Fw: FDA denies citizen petition

[Guest guest]

From: " m keeling (by way of ilena rose) " <keeling.m@...>

Sent: Monday, April 02, 2001 6:56 PM

Subject: FDA denies citizen petition

> Please post the following to your e-mail lists:

>

> In exerpts taken from a letter dated March 30, 2001, the FDA makes the

> following comments in denying citizen petition 00P-1607/CP-1 (regarding

> platinum in silicone gel-filled implants):

>

> " Although some new preliminary information was provided, FDA believes the

> IOM committee's conclusions regarding the lack of toxicity of platinum

> catalysts used to prepare silicone gel-filled breast implants are valid.

> FDA is aware that small amounts of residual platinum (parts per million)

may

> be present in breast implants. However, organoplatinum compounds, not

> hexachloroplatinate, are the catalysts that have been used to prepare

> silicones. Although hexachloroplatinate is used to synthesize these

> organoplatinum compounds, there is insufficient experimental evidence for

> the presence of hexachloroplatinate in silicone gel or elastomer. At our

> request, Dr. Lykissa provided additional unpublished information from his

> study on leakage of platinum from explanted breast implants. 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 that Dr. Lykissa's 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 cause

> hypersensitivity or other toxic reactions in the amounts that may leak

from

> breast implants (nanograms per month). No evidence was presented to

> establish an association or causal connection between clinical symptoms in

> the women in this study and platinum that might have leaked from their

> implants. "

>

> " FDA agrees that hexachloroplatinate and certain other chemically related

> platinum salts can cause allergic reactions in sensitized individuals.

> However, experimental evidence is lacking to support the claim that

> hexachloroplatinate is present in breast implants. Furthermore, the

> supplier of the platinum catalyst used to manufacture breast implants, and

> scientists who have studied the chemistry of these catalysts, have

recently

> assured FDA that chloroplatinic acid is consumed during the formation of

> these catalysts and is not present in the materials used to produce the

> implants. "

>

> " It is important to note that the chemical form of platinum is an

important

> factor in its toxicity. Platinum in hexachloroplatinate has a valence of

> +4. The organoplatinum catalysts contain platinum in the zero valence

> state, and do not contain chloride. "

>

> " FDA believes that statements in your petition suggesting that changes in

> NK-cell activity indicate neurologic or immunologic disease in women with

> silicone breast implants are inconsistent with the conclusions reached by

> the IOM committee. "

>

> " Although the IOM committee did not review Dr. Brawer's recent study, Dr.

> Brawer discussed his results with FDA at a meeting in September, 2000.

FDA

> considers the results preliminary, and believes the IOM report's

conclusions

> remain valid. "

>

> " In the introductory statement, you request that FDA issue a public health

> alert regarding breast-feeding or pregnancy to avoid possible genotoxic

> effects. The " ENVIRONMENTAL IMPACT " statement also refers to potential

> toxicity of breast implant constituents, including " hypersensitizing

> platinum, " that " ...are passed in the placenta or in breast milk. " FDA

> believes the IOM committee was thorough in reviewing the available

> information on health effects in children. Its conclusions on this

> important issue were clear and emphatic. Their report states, " The

> committee finds no evidence of elevated silicone in breast milk or any

other

> substance that would be deleterious to infants; the committee strongly

> concludes that all mothers with implants should attempt breast feeding. "

> Also, " The committee concludes that evidence for health effects in

children

> related to maternal breast implants is insufficient or flawed. " FDA

concurs

> with these statements. "

>

> " The Agency takes women's special health issues very seriously, and has

main

> tained an active interest in the issue of platinum toxicity for several

> years. Although your petition has been denied, FDA will continue to

> evaluate results of new studies, and will adjust our level of concern

> accordingly. "

>

> Sincerely yours,

>

> S. Kahan

> Deputy Director for Regulation

> and Policy

> Center for Devices and

> Radiological Health

>

> *NOTE - COURT STAMPED DOCUMENT NUMBERS WERE SUPPLIED TO THE FDA SHOWING

> CHLOROPLATINIC ACID WAS USED IN MAMMARY IMPLANT MATERIAL FORMULATION. OUR

> NEXT STEP MUST BE TO DUPLICATE DR. LYKISSA'S RESEARCH SHOWING PLATINUM 1+

> THROUGH PLATINUM 6+ LEAKS FROM EXPLANTS. ANY BODY WILLING TO WORK ON THIS

> PROJECT SHOULD CONTACT MARLENE KEELING AT keeling.m@.... We

> have just begun to fight for the health of women, children, and that of

our

> future generations. Just like the Bill Moyer's special reported, we can't

> trust the government to protect us. There is very little data to prove

> chemicals are safe. Only 8 to 10% of chemicals have ever been tested as

to

> how they might effect the developing brains of children. Children are the

> most vulnerable to toxic chemicals. Science is easy to manipulate by the

> chemical companies to achieve the desired outcome. No long term research

> has been done on platinum in breast implants by the manufacturers to prove

> they are safe. The FDA requires that we publish research, have it

> duplicated, and fund a large epidemiological study showing a significant

> increase in health effects, documenting that platinum is unsafe rather

than

> have the manufacturers prove it is safe as required by law of class III

> devices. We must not allow this to continue in America or elsewhere.

>

Keeling

> 281/444-0662

>

>

[Guest guest]

Martha Murdock, Director

National Silicone Implant Foundation

Dallas, Texas Headquarters

----- Original Message -----

From: " m keeling (by way of ilena rose) " <keeling.m@...>

<Recipient List Suppressed:>

Sent: Monday, April 02, 2001 8:56 PM

Subject: FDA denies citizen petition

> Please post the following to your e-mail lists:

>

> In exerpts taken from a letter dated March 30, 2001, the FDA makes the

> following comments in denying citizen petition 00P-1607/CP-1 (regarding

> platinum in silicone gel-filled implants):

>

> " Although some new preliminary information was provided, FDA believes the

> IOM committee's conclusions regarding the lack of toxicity of platinum

> catalysts used to prepare silicone gel-filled breast implants are valid.

> FDA is aware that small amounts of residual platinum (parts per million)

may

> be present in breast implants. However, organoplatinum compounds, not

> hexachloroplatinate, are the catalysts that have been used to prepare

> silicones. Although hexachloroplatinate is used to synthesize these

> organoplatinum compounds, there is insufficient experimental evidence for

> the presence of hexachloroplatinate in silicone gel or elastomer. At our

> request, Dr. Lykissa provided additional unpublished information from his

> study on leakage of platinum from explanted breast implants. 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 that Dr. Lykissa's 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 cause

> hypersensitivity or other toxic reactions in the amounts that may leak

from

> breast implants (nanograms per month). No evidence was presented to

> establish an association or causal connection between clinical symptoms in

> the women in this study and platinum that might have leaked from their

> implants. "

>

> " FDA agrees that hexachloroplatinate and certain other chemically related

> platinum salts can cause allergic reactions in sensitized individuals.

> However, experimental evidence is lacking to support the claim that

> hexachloroplatinate is present in breast implants. Furthermore, the

> supplier of the platinum catalyst used to manufacture breast implants, and

> scientists who have studied the chemistry of these catalysts, have

recently

> assured FDA that chloroplatinic acid is consumed during the formation of

> these catalysts and is not present in the materials used to produce the

> implants. "

>

> " It is important to note that the chemical form of platinum is an

important

> factor in its toxicity. Platinum in hexachloroplatinate has a valence of

> +4. The organoplatinum catalysts contain platinum in the zero valence

> state, and do not contain chloride. "

>

> " FDA believes that statements in your petition suggesting that changes in

> NK-cell activity indicate neurologic or immunologic disease in women with

> silicone breast implants are inconsistent with the conclusions reached by

> the IOM committee. "

>

> " Although the IOM committee did not review Dr. Brawer's recent study, Dr.

> Brawer discussed his results with FDA at a meeting in September, 2000.

FDA

> considers the results preliminary, and believes the IOM report's

conclusions

> remain valid. "

>

> " In the introductory statement, you request that FDA issue a public health

> alert regarding breast-feeding or pregnancy to avoid possible genotoxic

> effects. The " ENVIRONMENTAL IMPACT " statement also refers to potential

> toxicity of breast implant constituents, including " hypersensitizing

> platinum, " that " ...are passed in the placenta or in breast milk. " FDA

> believes the IOM committee was thorough in reviewing the available

> information on health effects in children. Its conclusions on this

> important issue were clear and emphatic. Their report states, " The

> committee finds no evidence of elevated silicone in breast milk or any

other

> substance that would be deleterious to infants; the committee strongly

> concludes that all mothers with implants should attempt breast feeding. "

> Also, " The committee concludes that evidence for health effects in

children

> related to maternal breast implants is insufficient or flawed. " FDA

concurs

> with these statements. "

>

> " The Agency takes women's special health issues very seriously, and has

main

> tained an active interest in the issue of platinum toxicity for several

> years. Although your petition has been denied, FDA will continue to

> evaluate results of new studies, and will adjust our level of concern

> accordingly. "

>

> Sincerely yours,

>

> S. Kahan

> Deputy Director for Regulation

> and Policy

> Center for Devices and

> Radiological Health

>

> *NOTE - COURT STAMPED DOCUMENT NUMBERS WERE SUPPLIED TO THE FDA SHOWING

> CHLOROPLATINIC ACID WAS USED IN MAMMARY IMPLANT MATERIAL FORMULATION. OUR

> NEXT STEP MUST BE TO DUPLICATE DR. LYKISSA'S RESEARCH SHOWING PLATINUM 1+

> THROUGH PLATINUM 6+ LEAKS FROM EXPLANTS. ANY BODY WILLING TO WORK ON THIS

> PROJECT SHOULD CONTACT MARLENE KEELING AT keeling.m@.... We

> have just begun to fight for the health of women, children, and that of

our

> future generations. Just like the Bill Moyer's special reported, we can't

> trust the government to protect us. There is very little data to prove

> chemicals are safe. Only 8 to 10% of chemicals have ever been tested as

to

> how they might effect the developing brains of children. Children are the

> most vulnerable to toxic chemicals. Science is easy to manipulate by the

> chemical companies to achieve the desired outcome. No long term research

> has been done on platinum in breast implants by the manufacturers to prove

> they are safe. The FDA requires that we publish research, have it

> duplicated, and fund a large epidemiological study showing a significant

> increase in health effects, documenting that platinum is unsafe rather

than

> have the manufacturers prove it is safe as required by law of class III

> devices. We must not allow this to continue in America or elsewhere.

>

Keeling

> 281/444-0662

>

>