THANKS: 130 of You Already Submitted Comments to the FDA to Research Toxic Platinum Salts in Implants

[Guest guest]

But we need more! . . . Please ask the FDA to investigate the platinum issue! - Rogene Note: forwarded message attached.

From: Command Trust

Network [mailto:info@...]

Sent: Wednesday, July 05, 2006

7:04 AM

Beverly Ezra

Subject: THANKS: 130 of You Already Submitted

Comments to the FDA to Research Toxic Platinum Salts in Implants

Thanks to all of you who already wrote your

comments to the FDA. 130 of you did. Hopefully, more of you

will. The FDA needs to hear your views on the need for more research on

toxic platinum salts in silicone implants.

- CTN

TELL FDA THAT RESEARCH IS

URGENTLY NEEDED ON TOXIC PLATINUM SALTS IN SILICONE BREAST IMPLANTS

A new peer-reviewed study

shows that platinum in silicone gel breast implants could be toxic for women

and their babies. The frightening results found toxic platinum in breast

milk, blood, and other bodily fluids of women with breast implants. The FDA

is now deciding whether to ignore the research, or delay approval of implants

until the government conducts research to confirm or refute the results.

The FDA has asked for public

comments, so they need to hear from you! Meanwhile, the FDA is quoting an

industry-funded researcher who questions the findings and insists that

implants are safe, despite this research to the contrary.

This might be the last

opportunity to take a stand and demand that government scientists do the

research necessary before the FDA makes a decision to approve silicone gel

implants. The FDA will review all the comments that are received through

their official process. Although the comment period doesn’t end until

October, the decision to approve silicone breast implants could happen much

sooner. We need to act quickly!

We are not providing a sample

letter, because the FDA will take your comments more seriously if they are

not identical to everyone else’s. Feel free to cut and paste or use any

information from the talking points below. Anything you do to make your

wording unique (but still sound reasonable) is a plus.

Click here to

make comments directly to the FDA using the FDA’s

website. (http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1004 & SUBTYP=CONTINUE & CID= & AGENCY=FDA)

Suggested Talking Points for

Comments:

1. Serious safety questions

about platinum in breast implants remain unanswered. More research is needed

on the toxicity of platinum in the bodies of women with silicone breast

implants, and the health affects on those women and the children they

breastfeed. The FDA should not make any decision on approving silicone breast

implants before more research is conducted and analyzed.

2. If the FDA approves

silicone breast implants, many young women will get them. Studies have found

higher than expected levels of platinum salts in breast milk and urine of

women with implants. If they breast feed, their babies could potentially be

permanently damaged or chronically ill from exposure to toxic platinum salts.

3. Platinum salts also could

be especially dangerous for breast cancer survivors. Chemotherapy often

includes platinum. If a breast cancer patient decides to get breast implants,

she potentially would already be exposed to platinum, and then get additional

exposure from her implants. Breast cancer patients already are more

susceptible than other patients to implant ruptures and other complications.

Unfortunately, the companies that are seeking FDA approval for silicone gel

breast implants have conducted research on relatively few breast cancer

patients.

4. So far, the FDA has relied

on implant makers and their paid consultants to examine this essential

question. Implant makers and their consultants claim that the platinum in

implants is safe, but have failed to study the platinum in the bodies of

women with implants, or their breast milk, to determine if it is platinum

salt. Platinum salt is a toxic form of platinum. These questions are too

important to wait until after the FDA makes implants more available.

WHAT WE WANT: FDA should ask

a government agency such as the CDC or the National Institute of

Environmental Health Study (NIEHS) to conduct a study of a large number of

women who have had silicone gel breast implants for at least 10 years. The

study should focus on women with leaking silicone implants, and evaluate the

amounts of platinum salts in their blood, urine, hair, nails, and breast

milk. The women’s sensitivity to platinum should also be studied, as

well as their health. The FDA should not consider approving silicone gel

breast implants until this study is completed.

Background:

Silicone gel breast implants

have never been approved by the FDA, but last summer the FDA announced its

plan to approve them if certain undisclosed conditions could be met. That

plan is under scientific fire, because a new study published in the Journal

of Analytical Chemistry found very high levels of a toxic form of platinum,

called platinum salt, in the blood and breast milk of women with breast

implants.

Concerned consumer groups,

including breast cancer support groups, have requested that the FDA delay

approval of silicone breast implants until there is additional independent

research on the health risks of platinum from silicone breast implants. One

consumer group filed a formal petition to the FDA on this topic.

Unfortunately, the FDA has hunkered down, claiming that there is no evidence

that silicone breast implants expose women to dangerous levels of

platinum—without taking time to conduct additional research to review the

latest study.

The lack of research on

platinum is one example of the unknown risks of breast implants, which is why

consumer groups have repeatedly insisted that the FDA require comprehensive

long-term studies before approving these products. Approximately 200,000

women have reported serious health problems linked to their breast implants.

Please email us after you

completed the comments to let us know you have done it (info@...). Thanks.

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