Re: 10 Similar to This Since the Weekend ! - From Ms. Benson, FDA

[Guest guest]

Ms. Benson, This message reminds me of my kids when they wanted something that wasn't good for them . . . They could make, what sounded, like an excellent argument for whatever they wanted . . . It didn't change the fact that what they wanted (alcohol, teen sex, fast cars, late hours, pockets full of money, etc.) was not in their best interest. Back to this ladies message - Why do her implants "need" to be replaced? What makes her think that silicone gel implants won't be just as inferior? Does she realize that silicone gel implants will need to be replaced periodically too? . .. At an ever increasing expense? . . . Does she have ANY idea of the risk to which she's exposing herself - or her unborn children? Personally, I believe the plastic surgeons and implants

manufacturer's have a ongoing PR campaign to persuade the FDA to approve implants . . . I have my account set to alert me whenever the term "Breast implants" comes up in the news . . . It's obvious from the eb and flow - and similar nature of these "news" articles, that they are being circulated by those with ties to the implant industry . .. and those trying to push up their stock prices. One obvious goal of the PR campaign is to create demand for breast implants! They've been doing an excellent job! Can the plastic surgeons or manufacturer's PROVE breast implants are safe? Can they PROVE breast implants are safe for unborn children? The very flawed studies they've presented so far leave a lot to question. What is the FDA's role in regulating ANYTHING? . . . Do they do it by poll? . .. When problems are reported (like MedWatch and personal reports), do they follow up with investigations? If not, why not? Rogene "Benson, M." <cynthia.benson@...> wrote: Sent: Saturday, August 19, 2006 2:44 PMTo:

CDRH Small Manu. AssistanceSubject: Breast Implants I would like to have you provide an explanation as to why silicone breast implants are not approved for general use. I currently have saline implants that need to be replaced and do not want to go to the expense of doing this with like quality inferior implants. I would like to choose to spend my resources to purchase the best possible device for this purpose. I know the panel approved the implants, therefore I do not understand your agency's

reluctance to allow them to be used. Please explain.