second response from FDA re: x-ray studies

[Guest guest]

--- " Leonard, M. " <NML@...> wrote:

> From: " Leonard, M. " <NML@...>

> " 'lanadearest@...' "

> <lanadearest@...>

> CC: " 'saxony01@...' " <saxony01@...>,

> " CDRH Small Manu. Assistance " <DSMA@...>

> 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 <lanadearest@...> 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

> > >

> > >

> > >

> >

>

>

>