Fwd: FW: URGENT ACTION NEEDED: Submit Comments to the FDA to Research Toxic Platinum Salts in Implants

[Guest guest]

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. If you no longer wish to receive e-mail from us, please click here