Re: Action Alert: Please Call Chairman Enzi of the Senate HELP Committee tomorrow, ...

[Guest guest]

Rogene, I hate to burst the bubble on this...but I

don't know how many of you have faith in the FDA...but

they are the dirtiest, most crooked agency in the

world!

Read Trudeau's book " Natural Cures THEY don't

want you to know about " ...the pharmaceutical and

medical industry rules the world pretty much.

If something is making us sick, then you can BET that

the FDA will keep it on the market so that the medical

industry can make MORE money!

I would guarantee that the FDA already KNOWS that

implants are unsafe and causing tons of medical

problems....so naturally they are NEVER going to ban

them! That would cause the medical industry to lose

billions of dollars! Just like they will never release

the cure for cancer, diabetes, etc. etc. etc.....and

we all know that there IS a cure for those things!

Sad, but very true.

--- Rogene S <saxony01@...> wrote:

> It's becoming more important than ever to call the

> FDA and let your concerns be known! . . .

>

> Please say a prayer that they will listen

>

> Rogene

>

>

>

--------------------------------------------------------------------------------\

---------

>

> Ilena Rose <ilena.rose@...> wrote:

> Date: Wed, 2 Aug 2006 17:03:34 -0600

> From: " Ilena Rose " <ilena.rose@...>

> Subject: Action Alert: Please Call Chairman Enzi of

> the Senate HELP Committee tomorrow, ...

>

>

>

>

>

>

> We need to make sure that

> Senator Enzi, Chairman for the Senate HELP

> committee, understands the importance requiring

> better research before the FDA approves the

> pre-market approval applications (PMAs) for silicone

> breast implants. So we are asking that you call

> his office tomorrow, Thursday (August 3), to voice

> your concern that more research with better data

> must be done before the FDA approves these PMAs. Ask

> to speak to the staff person responsible for matters

> relating to the FDA and silicone breast implants.

> When you call, please begin by thanking the

> Senator for sharing his report on the silicone

> implant PMAs.

> Then let the staff person you speak to know that

> you are concerned that the report does not go far

> enough. Specifically, explain how you think the

> report needs to address important concerns that were

> not covered, but should be.

> Please familiarize yourself with the concerns we

> have about the report (below) before you make your

> call. After you complete your call, please email us

> info@... to let us know you made your

> call and how it went.

> Our concerns about what is not in Senator Enzi's

> report are:

> • Lack of Clinical Data for Some of the Implant

> Models. Ask the Committee to investigate why the FDA

> accepted PMAs for implant styles that were not

> included in the Core study, the companies' clinical

> studies.

> o While the companies provided some data their

> adjunct studies, the FDA's PMA reviewers pointed out

> that these studies were flawed.

>

> o Therefore, the FDA is considering approving some

> models with absolutely no reliable clinical safety

> data.

>

> • Lack of Long-Term Safety Data. While the

> Committee's report partially substantiated concerns

> regarding the weaknesses of the Sharpe/Collis study,

> which was used by Mentor as its long-term data, it

> did not address the larger issue of how the FDA

> could consider approving SBIs without long-term data

> for reconstruction and revision patients (who were

> excluded from the Sharpe/Collis study) who tend to

> have much higher rupture rates than augmentation

> patients.

> o Both Mentor and Inamed failed to provide

> adequate data on the long-term safety of SBIs.

>

> o The Committee's report is correct that there are

> no legal requirements for companies to adhere to

> every recommendation of an FDA Guidance Document.

> However, the concern is that the FDA published an

> official Guidance Document describing the kind of

> research necessary to prove safety, but in issuing

> approvable letters, the FDA seems to have ignored

> several of the most important scientific requests in

> that document, for example: new platinum research

> and better long-term safety data.

>

> o The FDA's own review of the data in the PMAs

> presented at the Advisory Panel meeting clearly

> concluded both Inamed and Mentor inadequately

> addressed the concerns that formed the basis for the

> Agency's past refusals. Both companies failed to

> provide satisfactory data about long-term safety —

> despite FDA requests for this information since

> 1992.

>

> o Approval for Mentor's product would be an

> unwarranted, 180-degree departure from FDA's

> longstanding and consistent treatment of this

> issue--a position that thus far has been fully

> consistent with longstanding FDA policies and

> practices, and with the latest and best Agency

> science.

> o The Federal Food Drug & Cosmetic Act ( " FFDCA " ),

> in turn, requires FDA to deny any application for

> approval of a Class III device if " there is a lack

> of showing [by the applicant] of reasonable

> assurance that [the device] is safe under the

> conditions of use prescribed, recommended, or

> suggested in the proposed labeling thereof. " 21

> U.S.C. § 360e(d)(2)(A).

>

> o So the key question is: On what basis did the FDA

> send an approvable letter to Mentor?

> • Ask for an investigation by the HELP committee

> because you believe that Congress must fulfill its

> oversight responsibility and assure a transparent

> process. Women in this country must be assured that

> the FDA's decisions on silicone gel breast implants

> are based on a careful review of the merits of the

> scientific data regarding the products' safety and

> efficacy. And the public also needs to know that

> Congress will uphold its duty to ensure that the FDA

> is fulfilling this responsibility.

> After you complete your call, please email us

> info@... to let us know you made your

> call and how it went.

>

>

>

>

>

>

>

> If you no longer wish to receive e-mail from us,

> please click here

>

>

>

>

>

>

__________________________________________________

[Guest guest]

No faith whatsoever in the FDA. They are so corrupt...and I've known this for a looooong time now, thanks to my breast implants! I would love nothing more than the FDA to be dissolved, and the crooks in power there put behind bars for their scheming and conniving for money...blood money...they've killed so many people. We have got to get over this idea that our government agencies care for people. They do NOT, not in the sense that you or I would expect. That is the premise that they exist on, but they do not really care. They only care about making sure the economy is running well -oiled, so they can have tax dollars to spend the way they want....and they know nothing about spending wisely. If there is anything that can get my blood boiling, it is this because the government squashes the truth, and yet so many people blindly trust

them. They are wolves in sheeps clothing. PattyLeyna <leyna1964@...> wrote: Rogene, I hate to burst the bubble on this...but Idon't know how many of you have faith in the FDA...butthey are the dirtiest, most crooked agency in theworld! Read Trudeau's book "Natural Cures THEY don'twant you to know about"...the pharmaceutical andmedical industry rules the world pretty much. If something is making us sick, then you can BET thatthe FDA will keep it on the

market so that the medicalindustry can make MORE money!I would guarantee that the FDA already KNOWS thatimplants are unsafe and causing tons of medicalproblems....so naturally they are NEVER going to banthem! That would cause the medical industry to losebillions of dollars! Just like they will never releasethe cure for cancer, diabetes, etc. etc. etc.....andwe all know that there IS a cure for those things!Sad, but very true.--- Rogene S <saxony01 > wrote:> It's becoming more important than ever to call the> FDA and let your concerns be known! . . . > > Please say a prayer that they will listen> > Rogene> > >----------------------------------------------------------> > Ilena Rose <ilena.rosegmail> wrote:> Date: Wed, 2 Aug 2006 17:03:34 -0600> From: "Ilena Rose" <ilena.rosegmail>> Subject: Action Alert: Please Call Chairman Enzi of> the Senate HELP Committee tomorrow, ...> > > > > > > We need to make sure that> Senator Enzi, Chairman for the Senate HELP> committee, understands the importance requiring> better research before the FDA approves the> pre-market approval applications (PMAs) for silicone> breast implants. So we are asking that you call> his office tomorrow, Thursday (August 3), to voice> your concern that more research with better data> must be done before the FDA approves these PMAs. Ask> to speak to the staff person responsible for matters> relating to the FDA and silicone breast

implants. > When you call, please begin by thanking the> Senator for sharing his report on the silicone> implant PMAs.> Then let the staff person you speak to know that> you are concerned that the report does not go far> enough. Specifically, explain how you think the> report needs to address important concerns that were> not covered, but should be. > Please familiarize yourself with the concerns we> have about the report (below) before you make your> call. After you complete your call, please email us> infocommandtrust (DOT) org to let us know you made your> call and how it went.> Our concerns about what is not in Senator Enzi's> report are: > • Lack of Clinical Data for Some of the Implant> Models. Ask the Committee to investigate why the FDA> accepted PMAs for implant styles that were not>

included in the Core study, the companies' clinical> studies. > o While the companies provided some data their> adjunct studies, the FDA's PMA reviewers pointed out> that these studies were flawed. > > o Therefore, the FDA is considering approving some> models with absolutely no reliable clinical safety> data. > > • Lack of Long-Term Safety Data. While the> Committee's report partially substantiated concerns> regarding the weaknesses of the Sharpe/Collis study,> which was used by Mentor as its long-term data, it> did not address the larger issue of how the FDA> could consider approving SBIs without long-term data> for reconstruction and revision patients (who were> excluded from the Sharpe/Collis study) who tend to> have much higher rupture rates than augmentation> patients. > o Both Mentor and Inamed failed to provide> adequate

data on the long-term safety of SBIs.> > o The Committee's report is correct that there are> no legal requirements for companies to adhere to> every recommendation of an FDA Guidance Document.> However, the concern is that the FDA published an> official Guidance Document describing the kind of> research necessary to prove safety, but in issuing> approvable letters, the FDA seems to have ignored> several of the most important scientific requests in> that document, for example: new platinum research> and better long-term safety data. > > o The FDA's own review of the data in the PMAs> presented at the Advisory Panel meeting clearly> concluded both Inamed and Mentor inadequately> addressed the concerns that formed the basis for the> Agency's past refusals. Both companies failed to> provide satisfactory data about long-term safety —> despite FDA

requests for this information since> 1992. > > o Approval for Mentor's product would be an> unwarranted, 180-degree departure from FDA's> longstanding and consistent treatment of this> issue--a position that thus far has been fully> consistent with longstanding FDA policies and> practices, and with the latest and best Agency> science. > o The Federal Food Drug & Cosmetic Act ("FFDCA"),> in turn, requires FDA to deny any application for> approval of a Class III device if "there is a lack> of showing [by the applicant] of reasonable> assurance that [the device] is safe under the> conditions of use prescribed, recommended, or> suggested in the proposed labeling thereof." 21> U.S.C. § 360e(d)(2)(A).> > o So the key question is: On what basis did the FDA> send an approvable letter to Mentor?> • Ask for an investigation by

the HELP committee> because you believe that Congress must fulfill its> oversight responsibility and assure a transparent> process. Women in this country must be assured that> the FDA's decisions on silicone gel breast implants> are based on a careful review of the merits of the> scientific data regarding the products' safety and> efficacy. And the public also needs to know that> Congress will uphold its duty to ensure that the FDA> is fulfilling this responsibility. > After you complete your call, please email us> infocommandtrust (DOT) org to let us know you made your> call and how it went. > > > > > > > > If you no longer wish to receive e-mail from us,> please click here > > > > > >

__________________________________________________

[Guest guest]

Patty,

Well said!

--- Tricia Trish <glory2glory1401@...> wrote:

> No faith whatsoever in the FDA. They are so

> corrupt...and I've known this for a looooong time

> now, thanks to my breast implants!

>

> I would love nothing more than the FDA to be

> dissolved, and the crooks in power there put behind

> bars for their scheming and conniving for

> money...blood money...they've killed so many people.

>

> We have got to get over this idea that our

> government agencies care for people. They do NOT,

> not in the sense that you or I would expect. That

> is the premise that they exist on, but they do not

> really care. They only care about making sure the

> economy is running well -oiled, so they can have tax

> dollars to spend the way they want....and they know

> nothing about spending wisely.

>

> If there is anything that can get my blood

> boiling, it is this because the government squashes

> the truth, and yet so many people blindly trust

> them. They are wolves in sheeps clothing.

> Patty

>

> Leyna <leyna1964@...> wrote:

> Rogene, I hate to burst the bubble on

> this...but I

> don't know how many of you have faith in the

> FDA...but

> they are the dirtiest, most crooked agency in the

> world!

>

> Read Trudeau's book " Natural Cures THEY don't

> want you to know about " ...the pharmaceutical and

> medical industry rules the world pretty much.

>

> If something is making us sick, then you can BET

> that

> the FDA will keep it on the market so that the

> medical

> industry can make MORE money!

>

> I would guarantee that the FDA already KNOWS that

> implants are unsafe and causing tons of medical

> problems....so naturally they are NEVER going to ban

> them! That would cause the medical industry to lose

> billions of dollars! Just like they will never

> release

> the cure for cancer, diabetes, etc. etc. etc.....and

> we all know that there IS a cure for those things!

>

> Sad, but very true.

>

> --- Rogene S <saxony01@...> wrote:

>

> > It's becoming more important than ever to call the

> > FDA and let your concerns be known! . . .

> >

> > Please say a prayer that they will listen

> >

> > Rogene

> >

> >

> >

>

----------------------------------------------------------

> >

> > Ilena Rose <ilena.rose@...> wrote:

> > Date: Wed, 2 Aug 2006 17:03:34 -0600

> > From: " Ilena Rose " <ilena.rose@...>

> > Subject: Action Alert: Please Call Chairman Enzi

> of

> > the Senate HELP Committee tomorrow, ...

> >

> >

> >

> >

> >

> >

> > We need to make sure that

> > Senator Enzi, Chairman for the Senate HELP

> > committee, understands the importance requiring

> > better research before the FDA approves the

> > pre-market approval applications (PMAs) for

> silicone

> > breast implants. So we are asking that you call

> > his office tomorrow, Thursday (August 3), to voice

> > your concern that more research with better data

> > must be done before the FDA approves these PMAs.

> Ask

> > to speak to the staff person responsible for

> matters

> > relating to the FDA and silicone breast implants.

> > When you call, please begin by thanking the

> > Senator for sharing his report on the silicone

> > implant PMAs.

> > Then let the staff person you speak to know that

> > you are concerned that the report does not go far

> > enough. Specifically, explain how you think the

> > report needs to address important concerns that

> were

> > not covered, but should be.

> > Please familiarize yourself with the concerns we

> > have about the report (below) before you make your

> > call. After you complete your call, please email

> us

> > info@... to let us know you made your

> > call and how it went.

> > Our concerns about what is not in Senator Enzi's

> > report are:

> > • Lack of Clinical Data for Some of the Implant

> > Models. Ask the Committee to investigate why the

> FDA

> > accepted PMAs for implant styles that were not

> > included in the Core study, the companies'

> clinical

> > studies.

> > o While the companies provided some data their

> > adjunct studies, the FDA's PMA reviewers pointed

> out

> > that these studies were flawed.

> >

> > o Therefore, the FDA is considering approving some

> > models with absolutely no reliable clinical safety

> > data.

> >

> > • Lack of Long-Term Safety Data. While the

> > Committee's report partially substantiated

> concerns

> > regarding the weaknesses of the Sharpe/Collis

> study,

> > which was used by Mentor as its long-term data, it

> > did not address the larger issue of how the FDA

> > could consider approving SBIs without long-term

> data

> > for reconstruction and revision patients (who were

> > excluded from the Sharpe/Collis study) who tend to

> > have much higher rupture rates than augmentation

> > patients.

> > o Both Mentor and Inamed failed to provide

> > adequate data on the long-term safety of SBIs.

> >

> > o The Committee's report is correct that there are

> > no legal requirements for companies to adhere to

> > every recommendation of an FDA Guidance Document.

> > However, the concern is that the FDA published an

> > official Guidance Document describing the kind of

> > research necessary to prove safety, but in issuing

> > approvable letters, the FDA seems to have ignored

> > several of the most important scientific requests

> in

> > that document, for example: new platinum research

> > and better long-term safety data.

> >

> > o The FDA's own review of the data in the PMAs

> > presented at the Advisory Panel meeting clearly

> > concluded both Inamed and Mentor inadequately

> > addressed the concerns that formed the basis for

> the

> > Agency's past refusals. Both companies failed to

> > provide satisfactory data about long-term safety —

> > despite FDA requests for this information since

> > 1992.

> >

> > o Approval for Mentor's product would be an

> > unwarranted, 180-degree departure from FDA's

> > longstanding and consistent treatment of this

> > issue--a position that thus far has been fully

> > consistent with longstanding FDA policies and

> > practices, and with the latest and best Agency

> > science.

> > o The Federal Food Drug & Cosmetic Act ( " FFDCA " ),

> > in turn, requires FDA to deny any application for

> > approval of a Class III device if " there is a lack

> > of showing [by the applicant] of reasonable

> > assurance that [the device] is safe under the

> > conditions of use prescribed, recommended, or

> > suggested in the proposed labeling thereof. " 21

> > U.S.C. § 360e(d)(2)(A).

> >

> > o So the key question is: On what basis did the

> FDA

> > send an approvable letter to Mentor?

> > • Ask for an investigation by the HELP committee

> > because you believe that Congress must fulfill its

> > oversight responsibility and assure a transparent

> > process. Women in this country must be assured

> that

> > the FDA's decisions on silicone gel breast

> implants

> > are based on a careful review of the merits of the

> > scientific data regarding the products' safety and

> > efficacy. And the public also needs to know that

> > Congress will uphold its duty to ensure that the

> FDA

> > is fulfilling this responsibility.

> > After you complete your call, please email us

> > info@... to let us know you made your

> > call and how it went.

> >

> >

> >

>

=== message truncated ===

__________________________________________________

[Guest guest]

Ladies . . . I agree the the FDA is bad beyond belief . . . BUT . . . as things stand now, they are the only governmental agency to whom we can express our voice . . . One day, the records will be open for all to see . . . and the reputation of individuals will be ruined . . . hopefully there will be criminal charges so they spend the rest of their lives in prison . .. Not some plush retirement villa somewhere. They are mass torturers, murderers, thieves! . . . No punishment is good enough for them! . . . I pray one day that their families will think of them with shame. If we don't speak out . . . we can be sure this will continue . . . Rogene Tricia Trish <glory2glory1401@...> wrote: No faith whatsoever in the FDA. They are so corrupt...and I've known this for a looooong time now, thanks to my breast implants! I would love nothing more than the FDA to be dissolved, and the crooks in power there put behind bars for their scheming and conniving for money...blood money...they've killed so many people. We have got to get over this idea that our government agencies care for people. They do NOT, not in the sense that you or I would expect. That is the premise that they exist on, but they do not really care. They only care about making sure

the economy is running well -oiled, so they can have tax dollars to spend the way they want....and they know nothing about spending wisely. If there is anything that can get my blood boiling, it is this because the government squashes the truth, and yet so many people blindly trust them. They are wolves in sheeps clothing. PattyLeyna <leyna1964 > wrote: Rogene, I hate to burst the bubble on this...but Idon't know how many of you have faith in the FDA...butthey are the dirtiest, most crooked agency in theworld! Read Trudeau's book "Natural Cures THEY don'twant you to know about"...the pharmaceutical andmedical industry rules the world pretty much. If something is making us sick, then you can BET thatthe

FDA will keep it on the market so that the medicalindustry can make MORE money!I would guarantee that the FDA already KNOWS thatimplants are unsafe and causing tons of medicalproblems....so naturally they are NEVER going to banthem! That would cause the medical industry to losebillions of dollars! Just like they will never releasethe cure for cancer, diabetes, etc. etc. etc.....andwe all know that there IS a cure for those things!Sad, but very true.--- Rogene S <saxony01 > wrote:> It's becoming more important than ever to call the> FDA and let your concerns be known! . . . > > Please say a prayer that they will listen> > Rogene> > >----------------------------------------------------------> > Ilena Rose <ilena.rosegmail> wrote:> Date: Wed, 2 Aug 2006 17:03:34 -0600> From: "Ilena Rose" <ilena.rosegmail>> Subject: Action Alert: Please Call Chairman Enzi of> the Senate HELP Committee tomorrow, ...> > > > > > > We need to make sure that> Senator Enzi, Chairman for the Senate HELP> committee, understands the importance requiring> better research before the FDA approves the> pre-market approval applications (PMAs) for silicone> breast implants. So we are asking that you call> his office tomorrow, Thursday (August 3), to voice> your concern that more research with better data> must be done before the FDA approves these PMAs. Ask> to speak to the staff person responsible for matters> relating to the FDA and silicone breast

implants. > When you call, please begin by thanking the> Senator for sharing his report on the silicone> implant PMAs.> Then let the staff person you speak to know that> you are concerned that the report does not go far> enough. Specifically, explain how you think the> report needs to address important concerns that were> not covered, but should be. > Please familiarize yourself with the concerns we> have about the report (below) before you make your> call. After you complete your call, please email us> infocommandtrust (DOT) org to let us know you made your> call and how it went.> Our concerns about what is not in Senator Enzi's> report are: > • Lack of Clinical Data for Some of the Implant> Models. Ask the Committee to investigate why the FDA> accepted PMAs for implant styles that were not>

included in the Core study, the companies' clinical> studies. > o While the companies provided some data their> adjunct studies, the FDA's PMA reviewers pointed out> that these studies were flawed. > > o Therefore, the FDA is considering approving some> models with absolutely no reliable clinical safety> data. > > • Lack of Long-Term Safety Data. While the> Committee's report partially substantiated concerns> regarding the weaknesses of the Sharpe/Collis study,> which was used by Mentor as its long-term data, it> did not address the larger issue of how the FDA> could consider approving SBIs without long-term data> for reconstruction and revision patients (who were> excluded from the Sharpe/Collis study) who tend to> have much higher rupture rates than augmentation> patients. > o Both Mentor and Inamed failed to provide> adequate

data on the long-term safety of SBIs.> > o The Committee's report is correct that there are> no legal requirements for companies to adhere to> every recommendation of an FDA Guidance Document.> However, the concern is that the FDA published an> official Guidance Document describing the kind of> research necessary to prove safety, but in issuing> approvable letters, the FDA seems to have ignored> several of the most important scientific requests in> that document, for example: new platinum research> and better long-term safety data. > > o The FDA's own review of the data in the PMAs> presented at the Advisory Panel meeting clearly> concluded both Inamed and Mentor inadequately> addressed the concerns that formed the basis for the> Agency's past refusals. Both companies failed to> provide satisfactory data about long-term safety —> despite FDA

requests for this information since> 1992. > > o Approval for Mentor's product would be an> unwarranted, 180-degree departure from FDA's> longstanding and consistent treatment of this> issue--a position that thus far has been fully> consistent with longstanding FDA policies and> practices, and with the latest and best Agency> science. > o The Federal Food Drug & Cosmetic Act ("FFDCA"),> in turn, requires FDA to deny any application for> approval of a Class III device if "there is a lack> of showing [by the applicant] of reasonable> assurance that [the device] is safe under the> conditions of use prescribed, recommended, or> suggested in the proposed labeling thereof." 21> U.S.C. § 360e(d)(2)(A).> > o So the key question is: On what basis did the FDA> send an approvable letter to Mentor?> • Ask for an investigation by

the HELP committee> because you believe that Congress must fulfill its> oversight responsibility and assure a transparent> process. Women in this country must be assured that> the FDA's decisions on silicone gel breast implants> are based on a careful review of the merits of the> scientific data regarding the products' safety and> efficacy. And the public also needs to know that> Congress will uphold its duty to ensure that the FDA> is fulfilling this responsibility. > After you complete your call, please email us> infocommandtrust (DOT) org to let us know you made your> call and how it went. > > > > > > > > If you no longer wish to receive e-mail from us,> please click here > > > > > >

__________________________________________________