Another Health-Harming FDA Mistake

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http://www.mercola.com/2005/apr/27/fda_mistake.htm

 

Another Health-Harming FDA Mistake

 

 

Are silicone breast implants safe? Thirteen years after most use of

silicone-gel breast implants was banned due to safety concerns, the

Food and Drug Administration (FDA) seems to have changed its tune.

 

In a three-day hearing, two silicone implant manufacturers -- Inamed

and Mentor corporations -- were given the opportunity to prove their

implants were safe and durable enough to re-enter the U.S. market.

And, in addition to the manufacturers' " sales pitches, " more than 160

witnesses presented their pleas on both sides of the issue -- some of

which shared horrific testimonies of ruptured silicone implants

squeezing out of their eyes and ears.

 

FDA's Verdict

 

Despite arguments about serious health problems caused by silicon

implants, the FDA panel unexpectedly approved Mentor's application in

a 7-2 vote. The decision surprised many experts for two compelling

reasons:

 

*

 

Not only had the panel voted to reject a similar application

from Inamed, Mentor's top competitor, one day prior, but

*

 

Mentor was largely considered the weaker of the two

applications, as it followed patients in its principal breast-implant

study a year less than Inamed.

 

Trouble-a-Brewin'

 

Silicone implants have only been available since 1992 to women

participating in controlled research studies; however, due to the

FDA's approval of Mentor's application, more women have become eligible.

 

What does this mean? Considering more than 260,000 breast augmentation

procedures and more than 62,000 breast reconstruction procedures were

performed in the United States last year alone, the number of women

vulnerable to the adverse side effects of silicone implants is poised

to rise.

 

USA Today April 11, 2005

 

New York Times April 14, 2005

 

Houston Chronicle April 14, 2005

 

Dr. Mercola's Comment:

 

Coming on the heels of the recent Vioxx and Bextra debacles, the

latest edition in our ongoing series, " The Misadventures of the FDA, "

proves unequivocally that the folks who run things over there do not

seem to have your best long-term interests in mind.

 

A rational assumption would be that the FDA would learn something from

the Vioxx situation. Sadly, that does not appear to be the case.

 

The question here isn't about whether or not silicone breast implants

can be safe. They obviously can. If they were uniformly dangerous,

then every woman who got them would get sick, as silicone in the body

that is not adequately contained can wreak havoc on your health.

 

Therefore, the question should simply be, what happens if they rupture?

 

Read this testimony from one of my patients and see for yourself.

 

I simply don't understand how the FDA, unless it was influenced by

greed, could have come to their decision to allow silicone breast

implants back on the market. Even if the incidence of implant ruptures

are reduced from their previous numbers,

 

They Will Still Rupture.

 

Upon doing so, they will cause the same problems they have caused before.

 

I strongly believe that breast implants are a temporary solution to a

deeper issue: Poor self-image. Not being able to accept the way you

naturally look contributes greatly to a woman's decision to have this

surgery in the first place.

 

 

 

 

 

Related Articles:

 

Breast Implants: America's Silent Epidemic

 

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How Your Perceptions Can Improve Your Health

 

Most Women Satisfied With Having Their Healthy Breasts Removed