches, and difficulty swallow ingcan be brought on by suggestion.
As a result, people who hear that implants may cause certain problems may
then develop them. These are the same "side effects" described by participants
in drug studies who are actually receiving placebos.
And, in fact, most of the evidence against implants is anecdotal: It
is based on reports from women who are sick and have implants and claim
the two conditions are related. Thus, if a woman with implants ever develops
symptoms that doctors can't readily explain, everyone simply assumes that
silicone is the cause. Sometimes this sort of reasoning is expressed in
the very titles of the implant scare articles. Consider the headline for
the San Francisco Chronicle's article about Mariann Hopkins: "After Breast
Implant, Horror Began."
While such a loose correlation may be appealing to people looking for
quick and easy answers, it is essentially the same logical fallacy that
blames black cats for inexplicable illness. Yet, in some cases, the silicone-gel
symptoms actually predate the implants. Indeed, such a curious time frame
appears to have been the case even in the first big implant settlement.
One of Mariann Hopkins's treating physicians testified that, although
her diagnosis of mixed connective-tissue disease did not come until after
the implants were put in, she had already displayed symptoms of connective-tissue
disease as early as two years before receiving implants. The doctor even
testified that another physician was so concerned that he subjected her
to a battery of tests for one type of connective-tissue illness called
systemic rheumatic disease. Those came back negative, but they were not
tests specifically for mixed connective-tissue disease. Had they been and
had they come back positive, it's unlikely Hopkins would have ever received
the $7.3 million award.
But then again, the jury did not seem overly influenced by those most
knowledgeable of Hopkins's medical history. At the time of trial, Hopkins
was basically free of symptoms, thanks to a low dose of medicine. And none
of Hopkins's treating physicians testified at the trial that they believed
her illness to be related to the implants. Instead, the jury made its finding
on the basis of outside testimony that implants could cause such disease,
testimony from professional anti-implant witnesses such as Tampa, Florida,
physician Frank Vasey, who makes his living by treating women he says are
sick from their implants.
Perhaps the most serious charge against silicone implants is also the
weakestthat they may cause breast cancer. Although such influential groups
as Sidney Wolfe's Public Citizen (founded by Ralph Nader) have made the
claim, repeated studies have shown no such link. The only cancers ever
plausibly attributed to siliconein a study released over 40 years agowere
connective-tissue sarcomas that appeared in strains of rodents especially
susceptible to cancer.
The simple truth is that no epidemiological studies have linked cancer
in people to implants. The largest study is also the most recent: After
looking at a group of almost 11,000 women from the Alberta, Canada, area,
the Alberta Cancer Board concluded, "The incidence of breast cancer among
the women who had breast augmentation could not be said to be either significantly
higher or lower than that among the general population."
Polyurethane implants, which make up about 10 percent of implants currently
in use, are a special case. Manufactured by Surgitek Inc., a subsidiary
of Bristol-Myers Squibb Co., these im plants featured a gel-filled pouch
with a layer of polyurethane foam coating the silicone envelope. The implants
were a special target of Connie Chung's Face to Face report. Under such
heat, Surgitek felt it had no choice but to remove them from the market
in 1991. (Nevertheless, a USA Today illustration in May 1995 accompanying
an anti-implant editorial depicted a polyurethane -coated implant.)
The purpose of the foam was to reduce the chance of scar tissue contracting
around the im plant. But when the foam breaks down chemically, it produces
a substance called 2-toluene diamine (TDA) that is considered a probable
animal carcinogen and a possible human one. Although that would seem to
be an obvious source of trouble, it turns out that, like all the other
serious accusations against breast implants, the charges against polyurethane
implants don't hold up under epidemiologi cal scrutiny. The only difference
is that in this case the FDA has admitted it.
In late June, Bristol-Myers Squibb concluded an FDA-solicited study
to determine how much TDA really ended up in the system of women with polyurethane
implants. The amount (when any was found at all) was so small that even
assuming it is a definite human carcinogenusing the FDA's own rating systemthe
risk of cancer was one in a million. Since only about 110,000 women have
had such implants, the FDA stated in a position paper, "FDA estimates it
is unlikely that expo sure to TDA will cause cancer in even one of the
women with these implants." The agency added, "The health risk connected
with surgical removal of the implants is far greater than the risk of developing
cancer."
There's another, deeper irony in the whole polyurethane controversy,
one the FDA obviously couldn't state: that a product designed to alleviate
the only absolutely certain health problem clearly linked to implants was
forced off the market because of worries over other unproven health effects.
Since silicone gel from implants is most commonly accused of causing
autoimmune disease, or connective-tissue disease, it isn't surprising that
a large number of studies on both animals and humans have looked for a
link between silicone exposure and autoimmune/connective-tissue disease.
When the British Department of Health undertook a review of these studies
earlier this year, it found approximately 270 papers published after 1971
alone.
The animal studies, the department concluded, "provide no immunological
reason for concern over the use of silicone gels in implants." The report
went even further, however: "None of these studies demonstrated that the
coexistence of connective-tissue disease with silicone breast implants
is any more prevalent than would be expected by chance."
The largest study of connective-tissue disease to date appeared in the
New England Journal of Medicine this past June. Conducted by the Harvard
School of Public Health and the Brigham and Women's Hospital in Boston,
the study looked for evidence of 41 types of connective-tissue disease
among 87,501 nurses, of whom 1,183 had implants.
The results were unambiguous. The researchers found no "association
between silicone breast implants and connective-tissue diseases, defined
according to a variety of standardized criteria." Already anticipating
the charge that they knew would be forthcoming from plaintiffs' lawyersthat
silicone implants cause a special kind of autoimmune disease that doesn't
show up with standardized criteriathe authors added, "or signs or symptoms
of these diseases." In fact, they reported that women with silicone implants
were significantly less likely to relate symptoms of these diseases or
to complain of symptoms or signs of illness resembling connective-tissue
disease.
For many health professionals, the NEJM study, added on top of all the
others, was the final piece of proof needed. "I think we have enough data
to end the moratorium," George E. Erlich, a Philadelphia rheumatologist
and head of the FDA arthritis advisory committee, told TheNew York Times.
Erlich emphasized he was speaking for himself and not the FDA committee,
but he added that the International League of the Associations of Rheumatology
also agreed unanimously there was no evidence linking implants to connective-tissue
disease. And long before that, the American College of Rheumatology had
already issued its own statement, saying, "There is no convincing evidence
that these implants cause any generalized disease."
If the evidence against silicone implants is so weakand has always been
sowhy have they inspired such commotion and fear? The chief reason has
to do with the federal bureaucrat whose various power-grabbing machinations
would embarrass a villain from Central Casting: David Kessler, commissioner
of the FDA.
In December 1991, Kessler called together a panel of physicians, self-styled
consumer repre sentatives, and the like to evaluate the evidence of potential
harm caused by implants. The verdict of the panel, though by no means unanimous,
was that the devices should remain on the market pend ing collection of
further data from studies already underway.
That, however, did not please Kessler, who ordered FDA staffers to solicit
case histories from doctors of implant recipients who later claimed to
have suffered ills as a possible result. Since lawyers had already begun
soliciting women with complaints and sending them on to specially chosen
doctors, finding such case histories was probably not difficult. In any
event, case histories reveal little because they don't allow for comparison
groups. That's what the epidemiological studies were, but Kessler couldn't
wait for them.
In January 1992, Kessler implemented the moratorium, citing the case
studies as the reason (and glossing over the fact that he himself solicited
them). The next month, he reconvened the panel to ply them with his new
"evidence." The panel didn't budge and Kessler once again ignored its advice.
"We still saw no clear evidence of danger, though there were a number
of unanswered ques tions," says Emory's Connell, who served as the chair
of both panels. "We felt breast implants should stay available to women
who, with informed consent, wanted to use them." Three and a half years
after the first panel voted to recommend keeping the implants available,
Connell says she would clearly do so again. "I think the difference is
we could say it this time with a great deal more assurance."
"A whole new literature has been developed since that time," she explains.
"We were operating on anecdotal evidence and case history. Now the evidence
has been gathered by good people in well -designed studies so it's an entirely
different situation."
So why did the FDA ban silicone implants despite the lack of evidence
that they are harmful? Pressure came from repeated anecdotal reports in
both print and television media. The moratorium that became a ban occurred
after more than a year of intense media pressure, including Connie Chung's
inflammatory show, which was repeated a year later.
Congressional pressure, in the form of the late Rep. Ted Weiss (D-N.Y.),
also came down on the FDA. Weiss, who chaired the House committee with
jurisdiction over the FDA, accused Dow Corning of possible misconduct in
its effort to document the safety of silicone implants and called for both
the Justice Department and the FDA to investigate the company. (This May,
the Justice Department dropped the investigation for lack of evidence.)
He also accused the FDA of dragging its feet over the polyurethane-implant
issue.
To be sure, there was pressure to keep implants available, too. It came
from the American Medical Association, implant makers, plastic surgeons,
and breast-cancer groups. But this was not the sort of public pressure
that can embarrass an agency, and the breast cancer groups' objections
were dealt with by allowing continued use of silicone implants for breast
reconstruction following mastectomy.
The decision to ban implants was just the sort of thing one would expect
from a regulatory body that puts so much emphasis on safety that it can't
take anything else into account. New England Journal of Medicine Editor
Marcia Angell has said that the FDA probably acted the way it did because
implants are cosmetic and are therefore of only subjective worth. Such
worth, says Angell, can't be plugged into Kessler's cost-benefit analysis.
In an NEJM editorial, Angell noted that nobody questions allowing the
use of automobiles, even though they kill over 40,000 Americans a year,
because we all have a common understanding of the worth of cars. "In the
case of breast implants" though, wrote Angell, "the benefit has to do with
the personal judgments about the quality of life, which are subjective
and unique to each woman." But given "the difficulty of assessing the benefits,
the FDA has acted as though there were noneat least when implants are used
for augmentation." The result, said Angell, "is that [FDA Commissioner
Kessler] may be holding breast implants to an impossibly high standard:
Since there are no benefits, there should be no risks."
The FDA's pseudo-scientific approach lends support to the more obviously
ideological attack on breast implants from feminists. To many of the most
vocal and influential feminists, a preference for big breasts represents
female oppression. Susan K. Brownmiller, in her landmark 1984 book Femininity,
opined that "[e]nlarging one's breasts to suit male fantasies" represents
the exploitation of women. "Big breasts are one of many factors that have
slowed women down in the competitive race of life," she said. "Symbolically,
in the conservative Fifties, when American women were encouraged to stay
at home, the heavily inflated bosom was celebrated and fetishized as the
feminine ideal. In decades of spirited feminist activity such as the Twenties
and the present when women advance into untraditional jobs, small, streamlined
breasts are glorified in fashion."
If large breasts signal oppression, say these feminists, then the implants
used to enlarge one's breasts are tools of oppression. Scarsdale psychologist
Rita Freedman, writing in Beauty Bound, claims, "Having been taught that
feminine beauty means having full, softly rounded breasts, women judge
themselves against this standard. Missing the mark, they put on padded
bras or suffer silicone implants." Naomi Wolf, in her 1991 bestseller The
Beauty Myth, states, "Breast surgery, in its man gling of erotic feeling,
is a form of sexual mutilation."
Having gone this far with imagery, it's a small step to start blaming
implants for physical ills. This is precisely what happened after anecdotes
began to appear linking implants to disease. Susan Faludi, in her popular
book Backlash: The War Against Women , wrote matter-of-factly that leaking
implants "could cause toxicity, lupus, rheumatoid arthritis, and autoimmune
diseases such as scleroderma."
To such polemicists, it doesn't matter that the evidence for negative
effects was weak. It was just too fitting that something in their minds
so harmful to women as a class should be harmful to them as individuals.
Two women on the FDA panel translated such thoughts into direct action.
Vivian Snyder, the panel's "consumer representative," told Kessler in a
letter that "[t]he federal government now has the power to deliver a profoundly
important message to the American public involving basic values, concepts
of beauty and health," adding, "it would really be wonderful if the FDA
could address such attitude-impacting mental health issues as what is really
healthy and normal and maybe even beauti ful."
The other panelist was Beauty Bound author Rita Freedman. She sent a
letter to Kessler decry ing that implants "perpetuate the myth of Barbie
Doll's Body" and asked whether breast augmenta tion will become, "like
rhinoplasty [nose surgery], a rite of passage for affluent teens."
Such feminist participation in the anti-implant crusade has proven ironic,
since the FDA's virtual ban has denied what feminists have always proclaimed
as their goala woman's right to choose for herself. Faludi herself acknowledges
that at one time the leading feminist journal, Ms., "deemed plastic surgery
a way of 'reinventing yourselfa strategy for women who dare to take control
of their lives.'"
Writing in NEJM, Angell says, "It is possible to deplore the pressures
that women feel to conform to a stereotyped standard of beauty, while at
the same time defending their right to make their own decisions." If anything,
says Angell, the act of withdrawing implants could be viewed as sexist
because "people are regularly permitted to take risks that are probably
much greater than the likely risk from breast implants," citing cigarette
smoking and excess alcohol consumption.
When the FDA slapped the moratorium on implants, the impact went far
beyond prohibiting a single surgical technique. "The widespread fearand
the multimillion-dollar lawsuitshave dated largely from the FDA's removal
of breast implants from the market," says Angell.
One study comparing the attitudes of women with implants before and
after the FDA morato rium found that after the moratorium the level of
satisfaction dropped markedly, from 98 percent satisfied to 7179 percent
satisfied. The study authors said their findings were similar to those
of the American Society for Plastic and Reconstructive Surgery in another
poll.
As for prompting the "multimillion-dollar lawsuits," one need look no
further for evidence than so many of the attorney advertisements soliciting
silicone implant recipients. "THE FDA WARNS THAT SILICONE GEL-FILLED BREAST
IMPLANTS PRESENT HEALTH RISKS" blared a typical ad of this sort in the
Newark, New Jersey, Star-Ledger. Implant critics often cite money as the
only concern of Dow Corning and other manufacturers. But few notice that
the group which stands to gain the most from liability casestrial lawyershas
a love of filthy lucre. In a single case involving three women complaining
of implant-related illness, a jury in 1994 awarded $33.5 million, although
the judgment was later reversed by an appeals court and then settled. Thirty
-three percent of a multimillion-dollar awardlawyers typically take a third
off the topcan be a powerful incentive for a law firm.
It's hardly surprising, then, that the American Trial Lawyers Association
conducts regular seminars for implant plaintiffs' attorneys. It does so
using selected data provided by Sidney Wolfe of Public Citizen, the group
most identified with criticism of implants. For $750, Public Citizen will
also provide trial lawyers a list of medical experts and consultants, FDA
reviews and FDA panel testimony, and a variety of other litigation documents.
It will also refer clients to those lawyers.
Suing implant manufacturers has become a boom industry in the United
States, with lawyers out to convince women that even though they may feel
just fine they are really sick and must be properly compensated. With so
much money to spread around, it also isn't difficult to get doctors to
find patients.
"I get calls from women who say, 'I have implants. Where do I pick up
the money?'" says Sandy Finestone of the Women's Implant Information Center
in Irvine, California. The center dis seminates information on implant
safety. "You dangle $4 billion in front of them and it certainly gets their
attention." Finestone has two polyurethane-coated implants that she makes
clear will not be the subject of litigation.
Indeed, attorneys have not only ignored scientists, they've attacked
them. After Mayo Clinic rheumatologist Sherine E. Gabriel published a study
in NEJM in June 1994, a lawyer claiming to represent 2,0003,000 implant
recipients began filing legal demands against her. "The magnitude of the
demands is staggering; the burden is staggering," she told TheNew York
Times. "They want over 800 manuscripts from researchers that were here,
they want hundreds of data bases, dozens of file cabinets and the entire
medical records of all Olmsted County [Michigan] women, whether or not
they were in the study."
Not surprisingly, Gabriel says the demands have "severely compromised"
her ability to do research and made colleagues of hers back off from doing
their own implant research, for fear their findings would also infuriate
plaintiffs' lawyers. "Some," she says, "determined that the price in terms
of their own research careers is too high to pay."
The widespread association of silicone implants with various illnesses
is largely the result of unsophisticated reporting on the topic. "The media
may be portraying a closer link between implants and autoimmune disease
than is actually merited because younger women tend to be more prone to
autoimmune disease than other groups," explains David Leffell, associate
professor of dermatology at the Yale School of Medicine. But the real question,
says Leffel, is whether women with silicone implants are getting these
diseases at levels higher than expected. All signs point to no.
With silicone implants, the media have managed to make news as much
as report it. Clearly, they have had a significant impact on public perceptions,
which then fueled both litigation and contributed to the FDA moratorium.
This in turn fueled more litigation.
Whatever role sheer confusionand ignorance of scientific data and principlesplayed
on the part of the media, it is disturbing to realize that opportunities
to present the other side were often ignored. In 1991, for instance, CBS
reran the Connie Chung show that did so much to kick off the implant scare.
But at the last minute, the network yanked a Dow Corning rebuttal to the
program's charges. CBS didn't explain its decision. Apparently it felt
its viewers would not benefit from an airing of both sides of the issue.
Unfortunately, the antisilicone implant crusade has given women
something very tangible to fear. Because of the negative publicity, as
early as 1991 insurance companies were already denying or restricting medical
coverage to women with implants. Now, because some doctors and lawyers
have tied various illnesses to implants, women with implants who do eventually
get any of those illnesses may find themselves without medical coverage.
The founder of the Washington, D.C., chapter of the Y-ME National Breast
Cancer Organization told a congressional panel, "In some instances, it
is easier for a cancer patient to obtain insurance than one who has implants."
In early June, even before the NEJM connective-tissue disease study,
Y-ME Executive Director Sharon Green wrote to Kessler asking him to "make
a public statement regarding the most recent epidemiological studiesto
stop the current frenzy." The only statement he issued that month was a
response to the NEJM study saying yet more evidence was needed.
Emory's Connell says the FDA's actions and the legal profession's high-tech
ambulance chas ing are "costing us not only what we [already] have but
the chance for new and better products in the future. I think we're in
a worse mess in American medicine than we've ever been in. Instead of leading
the world, we're now a third-rate country in terms of our ability to develop
new drugs and devices."
Indeed, J. Donald Hill, chairman of cardiovascular surgery at California
Pacific Medical Center, worries that the anti-implant crusade will broaden
into an attack against a wide variety of medical aids already on the market.
The first device to go down the tubes may be the Norplant contraceptive,
which after implantation into the arm releases a tiny amount of silicone
into the system. While no suits have yet been filed, lawyers are encouraging
women with the devices who have any sort of illness to contact them. Trial
lawyer seminars are already being held, using some of the same instructors
and same self-styled medical experts who torpedoed breast implants.
In a country so heavily dependent on science to improve the quality
of our lives, to defend our shores, to feed our growing population, to
prevent and cure illness, the resoundingly anti-scientific and successful
crusade against silicone implants portends problems that right now cannot
even be guessed.
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