Conclusion: In depth understanding of the host
response to biomaterials is
needed in order to engineer materials that
perform suitably in their applications.
When biomaterial and medical devices are
surgically implanted into the body, a series of molecular and cellular events
lead to its encapsulation and isolation from surrounding tissue.
"I have this sinking feeling that after the victory
handed to medical device manufacturers on a silver platter by the United
States Supreme Court decision in Riegel v.
Medtronic, they are in need of even more oversight and
circumspection." - Michael B.
1667 The apparent danger of using animal
serums foreign to human beings and animal serums foreign to other animals is
reported in medical literature when lambs
blood is unsuccessfully used in a human blood transfusion.
1963 In a National Institutes
of Health sponsored study, a
researcher transplants a baboon kidney into a human and the experiment
first baboon-to-human transplants
So they attempt to use chimpanzee
A brief history of cross-species organ
1976 Medical Device Regulation
Class I - General Controls for devices considered as low
risks for human use.
Class II - Performance Standards for devices
considered as moderate risks for human use.
Class III - Premarket
Approval for devices considered as high risks for human use.
If you are
a device maker it is ideal to get your device classified as I or
United States Supreme Court rules that any medical device
manufacturer whose medical device has been approved for use by the FDA may not
be sued even if the medical
device fails to perform as advertised.
enlarged the breasts of thousands of women with silicone implants since they
were first introduced in the 1960s.
I even wrote articles in favor of
Paula S. came to see me in 1992. At age 32, she had at least
three breast surgeries, and each time her breasts became rock-hard and painful.
We replaced the silicone with smooth saline implants. Within a short time these
too became hard, as did the next set. Paula insisted on having her implants
removed. She would not heed my warnings about deformity and scarring, which we
had all been told inevitably follows removal without replacement.
To my surprise,
she looked terrific - normal, albeit
smaller - and she felt better.
Paula's problem turned out to be common:
Most breasts with silicone gel implants become hard with time. It's called
capsular contracture. All foreign objects in the body get encapsulated - just
as the tissue around a needle gets hard - until the foreign body is removed.
Women with capsular contracture often end up with disfigured breasts and pain.
Recently I saw Helen S., 71, who had implants 23 years ago. Her breasts
also had hardened and become painful. In addition, an MRI showed rupture of the
implants and calcification of the surrounding scar tissue. When I removed the
implants, the cavity was filled with gooey, liquid silicone that had ruptured;
there was virtualy no implant wall left.
In the last 14 years, I have
removed implants from almost 1,000 women.
I have found
roughly 50% of their implants have ruptured within 10 years, and more than 70%
have ruptured within 15 years.
We are still not sure of all the
places where the micro-droplets of silicone end up, though I have found it in
Despite these known hazards, the FDA, under pressure from
implant manufacturers, plastic surgeons and patients, is allowing as of January
2007, a next
generation of silicone implants in women age 22 and over.
monitor women's health, the FDA will require women who receive implants to have
regular MRls and has recommended that the implants be replaced every 10
It is a pity that women will become
the experimental lab rats for these
Most plastic surgeons
vehemently deny any connection
between health complaints and leaking silicone implants.
I have seen a disturbing number
of patients with symptoms, including
joint pain, muscle pain,
patterns, depression and hair
loss, that clear up when implants are removed.
Last year, I
completed a review of the last 500 gel implant removals I performed, and found
that more than half the women had similar symptoms, ranging from mild to
artificial breasts are a deformity that flouts medical
standards and plastic surgeons definition of "cosmetic" - often encouraged by
the media, which celebrates these water
balloons for self-esteem. I no longer perform cosmetic breast
augmentation." - Edward Melmed, MD
breast implants have a higher-than-average risk of underlying psychological
Women with breast implants are three times more likely to
kill themselves according to British Medical Journal.
"The slippery slope is if you go to a surgeon to
problems they will not be fixed." - Psychiatrist Mark I. Levy,
University of California, San Francisco
One the best examples of the way in which science was disregarded
by George Walker Bush,
just like his father
before him, is the way in which an advertising campaign was gutted to
placate the processed food
industry at the expense of the health of tens of millions of Americans.
The Health and Human Services Department had prepared a series
of public service announcements touting the benefits of breast feeding.
Once the food processors that manufacture infant formula heard about
the public service announcements they contacted GW Bush administration
officials and had the public announcement campaign "softened."
Information based on valid scientific research that would have made it
likely for women to chose breast feeding over infant formula is withdrawn.
It is well known within the medical and scientific communities that
breast fed infants are more healthy than those fed infant formula.
Unfortunately most American women do not have the information necessary
to make an informed
decision about breast feeding.
2006 Over a billion dollars worth of infant
formula is sold in the US.
Formula fed infants
likely to develop asthma;
likely to develop intestinal problems;
50% more likely to develop inner
40% more likely to develop
36% more likely to
experience sudden death syndrome;
more likely to develop childhood
"The problem with formula companies is
that they're marketing a
product clearly inferior to breast
Lawrence M. Gartner,
American Academy of Pediatrics
American Academy of Pediatrics issues a policy statement crediting
breast milk with reducing the incidence or severity of bacterial infections,
sudden infant death syndrome, diabetes,
asthma, obesity and some
No infant formula can compete, nutritionally or
immunologically, with human mammary milk tailored to the precise needs of
individual human infants.
Human mammary milk is tailored to the precise
needs of individual human infants as the mother has been exposed to the
proteins in the environment and passes that recognition on to her offspring
through her breast milk.
2008 Animals and humans
develop kidney stones.
In China 50,000 children are sickened.
least four infants die after consuming melamine tainted infant
April 3, 2009 Centers for Disease
Control (CDC) has found that 15 brands of infant formula are
contaminated with perchlorate.
Two brands account for 87% of milk based
infant formula US sales.
a potent thyroid toxin that
may interfere with fetal and infant brain development.
The study found
that reconstituting the formula with water that has levels as low as 4ppb of
perchlorate would cause 54% of infants to exceed "safe" dosage levels of the
2010 Lanzhou University finds ingestion of
melamine leads to rapid
aggregation of metabolites cyanuric acid diamide (ammeline) and cyanuric acid
building uric acid kidney
stones which lead to renal failure.
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