5 octobre, 2005 23:05

Heads Up, Ladies, FDA employee online

Ladies,

United States Senate Committee on Health,

As the FDA considers relaxing restrictions on the use of silicone it is more important than ever that we know the full story! PLEASE INVESTIGATE! Lets make sure that the chemicals we allow to be placed in the human body will do no harm!

I am writing to you in an appeal for justice. Innocent United States citizens are suffering injury and disfigurement at alarming rates from toxic chemical exposure, and toxic heavy metal poisoning from supposedly safe products, and are incurring millions of dollars of health care expense each year, much at taxpayer expense. What is happening is criminal, and should be investigated as such.

For many decades manufacturers have sold products, such as silicone gel/saline, single-lumen (saline mixed with silicone gel) and double-lumen adjustable breast implants.

Dr. Ray Biagini, Director Research Scientist/Research Toxicologist at CDC/NIOSH states that soluble salts of platinum are the most potent chemical sensitizers known to man.

THERE IS NO KNOWN WAY TO GET IONIZED PLATINUM AND SILICONE OUT OF THE BODY.

Saline Implants have leaky valves, shell defects (rupture). Micro Organisms accumulate over many years. As a result, with time, the closed space fills with a complex mixture of bacteria, fungi, algae, and slimes. Organisms Found In Such Environments Include: Pseudomonas Aeruginosa, Pseudomonas Putida, Streptococci, Spivarum, CoccidioidesImmitis, Papilloma Viri, Herpes Simplex, Aspergillus Fumigatus, Aspergillus Boufardi, Aspergillus Niger, Bacteroides Fragillis, Curvularia, Staphylococci, Mycobacterium Chelonei, Mycobacterium Fortuitum, Mycobacterium Tuberculosis, Mycobacterium Avium, Alternaria Tenuis, Rhodotorula Glutinis, Penicillium Notatum, Microsporum Epidermophyton, Ricophyton, Candida Albicans, Proteus Mirabillis, Propioni Bacterium Acne, Serratia Marcescens as well as their metabolites and toxins.

The chemicals that are used in the manufacturing process, and that remain in the finished product, are deadly. The chemicals that are present include heavy metals such as platinum, which in the ionized form used in the manufacturing process is so deadly that the Federal Government has determined that NO AMOUNT is safe in the human body.

Exposure to ionized platinum, silicone, heavy metals and toxic chemicals cause such diseases as Multiple Chemical Sensitivity, Multiple Sclerosis, Lupus, Connective Tissue Disease, Scleroderma, Sjogren's Syndrome, Fibromyalgia, Arthritis, Thyroid, Chronic Fatigue Syndrome, Leukemia, DNA Changes, Immune Dysfunction, Autoimmune Disorder, Loss of Memory, Loss of Smell and Taste, Organ Calcification, Neurological Disorders. Compounding the problem, ionized platinum and toxic chemicals involved readily cross the placental barrier, unpublished research document that significant amounts of ionized platinum are present in the milk of nursing mothers, so even the unborn future generations of poisoned mothers will be affected.

Although we, the victims, are just finding out about the toxicity of the products we have been exposed to, the companies that are manufacturing these products have known for as much as 40/50 years that their contaminated products can, and are, killing and maiming people. Rather than face the problem, many companies, such as Dow Corning/Chemical are actively engaged in covering up and hiding their complicity. They have withheld evidence from the FDA and others, and have quietly been buying up the labs that could test for things such as ionized platinum. Of the few recipients of silicone products who have managed to be tested for ionized platinum, significant concentrations have been found in many.

The United States has jurisdiction over the chemical companies that are injuring her citizens. These products are being sold in every state. The time has come to support an independent investigation into the suffering of the victims, and to hold the guilty responsible. PLEASE issue a call for an independent investigation to hold responsible those who have caused so much suffering. Criminal indictments are harsh, but so is the suffering and death that has resulted from the negligence of marketing untested products and the cover-up to hide the evidence.

1. Dow's List of Studies /92 - from the evidentiary files of breast implant litigation ~ 12/30/92

2. Canadian Research Funding - from the evidentiary files of breast implant litigation ~ 10/1/92

3. Canadian request for research funding & Dow response- from the evidentiary files of the breast implant litigation ~ 5/22/92

4. BMS donates to PSEF - from the evidentiary files of the breast implant litigation ~ 1/6/93

5. More on Birth Defects - from the evidentiary files of breast implant litigation ~ 12/11/92

6. Penile Concerns - from evidentiary files of breast implant litigation ~ 8/27/92

7. Congressman Seeks Dow Corning Hearings ~ 7/24/95 ~ Question about 1995 article

8. 1993/ Articles on Possible Link to Autoimmune Disease - from the evidentiary files of breast implant litigation

14. Breast Implants Linked to Cancer, Lung Diseases, and Suicide

15. Cover-Up..... An Internal memorandum that discloses the Dow Strategy for the Breast Implants Cover-Up ~ June 24, 1991

September 16, 2005

My letter has the information summarized that the packet contains, documents, letters, articles, testimonies, from toxicologist, pathologist, chemist, immunologist, allergist, researchers and some of the recent studies. Even CDC notified the FDA.

It was sent to you because there are a Million or more sick people that want to know why the FDA let this happen, KNEW and did nothing to stop it.

234,187 Adverse reports to FDA on Breast implants as of April 30 2002. This figure does not include the sick children from their injected or implanted mothers.

"Implanted and injected women, their children and men have been DENIED testing for toxic chemicals, heavy metals, silicone, ionized platinum, bacteria and fungi."

As the FDA considers relaxing restrictions on the use of silicone it is more important than ever that we know the full story! PLEASE INVESTIGATE! Let’s make sure that the chemicals we allow to be put in the human body will do no harm!

We want you to look at the whole big picture not just a very small section.

774 pages about platinum researching the archives from the CD from the PLO in Birmingham, documents and letters sent to FDA, NIH, other places and people that should have looked into the platinum issue instead they hid it.

Silica feared as the next asbestos. It is very toxic no matter who the manufactures are.

Silicone Toxicity: overexposed to the product, which could lead to silicosis "a disabling, non-reversible and sometimes fatal lung disease". Other problems can include lung cancer, pulmonary tuberculosis, airways diseases, autoimmune disorders, (The term ‘autoimmune disease’ refers to a varied group of more than 80 serious, chronic illnesses that involve almost every human organ system) and chronic renal disease. Calcification of organs, collagen diseases, female and male ratios, Hypothyroiditis, Peripheral neuropathy, Central neural toxic neuropathy, Cervical and axillary lymphadenopathy, Fibromyaligia, Myocytis, Fatigue, Night sweats, Hair loss, Abdominal pain, Pulmonary hypersensitivity with dyspnea, Emotional instability, Joint and tendon pain, Multiple chemical sensitivity (reaction to an array of other substances), Food and inhalant sensitivities, Skin problems… and more.

A saline-filled breast implant has a silicone rubber shell of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, … which is inflated with sterile isotonic saline. Silicone implants ALSO had saline in some of them. The sterile saline used as a filler is injection grade.

Conflict concerns raised on FDA panels

http://www.northjersey.com/page.php?qstr=eXJpcnk3ZjczN2Y3dnFlZUVFeXky...

Thursday, September 22, 2005
ASSOCIATED PRESS

WASHINGTON - Senators asked Congress's investigative arm Wednesday to look into the Food and Drug Administration's practice of letting scientists serve on its advisory panels even if they have conflicts of interest.

"We are concerned about the process that supports FDA's decisions to waive conflicts-of-interest rules for scientists with financial ties to the manufacturers of the products under consideration, or their competitors," senators said in a letter sent Wednesday to the Government Accountability Office.

It was signed by Sen. Mike Enzi, R-Wyo., the chairman of the Health, Education, Labor and Pensions Committee, and panel members Edward M. Kennedy, D-Mass., and Richard Durbin, D-Ill.

Members of FDA advisory committees are required by law to be free of conflicts of interest concerning products they discuss and recommend for approval. The FDA, however, can grant a waiver if an adviser's scientific expertise outweighs the risk of a conflict, or if the financial interest is small.

"These practices appear to have undermined the public's faith in the objectivity and fairness of FDA's advisory committees," the senators said in the letter.

Senators noted allegations of conflicts among the FDA panels that studied Cox-2 inhibitors - painkillers that have potential heart risks - and silicone gel-filled breast implants.

Why Are Silicone Breast Implants about to Be Approved by the FDA?

The US Food and Drug Administration is currently on the verge of approving two brands of silicone gel breast implants, which were taken off the market in 1992 by then FDA Commissioner David Kessler because of lack of adequate information on safety.

I am an FDA scientist who is posting this thread because I am concerned that the anti-regulatory and pro-corporate profit ideology of the Bush Administration is corrupting the traditional mission of the FDA which, since its inception in 1906 under the Administration of Theodore Roosevelt, has been to protect consumers against unsafe products.

None of the opinions expressed in this thread represent the official position of the FDA, but rather are my own personal opinions. All of the facts stated in this thread are publicly available knowledge. 

A brief history of the regulation of breast implants

Silicone gel breast implants have been marketed in the United States since 1963.

In 1976, the Medical Device Amendment to the Food, Drug and Cosmetic Act gave the FDA control over the approval of breast implants and other medical devices for the first time.

In 1988, breast implants were re-classified as Class III medical devices, which meant that there was significantly more concern over their safety than was previously the case. This concern was mostly attributable to the known fact that some unknown (at the time) percent of breast implants rupture, followed by unpredictable consequences. Soon after that, the FDA announced that it would require manufacturers to present evidence of the safety of their breast implants in order to be allowed to continue to market their product.

In 1992 silicone gel breast implants were taken off the US market (pending additional safety information to be submitted by the manufacturers), though still allowed under certain specified circumstances, such as controlled clinical trials, to correct congenital defects, to replace ruptured implants, and for reconstruction following surgical removal of a cancerous breast. 

Rupture rate of silicone gel breast implants

At the time that silicone gel breast implants were removed from the market in 1992, manufacturers claimed that the prevalence of breast implant rupture was about 1% or lower.

However, subsequent studies by an FDA colleague of mine, Dr. Lori Brown, using magnetic resonance imaging (MRI) to diagnose breast implant rupture in women whose implants had been in place for an average of a little over 16 years, found that the prevalence rate of rupture was at least 55% (Note: This figure applies to ruptures per implant, not per woman the rate per woman is substantially higher, since most women who use breast implants have them implanted in both breasts). In addition, a meta-analysis of 35 studies showed a rupture rate of 30% at 5 years and 70% at 17 years.

Consequences of silicone gel breast implant rupture

Consequences of silicone gel breast implant rupture include the following:

-- Migration of silicone to distant parts of the body

-- Formation of granulation tissue, with change in breast shape

-- Contracture of breast tissue

-- Chronic pain

-- Infection

-- Hematoma (formation of a pool of blood in breast tissue)

-- Repeat surgery because of the above problems

It must be noted that these problems are clinically significant and common. This is evident from another study by Dr. Brown, which documented that problems following the implantation of silicone gel breast implants were severe enough to require repeat surgery in 33% of women (average duration of implant for which surgery was required was eleven and a half years in this study).

In addition, Dr. Brown¡¦s study showed that women whose silicone migrated out of the fibrous capsule formed following the implant rupture were almost four times more likely than women whose silicone remained confined within the capsule to develop fibromyalgia. Silicone migration outside of the capsule occurred in 21% of women in her study.

Summary -- So why are silicone gel implants now about to be approved by the FDA?

In the FDA's recent approvable letters (an intermediate step towards approving products) to the manufacturers of silicone gel breast implants, one of the major stated conditions of approval was that the manufacturers conduct studies to see how long the implants last.

So, what has changed since major restrictions were placed by the FDA on the marketing of these implants in 1992, mainly because of lack of adequate information on safety relating to the rupture of these implants. I see these as the two most important changes:

1) In 1992 little was known about the prevalence rate of rupture of these implants. Manufacturers claimed this rate to be about 1%. Subsequent studies have shown rupture prevalence rates to be in the 30% to 70% range, depending on how old the implants are.

2) In 1992 the FDA Commissioner was David Kessler, best know for his courageous fight against the tobacco companies. In 2005 the FDA is under the Bush Administration, which is well known for its anti-regulatory, pro-corporate profit ideology, and lack of concern for the protection of US consumers.

Which of these two reasons do you think best explains the pending FDA approval?