FDA Considering Lifting the Ban on Silicone Breast Implants - A Public Editorial by Dr. Hufnagel, MD

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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

To:    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 Susan 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. Susan 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?

Dr Vikki Hufnagel MD

4/10/05

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Dr. Vicki Hufnagel, MD