Activists inflate women's fears about safe breast implants

[Guest guest]

Hi Ladies,

We need to educate this man. Please read article and

write to him. At the end of the article is an email I

sent him.

Kathy Nye

http://www.theunionleader.com/articles_showa.html?article=53806

mfumento@...

Commentary:

Activists inflate women's fears about safe breast

implants

By MICHAEL FUMENTO

Guest Commentary

A FOOD and Drug Administration advisory panel just

voted 7-2 to allow one corporation's silicone gel

breast implants back on the market with conditions to

monitor their safety. But the agency has a history of

rejecting its panel's decisions on the devices, which

have been banned for 13 years.

It thus remains to be seen whether the FDA will listen

to science and reason, or whether yet again it will be

swayed by anti-implant lobbyists and anecdotal reports

equating ruptured implants with black magic.

In 1992 FDA Commissioner Kessler rejected the

advice of two FDA panels and banned silicone implants

except for post-mastectomy breast reconstruction. So

doing, he capitulated to such far-left groups as

Fenton Communications (the PR firm that scared

everyone into believing Alar-treated apples were

poisonous) and Public Citizen. These groups alleged

the implants caused all sorts of horrible diseases,

especially autoimmune (or " connective tissue " )

illnesses like lupus.

While they had no scientific evidence of such harm, in

fairness implant makers had little evidence of lack of

harm. Meanwhile the activists trotted out women who

insisted implants had inflicted bizarre illnesses upon

them, giving no more evidence than that they allegedly

fell ill at some point after the devices crossed their

path. (One major lawsuit involved a Californian who

had the implants inserted to replace breast tissue

lost during surgery for fibrocystic breast disease,

then later claimed the implants gave her fibrocystic

breast disease!) But in the ensuing years, study after

study and panel after panel rejected the accusations.

In 1998, the European Committee on Quality Assurance

and Medical Devices in Plastic Surgery declared the

evidence " conclusive " that the implants do not cause

autoimmune disease. Moreover, the committee said,

" there is no scientific evidence that such things as

silicone allergy, silicone intoxication, atypical

disease or a 'new silicone disease' exist. "

The next year the National Academy of Sciences'

Institute of Medicine (IOM) issued its report based on

all existing scientific literature in the area, over

1,000 published studies. It concluded that diseases

attributed to the devices " are no more common in women

with breast implants than in women without implants. "

So when implants came up for review again in 2003,

activists needed a new tack.

They basically conceded that while no excess disease

had yet been found, not enough time had elapsed to be

certain. Nevertheless, between those hearings and the

completion of the IOM publication at least two dozen

new silicone implant studies appeared in medical

journals. More than half involved an average patient

follow-up of 10 years or longer.

Two studies, comprising a total of 18,500 implant

recipients, dated back three decades. Neither found

any ill effects. Once again, an FDA panel voted to

lift the ban; once again the FDA kept it firmly in

place. This time around, with an additional three

years of safety evidence available, opponents chose

yet another line of attack. They insisted we need more

data on how long the devices last.

But evidence indicates they usually last longer than

the average of 10 years for pacemakers and an average

eight years for biological mitral heart valves. The

newer " cohesive gel " or " gummy bear " implants are

designed to last even longer. And remember, a rupture

simply means more surgery — not illness.

The myriad aforementioned studies inevitably and

sometimes exclusively looked at women with ruptured

implants. Time for that ol' black magic! CNN.com

titillated us with news of a woman who complained of

" yellow strings of silicone oozing from her eyes. " The

New York Times kept readers abreast of women who " gave

gruesome testimony about silicone from ruptured

implants squeezing out of their eyes and ears. " In

fact, silicone from a ruptured implant usually stays

put because built-up body tissue " encapsulates " it.

When gel does migrate, it remains localized. It does

not go to the head. Actress Sally Kirkland even claims

ruptured implants gave her Epstein-Barr disease and

" borderline hepatitis. " Odd, insofar as Epstein-Barr

and hepatitis are both viral and there's no such thing

as " borderline hepatitis. " You either have it or you

don't. Urban legends aside, nobody ever awoke in a

bathtub of ice without kidneys. Nor will any woman

awake to discover implants in her mammaries. It's a

woman's choice and it's a safe one. It's time the FDA

honors it.

Fumento's e-mail address is

mfumento@.... He is author of " Silicone Breast

Implants: Why Has Science Been Ignored? " and a senior

fellow at the Hudson Institute.

============================================================

Dear Mr. M. Fumento:

>>>In fact, silicone from a ruptured implant usually

stays put because built-up body tissue " encapsulates "

it. When gel does migrate, it remains localized. <<<

I beg to differ with you. In my case I did not have

rupture, but I did have gel bleed. It did slide down

to over the rib area where I had to have the " foreign

material " tumors removed.

I had the original Cronin implant when I was 22 years

old (1968), after a bilateral mastectomy. It had the

mesh on the back and had to cut off my chest wall

(1976), taking part of the chest wall muscle.

I also had the Meme implant, which was taken off the

market because it released toxic material that could

cause cancer. And in spite of the mastectomy, I

developed cancer.

I have had a total of 15 implants and expanders. I

always believed my doctor that they were safe, new and

improved, and would not get hard. Unfortunately the

last one on my right side developed necrosis and

popped out, through the skin, on its own.

If you were at the FDA hearing you would have seen the

picture. It was shown when I gave testimony.

I have lived 35 years with breast implants. I know

first hand what can happen. I don't claim all of my

ills are caused by implants. But I do believe they are

unsafe to put in the human body.

I did have many ills reported to my doctor since 1969.

Unexplained illnesses. So many " like " illnesses. MS

like, lupus like. These are all documented long before

1992. I have been on SSD since 1987. I have also been

Dx with Parkinson's. I believe that there is some

correlation to the implants and the gel bleed and the

poly foam that dissolved into my body. Don't know how,

or to what extent, but its been in there.

Silicone.

There are some women who have had breast implants who

have no health problems.

Does this mean they are safe?

There are also many women who smoke cigarettes who

don't get lung cancer. Does this mean that cigarettes

are safe?

Why do you come down hard on the women who claim they

are sick from implants?

I believe the bottom line is money, the manufactures

and for the doctors who perform the surgery. Already

there is infighting between the board certified

plastic surgeons and the certified cosmetic surgeons,

because the FDA recommend the only board certified

plastic surgeons can use the silicone implant.

It should not be up to silicone implanted women to

prove they harmful, but up to the manufactures, not

taxpayers, to prove they are safe.

Sincerely,

Kathleen VF Nye