Fw: Toxic Discovery's Presentation to the FDA - Oct.14th, 2003

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Subject: Toxic Discovery's Presentation to the FDA - Oct.14th, 2003

'INFORMED CONSENT BEGINS WITH INFORMED INDIVIDUALS"

Kathy ley ston, R.N.Executive Director

601 W. Nifong - Bldg. 5AColumbia, MO. 65203

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Toxic Discovery's FDA Presentation - October 14, 2003

General and Plastic Surgery Devices Panel

________________________________________________

Presentation:

"Informed Consent Begins With Informed Individuals"

Kathy L. ley ston, R.N.

Executive Director/CO-Founder-Toxic Discovery

____________________________________

Good morning my name is Kathy ley ston and I am the Executive Director of Toxic Discovery, a national consumer organization whose primary goals are education and emotional support for individuals who have sustained injuries from silicone and saline breast implants. We presently maintain a data base of over 25,000 injured consumers. My expenses and the expenses of my staff to attend this hearing were paid for by private donations from our members and by our organization. I submit to you today a collection of individual stories from women that could not be present today because they were too ill or broke to travel. This collection of stories in this bound volume is entitled “We Are the Evidence”.

My personal journey has well prepared me for my current position as Director of Toxic Discovery. I am Registered Nurse, a former Surgical Nurse, former Director of Hematology/Oncology, a medical paralegal but above all else – I am an injured consumer from silicone gel breast implants. I am also one of the nurses in the Harvard Bingham & Women’s Study. I was implanted free of charge in Midland, Texas in 1984. I was implanted free of charge in exchange to do a video for the manufacturers. I so elected not to do the video or become a “poster-child” in support of breast implants.

During these hearings the FDA will be determining once again, whether or not to lift current restrictions on the use of silicone breast implants. We ask you the Committee “What Restrictions has the FDA truly enforced?” The breast implant manufactures and plastic surgeons of this Nation would like the consumers to believe that silicone implants have been restricted – I say there has NEVER been such a ruling or a protection. I ask you – “Who is minding the Breast Implant Store?”

The Experts here today and not this Committee nor are the Experts the many representatives from the Breast Implant Manufactures. The Real Experts are, and remain, the women and children injured by this elective, non life-saving so called required medical device.

Mark McClellan, the FDA Commissioner wrote a white paper titled, ‘Protecting the Public Health; FDA Pursues an Aggressive Enforcement Strategy’. In Mr. McClellan’s paper, and I quote, “the agency is committed to pursuing Food, Drug & Cosmetic Act violations”.

In view of the evidence supporting the facts – Breast implants are not safe. Lifting “restrictions” would appear purely motivated by the special interests of plastic surgeons and breast implant manufacturers.

It was Abraham Lincoln from my sister state of Illinois who said, “Sin by silence when they should protest makes cowards of men”. The breast implant women of this World “will no longer suffer in silence”. We the women and off-spring of the chemical injured will remain “The Evidence” with or without the FDA’s so-called protection! No Committee, including this one, can change those facts.

In Missouri we were fortunate concerning education and protection involving women’s and children’s health issues. On Jan 1, 2000, Informed Consent on breast implants became law in the State of Missouri. The only other state that has such a law is the one I am visiting today – The Great State of land!

I stand before you as a simple injured consumer – I hear you speak of research and yet you turn away from the TRUTH! We the injured consumers, are, and remain, your research! We the injured consumers are YOUR EVIDENCE and we will remain just that – Evidence that no medical device is totally safe! What we are demanding is that the FDA provides us with the protection that it has been so elected to provide.

Informed consent should begin with informed individuals. Freedom of Choice vs. Informed Consent implies that women are aware of the consequences of their actions, but the women requesting breast implants have lacked information and are victims of social pressure. “The right to choose is meaningless without the right to know”!

The poor unsuspecting cancer patient has received a “double” insult to injury. They have in a large majority of cases survived cancer to only learn years later that the very device they so believed would make them whole would only later cause further mutilation. Let us not forget that the largest contributors to cancer organizations are also some of the largest breast implant manufacturers in the World. As a former Director of Oncology, I know this personally.

Do you really want to hand over a legacy of a new generation of implant consumers to the very companies who were so irresponsible to the thousands of women who purchased their products the first time?

Women historically have been the “cash-cows” of the medical profession. Women are “spoon-fed” from the cradle to the grave on how we should look by a media funded, manufacturer driven, silicone cartel that fattens their pockets claiming to be the heroes of female vanity and the self-esteem Saviors of male desire?

In 1997, the Department of Justice filed claims against Dow Corning that Medicare and Medicaid, Indian Health Service, the Department of Defense and Veterans Health Administration had paid over $50 million dollars for injures related to breast implants.

In 1999, the DOJ entered into a settlement with Inamed, the very corporation who appears in front of you today. And in 2000, DOJ also filed a lawsuit against former manufacturers of breast implants, including Baxter, Bristol, and 3M, on behalf of the tens of thousands of American women and the Federal government. While the latter case was dismissed by a Federal District Court, the Court of Appeals for the Eleventh Circuit reinstated the government’s case just a few days ago.

How can the FDA on one hand proceed with pre-market approval of Inamed’s breast implants while on the other hand allowing reimbursement for the harms of this very device? Either breast implants do cause harm or they don’t – which is it? One should not be able to “have their cake and eat it too”, or in this case have the restrictions lifted on silicone while on the other hand reimbursing for it harms!

How can the FDA consider placing what we know to be a dangerous device back in 1992 back on the market today without restrictions? How can you deny that implants cause problems with hundreds of thousands of women suffer in exactly the same way with the very same progression of symptoms? The only common denominator in these sick individuals is that they ALL had silicone breast implants! Can you NOT see the problem or is it that you are so tainted by manufacturer funded studies that you prefer not to see the truth?

If you believe that silicone does not harm then establish an ICD-9 Code Number so that silicone injury can be clearly and finally documented. In nursing we say, when you can name it you can treat it”. Let us finally put a name to these injuries so we can move on and finally create what we all so demand – A safe breast implant!

I ask this Committee – “Since when did the migration from a faulty medical device become acceptable?” And since when did we as American’s allow such INJUSTICE? It is beyond time that the FDA stops this INSANITY!

We must remain aggressive in our research as medical device implant science evolves into the 21st Century. We must remain aggressive specifically concerning women and children’s health issues. If this Committee grants final approval then also establish a National Registry whereby the safety of this device can be tracked instead of the factious under reporting done by the plastic surgeons and the breast implant manufacturers.

Establish a Trust funded by the manufactures that will aid in the recovery of financial assistance when the product fails. It is not a matter of IF a breast implant fails but WHEN a breast implant fails!

Toxic Discovery believes it is a crime to expose women and children to potential long-term safety risks from such implants before the risks are adequately identified. It would be even more irresponsible to permit unrestricted marketing of such implants, only to pay again for the treatment of avoidable injures through taxpayer-funded health programs or via yet another Class Action against Inamed.

“Let us not forget that “anecdotal evidence is legitimate if it appears in sufficient quantity.”

The breast implant “quantities” will continue to increase until someday YOU, the FDA, will finally be held accountable for this experimentation on individual human lives.

We the breast implant injured must demand that the FDA not approve Inameds application and we ask you to defer approval until only a SAFE implant can be offered. The injured masses call on YOU the Committee to save the next generation of women and the 2nd generation that will breast fee from these mothers. Do not allow this “Silicone Holocaust” to continue.

FDA - Hear our voices! DO NOT APPROVE THIS APPLICATION! We the injured women urge you to reconsider final action on such application in the absence of more complete clinical and scientific information.

© 2003- Toxic Discovery