X-ray studies

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feel free to post thisLana Transue <lanadearest@...> wrote: From: "Lana Transue" <lanadearest@...>Subject: FW: x-ray studies-feel free to post thisDate: Sun, 20 Aug 2006 12:11:10 -0700This is what the FDA says about MRI's and silicone implant rupture, with gel migration. It's interesting how much things change when you challenge what they tell you with evidence. If you read the bottom e-mail response and compare it to the top answer, it's quite differant! Luckily in my case I had every thing they claimed that you need to find the migrated gel, they still couldn't see it. Lana>From: "Leonard, M." >"'lanadearest@...'" >CC: "'saxony01@...'" ,"CDRH Small Manu. >Assistance"

>Subject: FW: x-ray studies>Date: Wed, 19 Oct 2005 15:26:05 -0400>> Like the Office of Device Evaluation (ODE) said, unless you are specifically looking for migrated gel, take special views, and use specific magnetic weighting, you will not find migrated gel. Certainly it is possible to miss it depending on the quality of the MRI and the strength of the magnet used. Also, if the migrated gel is a small chunk, MRI could also miss it; however, the detection limit of MRI is quite good. We're not saying that MRI is the end all/be all for detecting migrated gel. It is, however, the currently best method available to detect migrated silicone. We also have data from the Core Studies where there were MRI scans showing gel nodules/chunks outside of the implant as well as in the axilla, representing migrated silicone. If you want to send your MRI readings, your biopsy results, and the surgical op note which details where the migrated gel was, ODE would like to see it. Please send this information to me at: Food and Drug Administration Center for Devices and Radiological Health Attn: Mrs. Leonard (HFZ-210) 1350 Piccard Drive, Room 110H Rockville, MD 20850 The MRI readings should include what strength magnet was used, whether a breast coil was used, and what the quality of the scan was; otherwise, your MRIs cannot be used to determine whether they were sufficiently accurate to detect migrated gel. Again, we're not saying that MRI is the end of the story, but that it's a beginning. If there is a clinical suspicion, then that should be used in the judgment as well as the MRI. I hope the information that I have provided is helpful. M. Leonard Public Health Advisor Consumer Staff, HFZ-210 Division of Small Manufacturers, International, and Consumer Assistance Office of Communication, Education and Radiation Programs Center for Devices and Radiological Health Phone: 1-800-638-2041 extension 141 Fax: 1-301-443-8818 This response represents to the best of my judgment how the device should be regulated, solely

based upon a review of the information you have provided. This response is not a classification decision for your device and does not constitute FDA clearance or approval for commercial distribution. Unless exempt from premarket notification submission (510(k)) requirements, the official classification for your device will appear on the final decision letter from any premarket review. All device types classified as exempt from the 510(k) requirements are subject to the limitations of exemptions. Limitations of device exemptions are found in the device classification chapters in 21 CFR xxx.9, where xxx refers to Parts 862-892 (e.g., 862.9, 864.9, etc.). Please be aware, if I have indicated that I believe your device falls within a device category classified as exempt from premarket review requirements, that it is your responsibility to ensure that you meet the exemption criteria and your device does not exceed the limitations of exemption. If your device exceeds the

limitations of exemption, you must submit a 510(k) and receive a letter from FDA stating that your device may be commercially distributed in the U.S. prior to marketing your device. This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. ----------------------------------------------------------------- Re: x-ray studies Lana, I'm

copying your message to Mrs. Leonard at the FDA . . . Maybe she knows the answer. I'm dumbfounded! I don't know why they think MRI's would detect leaking silicone! Rogene Schorer------------------------------------------------------------------------------ --- Lana Transue wrote: Rogene, I am really confussed here. If general practioners and surgeons know that an MRI won't show migrated silicone gel, then why is the FDA allowing the manufactures to use MRI's to detect silicone migration for their study? I don't get it! Call any

regular doctor and or surgeon and they will tell you that the silicone particles become to minute to show up on an MRI once they migrate out of the implant site. How are we ever supposed to know and or prove what the silicone and or it's componets are doing to our bodies, if we can't even see where the silicone went? I think it would be a whole lot harder from the manufactures to say that silicone is safe if the right x-rays were used. Lana