RE: My conversation with Benson . . . FDA public liason f or medical devices

[Guest guest]

Ms. Benson . . . I stand corrected on your job classification. However, before our conversation was completed, I summed up what I wrote in my previous message and asked you if that was correct. You said it was. One issue that troubles me greatly is that you told me that studies have been done on SICK women and SICK children that showed breast implants to be safe. . . I've been active in support for years and have never heard of any significant studies done on SICK women or SICK children. Could you give us the names of the researchers, the dates, the journals in which these studies were published and tell me who funded these studies? There are hundred of thousands of MedWatch reports for breast implants . . . but to my knowledge these have not been considered by the FDA when approving breast implants use. That would be one

way to uncover the serious health issues of both women and children. We have to wonder why these reports are, as far as the public knows, being ignored. Since the problems of women and children are significant, this is a very important issue! . . . Sincerely Rogene Schorer "Benson, M." <cynthia.benson@...> wrote: First, let me clarify that I am not the FDA's public liaison for medical devices; I am one of a number of Consumer Specialists that discusses with consumers all FDA policies and publicly available information on medical devices. The FDA maintains a staff in our Press Office which functions as a liaison with the media on all FDA issues. You have taken great license in your documentation of our discussion and, accordingly,

your correspondence reflects more of what you heard rather than what I said. Basically, we discussed that all medical devices, just like all foods, drugs, cosmetics and other commodities regulated by FDA, have a risk to benefit ratio as do all surgical procedures themselves. Medical devices which require approval by FDA prior to marketing must first undergo clinical trials whose results must prove safety and efficacy for their intended use and have an acceptable risk to benefit ratio. The use of breast implants is a personal decision and their risks, benefits, and suitability should be discussed with one's physician prior to making this

decision. A more accurate indicator of the content of our discussion is detailed in the source documentation which I and others on our Consumer Staff use for reference on breast implant inquiries. This document may be viewed on our website at www.fda.gov/cdrh/breastimplants/ . Benson Office of Communication, Education and Radiation Programs Center for Devices and Radiological Health U.S. Food and Drug Administration 1-800-638-2041, ext. 109 From: Rogene S [mailto:saxony01@...] Sent: Thursday, August 03, 2006 6:25 PM ; SiliconeKidsCc: Benson, M.; Zuckerman; Toxic Discovery; Command TrustSubject: My conversation with Benson . . . FDA public liason for medical devices I sent a message to Benson <cynthia.benson@...> this morning expressing

my grave concern about what's happening to the women who are getting breast implants, and their offspring. She was gracious enough to call me, and to listen to me vent . . . For that, I thank her. Basically, speaking for the FDA, this is what she told me: Consumers are assumed to be knowledgeable consumers because, with the Internet, most people are assumed to have the ability to check whatever devices are to be used for themselves. . . The FDA is not responsible for decisions people make . .. The FDA is NOT going to protect people from faulty devices. . . .Yes, DEVICES. She told me that they receive calls from people suffering from all kinds of devices. Many are very sick. She tells me that 50% of the people who call the FDA call to tell them how happy they are, and how glad they have access to whatever device they have. . . Her job is to take the punches (my word) - She can

do nothing. I told her about the sick children . . . She told me that the SICK implant women and their children have been studied, and no connection with implants has been found . . . She did not give me the name of those doing the studies of sick women and children, or tell me who is funding the studies . . . If anyone knows, please let us know! . . .She had no explanation for why women get much better after getting their implants removed. What I find interesting is that the Bush administration is trying to get legislation enacted that, if a device is approved by the FDA, the consumer will have NO recourse! . .. It makes one wonder what the FDA's role is . . . I guess I'm stupid! . . At one time the words "FDA approved" meant that the product had been tested and was safe. When products were found to be unsafe, the FDA stepped in to protect the public. I suggested

that they change the name of the FDA to "Buyer Beware" . . . That certainly is the position the FDA is taking, as she relayed it to me. I'm heartsick! Why am I not surprised? . . . this is the message we've been getting from the FDA for years! . . . Rogene