Re: Mentor's cohesive gel implants have been APPROVED

[Guest guest]

> Insane . . .

RIGHTO Rogene!

Just a word of clarification ... these are not the gummy bear

cohesive gel implants that got " approved " ... it's a liquid gel

implant that they say is thicker. What makes them thicker now, by

the way? What has been added?

Here are the 10 conditions:

Blumenstein and Newburger voted not to approve with these conditions.

Conditions Discussion.

1. Motion for educational component. Dr. Leitch moves for

educational

condition/Dr. seconds

Hands-on Training (Dr. --to require that any surgeon prove

he/she

knows how to handle the device.) Surgeon to be either board

certified or

board eligible. NOT AN FDA ENFORCEABLE CONDITION.

VOTE: UNANIMOUS

2. Dr Li proposes that sponsor continues to supply the data

collection/information they have already been supplying. If they do

not file

reports, FDA to call panel to review. No faith in registries.

Dr. Newburger proposes a panel meeting to review data in 5 years

(from now).

Concerned over ignored patients.

VOTE: UNANIMOUS

3. Dr. Blumenstein proposes independent monitoring committee,

following FDA

guidelines. including advocates from both sides of issue. Focus on

safety.

VOTE: 8-1 Dr. Ewing voted not to accept this condition.

4. Dr LoCicero proposes separate and distinct patient educational

process

for informed consent for patient.

VOTE: UNANIMOUS

5. Dr. Leitch proposes study that core study be amended to include

followup

for patients who have had implants removed and patients be re-

consented.

Dr. Blumenstein wants sypmtoms to be followed on all patients,

including

patients who are explanted without re-implanting.

VOTE: UNANIMOUS

6. Dr Newburger proposes voluntary registry of as many patients as

possible

to participate, guidelines including MRI data, CTD, explant data,

intracapsular data, pregnancy, mammography results, silent rupture,

signs

and symptoms, and health outcome of children born to women with

breast

implants. Dr. Blumenstein seconded because children are included.

Discussion: Dr. doesn't believe data is available for a

problem with

children. (Children have never been studied.) Dr. suggests

that

doctors who do not follow through with follow-up will lose their

ability to

use implants. Dr.Leitch doesn't want to step on sponsor's toes. Dr.

Newburger

VOTE: 8-1 Dr Li opposes

7. DID NOT PASS--Dr. Blumentstein proposes voluntary sub-study of

core

study of signs and symptoms and life-style in individuals with CTD

who

change scores and more frequent followup. Blood and Urine tests to

be

required.

Dr. Newburger seconded.

VOTE: 2-6 Blumenstein and Newburger voted for this condition. Dr

LoCicero

abstained.

8. Dr. Li proposes sponsor fulfills all post-market recommendations

conditions as provided by sponsor in application.

VOTE: UNANIMOUS

9. Dr. Leitch proposes tracking device. Physician to provide mail-

in card

to patient to track in case of recall.

VOTE: 8-1 Dr. Blumenstein voted not in favor.

10. Choti: Add to labeling a recommendation for MRI scan or other

appropriately sensitivity powered examination at year 5 and every 2

years

afterwards.

Consider implant removal if there is evidence of silent leak.

Newburger --does not eliminate need for regular mammography.

Silent leak the recommendation is that device be changed or removed.

VOTE: Passes-5-4

7-2 Final vote to approve with conditions.

Blumenstein, Newburger voted against approval.

[Guest guest]

Darling Ilena:

This is a sad day for all women and their families. Mentor is so corrupt,

they brought in their big guns today. Can this be appealed?

Loving you always....Lea

$$$$$$$$$$$$$ money talks $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

Re: Mentor's cohesive gel implants have been

APPROVED

>

>

>

>> Insane . . .

>

> RIGHTO Rogene!

>

> Just a word of clarification ... these are not the gummy bear

> cohesive gel implants that got " approved " ... it's a liquid gel

> implant that they say is thicker. What makes them thicker now, by

> the way? What has been added?

>

>

>

> Here are the 10 conditions:

>

>

>

> Blumenstein and Newburger voted not to approve with these conditions.

>

> Conditions Discussion.

>

> 1. Motion for educational component. Dr. Leitch moves for

> educational

> condition/Dr. seconds

> Hands-on Training (Dr. --to require that any surgeon prove

> he/she

> knows how to handle the device.) Surgeon to be either board

> certified or

> board eligible. NOT AN FDA ENFORCEABLE CONDITION.

>

> VOTE: UNANIMOUS

>

> 2. Dr Li proposes that sponsor continues to supply the data

> collection/information they have already been supplying. If they do

> not file

> reports, FDA to call panel to review. No faith in registries.

>

> Dr. Newburger proposes a panel meeting to review data in 5 years

> (from now).

> Concerned over ignored patients.

>

> VOTE: UNANIMOUS

>

> 3. Dr. Blumenstein proposes independent monitoring committee,

> following FDA

> guidelines. including advocates from both sides of issue. Focus on

> safety.

>

> VOTE: 8-1 Dr. Ewing voted not to accept this condition.

>

> 4. Dr LoCicero proposes separate and distinct patient educational

> process

> for informed consent for patient.

>

> VOTE: UNANIMOUS

>

> 5. Dr. Leitch proposes study that core study be amended to include

> followup

> for patients who have had implants removed and patients be re-

> consented.

>

> Dr. Blumenstein wants sypmtoms to be followed on all patients,

> including

> patients who are explanted without re-implanting.

>

> VOTE: UNANIMOUS

>

> 6. Dr Newburger proposes voluntary registry of as many patients as

> possible

> to participate, guidelines including MRI data, CTD, explant data,

> intracapsular data, pregnancy, mammography results, silent rupture,

> signs

> and symptoms, and health outcome of children born to women with

> breast

> implants. Dr. Blumenstein seconded because children are included.

>

> Discussion: Dr. doesn't believe data is available for a

> problem with

> children. (Children have never been studied.) Dr. suggests

> that

> doctors who do not follow through with follow-up will lose their

> ability to

> use implants. Dr.Leitch doesn't want to step on sponsor's toes. Dr.

> Newburger

>

> VOTE: 8-1 Dr Li opposes

>

> 7. DID NOT PASS--Dr. Blumentstein proposes voluntary sub-study of

> core

> study of signs and symptoms and life-style in individuals with CTD

> who

> change scores and more frequent followup. Blood and Urine tests to

> be

> required.

>

> Dr. Newburger seconded.

>

> VOTE: 2-6 Blumenstein and Newburger voted for this condition. Dr

> LoCicero

> abstained.

>

> 8. Dr. Li proposes sponsor fulfills all post-market recommendations

> conditions as provided by sponsor in application.

>

> VOTE: UNANIMOUS

>

> 9. Dr. Leitch proposes tracking device. Physician to provide mail-

> in card

> to patient to track in case of recall.

>

> VOTE: 8-1 Dr. Blumenstein voted not in favor.

>

> 10. Choti: Add to labeling a recommendation for MRI scan or other

> appropriately sensitivity powered examination at year 5 and every 2

> years

> afterwards.

>

> Consider implant removal if there is evidence of silent leak.

>

> Newburger --does not eliminate need for regular mammography.

>

> Silent leak the recommendation is that device be changed or removed.

>

> VOTE: Passes-5-4

>

> 7-2 Final vote to approve with conditions.

>

> Blumenstein, Newburger voted against approval.

>

>

>

>

>

>

>

>

>

> 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]

It's in no way a " done deal " ...

The FDA can still go against the " recommendation " of the Panel ...

like they did last year with Inamed.

It's not anywhere near over ...

Love, Ilena

--- In , " Lea " <devans@c...>

wrote:

> Darling Ilena:

>

> This is a sad day for all women and their families. Mentor is so

corrupt,

> they brought in their big guns today. Can this be appealed?

>

> Loving you always....Lea

> $$$$$$$$$$$$$ money talks $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

> Re: Mentor's cohesive gel implants have

been

> APPROVED

>

>

> >

> >

> > --- In , Rogene S <saxony01@y...>

wrote:

> >> Insane . . .

> >

> > RIGHTO Rogene!

> >

> > Just a word of clarification ... these are not the gummy bear

> > cohesive gel implants that got " approved " ... it's a liquid gel

> > implant that they say is thicker. What makes them thicker now, by

> > the way? What has been added?

> >

> >

> >

> > Here are the 10 conditions:

> >

> >

> >

> > Blumenstein and Newburger voted not to approve with these

conditions.

> >

> > Conditions Discussion.

> >

> > 1. Motion for educational component. Dr. Leitch moves for

> > educational

> > condition/Dr. seconds

> > Hands-on Training (Dr. --to require that any surgeon prove

> > he/she

> > knows how to handle the device.) Surgeon to be either board

> > certified or

> > board eligible. NOT AN FDA ENFORCEABLE CONDITION.

> >

> > VOTE: UNANIMOUS

> >

> > 2. Dr Li proposes that sponsor continues to supply the data

> > collection/information they have already been supplying. If they

do

> > not file

> > reports, FDA to call panel to review. No faith in registries.

> >

> > Dr. Newburger proposes a panel meeting to review data in 5 years

> > (from now).

> > Concerned over ignored patients.

> >

> > VOTE: UNANIMOUS

> >

> > 3. Dr. Blumenstein proposes independent monitoring committee,

> > following FDA

> > guidelines. including advocates from both sides of issue. Focus

on

> > safety.

> >

> > VOTE: 8-1 Dr. Ewing voted not to accept this condition.

> >

> > 4. Dr LoCicero proposes separate and distinct patient

educational

> > process

> > for informed consent for patient.

> >

> > VOTE: UNANIMOUS

> >

> > 5. Dr. Leitch proposes study that core study be amended to

include

> > followup

> > for patients who have had implants removed and patients be re-

> > consented.

> >

> > Dr. Blumenstein wants sypmtoms to be followed on all patients,

> > including

> > patients who are explanted without re-implanting.

> >

> > VOTE: UNANIMOUS

> >

> > 6. Dr Newburger proposes voluntary registry of as many patients

as

> > possible

> > to participate, guidelines including MRI data, CTD, explant data,

> > intracapsular data, pregnancy, mammography results, silent

rupture,

> > signs

> > and symptoms, and health outcome of children born to women with

> > breast

> > implants. Dr. Blumenstein seconded because children are

included.

> >

> > Discussion: Dr. doesn't believe data is available for a

> > problem with

> > children. (Children have never been studied.) Dr.

suggests

> > that

> > doctors who do not follow through with follow-up will lose their

> > ability to

> > use implants. Dr.Leitch doesn't want to step on sponsor's toes.

Dr.

> > Newburger

> >

> > VOTE: 8-1 Dr Li opposes

> >

> > 7. DID NOT PASS--Dr. Blumentstein proposes voluntary sub-study

of

> > core

> > study of signs and symptoms and life-style in individuals with

CTD

> > who

> > change scores and more frequent followup. Blood and Urine tests

to

> > be

> > required.

> >

> > Dr. Newburger seconded.

> >

> > VOTE: 2-6 Blumenstein and Newburger voted for this condition.

Dr

> > LoCicero

> > abstained.

> >

> > 8. Dr. Li proposes sponsor fulfills all post-market

recommendations

> > conditions as provided by sponsor in application.

> >

> > VOTE: UNANIMOUS

> >

> > 9. Dr. Leitch proposes tracking device. Physician to provide

mail-

> > in card

> > to patient to track in case of recall.

> >

> > VOTE: 8-1 Dr. Blumenstein voted not in favor.

> >

> > 10. Choti: Add to labeling a recommendation for MRI scan or

other

> > appropriately sensitivity powered examination at year 5 and

every 2

> > years

> > afterwards.

> >

> > Consider implant removal if there is evidence of silent leak.

> >

> > Newburger --does not eliminate need for regular mammography.

> >

> > Silent leak the recommendation is that device be changed or

removed.

> >

> > VOTE: Passes-5-4

> >

> > 7-2 Final vote to approve with conditions.

> >

> > Blumenstein, Newburger voted against approval.

> >

> >

> >

> >

> >

> >

> >

> >

> >

> > 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]

Maybe so, but I am truly disappointed.

Lynda

At 07:56 PM 4/13/2005, you wrote:

>It's in no way a " done deal " ...

>

>The FDA can still go against the " recommendation " of the Panel ...

>like they did last year with Inamed.

>

>It's not anywhere near over ...

>

>Love, Ilena

>

>

>--- In , " Lea " <devans@c...>

>wrote:

> > Darling Ilena:

> >

> > This is a sad day for all women and their families. Mentor is so

>corrupt,

> > they brought in their big guns today. Can this be appealed?

> >

> > Loving you always....Lea

> > $$$$$$$$$$$$$ money talks $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

> > Re: Mentor's cohesive gel implants have

>been

> > APPROVED

> >

> >

> > >

> > >

> > > --- In , Rogene S <saxony01@y...>

>wrote:

> > >> Insane . . .

> > >

> > > RIGHTO Rogene!

> > >

> > > Just a word of clarification ... these are not the gummy bear

> > > cohesive gel implants that got " approved " ... it's a liquid gel

> > > implant that they say is thicker. What makes them thicker now, by

> > > the way? What has been added?

> > >

> > >

> > >

> > > Here are the 10 conditions:

> > >

> > >

> > >

> > > Blumenstein and Newburger voted not to approve with these

>conditions.

> > >

> > > Conditions Discussion.

> > >

> > > 1. Motion for educational component. Dr. Leitch moves for

> > > educational

> > > condition/Dr. seconds

> > > Hands-on Training (Dr. --to require that any surgeon prove

> > > he/she

> > > knows how to handle the device.) Surgeon to be either board

> > > certified or

> > > board eligible. NOT AN FDA ENFORCEABLE CONDITION.

> > >

> > > VOTE: UNANIMOUS

> > >

> > > 2. Dr Li proposes that sponsor continues to supply the data

> > > collection/information they have already been supplying. If they

>do

> > > not file

> > > reports, FDA to call panel to review. No faith in registries.

> > >

> > > Dr. Newburger proposes a panel meeting to review data in 5 years

> > > (from now).

> > > Concerned over ignored patients.

> > >

> > > VOTE: UNANIMOUS

> > >

> > > 3. Dr. Blumenstein proposes independent monitoring committee,

> > > following FDA

> > > guidelines. including advocates from both sides of issue. Focus

>on

> > > safety.

> > >

> > > VOTE: 8-1 Dr. Ewing voted not to accept this condition.

> > >

> > > 4. Dr LoCicero proposes separate and distinct patient

>educational

> > > process

> > > for informed consent for patient.

> > >

> > > VOTE: UNANIMOUS

> > >

> > > 5. Dr. Leitch proposes study that core study be amended to

>include

> > > followup

> > > for patients who have had implants removed and patients be re-

> > > consented.

> > >

> > > Dr. Blumenstein wants sypmtoms to be followed on all patients,

> > > including

> > > patients who are explanted without re-implanting.

> > >

> > > VOTE: UNANIMOUS

> > >

> > > 6. Dr Newburger proposes voluntary registry of as many patients

>as

> > > possible

> > > to participate, guidelines including MRI data, CTD, explant data,

> > > intracapsular data, pregnancy, mammography results, silent

>rupture,

> > > signs

> > > and symptoms, and health outcome of children born to women with

> > > breast

> > > implants. Dr. Blumenstein seconded because children are

>included.

> > >

> > > Discussion: Dr. doesn't believe data is available for a

> > > problem with

> > > children. (Children have never been studied.) Dr.

>suggests

> > > that

> > > doctors who do not follow through with follow-up will lose their

> > > ability to

> > > use implants. Dr.Leitch doesn't want to step on sponsor's toes.

>Dr.

> > > Newburger

> > >

> > > VOTE: 8-1 Dr Li opposes

> > >

> > > 7. DID NOT PASS--Dr. Blumentstein proposes voluntary sub-study

>of

> > > core

> > > study of signs and symptoms and life-style in individuals with

>CTD

> > > who

> > > change scores and more frequent followup. Blood and Urine tests

>to

> > > be

> > > required.

> > >

> > > Dr. Newburger seconded.

> > >

> > > VOTE: 2-6 Blumenstein and Newburger voted for this condition.

>Dr

> > > LoCicero

> > > abstained.

> > >

> > > 8. Dr. Li proposes sponsor fulfills all post-market

>recommendations

> > > conditions as provided by sponsor in application.

> > >

> > > VOTE: UNANIMOUS

> > >

> > > 9. Dr. Leitch proposes tracking device. Physician to provide

>mail-

> > > in card

> > > to patient to track in case of recall.

> > >

> > > VOTE: 8-1 Dr. Blumenstein voted not in favor.

> > >

> > > 10. Choti: Add to labeling a recommendation for MRI scan or

>other

> > > appropriately sensitivity powered examination at year 5 and

>every 2

> > > years

> > > afterwards.

> > >

> > > Consider implant removal if there is evidence of silent leak.

> > >

> > > Newburger --does not eliminate need for regular mammography.

> > >

> > > Silent leak the recommendation is that device be changed or

>removed.

> > >

> > > VOTE: Passes-5-4

> > >

> > > 7-2 Final vote to approve with conditions.

> > >

> > > Blumenstein, Newburger voted against approval.

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > > 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]

WHEN DOES THE FDA VOTE ON THE COMMITTEE'S RECOMMENDATION ON THE MENTOR

GEL IMPLANTS? ANY OTHER IDEAS ON HOW TO INFLUENCE THE FINAL DECISION??

--- In , " colibrimama " <colibrimama@y...>

wrote:

>

> It's in no way a " done deal " ...

>

> The FDA can still go against the " recommendation " of the Panel ...

> like they did last year with Inamed.

>

> It's not anywhere near over ...

>

> Love, Ilena

>

>

[Guest guest]

I would just recommend as many women as possible get their stories out there.

Lynda

At 10:01 PM 4/13/2005, you wrote:

>WHEN DOES THE FDA VOTE ON THE COMMITTEE'S RECOMMENDATION ON THE MENTOR

>GEL IMPLANTS? ANY OTHER IDEAS ON HOW TO INFLUENCE THE FINAL DECISION??

>

>--- In , " colibrimama " <colibrimama@y...>

>wrote:

> >

> > It's in no way a " done deal " ...

> >

> > The FDA can still go against the " recommendation " of the Panel ...

> > like they did last year with Inamed.

> >

> > It's not anywhere near over ...

> >

> > Love, Ilena

> >

> >

>

>

>

>

>

>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 can't believe that they are allowing the implants

from the company that kept a faulty valve on the

market long after they knew it was causing problems

for implanted women!

There's a rat somewhere!

Hugs,

Rogene

[Guest guest]

GT,

What they have done with the latest implants is to

make them semi-solid. . . say like gummy bears. You

can cut them in two, and nothing will flow out.

Charmin should be squeezeabley soft by comparison!

That doesn't mean that the body won't try to break

them down and carry them away though. . .

Actually this type of implant was tried a long time

ago. The exterior degraded to something that I think

was called " elephant skin " .

My biggest concern is what are the using to make the

silicone semi-solid? In the past, they've used

platinum. Platinum is a very potent neurotoxin that

may be a the root for some of the illnesses the

children experience. . . Nobody is saying as far as I

know! They've also used tin . . . but that's not good

either!

Hugs,

Rogene

>

[Guest guest]

A few rats, I would say!!

Lynda

At 11:39 PM 4/13/2005, you wrote:

>I can't believe that they are allowing the implants

>from the company that kept a faulty valve on the

>market long after they knew it was causing problems

>for implanted women!

>

>There's a rat somewhere!

>

>Hugs,

>

>Rogene

>

>

>

>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 implants they took to the FDA to improve are just like the old ones,

not gummy. Those are still in the development stage. These are the

viscous oil ones that have killed and maimed and make us all sick. These

are the ones they are trying to get approved again.

Lynda

At 11:59 PM 4/13/2005, you wrote:

>GT,

>

>What they have done with the latest implants is to

>make them semi-solid. . . say like gummy bears. You

>can cut them in two, and nothing will flow out.

>Charmin should be squeezeabley soft by comparison!

>

>That doesn't mean that the body won't try to break

>them down and carry them away though. . .

>

>Actually this type of implant was tried a long time

>ago. The exterior degraded to something that I think

>was called " elephant skin " .

>

>My biggest concern is what are the using to make the

>silicone semi-solid? In the past, they've used

>platinum. Platinum is a very potent neurotoxin that

>may be a the root for some of the illnesses the

>children experience. . . Nobody is saying as far as I

>know! They've also used tin . . . but that's not good

>either!

>

>Hugs,

>

>Rogene

>

> >

>

>

>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]

You've got to be kidding! . . . I thought they were

their " new " ones!

This gets stranger and stranger by the day!

Rogene

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

> The implants they took to the FDA to improve are

> just like the old ones,

> not gummy. Those are still in the development

> stage. These are the

> viscous oil ones that have killed and maimed and

> make us all sick. These

> are the ones they are trying to get approved again.

>

> Lynda

>

>

> At 11:59 PM 4/13/2005, you wrote:

> >GT,

> >

> >What they have done with the latest implants is to

> >make them semi-solid. . . say like gummy bears. You

> >can cut them in two, and nothing will flow out.

> >Charmin should be squeezeabley soft by comparison!

> >

> >That doesn't mean that the body won't try to break

> >them down and carry them away though. . .

> >

> >Actually this type of implant was tried a long time

> >ago. The exterior degraded to something that I

> think

> >was called " elephant skin " .

> >

> >My biggest concern is what are the using to make

> the

> >silicone semi-solid? In the past, they've used

> >platinum. Platinum is a very potent neurotoxin that

> >may be a the root for some of the illnesses the

> >children experience. . . Nobody is saying as far as

> I

> >know! They've also used tin . . . but that's not

> good

> >either!

> >

> >Hugs,

> >

> >Rogene

> >

> > >

> >

> >

> >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]

Nope, these are the old ones, and they admitted that there have been few

changes. Some changes to the shell.

Lynda

At 12:07 AM 4/14/2005, you wrote:

>You've got to be kidding! . . . I thought they were

>their " new " ones!

>

>This gets stranger and stranger by the day!

>

>Rogene

>

>

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

> > The implants they took to the FDA to improve are

> > just like the old ones,

> > not gummy. Those are still in the development

> > stage. These are the

> > viscous oil ones that have killed and maimed and

> > make us all sick. These

> > are the ones they are trying to get approved again.

> >

> > Lynda

> >

> >

> > At 11:59 PM 4/13/2005, you wrote:

> > >GT,

> > >

> > >What they have done with the latest implants is to

> > >make them semi-solid. . . say like gummy bears. You

> > >can cut them in two, and nothing will flow out.

> > >Charmin should be squeezeabley soft by comparison!

> > >

> > >That doesn't mean that the body won't try to break

> > >them down and carry them away though. . .

> > >

> > >Actually this type of implant was tried a long time

> > >ago. The exterior degraded to something that I

> > think

> > >was called " elephant skin " .

> > >

> > >My biggest concern is what are the using to make

> > the

> > >silicone semi-solid? In the past, they've used

> > >platinum. Platinum is a very potent neurotoxin that

> > >may be a the root for some of the illnesses the

> > >children experience. . . Nobody is saying as far as

> > I

> > >know! They've also used tin . . . but that's not

> > good

> > >either!

> > >

> > >Hugs,

> > >

> > >Rogene

> > >

> > > >

> > >

> > >

> > >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 thought it was the gummies too. My plastic surgeon said he thought they would be on the market this summer.

Kenda

You've got to be kidding! . . . I thought they were

their " new " ones!

This gets stranger and stranger by the day!

Rogene

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

> The implants they took to the FDA to improve are

> just like the old ones,

> not gummy. Those are still in the development

> stage. These are the

> viscous oil ones that have killed and maimed and

> make us all sick. These

> are the ones they are trying to get approved again.

>

> Lynda

>

>

> At 11:59 PM 4/13/2005, you wrote:

> >GT,

> >

> >What they have done with the latest implants is to

> >make them semi-solid. . . say like gummy bears. You

> >can cut them in two, and nothing will flow out.

> >Charmin should be squeezeabley soft by comparison!

> >

> >That doesn't mean that the body won't try to break

> >them down and carry them away though. . .

> >

> >Actually this type of implant was tried a long time

> >ago. The exterior degraded to something that I

> think

> >was called " elephant skin " .

> >

> >My biggest concern is what are the using to make

> the

> >silicone semi-solid? In the past, they've used

> >platinum. Platinum is a very potent neurotoxin that

> >may be a the root for some of the illnesses the

> >children experience. . . Nobody is saying as far as

> I

> >know! They've also used tin . . . but that's not

> good

> >either!

> >

> >Hugs,

> >

> >Rogene

> >

> > >

> >

> >

> >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]

No, I think they are still in research. They will apply for a PMA on those

in a couple of years, at least that is what I heard. They have to have 5

years of research first, or is it 4 year, I cannot remember. But they may

actually be better, as they will not leak silicone as fast. I said better,

not good. I think they are all toxic time bombs.

Lynda

At 07:47 AM 4/14/2005, you wrote:

>I thought it was the gummies too. My plastic surgeon said he thought they

>would be on the market this summer.

>

>Kenda

>

>

>You've got to be kidding! . . . I thought they were

>their " new " ones!

>

>This gets stranger and stranger by the day!

>

>Rogene

>

>

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

> > The implants they took to the FDA to improve are

> > just like the old ones,

> > not gummy. Those are still in the development

> > stage. These are the

> > viscous oil ones that have killed and maimed and

> > make us all sick. These

> > are the ones they are trying to get approved again.

> >

> > Lynda

> >

> >

> > At 11:59 PM 4/13/2005, you wrote:

> > >GT,

> > >

> > >What they have done with the latest implants is to

> > >make them semi-solid. . . say like gummy bears. You

> > >can cut them in two, and nothing will flow out.

> > >Charmin should be squeezeabley soft by comparison!

> > >

> > >That doesn't mean that the body won't try to break

> > >them down and carry them away though. . .

> > >

> > >Actually this type of implant was tried a long time

> > >ago. The exterior degraded to something that I

> > think

> > >was called " elephant skin " .

> > >

> > >My biggest concern is what are the using to make

> > the

> > >silicone semi-solid? In the past, they've used

> > >platinum. Platinum is a very potent neurotoxin that

> > >may be a the root for some of the illnesses the

> > >children experience. . . Nobody is saying as far as

> > I

> > >know! They've also used tin . . . but that's not

> > good

> > >either!

> > >

> > >Hugs,

> > >

> > >Rogene

> > >

> > > >

> > >

> > >

> > >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]

There are many women now who I guess are in their “research”. All you need to do is ask for the gummies and you can get them.

Kenda

No, I think they are still in research. They will apply for a PMA on those

in a couple of years, at least that is what I heard. They have to have 5

years of research first, or is it 4 year, I cannot remember. But they may

actually be better, as they will not leak silicone as fast. I said better,

not good. I think they are all toxic time bombs.

Lynda

At 07:47 AM 4/14/2005, you wrote:

>I thought it was the gummies too. My plastic surgeon said he thought they

>would be on the market this summer.

>

>Kenda

>

>

>You've got to be kidding! . . . I thought they were

>their " new " ones!

>

>This gets stranger and stranger by the day!

>

>Rogene

>

>

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

> > The implants they took to the FDA to improve are

> > just like the old ones,

> > not gummy. Those are still in the development

> > stage. These are the

> > viscous oil ones that have killed and maimed and

> > make us all sick. These

> > are the ones they are trying to get approved again.

> >

> > Lynda

> >

> >

> > At 11:59 PM 4/13/2005, you wrote:

> > >GT,

> > >

> > >What they have done with the latest implants is to

> > >make them semi-solid. . . say like gummy bears. You

> > >can cut them in two, and nothing will flow out.

> > >Charmin should be squeezeabley soft by comparison!

> > >

> > >That doesn't mean that the body won't try to break

> > >them down and carry them away though. . .

> > >

> > >Actually this type of implant was tried a long time

> > >ago. The exterior degraded to something that I

> > think

> > >was called " elephant skin " .

> > >

> > >My biggest concern is what are the using to make

> > the

> > >silicone semi-solid? In the past, they've used

> > >platinum. Platinum is a very potent neurotoxin that

> > >may be a the root for some of the illnesses the

> > >children experience. . . Nobody is saying as far as

> > I

> > >know! They've also used tin . . . but that's not

> > good

> > >either!

> > >

> > >Hugs,

> > >

> > >Rogene

> > >

> > > >

> > >

> > >

> > >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]

Dearest Ladies:

I have just written to Dr. Zuckerman, but I had to send it to to be

edited. In this letter, I have asked if she could help me. I feel that we

just cannot sit back and allow rotten Mentor to kill more women, all in the

name of money. If I have to, I will print off all the names of the sick

womem who have contacted me. There are over two thousand names in my book.

Each and every women is sick from their breast implants. I have a story for

most all of them and it breaks my heart.

I do not display my religion on my sleeve; however, I believe that bad can

be turned into good. My girl friend, who has known me for over thirty years

gave me a book called When God Winks. It is all about How the Power of

Coincidence Guides Your Life. My letter should come soon.

Love always...Lea

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~``````````````

Re: Re: Mentor's cohesive gel implants have been

APPROVED

>

> I would just recommend as many women as possible get their stories out

> there.

>

> Lynda

>

>

> At 10:01 PM 4/13/2005, you wrote:

>

>>WHEN DOES THE FDA VOTE ON THE COMMITTEE'S RECOMMENDATION ON THE MENTOR

>>GEL IMPLANTS? ANY OTHER IDEAS ON HOW TO INFLUENCE THE FINAL DECISION??

>>

>>--- In , " colibrimama " <colibrimama@y...>

>>wrote:

>> >

>> > It's in no way a " done deal " ...

>> >

>> > The FDA can still go against the " recommendation " of the Panel ...

>> > like they did last year with Inamed.

>> >

>> > It's not anywhere near over ...

>> >

>> > Love, Ilena

>> >

>> >

>>

>>

>>

>>

>>

>>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)

>>

>>