Fwd: response to a post on SS

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Thank you Lana . . . Perhaps what I had wrong was the job classification . . . Ms. Benson is a "specialist" not a "liason" . . . It may be something that only one in the government can appreciate. Thanks RogeneLana Transue <lanadearest@...> wrote: From: "Lana Transue" <lanadearest@...>saxony01@...Subject: response to a post on SSDate: Tue, 08 Aug 2006 22:18:12 -0700Rogene, I thought you might like to have this letter from Ms. Benson where in she DOES say that she is the one who has been named to respond to any breast implant inquires! Lana>From: "Benson, M." >To:

lanadearest@...>CC: "CDRH Small Manu. Assistance" >Subject: FW: 06-344 cmh FW: silicon hypersensitivity>Date: Mon, 19 Jun 2006 15:30:26 -0400>>Your interest in contacting the US Food and Drug Administration (FDA)>through your June 19 e-mail is appreciated.>>>>To answer your question, yes, the FDA can require certain study elements if>they are consistent with its regulations and practices. However, as you may>be aware, if the devices in question are involved in clinical trials or not>yet approved, any related information is considered proprietary and>confidential. FDA is prohibited by law from releasing any statements about>it and only the manufacturer has the discretion to do so.>>>>Ms. Leonard has retired from federal service and I have been named to>respond to any breast implant inquiries. So I certainly

hope this reply is>helpful to you!>>>> 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>>>>>> silicon hypersensitivity>>>>I was trying to send this to Ms. Leonard but I can't seem to reach her.>>Could you please forward this e-mail to the proper contact person?>>>>Is it possible for the FDA to "require" the breast implant maunufactures,>>Mentor and Inamed, which is now

owned by Allergan, "an allergy medication>>manufacturing company", to do an assay for measuring an analyte for silicon>>hypersensitivity associated with implants?>>>>Thanks for your help, I will look forward to your response, Lana>>>