Dr. Zuckerman's comments to the FDA

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---------- Forwarded message ----------From: Zuckerman <dz@...>Date: Jun 30, 2006 7:39 AM Subject: our comment to FDA I just sent you a request for comments to the FDA. This is what I sent them. Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Docket No. 2006P-0151 – "Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants (SGFBI's) for an indefinite time due to the 2006 peer-reviewed published research finding significant levels of ionized platinum are released after implantation from second and third generation SGFBI's" To Whom It May Concern: The National Research Center for Women & Families submits the following comments regarding the Food and Drug Administration's (FDA) Proposed Collection of Information cited above. The National Research Center (NRC) for Women & Families is a

non-profit think tank that is dedicated to improving the health and safety of adults and children. Our Center uses objective, research-based information to encourage new, more effective programs and policies. The Center achieves its mission by gathering and analyzing research-based information and translating that information for the public, the media, and policy makers. We agree that FDA should stay its decision on the PMAs for silicone breast implants until government-funded research is conducted that conclusively supports or refutes the findings of the 2006 platinum stud by Lykissa and Maharaj. The Lykissa and Maharaj study is a small preliminary study, conducted on a modest budget, and needs to be replicated. However, it is a unique study, using a

new technology to study ionized platinum in the human body for the first time. It is my understanding that the technology was developed at the Armed Forces Institute of Pathology. Previous research without this technology, cited by Dr. Brook and the implant companies he has worked for, studied platinum in implants but did not study platinum in the body fluids of women with implants. It is possible that the zero valence platinum in implants could change to ionized platinum (platinum salts) in the human body. Such changes have been found in vitro, but have not been studied in vivo. The CDC's Occupational Health Guideline for Soluble Platinum Salts states that long-term exposure can cause repiratory and skin allergies. These symptoms have been reported by many women with implants.

It is therefore disappointing that the newly revised FDA backgrounder on breast implants and platinum quotes a review of the literature by Dr. Brook, who represented Inamed at the advisory panel meeting on silicone breast implants in April 2005. This is not an objective source of information, and even worse, there are no other in vivo studies of platinum salts in the research literature. It is therefore essential that new research be conducted, to determine if the Lykissa and Maharaj findings are accurate or not. The FDA should not rely on the implant manufacturers or their consultants to do this research. The implant manufacturers and plastic surgeons who support the approval of silicone gel breast implants have emphasized informed consent and choice. It is

not possible for women to make an informed choice until better platinum research is conducted, on a large sample with substantial numbers of women with leaking silicone implants. It is certainly not possible for the children that implanted women breastfeed to make an informed choice. In my meeting with Dr. von Eschenbach last April, I raised the concern that breast cancer patients could receive an especially high exposure to platinum – from chemotherapy and then from their implants. This is especially worrisome because Inamed and Mentor had rather small samples of reconstruction patients in their studies. The lack of research on platinum is one example of the unknown risks of breast implants, which is why I urge you to ensure that

the FDA does not make an approval decision until new research is conducted on platinum salts in women with leaking silicone implants. Sincerely, Zuckerman, Ph.D. President National Research Center for Women & Families 1701 K Street, NW, Ste. 700 Washington, DC 20006