That is absolutely untrue and typical Junk Science Disinformation ...
just like your lies about the science of breast implants.

The silicone gel breast implant has NEVER been approved ... and again
in January 2004 the FDA FAILED to approve Inamed's gel implants.

It was only in Spring, 2000 that the FDA gave the "safe enough"
"approval" to saline implants ... after PS's had been selling them for
close to 4 decades.

You might fool the other idiot shills and flacks ... but you are lying
yet again.

~~~ thanks to Marlene Keeling ~~~

http://www.khou.com/topstories/stories/khou040209_jw_upcloseplatinumbreastimplan
ts.49c2106.html

Up Close: Implant problems could be caused by toxic metal
10:30 PM CST on Monday, February 9, 2004

By Janice Williamson / 11 News

Click to watch video

It's commonly known as a precious metal. But some Houston women
believe platinum is taking something precious from them. The women,
along with a growing number of researchers, believe platinum in their
silicone breast implants poisoned them.

The quest for beauty often leads to plastic surgery. Much has been
written about the silicone gel breast implants that for a time were
blamed on a variety of illnesses in women.

KHOU-TV
Platinum is a catalyst used in the manufacture of silicone gel
implants.
Marlene Keeling spends hours every day working to solve the mystery.
If it wasn't the silicone that made her ill, then what did? "I
consider this the worst mistake of my life," laments Keeling. "This is
a foreign substance you're putting into your body. The body doesn't
have the mechanism to eliminate it from the body. Over time it's been
shown to break down."

She's come to believe it wasn't necessarily the silicone alone that
sapped her energy, caused shooting pains in her legs and affected her
memory. "My implant was in the small study that was tested. It
released significant amounts of platinum," explains Keeling. "And also
my blood, urine, sweat, hair and nails were all tested and they
contained significant amounts of platinum."

Platinum is a catalyst used in the manufacture of silicone gel
implants.

Dr. Ernest Lykissa also uses it in his toxicology lab. "You know why I
have it in this container?" asks Dr. Lykissa. "I wouldn't dare open it
unless I have personal protection."

The toxicologist has tested small groups of women for platinum
poisoning, including 32 women with ruptured implants. Of those, almost
half had high platinum levels. Dr. Lykissa says the women's levels
were as much as 60 percent higher than woman who didn't have silicone
implants.

German researchers have also published a small study that found
platinum and siloxanes leak from implants and accumulate in their
surrounding tissues.

Dr. Lykissa believes it's a reactive platinum that makes silicone gel
implants dangerous. "Ma'am, I wouldn't let my dog to have these things
in them," says Dr. Lykissa.

Platinum can be found in pollution. It's also emitted by the catalytic
converters in our vehicles.

But researchers doubt the exposure is great enough to cause the high
platinum levels found in women with ruptured implants.

"Is it the platinum? Is it the silicone? Is it the gel? Is it the
sand? Who knows, " says Dr. Rod Rohrich.

The president of the American Society of Plastic Surgeons argues it
has been impossible to scientifically link breast implants with any
specific illnesses. But Dr. Rohrich also says, "It comes back to the
fact we want every implant whether its silicone or not to be safe.
That's why we encourage more probing into these types of problems. We
want to do more patient safety studies."

For now, the Food and Drug Administration believes platinum does not
pose a risk. But told 11 news they will: "Continue to review the
scientific literature for any new information related to the safety of
platinum compounds that may be present in silicone gel implants."

"I never thought that would be possible because I thought certainly if
a doctor is putting them in me they're safe," says Yvonne Perkins. But
she doesn't think so anymore. She's been diagnosed with multiple
sclerosis and has tested positive for an extremely toxic type of
platinum.

What's worse she says is her daughter, Kaitlen. "My daughter had
levels high enough to be alarming," says Perkins.

Born after her mother got silicone implants, the 15-year-old has
suffered a variety of illnesses. At three there was leg pain. At the
age of 12, Kaitlen was put on human growth hormones because she
weighed less than 50 pounds.

Perkins worries her daughter's health problems, could be linked to the
decision she made to get silicone breast implants. "A very long, hard
road," says Perkins. "Forgiveness is the key. I've had to learn to
forgive myself."

Perkins wants young women willing to undergo surgery to achieve a
better body to be made aware of the price they could eventually pay.

Platinum isn't just used in the manufacture of silicone implants, it's
also used to make saline implants. And just to clarify, platinum is
used in the casing that surrounds the implant.

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

For more information on the risks of breast implants, please visit:

www.BreastImplantAwareness.org

Actually, it is quite clear that she edited the post specifically to make it
look like I said that. She removed the '>'s before your comments. news
editors  don't do that on purpose.

Jeff

The words "Get with the program, my dear, fixx'em.....and enjoy life" are
the words of another poster.

It is  up to a woman and her doctor to determine whether the potential
benefits outweigh the risks.

Someone who thinks that patients, along with their physicians should weigh
the risks and benefits of procedures.

Again, you will note that there are 3 '>'s in front of that text. I never
said that.

Again, those were not my words.

I never said it doesn't.

Jeff

Dear implanted and anti-implant friends -
As fascinating as your conversations and flames about silicone and boobs
has been, I must ask you to please stop cross-posting to
alt.support.scleroderma.   It's rude and confusing and has always been
considered poor etiquette on Usenet.
Amie

Women deserve choices of safe products ...

Regardless of your false claim earllier this week ... silicone gel
implants have been sold for nearly 40 years and have NEVER been
approved for safety by the FDA .. they still are being implanted
supposively if a woman is in a study group .. .but the follow ups are
not well monitored at all.

Saline implants were sold for nearly 40 years by PS's with NO safety
assurance... even now tho they are declared "safe enough" the risks
and resurgeries are staggering

The manufacturers and PS's  put enormous pressure on the FDA ...
thankfully, this Doctor in charge of the Panel had the good sense and
morality to write this:

http://www.humanticsfoundation.com/drwhalen.htm

October 31, 2003

Mark B. McClellan, M.D., PhD
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

Dear Doctor McClellan,

On October 14 and 15 of this year, I chaired the General and Plastic
Surgery Devices Advisory Panel in Gaithersburg, MD for consideration
of a PMA by Inamed Corporation for silicone gel breast implants. As I
am sure you are aware, the panel voted 9 to 6 that this PMA was
approvable and the matter is now under consideration for action at the
CDRH. I write to express as the Panel Chair my very strong
reservations concerning this vote having thoroughly reviewed the PMA,
heard my scientific colleagues on the panel as well as the
presentations of Inamed and the FDA, and having intently listened to
all of the over 100 individuals who gave public testimony.

At its essence, and as is mandated by federal code, the mission of an
FDA panel and then the FDA itself acting upon the panel recommendation
is really elegantly simple: to judge that the company bringing the PMA
before them has demonstrated with reasonable assurance that the
product under consideration is both safe and effective. Effectiveness
was demonstrated (and is almost self-evident). Long-term safety, the
concern that prompted the removal from the market eleven years ago,
was clearly not demonstrated and to approve this device poses threats
to women that are clearly unknown. In my opinion there is at least
one facet of long-term danger that was established during the panel –
specifically the obscuration of surrounding normal breast tissue to
mammographic detection of breast cancer. The re-operation rates and
other local complications from silicone leaking outside the breast
area have also been established by FDA scientists and are not minor
considerations for a cosmetic device. Moreover, despite the
sophistication of the Institute of Medicine's report, all of what was
considered by them reflected low-quality data in the age of
evidence-based medicine.

It is incumbent upon the FDA to demand that the manufacturer establish
in a rigorous prospective, controlled study that these devices,
despite their established breakage and leakage rates, are safe in the
long term. If that is deemed to be not feasible for the company, then
they should abandon pursuit of approval. However, the company's track
record suggests that they are capable of such research but have not
been sufficiently motivated to complete it.

The plethora of approval conditions that had my head spinning during
panel deliberations is proof that even those who voted the PMA as
approvable are deeply concerned about the lack of long-term safety
data on this product. What will motivate the company to follow these
FDA requirements? Most upsetting was when an FDA official admitted,
at my pressing, that there is little if any remedy for the FDA if
demands to demonstrate long-term safety are not carried out by the
company.

I need not point out to you in your position what the term "FDA
Approved" represents to our citizenry. Once this horse is out of the
barn, indeed for a second time, there will be no recourse.

I have the utmost respect for my colleagues on the panel, one and all.
This most assuredly includes the four well-respected and
knowledgeable plastic surgeons. Certainly, it was essential to
include board certified plastic and reconstructive surgeons when
considering a PMA on breast implants. On the other hand, it serves
the reputation of the FDA in general, and the standing of the panel
process in particular, exceedingly poorly to have had all of the
plastic surgeons vote the PMA as approvable on such a close vote.
Even in academic settings, plastic surgeons may stand to increase
their own income with the use of these devices. To cite a worn
aphorism, it just does not play well in Peoria.

In closing, I must add that the issue of medical care of women who
suffer complications from these implants is extraordinarily troubling.
Costs for removal of these implants and for extra-capsular silicone
can be enormous and are very rarely covered by a health plan. This is
a public health issue of no small import that must be addressed should
the FDA second this misguided panel decision.

I have been honored to be a part of the General and Plastic Surgery
Devices Advisory Panel these past few years, and have been extremely
impressed by the devotion and professionalism of those in your agency.
I regret that the final chapter of my FDA experience was this one and
implore you and Doctors Feigal and Witten to not approve this PMA. I
would be delighted to provide any further information if you desire
it.

Sincerely yours,

Thomas V. Whalen, MD

Professor of Surgery and
Pediatrics

cc: David W. Feigal Jr., MD
Celia Witten, MD, PhD
Senator Jon Corzine
Senator Edward Kennedy
Senator Frank Lautenberg
Representative Roy Blunt
Representative James Greenwood