RE: x-ray studies, response from Leonard

[Guest guest]

--- Lana Transue <lanadearest@...> wrote:

> From: " Lana Transue " <lanadearest@...>

> saxony01@...

> Subject: RE: x-ray studies, response from

> Leonard

> Date: Tue, 18 Oct 2005 19:17:07 -0700

>

> Hello Ms. Leonard,

>

> I'm sorry to disagree with you, but the ODE is

> definitely mistaken! MRI's do

> NOT show migrated gel and I can prove it! I will

> send you a copy of two

> MRI'S I HAD taken just ONE WEEK BEFORE MY BIOSPY

> WHEREIN THEY REMOVED 2

> CHUNCKS OF SILICONE THAT DID NOT SHOW UP ON EITHER

> MRI. If you ask a regular

> surgeon, they will tell you that once the silicone

> migrates out of the

> implant site it becomes to minute to show up on the

> MRI. Could you send me

> your mailing address and the mailing address for the

> ODE so that I can

> personally send out a copy's of both of my MRI

> x-rays and biopys reports as

> well.

>

> Feel free to contact one of my doctors, a well know

> highly educated surgeon,

> and ask him if small particles of silicone that have

> moved out of the

> implant site will show up on an MRI, Dr. Emory Chang

> 6210 75th st W

> Lakewood Washington 98498 or phone him at,

> 253-984-6200. I have several

> doctors that have told me that an MRI doesn't show

> the migrated gel. I could

> provide you with their names and contact information

> as well.

>

> If you would like, I would be happy to meet with you

> so that I can show you

> the lumps of silicone around my breast and armpit

> area, that you can feel by

> mere touch, but it DOESN " T show up on any MRI.

>

> The MRI techs gave me a second more extensive MRI

> " at no charge " because the

> silicone did NOT show up on the first one, even

> though you could feel it!

> Niether MRI revealed the silicone.

>

> If you have a special MRI machine that will show

> this silicone, then tell me

> where to go and I'll be there.

>

> Also, the " persons " that did my MRI " DID " know that

> they were looking for

> silicone both times. As I stated the lumps are

> rather obvious.

>

> I challenge you and the ODE to prove what you claim,

> and set me up with an

> MRI that will show the silicone that is forming

> large rocks (granulomas)

> formations in my armpits and chest area. I'll pay

> for the tests, you just

> monitor the test. I'm willing to back up my claims

> ARE YOU and the ODE?

> Lana

>

>

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

> > " 'lanadearest@...' "

> ><lanadearest@...>, " 'saxony01@...' "

> <saxony01@...>

> >CC: " CDRH Small Manu. Assistance "

> <DSMA@...>

> >Subject: x-ray studies

> >Date: Tue, 18 Oct 2005 15:29:20 -0400

> >

> >This is in response to your email to the Food and

> Drug Administration

> >(FDA),

> >regarding an MRI detecting leaking silicone.

> >

> >According to the Office of Device Evaluation (ODE),

> the office responsible

> >for conducting scientific reviews of medical

> devices and radiation

> >products,

> >leaking silicone gel will definitely appear on an

> MRI. The

> >technician/radiologist needs to know that leaking

> gel is what is being

> >looked for, for example, in the axilla, to get

> views of distant areas and

> >not just the breast. Also, different T-weighting

> is needed to look for

> >migrated silicone. MRI can also detect

> inflammation and granuloma

> >formation

> >( as well as migrated silicone) in lymph nodes

> which drain the breast (i.e.

> >axillary).

> >

> >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

> > >

> > >

> > >

> >

>

>

>

[Guest guest]

Dr. Middleton, UCSD, has been able to trace silicone on an MRI. It

could be that the silicone in some implants was more able to be

traced. Mine could not be, but I do believe that some women had proof on

an MRI that it could be traced.

Lynda

At 09:54 PM 10/18/2005, you wrote:

>--- Lana Transue <lanadearest@...> wrote:

>

> > From: " Lana Transue " <lanadearest@...>

> > saxony01@...

> > Subject: RE: x-ray studies, response from

> > Leonard

> > Date: Tue, 18 Oct 2005 19:17:07 -0700

> >

> > Hello Ms. Leonard,

> >

> > I'm sorry to disagree with you, but the ODE is

> > definitely mistaken! MRI's do

> > NOT show migrated gel and I can prove it! I will

> > send you a copy of two

> > MRI'S I HAD taken just ONE WEEK BEFORE MY BIOSPY

> > WHEREIN THEY REMOVED 2

> > CHUNCKS OF SILICONE THAT DID NOT SHOW UP ON EITHER

> > MRI. If you ask a regular

> > surgeon, they will tell you that once the silicone

> > migrates out of the

> > implant site it becomes to minute to show up on the

> > MRI. Could you send me

> > your mailing address and the mailing address for the

> > ODE so that I can

> > personally send out a copy's of both of my MRI

> > x-rays and biopys reports as

> > well.

> >

> > Feel free to contact one of my doctors, a well know

> > highly educated surgeon,

> > and ask him if small particles of silicone that have

> > moved out of the

> > implant site will show up on an MRI, Dr. Emory Chang

> > 6210 75th st W

> > Lakewood Washington 98498 or phone him at,

> > 253-984-6200. I have several

> > doctors that have told me that an MRI doesn't show

> > the migrated gel. I could

> > provide you with their names and contact information

> > as well.

> >

> > If you would like, I would be happy to meet with you

> > so that I can show you

> > the lumps of silicone around my breast and armpit

> > area, that you can feel by

> > mere touch, but it DOESN " T show up on any MRI.

> >

> > The MRI techs gave me a second more extensive MRI

> > " at no charge " because the

> > silicone did NOT show up on the first one, even

> > though you could feel it!

> > Niether MRI revealed the silicone.

> >

> > If you have a special MRI machine that will show

> > this silicone, then tell me

> > where to go and I'll be there.

> >

> > Also, the " persons " that did my MRI " DID " know that

> > they were looking for

> > silicone both times. As I stated the lumps are

> > rather obvious.

> >

> > I challenge you and the ODE to prove what you claim,

> > and set me up with an

> > MRI that will show the silicone that is forming

> > large rocks (granulomas)

> > formations in my armpits and chest area. I'll pay

> > for the tests, you just

> > monitor the test. I'm willing to back up my claims

> > ARE YOU and the ODE?

> > Lana

> >

> >

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

> > > " 'lanadearest@...' "

> > ><lanadearest@...>, " 'saxony01@...' "

> > <saxony01@...>

> > >CC: " CDRH Small Manu. Assistance "

> > <DSMA@...>

> > >Subject: x-ray studies

> > >Date: Tue, 18 Oct 2005 15:29:20 -0400

> > >

> > >This is in response to your email to the Food and

> > Drug Administration

> > >(FDA),

> > >regarding an MRI detecting leaking silicone.

> > >

> > >According to the Office of Device Evaluation (ODE),

> > the office responsible

> > >for conducting scientific reviews of medical

> > devices and radiation

> > >products,

> > >leaking silicone gel will definitely appear on an

> > MRI. The

> > >technician/radiologist needs to know that leaking

> > gel is what is being

> > >looked for, for example, in the axilla, to get

> > views of distant areas and

> > >not just the breast. Also, different T-weighting

> > is needed to look for

> > >migrated silicone. MRI can also detect

> > inflammation and granuloma

> > >formation

> > >( as well as migrated silicone) in lymph nodes

> > which drain the breast (i.e.

> > >axillary).

> > >

> > >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

> > > >

> > > >

> > > >

> > >

> >

> >

> >

>

>

>

>Opinions expressed are NOT meant to take the place of advice given by

>licensed health care professionals. Consult your physician or licensed

>health care professional before commencing any medical treatment.

>

> " Do not let either the medical authorities or the politicians mislead you.

>Find out what the facts are, and make your own decisions about how to live

>a happy life and how to work for a better world. " - Linus ing,

>two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)

>

>

[Guest guest]

A woman at the gym I go to had ruptured implants and her MRI showed that she

had " something " in her armpits but they weren't able to confirm what it was

until they went in surgically.

Kenda

> Dr. Middleton, UCSD, has been able to trace silicone on an MRI. It

> could be that the silicone in some implants was more able to be

> traced. Mine could not be, but I do believe that some women had proof on

> an MRI that it could be traced.

>

> Lynda

>

>

> At 09:54 PM 10/18/2005, you wrote:

>

>

>> --- Lana Transue <lanadearest@...> wrote:

>>

>>> From: " Lana Transue " <lanadearest@...>

>>> saxony01@...

>>> Subject: RE: x-ray studies, response from

>>> Leonard

>>> Date: Tue, 18 Oct 2005 19:17:07 -0700

>>>

>>> Hello Ms. Leonard,

>>>

>>> I'm sorry to disagree with you, but the ODE is

>>> definitely mistaken! MRI's do

>>> NOT show migrated gel and I can prove it! I will

>>> send you a copy of two

>>> MRI'S I HAD taken just ONE WEEK BEFORE MY BIOSPY

>>> WHEREIN THEY REMOVED 2

>>> CHUNCKS OF SILICONE THAT DID NOT SHOW UP ON EITHER

>>> MRI. If you ask a regular

>>> surgeon, they will tell you that once the silicone

>>> migrates out of the

>>> implant site it becomes to minute to show up on the

>>> MRI. Could you send me

>>> your mailing address and the mailing address for the

>>> ODE so that I can

>>> personally send out a copy's of both of my MRI

>>> x-rays and biopys reports as

>>> well.

>>>

>>> Feel free to contact one of my doctors, a well know

>>> highly educated surgeon,

>>> and ask him if small particles of silicone that have

>>> moved out of the

>>> implant site will show up on an MRI, Dr. Emory Chang

>>> 6210 75th st W

>>> Lakewood Washington 98498 or phone him at,

>>> 253-984-6200. I have several

>>> doctors that have told me that an MRI doesn't show

>>> the migrated gel. I could

>>> provide you with their names and contact information

>>> as well.

>>>

>>> If you would like, I would be happy to meet with you

>>> so that I can show you

>>> the lumps of silicone around my breast and armpit

>>> area, that you can feel by

>>> mere touch, but it DOESN " T show up on any MRI.

>>>

>>> The MRI techs gave me a second more extensive MRI

>>> " at no charge " because the

>>> silicone did NOT show up on the first one, even

>>> though you could feel it!

>>> Niether MRI revealed the silicone.

>>>

>>> If you have a special MRI machine that will show

>>> this silicone, then tell me

>>> where to go and I'll be there.

>>>

>>> Also, the " persons " that did my MRI " DID " know that

>>> they were looking for

>>> silicone both times. As I stated the lumps are

>>> rather obvious.

>>>

>>> I challenge you and the ODE to prove what you claim,

>>> and set me up with an

>>> MRI that will show the silicone that is forming

>>> large rocks (granulomas)

>>> formations in my armpits and chest area. I'll pay

>>> for the tests, you just

>>> monitor the test. I'm willing to back up my claims

>>> ARE YOU and the ODE?

>>> Lana

>>>

>>>

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

>>>> " 'lanadearest@...' "

>>>> <lanadearest@...>, " 'saxony01@...' "

>>> <saxony01@...>

>>>> CC: " CDRH Small Manu. Assistance "

>>> <DSMA@...>

>>>> Subject: x-ray studies

>>>> Date: Tue, 18 Oct 2005 15:29:20 -0400

>>>>

>>>> This is in response to your email to the Food and

>>> Drug Administration

>>>> (FDA),

>>>> regarding an MRI detecting leaking silicone.

>>>>

>>>> According to the Office of Device Evaluation (ODE),

>>> the office responsible

>>>> for conducting scientific reviews of medical

>>> devices and radiation

>>>> products,

>>>> leaking silicone gel will definitely appear on an

>>> MRI. The

>>>> technician/radiologist needs to know that leaking

>>> gel is what is being

>>>> looked for, for example, in the axilla, to get

>>> views of distant areas and

>>>> not just the breast. Also, different T-weighting

>>> is needed to look for

>>>> migrated silicone. MRI can also detect

>>> inflammation and granuloma

>>>> formation

>>>> ( as well as migrated silicone) in lymph nodes

>>> which drain the breast (i.e.

>>>> axillary).

>>>>

>>>> 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

>>>>>

>>>>>

>>>>>

>>>>

>>>

>>>

>>>

>>

>>

>>

>> Opinions expressed are NOT meant to take the place of advice given by

>> licensed health care professionals. Consult your physician or licensed

>> health care professional before commencing any medical treatment.

>>

>> " Do not let either the medical authorities or the politicians mislead you.

>> Find out what the facts are, and make your own decisions about how to live

>> a happy life and how to work for a better world. " - Linus ing,

>> two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)

>>

>>

[Guest guest]

I wonder if the difference is, in part, due to the

size of silicone micro-particles? I very much doubt

that micro-particles will be seen. However, a bunch of

micro-particles have a much larger surface areas than

a single blob. . .

As I see it, micro-particles would lead to a more

severe reaction with greater distribution throughout

the body - including the liver, the brain AND the

placenta.

However, I know that Lana's granulomas were sizable

and didn't show though!

Rogene

--- Lynda <coss@...> wrote:

> Dr. Middleton, UCSD, has been able to trace

> silicone on an MRI. It

> could be that the silicone in some implants was more

> able to be

> traced. Mine could not be, but I do believe that

> some women had proof on

> an MRI that it could be traced.

>

> Lynda

>

>

> At 09:54 PM 10/18/2005, you wrote:

>

>

> >--- Lana Transue <lanadearest@...> wrote:

> >

> > > From: " Lana Transue " <lanadearest@...>

> > > saxony01@...

> > > Subject: RE: x-ray studies, response from

> > > Leonard

> > > Date: Tue, 18 Oct 2005 19:17:07 -0700

> > >

> > > Hello Ms. Leonard,

> > >

> > > I'm sorry to disagree with you, but the ODE is

> > > definitely mistaken! MRI's do

> > > NOT show migrated gel and I can prove it! I will

> > > send you a copy of two

> > > MRI'S I HAD taken just ONE WEEK BEFORE MY BIOSPY

> > > WHEREIN THEY REMOVED 2

> > > CHUNCKS OF SILICONE THAT DID NOT SHOW UP ON

> EITHER

> > > MRI. If you ask a regular

> > > surgeon, they will tell you that once the

> silicone

> > > migrates out of the

> > > implant site it becomes to minute to show up on

> the

> > > MRI. Could you send me

> > > your mailing address and the mailing address for

> the

> > > ODE so that I can

> > > personally send out a copy's of both of my MRI

> > > x-rays and biopys reports as

> > > well.

> > >

> > > Feel free to contact one of my doctors, a well

> know

> > > highly educated surgeon,

> > > and ask him if small particles of silicone that

> have

> > > moved out of the

> > > implant site will show up on an MRI, Dr. Emory

> Chang

> > > 6210 75th st W

> > > Lakewood Washington 98498 or phone him at,

> > > 253-984-6200. I have several

> > > doctors that have told me that an MRI doesn't

> show

> > > the migrated gel. I could

> > > provide you with their names and contact

> information

> > > as well.

> > >

> > > If you would like, I would be happy to meet with

> you

> > > so that I can show you

> > > the lumps of silicone around my breast and

> armpit

> > > area, that you can feel by

> > > mere touch, but it DOESN " T show up on any MRI.

> > >

> > > The MRI techs gave me a second more extensive

> MRI

> > > " at no charge " because the

> > > silicone did NOT show up on the first one, even

> > > though you could feel it!

> > > Niether MRI revealed the silicone.

> > >

> > > If you have a special MRI machine that will show

> > > this silicone, then tell me

> > > where to go and I'll be there.

> > >

> > > Also, the " persons " that did my MRI " DID " know

> that

> > > they were looking for

> > > silicone both times. As I stated the lumps are

> > > rather obvious.

> > >

> > > I challenge you and the ODE to prove what you

> claim,

> > > and set me up with an

> > > MRI that will show the silicone that is forming

> > > large rocks (granulomas)

> > > formations in my armpits and chest area. I'll

> pay

> > > for the tests, you just

> > > monitor the test. I'm willing to back up my

> claims

> > > ARE YOU and the ODE?

> > > Lana

> > >

> > >

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

> > > > " 'lanadearest@...' "

> > >

> ><lanadearest@...>, " 'saxony01@...' "

> > > <saxony01@...>

> > > >CC: " CDRH Small Manu. Assistance "

> > > <DSMA@...>

> > > >Subject: x-ray studies

> > > >Date: Tue, 18 Oct 2005 15:29:20 -0400

> > > >

> > > >This is in response to your email to the Food

> and

> > > Drug Administration

> > > >(FDA),

> > > >regarding an MRI detecting leaking silicone.

> > > >

> > > >According to the Office of Device Evaluation

> (ODE),

> > > the office responsible

> > > >for conducting scientific reviews of medical

> > > devices and radiation

> > > >products,

> > > >leaking silicone gel will definitely appear on

> an

> > > MRI. The

> > > >technician/radiologist needs to know that

> leaking

> > > gel is what is being

> > > >looked for, for example, in the axilla, to get

> > > views of distant areas and

> > > >not just the breast. Also, different

> T-weighting

> > > is needed to look for

> > > >migrated silicone. MRI can also detect

> > > inflammation and granuloma

> > > >formation

> > > >( as well as migrated silicone) in lymph nodes

> > > which drain the breast (i.e.

> > > >axillary).

> > > >

> > > >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

>

=== message truncated ===

[Guest guest]

From: " Lana Transue " <lanadearest@...

saxony01@...

Subject: RE: x-ray studies, response from

Leonard

Date: Wed, 19 Oct 2005 08:16:45 -0700

If you have your MRI report that does not show the

silicone and a biopsy report that does, PLEASE forward

that information to Ms. Leonard

<nml@....

The manufactures claim that the MRI will show all

migrated silicone and it doesn't. I am not sure why

some may show and some may not but that makes the

studies inconclusive! My armpit is full of silicone

too and I am not going to rest until I can see it on a

x-ray. I also want to know where else it is. Also, it

took almost 15 years for these granulomas to become

big enough to be felt by the mere touch so an MRI

study of long term implant use with confirmation of a

rupture must be conducted.

Dr. Middleton is the doctor that used to work with

Doctor Graham Woods correct? If so, then he had access

to the xerogrammography machines and he would

definitely be the one to talk to about x-ray studies.

My xerogramographys brought tears to my eyes. I could

see the silicone pouring out of the top of the implant

like a river. It was very frightening! With my MRI's,

NOTHING-- 0-- not a drop of silicone in sight. I too

had to have surgery in order to find out what the

lumps were, in my case the lumps didn't even show up.

Thanks for your response, Lana

At 09:54 PM 10/18/2005, you wrote:

--- Lana Transue <lanadearest@... wrote:

From: " Lana Transue " <lanadearest@...

saxony01@...

Subject: RE: x-ray studies, response from

Leonard

Date: Tue, 18 Oct 2005 19:17:07 -0700

Hello Ms. Leonard,

I'm sorry to disagree with you, but the ODE is

definitely mistaken! MRI's do NOT show migrated gel

and I can prove it! I will send you a copy of two

MRI'S I HAD taken just ONE WEEK BEFORE MY BIOSPY

WHEREIN THEY REMOVED 2 CHUNCKS OF SILICONE THAT DID

NOT SHOW UP ON EITHER MRI. If you ask a regular

surgeon, they will tell you that once the silicone

migrates out of the implant site it becomes to minute

to show up on the MRI. Could you send me your mailing

address and the mailing address for the ODE so that I

can personally send out a copy's of both of my MRI

x-rays and biopsy reports as well.

Feel free to contact one of my doctors, a well know

highly educated surgeon, and ask him if small

particles of silicone that have moved out of the

implant site will show up on an MRI, Dr. Emory Chang

6210 75th St. W Lakewood Washington 98498 or phone him

at, 253-984-6200. I have several doctors that have

told me that an MRI doesn't show the migrated gel. I

could provide you with their names and contact

information as well.

If you would like, I would be happy to meet with you

so that I can show you the lumps of silicone around my

breast and armpit area, that you can feel by mere

touch, but it DOESN " T show up on any MRI.

The MRI techs gave me a second more extensive MRI " at

no charge " because the silicone did NOT show up on the

first one, even though you could feel it! Neither MRI

revealed the silicone.

If you have a special MRI machine that will show this

silicone, then tell me where to go and I'll be there.

Also, the " persons " that did my MRI " DID " know that

they were looking for silicone both times. As I stated

the lumps are rather obvious.

I challenge you and the ODE to prove what you claim,

and set me up with an MRI that will show the silicone

that is forming large rocks (granulomas) formations in

my armpits and chest area. I'll pay for the tests, you

just monitor the test. I'm willing to back up my

claims ARE YOU and the ODE?

Lana

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

" 'lanadearest@...' "

<lanadearest@... , " 'saxony01@...' "

<saxony01@...

CC: " CDRH Small Manu. Assistance "

<DSMA@...

Subject: x-ray studies

Date: Tue, 18 Oct 2005 15:29:20 -0400

This is in response to your email to the Food and

Drug Administration (FDA), regarding an MRI detecting

leaking silicone.

According to the Office of Device Evaluation (ODE),

the office responsible for conducting scientific

reviews of medical devices and radiation products,

leaking silicone gel will definitely appear on an MRI.

The technician/radiologist needs to know that leaking

gel is what is being looked for, for example, in the

axilla, to get views of distant areas and not just the

breast. Also, different T-weighting is needed to look

for migrated silicone. MRI can also detect

inflammation and granuloma formation ( as well as

migrated silicone) in lymph nodes which drain the

breast (i.e. axillary).

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 confused here. If general practitioners

and surgeons know that a 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 components 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

[Guest guest]

--- Lana Transue <lanadearest@...> wrote:

> From: " Lana Transue " <lanadearest@...>

> saxony01@...

> Subject: RE: x-ray studies, response from

> Leonard

> Date: Wed, 19 Oct 2005 09:38:29 -0700

>

> It could be that once the silicone is incased in

> scar tissue it won't show

> on the MRI. But when my implants were first ruptured

> no one would send me

> for an MRI then either. Has anyone ever been sent

> for an MRI by their

> plastic surgeon? I never have and I've probally seen

> a dozen plastic

> surgeons over the years, after my implants ruptured.

> Why aren't the plastic

> surgeons sending women for MRI studies before

> implant rupture removal? I

> would think if the MRI showed the migrated gel, then

> the plastic surgeon

> would be using the x-rays for preporations for

> removal surgerys. HMM....

> Lana

>

>

[Guest guest]

In 1994 I had a MRI of my silicone implants which showed that I had seepage on both the left and right breast. The plastic surgeon suspected a possible rupture and advised that I remove them, which I did but not until 2000. Both the left and right breasts were indeed ruptured.

ShirleyRogene S <saxony01@...> wrote:

--- Lana Transue <lanadearest@...> wrote:> From: "Lana Transue" <lanadearest@...>> saxony01@...> Subject: RE: x-ray studies, response from > Leonard> Date: Wed, 19 Oct 2005 09:38:29 -0700> > It could be that once the silicone is incased in> scar tissue it won't show > on the MRI. But when my implants were first ruptured> no one would send me > for an MRI then either. Has anyone ever been sent> for an MRI by their > plastic surgeon? I never have and I've probally seen> a dozen plastic > surgeons over the years, after my implants ruptured.> Why aren't the plastic > surgeons sending women for MRI studies before> implant rupture removal? I > would think if the MRI showed the migrated gel,

then> the plastic surgeon > would be using the x-rays for preporations for> removal surgerys. HMM.... > Lana> >

[Guest guest]

Lana, I don't think PS want to know.

>

> > From: " Lana Transue " <lanadearest@h...>

> > saxony01@y...

> > Subject: RE: x-ray studies, response from

> > Leonard

> > Date: Wed, 19 Oct 2005 09:38:29 -0700

> >

> > It could be that once the silicone is incased in

> > scar tissue it won't show

> > on the MRI. But when my implants were first ruptured

> > no one would send me

> > for an MRI then either. Has anyone ever been sent

> > for an MRI by their

> > plastic surgeon? I never have and I've probally seen

> > a dozen plastic

> > surgeons over the years, after my implants ruptured.

> > Why aren't the plastic

> > surgeons sending women for MRI studies before

> > implant rupture removal? I

> > would think if the MRI showed the migrated gel, then

> > the plastic surgeon

> > would be using the x-rays for preporations for

> > removal surgerys. HMM....

> > Lana

> >

> >

>

>

> Opinions expressed are NOT meant to take the place of advice given by licensed

health

care professionals. Consult your physician or licensed health care professional

before

commencing any medical treatment.

>

> " Do not let either the medical authorities or the politicians mislead you.

Find out what

the facts are, and make your own decisions about how to live a happy life and

how to work

for a better world. " - Linus ing, two-time Nobel Prize Winner (1954,

Chemistry; 1963,

Peace)

>

>

[Guest guest]

The MRIs of my breasts showed a 'linguini rupture' or a significant rupture.

There was

nothing on my MRI about migration of silicone gel. Yet, Dr. Kolb told me that

most of the

silicone was gone from my implants, and it had to go somewhere...

> >

> > > From: " Lana Transue " <lanadearest@h...>

> > > saxony01@y...

> > > Subject: RE: x-ray studies, response from

> > > Leonard

> > > Date: Wed, 19 Oct 2005 09:38:29 -0700

> > >

> > > It could be that once the silicone is incased in

> > > scar tissue it won't show

> > > on the MRI. But when my implants were first ruptured

> > > no one would send me

> > > for an MRI then either. Has anyone ever been sent

> > > for an MRI by their

> > > plastic surgeon? I never have and I've probally seen

> > > a dozen plastic

> > > surgeons over the years, after my implants ruptured.

> > > Why aren't the plastic

> > > surgeons sending women for MRI studies before

> > > implant rupture removal? I

> > > would think if the MRI showed the migrated gel, then

> > > the plastic surgeon

> > > would be using the x-rays for preporations for

> > > removal surgerys. HMM....

> > > Lana

> > >

> > >

> >

> >

> > Opinions expressed are NOT meant to take the place of advice given by

licensed

health

> care professionals. Consult your physician or licensed health care

professional before

> commencing any medical treatment.

> >

> > " Do not let either the medical authorities or the politicians mislead you.

Find out what

> the facts are, and make your own decisions about how to live a happy life and

how to

work

> for a better world. " - Linus ing, two-time Nobel Prize Winner (1954,

Chemistry;

1963,

> Peace)

> >

> >