A must read message by a doctor barred from testifying before the FDA

[Guest guest]

http://health.blogharbor.com/blog/_archives/2005/4/12/574543.html

[Guest guest]

> http://health.blogharbor.com/blog/_archives/2005/4/12/574543.html

I wanted to post this whole page in case this link ever goes dead.

This is too important to lose!

FDA Considering Lifting the Ban on Silicone Breast Implants - A

Public Editorial by Dr. Hufnagel, MD

by texasrn at 08:55AM (CDT) on April 12, 2005 | Permanent Link |

Cosmos

The following is a public editorial regarding the FDA's April 11,

2005 review and consideration of lifting the ban on silicone gel-

filled breast implants.

Please note: Dr. Hufnagel requested to speak at the April 11th FDA

meeting regarding the breast implants. She is the only MD who has

spoken out against such abuses, and has paid the price for doing so.

When she called about this meeting she was met with hostility, and

was told no that she could not speak. In 2001, she spoke in front of

the FDA about UAE (silicon pellets put in the ovarian artery), which

can be read about at http://drhufnagel.com/FDAissuesUAEakaUFE.htm

and at http://drhufnagel.com/05222001FDATranscript.htm

(http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3753t2.rtf) FYI,

after this meeting the UAE was approved by the FDA. It is still

considered experimental, and in trials - a little known fact -

Something that Condoleeza Rice may not have been aware of when she

had her recent UAE. For more about UAE, and what Condoleeza Rice

underwent see here: http://drhufnagel.com/UAEbloodsupply.htm

Please read the following from Dr. Hufnagel regarding this current

FDA action. In Dr. Hufnagel's words, " The FDA has already made the

decision to allow these " Silicone Gel-Filled Breast Prostheses " .

This meeting is just going through the steps required so that they

can go to market.

Release

Public and Press

From: The Hufnagel Foundation : The Insider by Dr.Vikki Hufnagel MD

Date: 04/08/05

Re: FDA and Silicone Breast Implants

Hearings April 11-13 at the FDA on Silicone Breast Implants

The Insider Report

In 1994 I traveled to the FDA to make an important report to the

device committee. I had witnesses as a surgeon operations on women

with silicone breast implants. I saw the mutilation that took place

when implants where removed. I saw that plastic surgeons did not

remove the capsule and leaked silicone. They simply took out one

implant and replaced it with another. The public and there patients

had no idea that disease tissue was left in their chest .

What was found need to be reported so I had Marc Popp a film maker

from Germany and Wine who now owns the Vintage Wine NY and was

a health advocate at that time with me. I had found that silicone

was being left that in the body by plastic surgeons. It stuck like a

super glue so the plastic surgeons were removing the leaking

implants but left behind the majority of the spilled silicone.

Also surgeons were putting implants back in women stating that

otherwise they would be deformed if they did not have replacement

implants. I saw such deformity take place. The instruments used by

plastic surgeons did not assist in removal of spillage nor the full

capsule created from the implant.

What I reported also was that saline implants also put fragments of

silicone in the chest wall. This was 1994 in an official report to

the committee at that time that over saw breast implants. I provided

case studies and pathology reports to the FDA to prove these points.

Since 1994 none of this has been made public by the FDA.

However at that time I began and did informed the FDA that Plasma

State surgery allowed one to remove the silicone and assisted in

preventing deformity. I then created a means to expand the breast

cavity without an implant so that there was no deformity. The points

I made to the FDA were based on over ten cases in which the

following was noted:

1. In cases of silicone implants which were filled with saline the

tissue next to the implant was removed and tested. Silicone was

found in this tissue. Repeated pathology studies showed silicone. I

then had this sent to the US Army Pathology Group to confirm

silicone fragments. They confirmed the silicone fragments.

2. Thus the silicone in the implant capsule migrated into the

surrounding tissue. Many people feel that saline implants have no

problems with silicone which is not correct. The removal of saline

implants and testing of the tissue to show silicone fragments in the

tissue was of significant importance. The pathology reports were all

provided to the FDA in 1994. I have no idea why the FDA never made

this study public. It was and remains the only study which evaluated

the tissue in the chest wall.

3. With this information all removed implants should have had

testing in the capsule for silicone. Yet, still now 11 years later

this is not being tested for.

4. Continued studies provided to the FDA that the breast implants no

matter what they were made with silicone or saline causes chest wall

defects. The implant deforms the ribs which they are laid over. The

weight of the implant crushes the rib to be deformed and weakened.

The rib is indented from the implant. This is a deformity of the

structure of the chest. This I have never seen reported or even

discussed. In every case there is rib deformity. I had x rays and

MRIs to prove this and provided this as well. I know al the plastic

surgeons had to see this each time they operated it is obvious. This

will have an affect on lung function. This deformity also can deform

the nerves and blood supply under each rib. This needs to be studied

and made public as well and it is not. I was very clear to provide

this to the FDA.

5. The studies that are need to be done to prove problems, or the

possibility of problems with implants are not being properly

performed.

6. Chest wall studies need to be performed

7. Tissue of the capsule submitted for pathological evaluation

8. Many women have an allergic and negative response to silicone.

These women develop an antigen to silicone,. Researchers at the NIH

clearly have established that antigens and antibodies to silicone

are real and exist. Anyone involved in silicone complications is

well aware that blood tests are need to evaluate for these reactions

to silicone. To not test for the antibodies and antigens is not

acceptable science. However, none of the current implant companies

have studied for this response. This test is available to all. Yet

the plastic surgeons never order this test for their patients with

complaints.

9. There are no proper guidelines to test for the serum changes in

the body when it comes into contact with silicone.

10. Any of us involved in research in this area also run other blood

tests to look for inflammatory changes in the body . These are

common and accepted studies. Yet these to are not being performed to

evaluate breast implants.

1/WBC

2/Sed Rate

3/Rh factor / Lupus/ Compliment Fixation

4/Galium Study

However women in the public still are not aware that they can be

tested for reactions to silicone. The pain , inflammation, itching

are common symptoms. . This is real science which the FDA and so

called reporters have ignored . Few members of the public are aware

that antibodies and antigens exist to silicone. This is not a

progressive state of education we have been reporting on this for

ten years with no response from the media and press. Pure science is

ignored.

11. The medical community is unaware that the breast can regenerate

breast tissue. In cases of lumpectomy in which the tumor is removed

and tissue expansion placement takes place . It takes several months

but normal breast tissue grows to fill areas where tumor is removed

from the breast. This is a basic concept that is not known by the

public and not used by the medical community in their reparative

work. Safe dissolving material can be used in the breast to prevent

deformity and allow normal breast tissue to occupy the vacant space.

This will be another Press Release will be making on FRS for Breast

operations.

12. Recently our center has developed non mutilating and reduced

pain operation Female Reconstructive Surgery for the Breast. This

technology can reduce the mutilation of the female breast. Thus the

pretext that has been brought to the FDA that Breast Implants are

prosthesis is a social scam.

13. Women have breasts normally the concept that normal breasts are

not adequate and a prosthesis is necessary is bizarre. Certainly one

could state these are needed after a mastectomy. However a

traditional mastectomy does not leave enough skin to have said

implant. The rosthesis is for looks alone because it does not

function in the breast. The breast in the female is an immunological

and hormonal organ. This function has been ignored by the medical

community. An few in the public are aware as well . And the media

and press has Never covered this aspect of the breast.

14. Other areas such as limb replacement we are seeking function and

improved appearance. Certainly the normal breast does not require a

prosthesis. An implant has no function at all. It serves to destroy

normal breast tissue and the chest wall.

15. And now we know that in reparative operations the breast tissue

can grow back and fill out the breast in a matter of 3 to 4 months.

Using new techniques and technology women do not have to have their

breasts mutilated .

16. FDA hearings seem to be open and full of input to the public.

The reality is the hearing is the formal event of what has likely

already taken place. Papers are submitted. The evaluators have read

all the submitted papers and have made their minds up pretty much

before the hearing takes place. The hearing is the formal public

event. The ublic speaking time is limited and often is only about 2

hours per hearing. So that very little opposition can actual take

place. Also the ocuments need to be reviewed to make proper comment

and challenge are not made public before the hearing.

17. Having testified at the last FDA hearing on breast implants I

signed up to get notices on all of the meetings and reports. The FDA

failed to send these . You sign up for them. Bucher was

present when I testified last time. .My name disappears from the

list, Submitted documents are not provided to the public . The FDA

allows one to submit papers . So thatat no one ever knows the number

of complaints made by the . Oral testimony is limited to a few

minutes and often speakers who signed up never get to speak. Or they

are cut off.

18. Many of the self help groups against silicone implants will not

be part of the hearing. They were not given notice and did not sign

up to speak. But you will read the report of the hearing and believe

it was just and fair and that nothing was wrong with silicone so it

was passed so it could be used. The mechanism of these hearings is

not covered by the press. Also in the past many relationships are

covered up. Who owns what stock? Who is a consultant of a company?

What is the self interest of the committee members?

19. I am working on another report on new technology for the breast.

This notice though I hope caused some one to think about these

issues. And why is my Foundation the only one standing up to the FDA

and drug companies?

Posted to: Main Page

General Health

Women's Health

Comments

Re: FDA Considering Lifting the Ban on Silicone Breast Implants - A

Public Editorial by Dr. Hufnagel, MD

by Mollyb54 at 08:17PM (CDT) on Apr 15, 2005 | Permanent Link

Excellent post! The FDA should not lift the ban on silicone breast

implants. There are no studies of the long term effects of silicone

rupture in the body. Contrary to what some say, silicone implants

have NOT been exonerated, with respect to the correlation between

rupture and systemic autoimmune illnesses.

Two years ago, an acquaintance (a retired doctor) asked me if I had

breast implants, after I explained the health problems I was

experiencing. Our only contact had been by telephone (I was helping

him with some legal research on unrelated issues), and I was stunned

that he asked me such a question. He advised me to have MRIs taken,

correctly suggesting that the implants may be ruptured. I do not

know how long they were ruptured, but I can pinpoint the time when I

started having serious problems -- shortly after a mammogram when my

implants were 15 years old. This was 6 years before I discovered the

rupture.

Since I had the implants removed my health has improved, but it has

been an uphill battle. I also do not know what the long term

prognosis is, since no studies of the long term effects of rupture

exist. There likely will never be adequate studies as long as

implant manufacturers and plastic surgeons continue to exert

influence over the FDA and implant research (or lack thereof).