"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. Mundorff 02/08/09
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.
"I have enlarged the breasts of
thousands of women with silicone implants since they were first introduced in
I even wrote articles in favor of silicone.
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.
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 splinter 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
In the last 14 years, I have removed implants from almost
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 lymph nodes.
these known hazards, the FDA, under pressure from implant manufacturers,
plastic surgeons and patients, is allowing as of January 2007, a new generation
of silicone implants in women age 22 and over.
To 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 years.
It is a pity that women will become the
experimental lab rats for these implants.
surgeons vehemently deny any connection between health complaints and leaking
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
seeking breast implants have a higher-than-average risk of underlying
Women with breast implants are three times more
likely to kill themselves according to British Medical
"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
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