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http://thenav.ca/index/news-app/story.470/title.toxic-breasts-a-peek-inside-the-
breast-implant-industry

Toxic Breasts: a peek inside the breast implant industry

By Julie Chadwick

November 22, 2006
Few aspects of the human anatomy have generated more hype, insecurity
and fetishization than the female breast. It has been used to sell
products; been the object of fame and obsession, and the cause of
wishful thinking and embarrassment. It has been pushed, lifted,
separated and prodded into every shape imaginable, as dictated by the
fickle face of fashion. However, nothing has been quite as dangerous
as the trend towards a surgically enhanced bust.
  The possibility of changing one’s “God-given” lot must have seemed
like a miracle to certain hopeful young women when the prospect of
breast implants first loomed in the early 1900s. These first
experimentations were not actually implants but injections—first with
paraffin, with disastrous results, and later with the patient’s own
fat tissue, which was quickly reabsorbed and left scarring and
unsightly lumps. Both methods were abandoned by the 1920’s and by the
middle of the century, the body ideal was moving away from the svelte
“flat” flapper and towards the curviness of the cheesecake pin-up.
With this shift came more pressure on women to conform to the ideal,
and subsequently created more desire for, and interest in, surgical
options.
  Medical knowledge gained during World War II, coupled with
technological advances with synthetics led surgeons to experiment with
the insertion of spongy polyurethane derivatives with names like
Surgifoam and Ivalon. These too, however, proved to be unsuccessful,
as breast tissue filled in the holes and contracted around the sponge,
often reducing it to a hard lump that was difficult to extricate.
  Inspired by Japanese prostitutes that were injecting silicone
directly into their breasts in an attempt to attract American sailors,
doctors in the US began to experiment with liquid silicone.
  Through the 50s and 60s, this practice became popular with topless
dancers in Las Vegas and San Francisco. Its use became more widespread
as, initially, it appeared to be a less-invasive procedure that any
doctor could do. It is estimated that anywhere from at least 12,000 to
50,000 women received silicone injections during its period of
popularity, which began to wane in the mid-60’s. It wasn’t long before
complications associated with the injection of silicone began to set
in.
  Some of the noted clear-cut effects were pain, skin discoloration,
edema, ulceration and necrosis, calcification, granulomas, migration
of the fluid, infection, cysts, axillary adenopathy, disfigurement and
loss of the breast, liver granulomas and dysfunction, acute
pneumonitis or adult respiratory distress syndrome, pulmonary
embolism, coma, and death.
 As Frank Gerow and Thomas Cronin, two plastic surgeons from Texas,
were developing the first silicone breast implant in 1961, there was
already some dissent from within the ranks. On Jan. 24 of that same
year, Ethel Mullison, the Staff Associate from the Dow Corning Center
for Aid to Medical Research, sent a memo to Cronin. In the letter, she
states that there are problems with silicone being “injected directly
into the body,” and that “if enclosed within a silicone bag, the
fluids would tend to diffuse out through the walls of the silicone
rubber and be absorbed into the tissues.”
  This problem came to be known as ‘bleed’ - the tendency of silicone
to ooze out of its protective shell (also made of silicone) and behave
exactly like silicone injections - with all of the attendant
complications.
  The first woman to receive silicone breast implants was Timmie Jean
Lindsey, in 1962, and the following year Dow Corning began selling
their Silastic brand of implants, without any long term testing or
monitoring of their effects in humans.
  By 1976, the state of Nevada felt compelled to make the practice of
injecting silicone a felony. Today, it is not approved by the FDA for
any cosmetic use.
  As silicone made the journey from injections to implantations, many
of the earlier problems and complications proved difficult to shake.
Controversy over the safety of silicone dogged the breast augmentation
industry every step of the way.
     The awareness of potential health threats associated with breast
implants rocketed its way into the public consciousness when Dow
Corning was hit with multiple lawsuits in the early 90’s. However, Dow
had been quietly fighting complaints and court actions for a long
time.
  In 1976, an amendment enacted by the FDA granted the Administration
new power to regulate medical devices. However, it was a little too
late for implants—they had already been on the market for a number of
years, and as a result had been “grandfathered” into the system.
  The first court settlement was quietly awarded in 1977, to the tune
of $170,000 (US). Another case against Dow Corning was subsequently
won in 1984, for over $1.5 million (US), during which numerous
internal company documents and memos were leaked. By 1988 the FDA
jumped into action and recategorized breast implants as a high-risk
product. They set a deadline for manufacturers to prove the safety of
implants by July of 1991.
  By the time the deadline arrived, another settlement was awarded
—the largest yet—of $5.4 million. By September of that same year, the
evidence that was submitted to the FDA was determined insufficient to
judge whether breast implants were safe or unsafe, and they were
required to submit further data. Three months later another case
against Dow Corning was won, with $7.3 million awarded. Another 137
lawsuits were pending. In 1992, the FDA clamped down and severely
limit the use of silicone breast implants.
  By 1995, Dow Corning was facing some 20,000 lawsuits and a global
settlement suit in which about 440,000 women had registered. Dow filed
for bankruptcy.  
  The court heard plaintiffs’ testify that their ruptured and leaking
implants were causing them a range of health problems including joint
pain, headaches, autoimmune diseases, connective tissue diseases,
arthritic-like conditions, chronic fatigue, muscle pain, and
dizziness.
  The verdict seemed to be that there were grave problems with the
use of silicone from the beginning, and that it’s containment within a
silicone bag did little to limit it’s adverse effects within the body.
This was the conclusion of not only the growing numbers of “implant
survivors” but that of a growing body of experts as well.
  Dr. Pierre Blais was the former Senior Scientific Advisor for
Canada’s now-defunct Department of Health and Welfare for fourteen
years. He now runs Innoval Consultants, a firm engaged in the design,
testing and failure analysis of high risk medical systems
  In his line of work he has examined over 7,000 cases of
explantation, from which they have recovered over 9,000 different
implants. Blais says they’ve seen “every single type that has ever
been used worldwide. Some are as old as the 1950’s.”
“[They’re] mostly of US  manufacturing origin because they dominate
the field.” Blais continues: “what we’re seeing is an unprecedented
degree of poor quality. It doesn’t matter where you get them from, it
doesn’t matter when they were put in, what we see consistently across
all years and all types is very poor quality, frequent manufacturing
defects, and in almost all cases, major problems that arose as a
result of the implant. At the very least, a poor appearance; at the
very worst, death.
  “We  have a very substantial number of these implants which were
removed at death. We call that necropsy.”
  In October of this year, Health Canada made a strange move - the
decision to lift the restrictions on silicone implants that have been
in place for over fifteen years, specifically for two corporations -
Inamed and Mentor.  What has changed between  the early 90’s—when the
ban was put into effect—and now?
  Health Canada’s Dr. Supriya Sharma told CTV Newsnet on Oct. 20 of
this year that there have been many changes since the early 90’s in
terms of how silicone implants are manufactured.
     “It’s an illusion,” stresses Blais. “Basically, the technology’s
exactly the same, the materials are still the same […] the same people
who were around in the 60’s, 70’s and 80’s making breast implants are
still around. Only the names of the companies have changed as a result
of multiple acquisitions, bankruptcies, problems, movement of the
company abroad and so on.”
  Sharma went on to say that Health Canada believed that because the
gel inside and the layers on the outside of silicone breast implants
is now thicker, it is a safer product than it was in the 90’s. Blais
disagrees.
  “It’s a total misconception,” explains Blais. First of all, “there
is no such thing as ‘silicone’ in the singular. It’s thousands of
different compounds, mixed very much like rubbers. [...] There is
enormous variations between silicones. It’s no more descriptive a term
[to say silicone] than it is to say, ‘rubber’.
   “In the case of breast implants, even the process to make breast
implants does not ensure uniformity from implant to implant of the
same batch, and we have instances where the silicones are from the
same implant and yet have different properties from point to point.
It’s extremely variable.”  
  This makes it very difficult to determine the safety of silicone
implants and how they behave in a woman’s body, says Blais. Even if
there had been long-term testing or studies done in the 60s before
silicone breast implants went on the market, Blais says that “the
studies would apply specifically, only, to the batch of product that
has been studied. It would not apply to anything before, and most
probably nothing after.”
  How is it, then, that Health Canada managed to approve silicone
implants with confidence?
  They cite reviews from the UK and  the US that conclude there is
“no evidence of a causal relationship between silicone gel-filled
implants and a number of auto-immune diseases or other systemic
illnesses.” They also cite a Canadian study that “showed that women
undergoing cosmetic breast augmentation do not appear to be at an
increased long-term risk of developing cancer,” and a publication
published in an American journal that showed that “women undergoing
cosmetic breast augmentation do not appear to be at an increased
long-term risk of developing cancer.”
  They also established an Expert Advisory Panel to advise Health
Canada in their decision.
  The integrity of the Expert Advisory Panel was called into question
in early Nov. of 2005. The Canadian Medical Association Journal (CMAJ)
reported that Nanaimo/Cowichan MP Jean Crowder was calling for the
removal of three of the panel members because all three had either
worked for, or accepted money from  Inamed and Mentor. These were the
very companies who’s breast implant license applications, and safety
and efficacy data, were under review.
  Two panel members—Dr. Harold  Brandon from Washington University
and Dr. Michael Brook from McMaster University—had accepted money from
Inamed to make presentations on behalf of the company at FDA hearings
five months before being appointed to the Health Canada Expert
Advisory Panel.
  “It was shameful and outrageous,” says Dr. Diana Zuckerman,
president of the National Center for Policy Research for Women &
Families, “but at least in the US it was clear that they were paid
consultants, there to make a presentation on behalf of the company
about how great the product is. In Canada, that wasn’t the case.”
  Panel member Dr. Mitchell Brown of Sunnybrook & Women’s College
Health Sciences Centre was busy being paid to promote the
(as-yet-unapproved) implants at his clinic and writing in a medical
journal about “when silicone gel implants are reintroduced” a full
year before they were officially given the green light by Health
Canada (emphasis added).
  “It distresses me greatly that Health Canada has decided to lift
the ban on silicone gel implants,” says Patty Faussett, who received
implants in 1997 and had them out the following year after
experiencing Multiple Sclerosis-type symptoms. “We’ve been shouting
and waving our arms for years trying to get [experts’] attention about
these very real dangers to so many women, but they have chosen to
disregard the many reports of women harmed, in favor of profits for
the corporations. ”
  Fausset says that before she had the implants, she wasn’t sick in
over ten years. After having them out, she got tests back from a
rheumatologist that told her that she had an elevated rheumatoid
factor (80% of people with rheumatoid arthritis have this, and it is
also linked with autoimmune diseases), a lowered C3 Complement and
macrocytosis (the enlargement of red blood cells that is linked to
liver disease, bacterial overgrowth and parasitic infestation, among
other things).
  And here’s the catch—Patty Faussett’s implants were saline. Canada
is only now lifting its ban on silicone implants—however,
saline-filled implants have been on the market since the 60’s.
Although saline is generally regarded as a safe alternative to
silicone, Blais insists this is not the case.
  “The main problem with saline,” asserts Blais, “is that the
companies who make them do not make the port—the valve, as it is
called—secure. The result is that during the lifetime of the implant,
the patient’s body fluids percolate or leak back into the implant, and
this stuff rots ‘in situ’. In other words, blood, proteins and tissue
which somehow finds its way into the implant becomes entrapped within
the implant and sooner or later bacteria and fungi goes in too, and it
uses the patient’s fluids and protiens as food. And it then grows.”
  Blais says the valves used in today’s saline implants are the same
valves used on saline implants in 1976, and in 80% of saline implants,
the valves come from the same manufacturer.
  Another problem that arises with saline implants is that the
silicone bag around the saline is porous, and becomes more and more
porous over time—notably so, according to Blais, after a period of
about five years.
  “As more and more fluid from the patient becomes pumped into the
[implant], the water part of this fluid leaks out through the bag,
making the inside more and more concentrated with decaying tissue. It
acts as a concentration machine where the inside is the nest for
ongoing—what we call in our trade—colonization.”
  Following Blais down the rabbit hole of this grotesque underground
world of butchered beauty, I wondered aloud what that would look like.
He was only too happy to oblige with a description, remarking that the
saline implants that were sent to him were “always like that.”
  “Even for the implants where the effect is not so ‘gross’, in other
words, you don’t see a huge amount of foreign stuff stuck inside—like
a bad aquarium? You find that when you look at the fluid closely. The
particles and the inoculae—the ‘seeds’, so to speak, of the
bacteria—are already there after a year. The amount increases with
time.
  “Occasionally, very rarely, we will get one that is not badly
colonized after five or six years but more than 80% of them have such
a level of contamination on the inside that you can see it by looking
at the implant at a distance of one meter. In some cases the implants
are totally black.”
  So is there no way to make both silicone and saline implants high
quality, safe products? Can’t technology save us in our quest for the
perfect pair of breasts? Blais, who has been in the business of failed
implants, among other things, for over a quarter of a century, doesn’t
mince his words.
  “A breast implant—or for that matter, most implants—don’t just sit
there. They cause the tissue around them to reshape, to re-form in a
different way. In other words, the implant does not accommodate to the
patient, the patient accommodates to the implant.
  “Firstly, the implant becomes surrounded by a tissue layer which
gradually increases in thickness with time. Think of it as a tissue
envelope, containing an implant. The space around the implant that is
still within the capsule is usually a liquid. This liquid is stagnant.
It’s like a marsh. There is no automatic cleansing of this fluid by
body processes.
  “So, the liquid being stagnant in turn causes the death of the
surrounding tissue. So as a result, the capsule becomes thicker and
thicker. With time, there is less and less cleansing, and after about
ten years, processes that are never found in living organisms without
implants takes place.
  “For example, large quantities of very hard, glass-like calcific
deposits form, and in large amounts. I’ve seen implants removed after
twenty years where the surrounding tissue was like a mass of leather
with the inside part consisting of [something like] crushed
lightbulbs.
  “This is not an exception. The near-totality of implants that were
put in between 1962 to about 1980 that are now being removed come out
in this condition. It’s not just a statistical risk. It’s a…” Blais
pauses, searching for the word, “ …guarantee. And the guarantee is
that it’s the result of the way we are built.”
     “Now, it doesn’t stop there.” My head is reeling, and I consider
asking him to slow down, but Blais is just getting warmed up. “A
breast implant sits at the crossroads of a lot of machinery. The chest
is not just a bag of tissue in which you can put anything. When you
put an implant into a place like this, you force it between muscles,
you have it sit on top of arteries, veins, lymphatic tissue and
what-have-you.
  “So as a result, all of these other bits of machinery that we call
our anatomy are changed. For example, blood flow into the chest is
drastically reduced. Part of this blood is part-and-parcel of our
coronary system. Basically the mammary artery, which is often very
close to these implants, is affected to the point that it seizes to
function and it calcifies. And that’s again, an expected [result].
  “With time, the implants exert a sustained pressure. […] As a
result of this sustained pressure, the ribcage gradually collapses and
indents. We have patients where X-rays show incurvation or collapse of
individual ribs that sit underneath the implant. And on and on it
goes. It’s not rocket science, it’s just the way we are made.”
  With that final nail banged in the coffin, I turn to the question
of how did we, as women, as a society, get to this point? In all this
obsession over the appearance of our breasts—how big, how pert, how
they spill over, their upward (or downward) tilt—I feel like something
has been lost. We have forgotten what the biological function of
breasts was in the first place. Faussett brought it home for me.
  “There is no doubt that the female breast has been considered one
of a woman’s most alluring features. I don’t think that will ever
change,” she muses, “but the difference is that in societies [in the]
past, the female breast was the source of nourishment that meant life
or death for an infant.  The very survival of humankind depended upon
the functioning human breast. In modern times, this is no longer the
case. Yes, breasts are still nourishment for infants worldwide, but in
our culture, we’ve made it optional to the health of the infant.
Formula abounds for the woman who does not want to use her breasts as
they were intended to be used. Couple the rise of the Playboy empire
with the advent of easily-obtainable infant formulas, and, the breast
has become more glamourous and sexy than ever before.”
  And of course, this glamour has a downside. “Breast implants are
deceptive. They give women hope that they, too, can have glamourous,
sexy breasts. Unfortunately, that is not always the case,” says
Faussett. “Hard breasts are not sexy. Obviously fake breasts are not
sexy. Numb breasts greatly reduce sexual pleasure. And if you happen
to be one who suffers from immune system dysfunction as a result of
exposure to breast implants, you can pretty much forget about sex, as
the last thing you will ever feel is sexy. Instead, you will feel like
you are an eighty year old woman in a much younger body as you fight
to function normally. It is definitely not sexy.”
  However, Faussett asserts, “there is a dark side, and there is the
lighter side, which I think I’ve found when I realized that my
experience brought me closer to living a life that is purposeful,
joyful and satisfying, and without all the baggage of insecurity about
my body that I had. […] I realized my inward beauty more than ever,
regardless—or in spite of—my suffering.”

Addendum: as of Nov 17, the US FDA has decided it, too will be lifting
the ban on silicone breast implants (but not silicone testicular
implants, because of “inadequate testing”). For more information,
visit the implant awareness website I am setting up at
<www.implanttruth.jshood.com> It will include audio of the full
interview with Dr. Pierre Blais, as well as links to Dr. Diana
Zuckerman’s, Patty Faussett’s, Kathy Nye’s and many other survivors’
and experts’ sites, and much more.

~~~~~~~~~~~~~~

www.BreastImplantAwareness.org/

www.BreastImplantInfo.org/

www.BreastImplantAwareness.org/Patty.html

http://kathynyebreastimplants.homestead.com/