My conversation with Benson . . . FDA public liason for medical devices

[Guest guest]

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