Fw: Dr. Harbut's Citizen Petition on Platinum in Breast Implants

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Dearest Patty:

Here is more old information on platinum.

Much love...Lea

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>

> Dr. Harbut's Citizen Petition on Platinum in Breast Implants

>

>

> > ~~~ thanks to Keeling ~~~

> >

> > A copy of Dr. Harbut's Citizen Petition to the FDA can now be found

at

> >

> > http://www.info-implants.com/USA/Keeling/01.html

> >

> >

> > CITIZEN PETITION 00P-1607/CP 1

> >

> > November 7, 2000

> >

> > Dockets Management Branch

> >

> > Food and Drug Administration

> >

> > Department of Health and Human Services, rm 1-23

> >

> > Rockville, MD 20857

> >

> > The undersigned submits this petition to request the Commissioner of

> Food

> > and Drugs, revoke the implantation of silicone gel-filled breast

> implants

> > (SGFBIs) for any reason, in light of new research documenting the

> > significant release of platinum in a reactive valence from intact

> implants.

> > FDA's own research " Prevalence of Rupture of Silicone Gel Breast

> Implants

> > Revealed on MR Imaging in a Population of Women in Birmingham,

Alabama

> > (October 2000) documents 77% or 265 of 344, had at least one breast

> implant

> > that was rated as ruptured or indeterminate. Silicone gel was found

> outside

> > the scar capsule in 73 women or 21.2% of implanted women in this

study.

> It

> > would be presumed that toxic hypersensitizing platinum would also

leak

> > outside the scar capsule. Thus, making the risks of chronic exposure

to

> > toxic platinum outweigh the benefits of this class III device which,

by

> > law, must be proven safe and effective. As no manufacturer of SGFBIs

has

> in

> > the thirty year history of their use, been able to prove them to

either

> be

> > safe or effective and since other forms of breast reconstruction are

> > available, no justification can be envisioned to allow the continued

> > marketing of this defective toxic device.

> >

> > Upon confirmation from other independent research, the undersigned

also

> > requests the Commissioner of Food and Drugs issue a public health

alert

> as

> > to breast-feeding or pregnancy to avoid possible genotoxic effects

and

> > advice as to removal to avoid potential or worsening health

> consequences.

> > It is further requested that all remaining inventories of SGFBIs in

the

> > United States be destroyed in order to protect the health of women

and

> our

> > future generations.

> >

> > In support of the above requests, I submit the following:

> >

> > 1. Published peer-reviewed research " Release of Low Molecular Weight

> > Silicones and Platinum from Silicone Breast Implants " (1997) by

Baylor

> > College of Medicine documents the ability of new equipment (GC-AED,

> GC/MS,

> > ICP-MS) to detect silicones in the nanogram range and platinum in

the

> parts

> > per trillion range. This research also studies the rates at which

low

> > molecular (LM) silicones and platinum leak through the intact

implant

> outer

> > shell into surrounding media under a variety of conditions. Leakage

was

> > greatest when the surrounding medium was lipid-rich and,

potentially,

> could

> > lead to significant accumulation within lipid rich tissues (breast

> tissue,

> > brain tissue, myelin, etc.). Previous research " Measurement of

Platinum

> in

> > Biomedical Silicones by ICP-MS " (1995) and subsequent research

" Platinum

> > Concentration in Urban Road Dust and Soil, and in Blood and Urine in

the

> > United Kingdom " (1998), both used ICP-MS to measure platinum release

> from

> > either silicone gel-filled implants or concentration in body fluids.

The

> > 1995 research by El-Jammal and Templeton found platinum was present

at

> > approximately 4.5 micrograms per gram (-1) in a silicone breast

implant

> but

> > was absent from medical grade silicone oil, indicating that platinum

> used

> > as a catalyst in polymerization was not removed from implanted

devices.

> >

> > 2. New research soon to be submitted for publication by Ernest

Lykissa,

> > Ph.D., using ICP-MS to measure the amount of platinum release and

ion

> > chromatography to speciate the platinum release, has shown that of

the

> > eight SGFBIs tested, all eight had significant release of platinum.

Most

> of

> > which was in a toxic hypersensitizing reactive valence (see attached

> table

> > - Attachment 1). See included symptoms and diagnoses of the

explanted

> women

> > in this study (Attachment 2 - further documentation will be provided

> upon

> > request). While this is not a large study, a small study by Semple

et

> al.,

> > " Breast Milk Contamination and Silicone Implants " (1998) of fifteen

> > lactatin g women with breast implants measuring silicon (the second

most

> > abundant element on earth) is quoted in the FDA's Breast Implants -

An

> > Information Update 2000. Furthermore, the FDA and the Institute of

> Medicine

> > (IOM) uses this small study to erroneously imply that breast-feeding

by

> > breast implanted women is safe.

> >

> > 3. The manufacturers of implants agree that " platinum salts "

> > (chloroplatinic acid) can cause systemic disease in humans as a

result

> of

> > toxic and/or hypersensitivity reactions. The manufacturers claim

there

> are

> > no " platinum slats " in silicone gels and elastomers. Court stamped

> > documents indicate the platinum catalyst used by the manufacturers

is

> > hexachloroplatinic acid or chloroplatinic acid (platinum salts). The

> > manufacturers, in private correspondence to the IOM, claim any

platinum

> > residual left in SGFBIs is in a zero oxidate state or is colloidal,

> > elemental platinum. The manufacturers' internal documents, the

testimony

> of

> > manufacturers' employees, and the admissions of the manufacturers in

the

> > Supplemental Submission on Platinum all point to the conclusion this

is

> not

> > true. In document DCCKK A028229 Dow Corning Corporation Proprietary

> > Information for mammary implant material formulation Q7-2046, it

lists

> > chloroplatinic acid among the ingredients. A foot note at the bottom

> states

> > " (a) denotes ingredient removed during manufacturing process " . There

is

> no

> > (a) after chloroplatinic acid.

> >

> > 4. L. Wabeke, MSc, MscChE, CHMM, PE, President of Chemical

Risk

> > Management estimates the amounts of platinum salts present in two

260 cc

> > silicone gel implants demonstrate an in vivo platinum salts exposure

to

> > platinum in women with silicone gel implants 1000 times greater then

the

> > occupationally allowed limit. The OSHA permissible air-borne

exposure

> limit

> > is 0.002 mg Pt/m3 for soluble platinum salts in industrial workers

(OSHA

> > 1981). Dr. Wabeke states " How much ionized platinum remains in vivo

is

> > debatable, but any analytically-detectable amount, in my view, given

the

> > high toxicity and biological reactivity of soluble ionized platinum,

is

> too

> > much " . Wabeke sites the research by Agnew et al., " Neuropathological

> > Effects of Intracerebral Platinum Salt Injections " which studied the

> > effects of multiple injections of two platinum salts (potassium

> > chloroplatinate and chloroplatinic acid) on cat brain. He concludes

the

> > amounts of platinum used in this research are within the same order

of

> > magnitude as those detected in the silicone implants. Furthermore,

> Schuppe

> > et al., " T-Cell-Dependent Popital Lymph Node Reactions to Platinum

> > Compounds in Mice " (1992) demonstrated immunogenicity after

injections

> of

> > hexachloroplatinate in mice. As in the Agnew et al research, the

amounts

> of

> > platinum used are in the same range as amounts of platinum in the

> silicone

> > implant materials. Wabeke states " Clearly, breast implants weigh

more

> than

> > one gram, so the amount of implanted platinum in humans exceeds

> > treated-mice amounts. "

> >

> > 5. The research of Potter, et al., " Induction of Plasmacytomas with

> > Silicone Gel in Genetically Susceptible Strains of Mice " (1994)

> establishes

> > that platinic chloride is a water-soluble form of the metal that is

used

> as

> > the preferred catalyst in medical silicone gels and elastomers.

Their

> work

> > further establishes that any soluble platinum leaching from an

implant

> > would be expected to distribute in the circulation as a

chloroplatinate.

> > Dow Corning research on nipples for baby bottles determined that

> platinum

> > leached out into a water solution as well as the other solutions

used

> > including ethanol in water, acatic acid and olive oil.

> >

> > 6. The toxicity and hypersensitivity of platinum salts is already

known

> and

> > well documented. The following statements can be found in the book

> > " Platinum " published by the World Health Organization and the

> International

> > Programme on Chemical Safety (1991): " During the course of a

> reproduction

> > study, behavioral effects were observed in the offspring of mice

treated

> > with sodium hexachloroplatinate... The symptoms typical of platinum

salt

> > sensitization ( 1990) include watering of the eyes, sneezing,

> > tightness of the chest, wheezing, breathlessness, coughing,

eczematous

> and

> > urticarial skin lesions, and signs of mucous membrane

inflammation...The

> > compounds mainly responsible for platinum sensitizations include

> > hexachloroplatinic acid...The symptoms usually worsen with

increasing

> > duration of exposure but generally disappear when the subject is

removed

> > from exposure. However, Schultze-Werninghaus, et al., (1989)

reported

> that

> > after long duration exposure following sensitization, individuals

may

> never

> > become completely free of symptoms...Only limited experimental data

are

> > available for platinum effects on reproduction, embryotoxicity, and

> > teratogencity...Several platinum compounds have been found to be

> mutagenic

> > in a number of bacterial systems. "

> >

> > 7. Further documentation of toxicity and hypersensitivity of

platinum

> can

> > be found in the book " Toxicology and Biological Monitoring of Metals

in

> > Humans " (1986). " After inhalation of platinum metal, lung clearance

is

> > rather slow, and kidney and bone accumulate platinum...There is some

> > transplacental platinum passage...In an extensive survey of

California

> > autopsy tissues, only 4.7% contained detectable platinum (Stokinger

> 1981).

> > After subcutaneous fat; kidney, pancreas, and liver had the highest

> > detection frequencies...After ingesting drinking water containing

> platinum

> > for 8 and 9 days, highest concentrations were in kidney and liver

> (Holbrook

> > 1975)...Simple (platinum) salts cause vomiting and diarrhea with

bloody

> > stools...Platinum complexes cause epileptiform convulsions, coma,

and

> > death.. Non-lethal doses cause hyperirritability, restlessness,

motor

> > excitement, and delayed heart action (Stokinger 1981)...In rats,

signs

> of

> > acute oral toxicity also include dystrophic changes in the liver and

> > kidneys (Veselov 1977)...Platinum compounds bind to DNA molecules

(NAS

> > 1977)...A platinum complex has been reported to interfere with

> > mitocrondrial transport of calcium (Stokinger 1981)...An asthma-like

> > syndrome called platinosis occurs after preliminary eye and upper

> > respiratory tract irritation with cough, tightness of the chest,

> wheezing,

> > and shortness of breath. The severest cases experience cyanosis,

> > diaphoresis, feeble pulse, and clammy coldness of the extremities

> (Browning

> > 1969)...Scaling, dryness, cracking, and eczematous patches

characterize

> the

> > dermatitis (Browning 1969)...The platinum diammine slats are

> > immunosuppressive (Stokinger 1981). A low-grade fibrosis has been

> described

> > in the lungs of some workers with platinosis (Browning 1969)...no

> > information on teratogenicity " .

> >

> > 8. Research by Kala, et al., " Low Molecular Weight Silicones are

Widely

> > Distributed after a Single Subcutaneous Injection in Mice " (1998)

> indicates

> > highest levels at 3, 6, or 9 weeks were found in the mesenteric

lymph

> > nodes, ovaries, and uterus, but all organs examined contained

> > cyclosiloxanes. At one year, highest levels were found in the

mesenteric

> > lymph nodes, abdominal fat, and ovaries. Animals receiving linear

> siloxanes

> > were found to have manimum levels in the brain, lungs, and

mesenteric

> lymph

> > nodes at 9, 12, and 15 weeks. Detectable levels are found to persist

for

> at

> > least a year, which is approximately 40% of the life span of a

mouse.

> > Whether these compounds persist indefinitely and to what extent is

an

> > important area for additional study. The wide spread distribution of

low

> > molecular weight silicone and their persistence raises the issue of

> > possible untoward consequences.

> >

> > 9. In a public statement made 12/1/98, W. Lieberman, MD,

Ph.D.,

> > Department of Pathology, Baylor College of Medicine stated " I

believe

> there

> > is significant evidence that components of breast implants are

highly

> toxic

> > and may cause serious health effects. " Research (Lieberman et al,

1999)

> > published in the DHHS sponsored Environmental Health Perspectives

> clearly

> > shows that cyclosiloxane-platinum silane (distilate) is toxically

> > equivalent to toxins like carbon tetrachloride (equivalent median

lethal

> > dose LD50).

> >

> > 10. Based on the Agnew research (1975) suggesting an inhibitory

effect

> of

> > platinum on brain enzymes, Harbut, MD, MPH (March 1999

> Plaintiffs

> > Submission) concludes that platinum salts can cause brain disease.

> Ernest

> > Lykissa, Ph.D. (March 1999 Plaintiffs Submission) states " the

evidence

> > clearly demonstrates the propensity of the cyclosiloxane-platinum

silane

> > mixture, to accumulate in the brain tissue of living animals and to

> persist

> > there for the duration of one year following a signal

administration. It

> is

> > highly unlikely, that the rich in lipids brain tissues, that depend

to a

> > great extent on lipophilicity (lipid solubility) for the

transmission of

> > electric, in nature, nerve impulses are not affected by high

> concentrations

> > of very lipid soluble cyclosiloxane-platinum silane toxins, residing

on

> the

> > membranes of their constituent cells. "

> >

> > 11. The toxic and hypersensitivity reactions to platinum salts can

range

> > from asthma,rhinorrhea, tinnitus, conjunctivitis, urticaria, fatigue

> > syndromes secondary to impaired oxygen exchange, neurotoxicity,

sicca

> > syndrome, and macular rashes. Research that document these

conditions in

> > women with breast implants or their children born after implantation

> when

> > examined by treating physicians, include the following:

> >

> > (a) Brawer AE " Chronology of Systemic Disease Development in 300

> > Symptomatic Recipients of Silicone Gel-filled Breast Implants " J.

Clean

> > Technol Environ Toxicol & Occup Med, 1996, 5; (3): 223-233

> >

> > ( Harbut MR, et al " Asthma in Patients with Silicone Breast

Implants:

> > Report of a Case Series and Identification of Hexachloroplatinate

> > Contaminant as a Possible Etiologic Agent " Israel J of Occup Health

> 1999, 3

> > (1) 73-81

> >

> > © Levine JJ, et al " Esophageal Dysmotility in Children Breast-fed

by

> > Mothers with Silicone Breast Implants " Digestive Diseases and

Sciences,

> > 1996, 41; (8): 1600-1603

> >

> > (d) sson AD " Syndromes Associated with Silicone Breast Implants:

A

> > Clinical Study and Review " J of Nutritional & Environ Med 1998, 8:

35-51

> >

> > (e) Bridges AJ, et al " A Clinical and Immunologic Evaluation of

Women

> with

> > SBI and Symptoms of Rheumatic Disease " ls of Internal Medicine,

June

> > 1993, 18; (12) 926-936

> >

> > 12. An immunosuppressive reaction to platinum salts is documented in

the

> > following research:

> >

> > (a) AW, et al " Suppressed Natural Killer Cell Activity in

> Patients

> > with Silicone Implants: Reversal Upon Explantation " Toxicology and

> > Industrial Health, 1994; 10, (3) 149-154

> >

> > ( The IOM report states " Consistent with animal toxicology studies

> noted

> > earlier, it appears that NK cells in humans might be affected by

> exposure

> > to silicone gel, since removal of silicone breast implants was

followed

> by

> > an increase in NK-cell function in 50% of women studied by .

> This

> > research is supported by the, as yet, unpublished data (see

Sttachment

> 3)

> > submitted by D. Salvato, MD (Sept. 2000) " Silicone Breast

> Implants

> > and Natural Killer Cell Numbers " . Of 633 breast implanted patients

> > evaluated by Dr. Salvato, the range of natural killer cell counts

was

> from

> > 8 to 256, with an average of 110. Of 136 healthy controls, the range

was

> > from 320 to 550, with an average of 410. Dr. Salvato states " From

this

> data

> > it can be postulated that silicone has a direct and toxic effect on

> natural

> > killer cell numbers in patients with silicone breast disease. It has

> been

> > reported in the medical literature that natural killer cell activity

may

> > somehow impinge on the central nervous system. Natural killer cells

are

> > capable of crossing the blood brain barrier and are present in the

brain

> > and certain pathological states. It has also been reported that

natural

> > killer cells express receptors for neuropeptides and hormones. It

has

> also

> > been shown that products of activated natural killer cells are

damaging

> to

> > the neurons. Some of the activated natural killer cells infiltrating

> normal

> > systems of patients, thus manifesting as a cause of neuro-endocrine

> > abnormalitites. This research lend more evidence to the growing

medical

> > literature supportive of silicone's toxic effects on the immune

system,

> > central nervous system, and peripheral nervous system. "

> >

> > 13. The argument could be made that there are no published

controlled

> > epidemiological studies demonstrating a risk of allergy

> (hypersensitivity)

> > related to breast implants, only because no study has actually

examined

> and

> > tested breast implanted patients. Compelling new research by Brawer

> (2000)

> > demonstrating improvement of systemic phenomena and disease

amelioration

> > following explantation, provides supportive evidence for the

existence

> of a

> > novel illness triggered by silicone gel-filled devices. The argument

> that a

> > large controlled epidemiological study documenting a health risk to

> > platinum salts is needed before gel-filled breast implants can be

> removed

> > from the market is not applicable here because of the enormous

potency

> of

> > platinum salts. To quote Drs. Niezborala and Garner in regard to

> industrial

> > contact " At no stage should a worker be able to come into contact

with a

> > solution or a solid containing these particular complex platinum

salts " .

> In

> > other words, there is no " safe " level of platinum salts in implanted

> > devices. Furthermore, platinum salts are considered so toxic that

the

> > consensus opinion in Occupational Medicine is that platinum allergy

> exists

> > in a worker presenting with classic allergy symptoms (who is exposed

to

> > platinum salts) until proven otherwise according to Machael Harbut,

MD.

> >

> > >From 1985 until January 2000, FDA has received 127,770 adverse

reaction

> > reports for SGFBIs (adverse events include death, life-threatening

> injury

> > or illness, hospitalization, disability, birth abnormality, or

medical

> > intervention to prevent permanent impairment or damage). To allow

this

> > toxic defective class III device to remain on the market is

egregious

> > conduct on the part of the manufacturers, who are required by law to

> prove

> > breast implants to be safe, and the FDA, whose mission is to protect

the

> > consumer and their unborn children. The Nuremberg Code states a

person

> > should give consent and exercise free power of choice without the

> > intervention of any element of force, fraud, deceit, duress,

> over-reaching,

> > or other ulterior from of constraint or coercion. They also should

have

> > sufficient knowledge and comprehension of the elements of the

subject

> > matter involved to make an understanding and enlightened decision.

> > Furthermore during the course of the experiment, the scientist in

charge

> > must be prepared to terminate the experiment at any stage, if he has

> > probable cause to believe, in the exercise of the good faith,

superior

> > skill, and careful judgment required of him, that a continuation of

the

> > experiment is likely to result in injury, disability or death to the

> > experimental subject. While women can remove their implants, there

is no

> > way for them to end the experiment and remove the

platinum-cyclosiloxane

> > complexes when it spreads to all parts of their bodies. Safety must

> matter.

> >

> >

> > ENVIRONMENTAL IMPACT -

> >

> >

> > I request a waiver on the environmental assessment under Sec. 25.31.

I

> > believe there will be a positive environmental impact when SGFBIs

are

> > removed from the market because there will be less toxic waste to

> dispose

> > of when implants are removed. I believe women and their children

will

> > experience less toxic poisoning and environmental injury when SGFBIs

are

> no

> > longer placed in their bodies or when silicone, silica, or its

> components

> > (toxic and hypersensitizing platinum) are passed in the placenta or

in

> > breast milk.

> >

> > ECONOMIC IMPACT -

> >

> >

> > Revoking the implantation of SGFBIs will help balance the budget and

> reduce

> > the deficit. Less money will have to be paid out when former hard

> working

> > productive women implanted with SGFBIs become disabled, can no

longer

> work,

> > lose their insurance, or can no longer care for themselves and their

> > families (refer to the U.S. Justice Dept. claim in the Dow

Bankruptcy).

> > This should have a favorable economic impact on the individual

> considering

> > SGFBIs in long term health care savings. Just because there is

> insufficient

> > data does not mean that a new disease as a result of exposure to

toxic

> and

> > hypersensitizing chemicals does not exist, it simply means that the

> > long-term studies have not been done. We do not know the frequency

of

> > complication or the severity of disease, because a national registry

was

> > never mandated. Because of the latency period of systemic symptoms

to

> > appear, doctors and women have been slow to recognize their disease

and

> > that of their children born after implantation, may be related to

their

> > implants. The FDA's Scleroderma Court Study and the NCI's Study of

> 13,500

> > Breast Implanted Women should soon document that something has gone

> > tragically wrong. Furthermore the FDA's own research as published in

the

> > Annual Report 1998 Office of Science and Technology documents

> statistically

> > significant elevated autoantibodies to collagen type I, collagen

type II

> > and anti-DNA were detected in serum of patients with Connective

Tissue

> > Disease (CTD), CTD + silicone implants, and silicone implants

without

> CTD.

> >

> > A possible negative impact to the economy might be a loss of income

for

> the

> > plastic surgeons who have come to depend on the easy money generated

by

> > breast implants, the repeat surgeries they require, and the high

cost of

> > explantation when rupture or severe gel bleed occur. However, with

the

> > availability of saline-filled implants and other reconstruction

options,

> > this should not be an undue hardship. When choice may damage a

woman's

> > health and that of her unborn children, they must be protected.

> >

> > Keeling, President

> >

> > Chemically Associated Neurological Disorders

> >

> > P.O. Box 682633

> >

> > Houston, Tx. 77268-2633

> >

> > 281/444-0662

> >

> > 281/44405468 FAX

> >

> > REFERENCES

> >

> > (1) Brown SL, Middleton MS, Berg WA, Soo MS, Pennello G. " Prevalence

of

> > Rupture of Silicone Gel Breast Implants Revealed on MR Imaging in a

> > Population of Women in Birmingham, Alabama " AJR Am J Roentgenol 2000

> Act;

> > 175 (4): 1057-1064

> >

> > (2) Lykissa ED, Kala SV, Hurley JB, Lebovitz RM " Release of Low

> Molecular

> > Weight Silicones and Platinum from Silicone Breast Implants "

Analytical

> > Chemistry, Vol. 69, No. 23, December 1, 1997

> >

> > (3) El-Jammal A, Templeton DM " Measurement of Platinum in Biomedical

> > Silicones by ICP-MS " Analytical Proceedings including Analytical

> > Communications, August 1995, Vol. 32

> >

> > (4) Farrago ME, et al " Platinum Concentrations in Urban Road Dust

and

> Soil,

> > and in Blood and Urine in the United Kingdom " Analyst, 1998 Mar;

123,

> > 451-454

> >

> > (5) Semple JL, et al " Breast Milk Contamination and Silicone

Implants:

> > Preliminary Results Using Silicon as a Proxy Measurement for

Silicone "

> > Plast Reconstr Surg 1998 Aug; 102, (2): 528-33

> >

> > (6) Schuppe HC, et al " T-Cell-Dependent Popliteal Lymph Node

Reactions

> to

> > Platinum Compounds in Mice " Int Arch Allergy Immunol 1992; 97:

308-314

> >

> > (7) Plaintiffs' Supplemental Submission on the Chemistry and

Toxicology

> of

> > Platinum. Master File CV 92-P-10000-S, March 25, 1999

> >

> > (8) Safety of Silicone Breast Implants. IOM, July 1999, p.

50,51,81,82

> (9)

> > DCCKK A028218-19, A028224-25, A0228229-30-33-34-35-36

> >

> > (10) Agnew WF, et al " Neuropathological Effects of Intracerebral

> Platinum

> > Salt Injections " Surg Neurol, 1075, 4: 438-448

> >

> > (11) Potter M, et al " Induction of Plasmacytomas with Silicone Gel

in

> > Genetically Susceptible Strains of Mice " J of the NCI, 1994 Jul 20;

85,

> >

> > (14): 1058-1065

> >

> > (12) Kala SV, et al " Low Molecular Weight Silicones Are Widely

> Distributed

> > after a Single Subcutaneous Injection in Mice " Am J of Pathol, March

> 1998,

> > 152, (3): 645-649

> >

> > (13) Brawer AE " Amelioration of Systemic Disease after Removal of

> Silicone

> > Gel-filled Breast Implants " J of Nutritional & Environ Medicine

2000:

> 10,

> > 125-132

> >

> > (14) Lieberman MW, et al " Cyclosiloxanes Produce Fatal Liver and

Lung

> > Damage in Mice " Environmental Health Perspectives, February 1999:

107,

> (2);

> > 161-165

> >

> >

> >

> >

> >

> > P E T I T I O N

> >

> >

> >

> > ACTION REQUESTED: That the United States Food and Drug

Administration

> issue

> > a warning statement, or cause appropriate parties to issue warning

> > statements, consistent with the known, available science in regard

to

> the

> > safety of medical devices manufactured with silicone which has been

> > catalyzed with hexachloroplatinate.

> >

> > This warning statement should include at a minimum the following

> statements

> > (or words to this effect):

> >

> > (1) In the workplace setting, the medical literature states that no

> person

> > should come into contact with a liquid or solid containing the

chemical

> > catalyst called hexachloroplatinate. Some products sold for human

> internal

> > and external use contain this catalyst, including silicone gel

breast

> > implants, silicone-envelope saline-filled breast implants, certain

> > implanted fluid shunting devices, other implanted devices used in

> plastic

> > and bone surgery and dermatological-use silicone gel used to help

reduce

> > scarring.

> >

> > (2) Although no large scale human epidemiological studies in regard

to

> > platinum-caused disease caused via medical devices have been

undertaken,

> in

> > the workplace setting, persons with evidence of asthma and rhinitis

who

> > have been exposed to hexachloroplatinate are considered to have a

> disease

> > caused by hexachloroplatinate until proven otherwise.

> >

> > (3) Extremely small amounts of hexachloroplatinate are known to

trigger

> > immunologic reactions, cause asthma and damage brain cells, in

addition

> to

> > the other health effects which have been reported in the medical

> > literature.

> >

> > (4) Although there has been disagreement over the exact type of

platinum

> > emitted by silicone gel breast implants, there is no disagreement

that

> > hexachloriplatinate is used in their manufacture. Furthermore, there

has

> > been no disagreement that even intact breast implants emit some form

of

> > platinum.

> >

> > STATEMENT OF GROUNDS: Attached to this Petition is a document

prepared

> for

> > the United States Federal Court which had contemplated the legal

issues

> > invoked by illnesses perceived to be caused by silicone gel breast

> > implants. It sets forth the scientific grounds for the Petitioner's

> > request. It does not include the recently presented work of E.

Lykissa,

> > PhD. in which Dr.Lykissa speciated platinum ions liberated from

Silicone

> > Gel Breast Implants, providing a basis for even a stronger warning

than

> > this Petition requests.

> >

> > This Attachment was prepared after the Petitioner acting

individually

> > notified Judge Pointer of serious factual errors published by his

> so-called

> > Science Panel in regard to the biological activity of platinum

catalyst.

> > Although the Petitioner is unaware of the entire spectrum of ensuing

> > legalities, the Attachment was ultimately prepared for the benefit

of

> the

> > so-called Science Panel at Judge Pointer's initiation.

> >

> > Based on a review of the published depositions of the so-called

Science

> > Panel, it is clear that this document was not read in its totality

by

> the

> > so-called Science Panel. Furthermore, this document was not

contemplated

> by

> > the National Academy of Science Committee assembled in regard to the

> issue

> > of Silicone Gel Breast Implants. It was completed after the close of

> it's

> > deliberations.

> >

> > CERTIFICATION: The Attachment includes in it the criticisms raised

by

> the

> > attorneys defending the manufacturers of Silicone Gel Breast

Implants,

> and

> > the science which answers them, providing a concrete grounding for

> granting

> > of this petition. It is the Petitioner's understanding that a

separate

> > document exists which was assembled by these defense attorneys.

> >

> > The Petitioner does not possess a copy of this document. Although it

is

> the

> > Petitioner's belief that criticisms raised were answered in the

> Attachment,

> > it is furthermore the Petitioner's belief that it would be much

easier

> for

> > the FDA to get a copy of this document than it is for the

Petitioner.

> >

> > Submitted October 16, 2000.

> >

> > R. Harbut, MD, MPH

> >

> > 248.559.6663

> >

> > 22255 Greenfield, #440

> >

> > Southfield, Michigan.

> >

> >

> >

> >

> >

> >

>

>