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Ladies, I'm thrilled to see that our efforts are being heard . . . But we're not done yet! . . . Please read this message carefully, and continue to make your voice heard! Sooner or later, there MUST be an end to this madness! God Bless All! Rogene Zuckerman <dz@...> wrote: Subject: URGENT can you send this to your list?Date: Fri, 30 Jun 2006 09:38:56 -0400 I'm happy to say that rumors that the FDA was going to approve silicone implants around July 4th were untrue -- apparently wishful thinking on the part of some plastic surgeons. But, it is still ESSENTIAL that as many people as possible write to the FDA on their website in response to the FDA's request for comments about whether they should delay a decision because of the platinum study. Please be careful who you send this to. We don't want hundreds of letters from Mentor spies, etc. For that reason, I an NOT sending it to my list. And please urge everyone you contact to write calm, carefully written, respectful letters. Angry notes or bad grammar are not helpful. It's fine to be angry with the FDA, but this is a formal public comment period and it is much more effective to write a short, calm note. One or 2 sentences is fine! Be sure to focus on the main point: FDA should delay a decision and our government health agencies should do their own independent research on platinum inside the body of women with implants for a long time! Any woman who was tested for platinum should say so. See guidelines below. And please send us a copy of what you send. THANKS! Best wishes, TELL FDA THAT RESEARCH IS URGENTLY NEEDED ON TOXIC

PLATINUM SALTS IN SILICONE BREAST IMPLANTSA 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 any day now. 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 on this link 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 breast implants, and the health effects 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.