Fw: FDA denies Dr. Harbut's citizen petition regarding platinum

[Guest guest]

From: " ilena rose " <ilena@...>

Sent: Wednesday, April 11, 2001 10:12 AM

Subject: FDA denies Dr. Harbut's citizen petition regarding platinum

> keeling.m@... wrote:

>

> Please post the following excerpt's from the FDA letter dated March 30,

2001

> to R. Harbut, M.D., M.P.H., at the Center for Occupational &

> Environmental Medicine to your e-mail lists (INFORMATION IN ALL CAPS ADDED

> BY ME FOR CLARIFICATION PURPOSES):

>

> " Your petition requested that FDA or another appropriate party issue a

> warning statement on the safety of medical devices containing silicones

that

> have been prepared using hexachloroplatinate as the catalyst. Your

petition

> also specified information that should be part of the warning statement. "

>

> " For several years FDA has been interested in the safety of platinum

> compounds used to prepare silicone gel and elastomer. As a result, FDA

> asked the Institute of Medicine (IOM) to evaluate the safety of platinum

> catalysts used in the manufacture of silicone breast implants. Their

> recently published report, 'Safety of Silicone Breast Implants', includes

a

> comprehensive and authoritative review of platinum chemistry and

toxicology.

> Although the report focuses on breast implants, it also draws conclusions

> pertinent to the safety of other medical devices that contain

> platinum-catalyzed silicones. "

>

> " FDA believes the IOM report is highly relevant to your petition, since

both

> documents rely on much of the same information and address the same major

> issues; the chemical form and potential toxicity of platinum catalysts

used

> to prepare silicones for breast implants and other medical devices. With

> regard to other silicone-containing medical devices, the report concludes,

> 'Many silicone-containing implants other than breast implants (listed in

> Chapter 2) are found at high frequency in the general population and

> presumably contain platinum also; the committee is not aware of any

evidence

> that platinum toxicity is present in these persons. "

>

> " Although your supporting document (PLAINTIFFS' SUPPLEMENTAL SUBMISSION ON

> THE CHEMISTRY AND TOXICOLOGY OF PLATINUM) was not available to the IOM

> committee, FDA has carefully reviewed it and believes the committee's

> conclusions regarding the lack of toxicity of platinum catalysts used to

> prepare silicone-containing medical devices remain valid. FDA, therefore,

> is denying your petition. "

>

> " Hexachloroplatinate has been used to synthesize the organoplatinum

> catalysts, but there is insufficient experimental evidence for the

presence

> of residual hexachloroplatinate in silicone gel or solid in either the

> scientific literature or your supplemental document. "

>

> " The IOM committee did not have access to Dr. Lykissa's more recent

studies

> on the form of platinum that leaks from explanted breast implants.

However,

> last September, Dr. Lykissa presented these unpublished data to FDA.

> Although the data are suggestive that ionic platinum in various oxidation

> states may be present, neither hexachloroplatinate nor other platinum

salts

> were identified. FDA believes the results are preliminary; they do not

> conclusively identify the molecular form of platinum, nor do they

establish

> that, if present, the reported ionic forms of platinum are toxic in the

> amounts that may leak from breast implants. "

>

> " In your supplemental document, you discuss information related to effects

> in persons with silicone-containing implants. The 1999 study of Harbut

and

> Churchill, 'Asthma is patients with silicone breast implants: report of a

> case series and identification of hexachloroplatinate contaminant as a

> possible etiologic agent' was reviewed by the IOM committee. Their report

> states, 'The authors speculated that the respiratory signs and symptoms

were

> the result of exposure to hexachloroplatinate in their implants. No

> evidence for this was reported. Conclusions regarding platinum toxicity

in

> women with breast implants should await further evaluations that

positively

> relate platinum to the symptomatology.' FDA concurs with this statement.

> In reference to allergies and asthma in women with breast implants, the

IOM

> report states, 'These complaints are not prominent in lists of problems in

> breast implant patients(SEE APPENDIX B OF THIS REPORT)...' (THE BIAS OF

THE

> IOM COMMITTEE IS EVIDENT HERE BECAUSE WHEN YOU TURN TO APPENDIX B ON PAGE

> 434 TITLED SYMPTOMS REPORTED BY INDIVIDUAL WOMEN OR CONSUMER GROUPS - NOT

IN

> ORDER OF PREVALENCE OR SEVERITY YOU FIND BREATHING DIFFICULTIES, ALLERGIC

> REACTIONS, CHEMICAL AND ENVIRONMENT SENSITIVITIES, AND ASTHMA). FDA

> believes the available information does not implicate platinum in allergic

> reactions or asthma in women with silicone breast implants. "

>

> " Your supplemental document also refers to immunological effects in

patients

> with silicone shunts. Adverse immunological effects of silicone have

> largely been discounted (IOM report, Chapter 8) and FDA believes that

> conclusions regarding adverse clinical effects of platinum in silicones

are

> speculative. "

>

> You also discuss cases of individuals who have shown allergic-type

reactions

> to elemental platinum (SUCH AS WITH JEWELRY MADE OF PLATINUM).

> FDA believes true allergic reactions to elemental platinum are rare and

not

> representative of any group with silicone-containing medical implants.

> Also, in reference to platinum in catalysts used to prepare silicones for

> breast implants, the 1998 report of the British Independent Review Group

> (IRG), 'Silicone Breast Implants,' states, '...it is a chemically stable

> form not associated with the well known true immunological

sensitization... "

>

> " FDA also believes that a relationship between reactions to

chemotherapeutic

> platinum-containing drugs and platinum in medical devices has not been

> established. The high doses of drugs (e.g. cisplatin) used to treat

cancer

> patients are known to be toxic. However, these platinum-based compounds

are

> not present in silicone-containing medical devices. The IOM report

states,

> 'Cisplatin...is highly toxic to the gastrointestinal tract, kidney, bone

> marrow, and peripheral nervous system. This compound does not occur in

> silicone breast implants, however.' With regard to platinum catalysts,

the

> IRG report states, 'These...are much less toxic than platinum compounds

> used as cytoxic drugs. "

>

> Finally, as reported by Nuttall, et al. in 1994, whereas urinary platinum

> levels in women with breast implants and a negative reference group were

> equivalent (<4ug/L), platinum levels in patients receiving cisplatin often

> reach 100-1000 ug/L.

>

> NO LONG TERM TESTING FOR PLATINUM IN EXPLANTS BY ICP-MS AND ION

> CHROMATOGRAPHY HAS BEEN DONE EXCEPT BY ERNEST LYKISSA, Ph.D. THIS IS

> SIMILAR TO RESEARCHING FIRESTONE TIRES ON AN EXPLORER AS IT ROLLS OFF THE

> ASSEMBLY LINE AND DECLARING THEM SAFE RATHER THAN RESEARCHING SHREDDING

AND

> DISINTEGRATING TIRES AFTER A CAR WRECK. PRELIMINARY RESEARCH PRESENTED TO

> THE FDA INDICATED THAT SIGNIFICANT AMOUNTS OF PLATINUM LEAKS FROM BREAST

> IMPLANTS OVER TIME, AND WHEN SPECIATED USING NEW STATE OF THE ART

EQUIPMENT,

> THE PLATINUM WAS FOUND TO BE IN A HIGHLY REACTIVE AND TOXIC FORM WHICH MAY

> INDICATE CATALYST MOLECULAR DETERIORATION DUE TO THE AGING PROCESSES

DURING

> IMPLANTATION.

>

>