Helman's speech to the FDA

[Guest guest]

I took the liberty of posting this because, while I

could open her post, it came in fragmented. I hope

I've put it together properly.

Thanks so very much ,

Rogene

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Tuesday, July 9, 2002

Good Morning! Thank you for the opportunity to speak

to you this morning.

My name is Helman, I reside in Vero Beach,

Florida. My reason for being here is to enlighten the

F D A’ s General and Plastic Surgery Devices Panel

regarding the use of NON-ORGANIC PLATINUM in the

manufacturing of silicone medical devices.

I will be very brief.

I received breast implants in 1990 and had them

removed in 1992. ..Less than TWO years!

Nine years later

In May, 2001, samples of my hair, fingernails and

toenails, urine, blood, sweat, an excised left axilla

lymph nodule, and skin cells were obtained by ExperTox

Forensic Toxicology Laboratories in Houston, Texas for

analysis looking for heavy metals and toxins. The

Specimens were specifically analyzed for their

PLATINUM content by Inductively Coupled Argon Plasma -

Mass Spectroscopy (ICP-MS).

The PLATINUM’ S valence state (oxidation, speciation

state) additionally was characterized by Ion

Chromatography (IC) - ICP_MS).

On August 15, 2001, a bone marrow biopsy was obtained

by Dr. Marguerite Barnett, of Venice, Florida,

during surgical removal of RESIDUAL SILICONE

GRANULOMATA in my left breast and SILICONE-

CONTAINING LYMPHADENOPATHY AND PTOSIS. As well, she

removed the right axillary, breast lymph nodes and

selective thoracic lymph nodes. Samples of these

specimens were sent to The University of Florida.

Diagnostic Referral Laboratories, Department of

Pathology & Laboratory Medicine, Gainesville, Florida,

for analysis.

The results from The University of Florida are as

follows:

DIAGNOSES

A. Left retroglandular silicone granuloma with

pectoral LN (lymph node).

Fragments of implant related CAPSULE.

FOREIGN MATERIAL:

Innumerg 58%.

ExperTox states:

These results are consistent with a person that has

been employed in the manufacture of PLATINUM

containing chemical catalysts, or PLATINUM containing

jewelry, or mining PLATINUM containing ores, or a

motorway maintenance worker. In the absence of any of

the above mentioned possible routes of exposure, the

high levels of PLATINUM detected in Ms. Helman’s body

fluids and tissues, may be attributed to breast

implant PLATINUM

CATALYST, leaching out of the breast prosthetic

devices into her tissues over the period of the

implantation. In addition, further analysis of the

blood PLATINUM by ion chromatography coupled to

inductively coupled argon plasma-mass spectrometry

ICP-MS yielded evidence of PLATINUM 2+: 38% of total,

and 4+: 40% of total and 5+: 12%. This data is

indicative of the PLATINUM in Ms. Helman’s

tissues being CYTOTOXIC, and highly DELETERIOUS to the

PHYSIOLOGICAL HOMEOSTASIS AND OVERALL HEALTH STATUS OF

Ms. Helman. This is because PLATINUM was detected in

the +2 and +4 CHARGED forms and it is well accepted

among Toxicologists that this property renders it

EASILY TRANSPORTABLE ACROSS THE BLOOD BRAIN BARRIER

WITH A GREAT POTENTIAL OF ASSOCIATED NEUROTOXICITY.

The oxidation state of HEXACHLOROPLATINIC ACID

provides similar pattern in ion chromatography/ICP-MS,

with the exception of the +5 OXIDATIVE STATE that was

FOUND in Ms. Helman’s BONE MARROW In 6% of the total

PLATINUM measured. This should be viewed as an

indication of a HIGHER OXIDATION STATE, which could

provide a SERIOUS TOXIC THREAT FOR Ms. Helman’s

TISSUES.

In a comparison between this form of PLATINUM and the

known PLATINUM containing cancer chemotherapeutic

agent cisplatin; it is noted that cisplatin has a well

documented CYTOTOXIC and NEUROTOXIC ACTION and

furthermore, cisplatin is an ORGANOBOUND form of

PLATINUM MOLECULE, which property renders it LESS

TOXIC THAN THE FREE FORM FOUND IN Ms. Helman’s blood.

As part of the toxic assessment of Ms. Helman, we

established viable tissue cultures of epithelial cells

obtained from her mouth (cheek cells). These cells

were subjected to two serial passes and then to

exposures of varying concentrations of PLATINUM

extracted and concentrated by Ion Chromatography from

Ms. Helman. The results obtained clearly demonstrate

ACUTE TOXIC CHANGES AT CONCENTRATIONS GREATER THAN 2.0

TIMES the concentrations of PLATINUM measured in Ms.

Helman’s blood. At the concentration of PLATINUM

EQUIVALENT to the concentration found in Ms. Helman’s

blood the results CLEARLY DEMONSTRATE SIGNIFICANT

CHRONIC TOXIC CHANGES, SUCH AS VACUOLATION AND CELL

DEGENERATION.

These data CONCLUSIVELY ESTABLISH that Ms.

Helman HAS SUSTAINED CHRONIC TOXIC CELLULAR INJURY,

with PLATINUM PRESENTLY DISSEMINATED THROUGHOUT HER

BODY FLUIDS AND TISSUES.

I can only speak for myself; however, I am an example.

This is how I have been affected, how my body has been

affected. My body is KILLING itself!

There are many women like me in these United States

with illnesses and challenges too numerous to list;

nevertheless, we would ask this F D A Panel to be

thorough in its understanding of the manufacture and

use of silicone in medical devices.

Respectfully Submitted

A. Pope Helman

3010 Par Drive

Vero Beach, Florida 32960

(772) 562-1205

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