Re: Fw: Letter to the FDA from your Senator or Congressman

[Guest guest]

Patty

Maybe I am a bit confused, What letter do you think The Senator, Congressman will need to benefit us. I have been sending letters daily. I fail to see any benefits. I still am unable to get any benefit of having consent forms IN MY HANDS THAT WERE SENT 16 MONTHS AFTER MY SURGERY. I fail to see any benefit, I keep plugging away, I am so damm tired of being ignored, this is becoming a assinite situation. Tell me ? Everyone talks about remidies of getting better. Well I am damm broke spent thousands, Just left my Husband and am real pissed off right now. No one writes me back, . I still am unable to get a Attorney to take my case, The Doctors want their money Well they can kiss my ----..

I am tired, Dr Joiner is an A--------. The FDA S---K, I had Silicone 14 YEARS, I wrote the damm Suicide Letters. I lost my Business to debts now. And I keep writing Letters, People keep saying They will Help, B--------T. I am really P-------O----Now. He not only Put me in a experiment and sent the papers to sign after, He did'nt clean out the old shit, And to top it off they were Textured, LIES,LIES, Even my California Bill of Rights, Inside the package ignored. Five Hours of Surgery, They Still left One Piece, too close to the Heart to remove. Yes I'll keep writing , Just to Whom? .The PS said this is still in my blood, I still get very sick. I know it takes time, After 14 years.

I am angry, And Yes I pray, Yes I am Positive, And tired of people in this group telling me to keep Positive I am damm positive. I have been working on this Silicone Poison For months, It gives me the energy to get well, I don't STOP. If you have any one that wants to tell me about the So Called Study Of Silicone, Than where the Hell is it. No one has showed it to me I' have wrote Ps, Attorneys, News Media, Authors, FDA, Doctors, Congress, Even the Damm White House, all they do is ignore,ignore, or say Oh I am so sorry, You better hurry up and get an attorney ,You definitely have a case but, time is running out. No Shit! Not for them for me.

I feel like I am tired of casting pearls amongst the swine, (our government) I truly believe that this nation has been turned over to Satan.

I've signed the petitions, Even voulenteered to give my statement in Washington, before the FDA board, Still no answer. I have called the attorneys that are on our side. Still no answer. How much more proof do they Want. There is no Silicone Study....If so than will someone show me these statistics they keep talking about.

Please No one tell me to keep the faith, Pray, Be Positive, I am and I do. This is a battle not just a prayer group. I am here to fight the Fight. Prayer with action, God will not do it for us. We must do it through Him, He uses us to do his work.

Yes, I am expressing Anger, This is the time for me to do this. Those that keep asking for women that have, or had Silicone for over 10 years write. I DID,DO, Still nothing. I wonder if this is just a big stupid waste of time. My body looks so ugly now, I have lost so much weight, am unable to eat, 5'6" maybe 110 lbs, My hair is falling out I feel like an upside down MOP. My breasts are gone, now sunk in, Theres still little hard lumps, It's so hard to breath, Very stressed out. I just feel Like I dont care anymore. Now my parents don't talk to me, Oh of course this is ALL my fault, So Be It.

I have been called Sunshine. I don't feel the Sun Shining.

My intent is not to hurt anyones feelings in this group. I know so many feel the anger. I needed a safe Haven to express my feelings. This Silicone has ruined My Life, and The places that want me to write to help. Dont Help! Dont Return Letters, Dont Call Back, Dont Care.

Kay L Varni.*~Patty~* <fdp@...> wrote:

Sent: Saturday, October 04, 2003 10:20 AM

Subject: Letter to the FDA from your Senator or Congressman

ALL BREAST IMPLANT WOMEN AND THEIR LAWYERS - PLEASE FAX A COPY OF THIS LETTER REQUESTING THAT YOUR SENATOR OR CONGRESSMAN SIGN THIS AND FAX TO THE FDA PRIOR TO OUR OCT. 14-15 MEETINGS.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

September 29, 2003

The Honorable Mark McClellan, M.D.

Commissioner

Food and Drug Administration

Parklawn Building

5600 Fishers Lane

Rockville, land 20857

Dear Dr. McClellan:

We are writing to express our concern about the upcoming Food and Drug Administration (FDA) review of clinical data on silicone gel-filled breast implants scheduled for October 14 and 15, 2003.

It has come to our attention that at least one manufacturer of silicone gel-filled breast implants has filed clinical data from an investigational device exemption (core) clinical trial based on only a few years of patient follow-up. It is our concern that clinical data based on only a few years of clinical patient follow-up will fail to address the long-term problems that can affect women’s health.

Due to the late onset of local, regional and systemic complications and that potential long-term risks of silicone gel-filled breast implants could vastly outweigh any benefits for the “healthy” patient population, we strongly believe the core clinical trials should be extended to better assess long-term safety prior to approval.

In a recent letter sent to Senator Kennedy (D-MA), the FDA acknowledged that “there are additional safety issues that apply to the silicone implants that do not apply to the saline implants, such as silent rupture and gel migration, which will need to be evaluated.” Research has consistently demonstrated that the onset of the majority of complications related to silicone gel-filled breast implants occur between 7 to 10 years and, unlike saline breast implants, are often not detected by women for many years after they occur. Research conducted at the FDA by S. Lori Brown, Ph.D., verified the latency of developing complications associated with

silicone gel-filled breast implants, including rupture and gel migration. [1][1]

The manufacturing community has acknowledged the potential risks associated with silicone breast implants. A United States Patent dated June 26, 2001 filed by McGhan Medical Corporation (now Inamed Corporation) states:

“Adverse medical consequences have recently become associated with the use of silicone gel filled implants because it has been discovered that the silicone oil can migrate through the implant shell and the silicone oil is not biocompatible with other human tissues. Therefore, the use of silicone based filler materials has been discontinued in the industry.”

Despite a decade passing since silicone gel-filled breast implants were restricted on the market, a prevailing concern remains about the long-term safety of these devices, particularly an elevated risk of an immunological response, potentially contributing to the development of systemic illness, following long-term implantation of silicone gel-filled breast implants. Recently published and ongoing research continues to demonstrate the real potential of an immunological response to long-term implantation of silicone gel filled breast implants particularly in the presence of significant rupture or verifiable gel migration. Research at the National Institutes

of Environmental Health Sciences and published research by the FDA has demonstrated the presence of immunological responses to silicone gel-filled breast implants including a significant association with fibromyalgia. [2][2]

Given the decades-long availability of silicone gel-filled breast implants despite never having been approved, it is imperative that the FDA complete a thorough assessment of the long-term safety of these devices prior to approval. Recent research suggests that complications often have a delayed onset. The ongoing and loosely monitored adjunct “study” is not a sufficient substitute for long-term safety data collected through rigorous core clinical trials. Therefore, we request that the FDA delay the review of the current trials in order to collect long-term data and fully assess the risks of silicone

gel-filled breast implants. It is vital to ensure that the health of future generations of women is not put in jeopardy by a device whose long-term risks far outweigh the long-term benefits.

We also request a meeting with you on or prior to September 30, 2003 to discuss these outstanding issues.

Sincerely,

Gene Green

Member of Congress

GG:sgs

[1][1] Brown SL, MS Middleton, WA Berg, MS Soo, G Pennello. Presence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama. American Journal of Roentgeonology; 175: 1057-1064, 2000.

[2][2] Brown SL, Duggirala HJ, Pennello G. An Association of Silicone-Gel Breast Implant Rupture and Fibromyalgia. Current Rheumatology Reports, 2002; 4:293-298.

[Guest guest]

Patty

Maybe I am a bit confused, What letter do you think The Senator, Congressman will need to benefit us. I have been sending letters daily. I fail to see any benefits. I still am unable to get any benefit of having consent forms IN MY HANDS THAT WERE SENT 16 MONTHS AFTER MY SURGERY. I fail to see any benefit, I keep plugging away, I am so damm tired of being ignored, this is becoming a assinite situation. Tell me ? Everyone talks about remidies of getting better. Well I am damm broke spent thousands, Just left my Husband and am real pissed off right now. No one writes me back, . I still am unable to get a Attorney to take my case, The Doctors want their money Well they can kiss my ----..

I am tired, Dr Joiner is an A--------. The FDA S---K, I had Silicone 14 YEARS, I wrote the damm Suicide Letters. I lost my Business to debts now. And I keep writing Letters, People keep saying They will Help, B--------T. I am really P-------O----Now. He not only Put me in a experiment and sent the papers to sign after, He did'nt clean out the old shit, And to top it off they were Textured, LIES,LIES, Even my California Bill of Rights, Inside the package ignored. Five Hours of Surgery, They Still left One Piece, too close to the Heart to remove. Yes I'll keep writing , Just to Whom? .The PS said this is still in my blood, I still get very sick. I know it takes time, After 14 years.

I am angry, And Yes I pray, Yes I am Positive, And tired of people in this group telling me to keep Positive I am damm positive. I have been working on this Silicone Poison For months, It gives me the energy to get well, I don't STOP. If you have any one that wants to tell me about the So Called Study Of Silicone, Than where the Hell is it. No one has showed it to me I' have wrote Ps, Attorneys, News Media, Authors, FDA, Doctors, Congress, Even the Damm White House, all they do is ignore,ignore, or say Oh I am so sorry, You better hurry up and get an attorney ,You definitely have a case but, time is running out. No Shit! Not for them for me.

I feel like I am tired of casting pearls amongst the swine, (our government) I truly believe that this nation has been turned over to Satan.

I've signed the petitions, Even voulenteered to give my statement in Washington, before the FDA board, Still no answer. I have called the attorneys that are on our side. Still no answer. How much more proof do they Want. There is no Silicone Study....If so than will someone show me these statistics they keep talking about.

Please No one tell me to keep the faith, Pray, Be Positive, I am and I do. This is a battle not just a prayer group. I am here to fight the Fight. Prayer with action, God will not do it for us. We must do it through Him, He uses us to do his work.

Yes, I am expressing Anger, This is the time for me to do this. Those that keep asking for women that have, or had Silicone for over 10 years write. I DID,DO, Still nothing. I wonder if this is just a big stupid waste of time. My body looks so ugly now, I have lost so much weight, am unable to eat, 5'6" maybe 110 lbs, My hair is falling out I feel like an upside down MOP. My breasts are gone, now sunk in, Theres still little hard lumps, It's so hard to breath, Very stressed out. I just feel Like I dont care anymore. Now my parents don't talk to me, Oh of course this is ALL my fault, So Be It.

I have been called Sunshine. I don't feel the Sun Shining.

My intent is not to hurt anyones feelings in this group. I know so many feel the anger. I needed a safe Haven to express my feelings. This Silicone has ruined My Life, and The places that want me to write to help. Dont Help! Dont Return Letters, Dont Call Back, Dont Care.

Kay L Varni.*~Patty~* <fdp@...> wrote:

Sent: Saturday, October 04, 2003 10:20 AM

Subject: Letter to the FDA from your Senator or Congressman

ALL BREAST IMPLANT WOMEN AND THEIR LAWYERS - PLEASE FAX A COPY OF THIS LETTER REQUESTING THAT YOUR SENATOR OR CONGRESSMAN SIGN THIS AND FAX TO THE FDA PRIOR TO OUR OCT. 14-15 MEETINGS.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

September 29, 2003

The Honorable Mark McClellan, M.D.

Commissioner

Food and Drug Administration

Parklawn Building

5600 Fishers Lane

Rockville, land 20857

Dear Dr. McClellan:

We are writing to express our concern about the upcoming Food and Drug Administration (FDA) review of clinical data on silicone gel-filled breast implants scheduled for October 14 and 15, 2003.

It has come to our attention that at least one manufacturer of silicone gel-filled breast implants has filed clinical data from an investigational device exemption (core) clinical trial based on only a few years of patient follow-up. It is our concern that clinical data based on only a few years of clinical patient follow-up will fail to address the long-term problems that can affect women’s health.

Due to the late onset of local, regional and systemic complications and that potential long-term risks of silicone gel-filled breast implants could vastly outweigh any benefits for the “healthy” patient population, we strongly believe the core clinical trials should be extended to better assess long-term safety prior to approval.

In a recent letter sent to Senator Kennedy (D-MA), the FDA acknowledged that “there are additional safety issues that apply to the silicone implants that do not apply to the saline implants, such as silent rupture and gel migration, which will need to be evaluated.” Research has consistently demonstrated that the onset of the majority of complications related to silicone gel-filled breast implants occur between 7 to 10 years and, unlike saline breast implants, are often not detected by women for many years after they occur. Research conducted at the FDA by S. Lori Brown, Ph.D., verified the latency of developing complications associated with

silicone gel-filled breast implants, including rupture and gel migration. [1][1]

The manufacturing community has acknowledged the potential risks associated with silicone breast implants. A United States Patent dated June 26, 2001 filed by McGhan Medical Corporation (now Inamed Corporation) states:

“Adverse medical consequences have recently become associated with the use of silicone gel filled implants because it has been discovered that the silicone oil can migrate through the implant shell and the silicone oil is not biocompatible with other human tissues. Therefore, the use of silicone based filler materials has been discontinued in the industry.”

Despite a decade passing since silicone gel-filled breast implants were restricted on the market, a prevailing concern remains about the long-term safety of these devices, particularly an elevated risk of an immunological response, potentially contributing to the development of systemic illness, following long-term implantation of silicone gel-filled breast implants. Recently published and ongoing research continues to demonstrate the real potential of an immunological response to long-term implantation of silicone gel filled breast implants particularly in the presence of significant rupture or verifiable gel migration. Research at the National Institutes

of Environmental Health Sciences and published research by the FDA has demonstrated the presence of immunological responses to silicone gel-filled breast implants including a significant association with fibromyalgia. [2][2]

Given the decades-long availability of silicone gel-filled breast implants despite never having been approved, it is imperative that the FDA complete a thorough assessment of the long-term safety of these devices prior to approval. Recent research suggests that complications often have a delayed onset. The ongoing and loosely monitored adjunct “study” is not a sufficient substitute for long-term safety data collected through rigorous core clinical trials. Therefore, we request that the FDA delay the review of the current trials in order to collect long-term data and fully assess the risks of silicone

gel-filled breast implants. It is vital to ensure that the health of future generations of women is not put in jeopardy by a device whose long-term risks far outweigh the long-term benefits.

We also request a meeting with you on or prior to September 30, 2003 to discuss these outstanding issues.

Sincerely,

Gene Green

Member of Congress

GG:sgs

[1][1] Brown SL, MS Middleton, WA Berg, MS Soo, G Pennello. Presence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama. American Journal of Roentgeonology; 175: 1057-1064, 2000.

[2][2] Brown SL, Duggirala HJ, Pennello G. An Association of Silicone-Gel Breast Implant Rupture and Fibromyalgia. Current Rheumatology Reports, 2002; 4:293-298.

[Guest guest]

Patty

Maybe I am a bit confused, What letter do you think The Senator, Congressman will need to benefit us. I have been sending letters daily. I fail to see any benefits. I still am unable to get any benefit of having consent forms IN MY HANDS THAT WERE SENT 16 MONTHS AFTER MY SURGERY. I fail to see any benefit, I keep plugging away, I am so damm tired of being ignored, this is becoming a assinite situation. Tell me ? Everyone talks about remidies of getting better. Well I am damm broke spent thousands, Just left my Husband and am real pissed off right now. No one writes me back, . I still am unable to get a Attorney to take my case, The Doctors want their money Well they can kiss my ----..

I am tired, Dr Joiner is an A--------. The FDA S---K, I had Silicone 14 YEARS, I wrote the damm Suicide Letters. I lost my Business to debts now. And I keep writing Letters, People keep saying They will Help, B--------T. I am really P-------O----Now. He not only Put me in a experiment and sent the papers to sign after, He did'nt clean out the old shit, And to top it off they were Textured, LIES,LIES, Even my California Bill of Rights, Inside the package ignored. Five Hours of Surgery, They Still left One Piece, too close to the Heart to remove. Yes I'll keep writing , Just to Whom? .The PS said this is still in my blood, I still get very sick. I know it takes time, After 14 years.

I am angry, And Yes I pray, Yes I am Positive, And tired of people in this group telling me to keep Positive I am damm positive. I have been working on this Silicone Poison For months, It gives me the energy to get well, I don't STOP. If you have any one that wants to tell me about the So Called Study Of Silicone, Than where the Hell is it. No one has showed it to me I' have wrote Ps, Attorneys, News Media, Authors, FDA, Doctors, Congress, Even the Damm White House, all they do is ignore,ignore, or say Oh I am so sorry, You better hurry up and get an attorney ,You definitely have a case but, time is running out. No Shit! Not for them for me.

I feel like I am tired of casting pearls amongst the swine, (our government) I truly believe that this nation has been turned over to Satan.

I've signed the petitions, Even voulenteered to give my statement in Washington, before the FDA board, Still no answer. I have called the attorneys that are on our side. Still no answer. How much more proof do they Want. There is no Silicone Study....If so than will someone show me these statistics they keep talking about.

Please No one tell me to keep the faith, Pray, Be Positive, I am and I do. This is a battle not just a prayer group. I am here to fight the Fight. Prayer with action, God will not do it for us. We must do it through Him, He uses us to do his work.

Yes, I am expressing Anger, This is the time for me to do this. Those that keep asking for women that have, or had Silicone for over 10 years write. I DID,DO, Still nothing. I wonder if this is just a big stupid waste of time. My body looks so ugly now, I have lost so much weight, am unable to eat, 5'6" maybe 110 lbs, My hair is falling out I feel like an upside down MOP. My breasts are gone, now sunk in, Theres still little hard lumps, It's so hard to breath, Very stressed out. I just feel Like I dont care anymore. Now my parents don't talk to me, Oh of course this is ALL my fault, So Be It.

I have been called Sunshine. I don't feel the Sun Shining.

My intent is not to hurt anyones feelings in this group. I know so many feel the anger. I needed a safe Haven to express my feelings. This Silicone has ruined My Life, and The places that want me to write to help. Dont Help! Dont Return Letters, Dont Call Back, Dont Care.

Kay L Varni.*~Patty~* <fdp@...> wrote:

Sent: Saturday, October 04, 2003 10:20 AM

Subject: Letter to the FDA from your Senator or Congressman

ALL BREAST IMPLANT WOMEN AND THEIR LAWYERS - PLEASE FAX A COPY OF THIS LETTER REQUESTING THAT YOUR SENATOR OR CONGRESSMAN SIGN THIS AND FAX TO THE FDA PRIOR TO OUR OCT. 14-15 MEETINGS.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

September 29, 2003

The Honorable Mark McClellan, M.D.

Commissioner

Food and Drug Administration

Parklawn Building

5600 Fishers Lane

Rockville, land 20857

Dear Dr. McClellan:

We are writing to express our concern about the upcoming Food and Drug Administration (FDA) review of clinical data on silicone gel-filled breast implants scheduled for October 14 and 15, 2003.

It has come to our attention that at least one manufacturer of silicone gel-filled breast implants has filed clinical data from an investigational device exemption (core) clinical trial based on only a few years of patient follow-up. It is our concern that clinical data based on only a few years of clinical patient follow-up will fail to address the long-term problems that can affect women’s health.

Due to the late onset of local, regional and systemic complications and that potential long-term risks of silicone gel-filled breast implants could vastly outweigh any benefits for the “healthy” patient population, we strongly believe the core clinical trials should be extended to better assess long-term safety prior to approval.

In a recent letter sent to Senator Kennedy (D-MA), the FDA acknowledged that “there are additional safety issues that apply to the silicone implants that do not apply to the saline implants, such as silent rupture and gel migration, which will need to be evaluated.” Research has consistently demonstrated that the onset of the majority of complications related to silicone gel-filled breast implants occur between 7 to 10 years and, unlike saline breast implants, are often not detected by women for many years after they occur. Research conducted at the FDA by S. Lori Brown, Ph.D., verified the latency of developing complications associated with

silicone gel-filled breast implants, including rupture and gel migration. [1][1]

The manufacturing community has acknowledged the potential risks associated with silicone breast implants. A United States Patent dated June 26, 2001 filed by McGhan Medical Corporation (now Inamed Corporation) states:

“Adverse medical consequences have recently become associated with the use of silicone gel filled implants because it has been discovered that the silicone oil can migrate through the implant shell and the silicone oil is not biocompatible with other human tissues. Therefore, the use of silicone based filler materials has been discontinued in the industry.”

Despite a decade passing since silicone gel-filled breast implants were restricted on the market, a prevailing concern remains about the long-term safety of these devices, particularly an elevated risk of an immunological response, potentially contributing to the development of systemic illness, following long-term implantation of silicone gel-filled breast implants. Recently published and ongoing research continues to demonstrate the real potential of an immunological response to long-term implantation of silicone gel filled breast implants particularly in the presence of significant rupture or verifiable gel migration. Research at the National Institutes

of Environmental Health Sciences and published research by the FDA has demonstrated the presence of immunological responses to silicone gel-filled breast implants including a significant association with fibromyalgia. [2][2]

Given the decades-long availability of silicone gel-filled breast implants despite never having been approved, it is imperative that the FDA complete a thorough assessment of the long-term safety of these devices prior to approval. Recent research suggests that complications often have a delayed onset. The ongoing and loosely monitored adjunct “study” is not a sufficient substitute for long-term safety data collected through rigorous core clinical trials. Therefore, we request that the FDA delay the review of the current trials in order to collect long-term data and fully assess the risks of silicone

gel-filled breast implants. It is vital to ensure that the health of future generations of women is not put in jeopardy by a device whose long-term risks far outweigh the long-term benefits.

We also request a meeting with you on or prior to September 30, 2003 to discuss these outstanding issues.

Sincerely,

Gene Green

Member of Congress

GG:sgs

[1][1] Brown SL, MS Middleton, WA Berg, MS Soo, G Pennello. Presence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama. American Journal of Roentgeonology; 175: 1057-1064, 2000.

[2][2] Brown SL, Duggirala HJ, Pennello G. An Association of Silicone-Gel Breast Implant Rupture and Fibromyalgia. Current Rheumatology Reports, 2002; 4:293-298.

[Guest guest]

Patty

Maybe I am a bit confused, What letter do you think The Senator, Congressman will need to benefit us. I have been sending letters daily. I fail to see any benefits. I still am unable to get any benefit of having consent forms IN MY HANDS THAT WERE SENT 16 MONTHS AFTER MY SURGERY. I fail to see any benefit, I keep plugging away, I am so damm tired of being ignored, this is becoming a assinite situation. Tell me ? Everyone talks about remidies of getting better. Well I am damm broke spent thousands, Just left my Husband and am real pissed off right now. No one writes me back, . I still am unable to get a Attorney to take my case, The Doctors want their money Well they can kiss my ----..

I am tired, Dr Joiner is an A--------. The FDA S---K, I had Silicone 14 YEARS, I wrote the damm Suicide Letters. I lost my Business to debts now. And I keep writing Letters, People keep saying They will Help, B--------T. I am really P-------O----Now. He not only Put me in a experiment and sent the papers to sign after, He did'nt clean out the old shit, And to top it off they were Textured, LIES,LIES, Even my California Bill of Rights, Inside the package ignored. Five Hours of Surgery, They Still left One Piece, too close to the Heart to remove. Yes I'll keep writing , Just to Whom? .The PS said this is still in my blood, I still get very sick. I know it takes time, After 14 years.

I am angry, And Yes I pray, Yes I am Positive, And tired of people in this group telling me to keep Positive I am damm positive. I have been working on this Silicone Poison For months, It gives me the energy to get well, I don't STOP. If you have any one that wants to tell me about the So Called Study Of Silicone, Than where the Hell is it. No one has showed it to me I' have wrote Ps, Attorneys, News Media, Authors, FDA, Doctors, Congress, Even the Damm White House, all they do is ignore,ignore, or say Oh I am so sorry, You better hurry up and get an attorney ,You definitely have a case but, time is running out. No Shit! Not for them for me.

I feel like I am tired of casting pearls amongst the swine, (our government) I truly believe that this nation has been turned over to Satan.

I've signed the petitions, Even voulenteered to give my statement in Washington, before the FDA board, Still no answer. I have called the attorneys that are on our side. Still no answer. How much more proof do they Want. There is no Silicone Study....If so than will someone show me these statistics they keep talking about.

Please No one tell me to keep the faith, Pray, Be Positive, I am and I do. This is a battle not just a prayer group. I am here to fight the Fight. Prayer with action, God will not do it for us. We must do it through Him, He uses us to do his work.

Yes, I am expressing Anger, This is the time for me to do this. Those that keep asking for women that have, or had Silicone for over 10 years write. I DID,DO, Still nothing. I wonder if this is just a big stupid waste of time. My body looks so ugly now, I have lost so much weight, am unable to eat, 5'6" maybe 110 lbs, My hair is falling out I feel like an upside down MOP. My breasts are gone, now sunk in, Theres still little hard lumps, It's so hard to breath, Very stressed out. I just feel Like I dont care anymore. Now my parents don't talk to me, Oh of course this is ALL my fault, So Be It.

I have been called Sunshine. I don't feel the Sun Shining.

My intent is not to hurt anyones feelings in this group. I know so many feel the anger. I needed a safe Haven to express my feelings. This Silicone has ruined My Life, and The places that want me to write to help. Dont Help! Dont Return Letters, Dont Call Back, Dont Care.

Kay L Varni.*~Patty~* <fdp@...> wrote:

Sent: Saturday, October 04, 2003 10:20 AM

Subject: Letter to the FDA from your Senator or Congressman

ALL BREAST IMPLANT WOMEN AND THEIR LAWYERS - PLEASE FAX A COPY OF THIS LETTER REQUESTING THAT YOUR SENATOR OR CONGRESSMAN SIGN THIS AND FAX TO THE FDA PRIOR TO OUR OCT. 14-15 MEETINGS.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

September 29, 2003

The Honorable Mark McClellan, M.D.

Commissioner

Food and Drug Administration

Parklawn Building

5600 Fishers Lane

Rockville, land 20857

Dear Dr. McClellan:

We are writing to express our concern about the upcoming Food and Drug Administration (FDA) review of clinical data on silicone gel-filled breast implants scheduled for October 14 and 15, 2003.

It has come to our attention that at least one manufacturer of silicone gel-filled breast implants has filed clinical data from an investigational device exemption (core) clinical trial based on only a few years of patient follow-up. It is our concern that clinical data based on only a few years of clinical patient follow-up will fail to address the long-term problems that can affect women’s health.

Due to the late onset of local, regional and systemic complications and that potential long-term risks of silicone gel-filled breast implants could vastly outweigh any benefits for the “healthy” patient population, we strongly believe the core clinical trials should be extended to better assess long-term safety prior to approval.

In a recent letter sent to Senator Kennedy (D-MA), the FDA acknowledged that “there are additional safety issues that apply to the silicone implants that do not apply to the saline implants, such as silent rupture and gel migration, which will need to be evaluated.” Research has consistently demonstrated that the onset of the majority of complications related to silicone gel-filled breast implants occur between 7 to 10 years and, unlike saline breast implants, are often not detected by women for many years after they occur. Research conducted at the FDA by S. Lori Brown, Ph.D., verified the latency of developing complications associated with

silicone gel-filled breast implants, including rupture and gel migration. [1][1]

The manufacturing community has acknowledged the potential risks associated with silicone breast implants. A United States Patent dated June 26, 2001 filed by McGhan Medical Corporation (now Inamed Corporation) states:

“Adverse medical consequences have recently become associated with the use of silicone gel filled implants because it has been discovered that the silicone oil can migrate through the implant shell and the silicone oil is not biocompatible with other human tissues. Therefore, the use of silicone based filler materials has been discontinued in the industry.”

Despite a decade passing since silicone gel-filled breast implants were restricted on the market, a prevailing concern remains about the long-term safety of these devices, particularly an elevated risk of an immunological response, potentially contributing to the development of systemic illness, following long-term implantation of silicone gel-filled breast implants. Recently published and ongoing research continues to demonstrate the real potential of an immunological response to long-term implantation of silicone gel filled breast implants particularly in the presence of significant rupture or verifiable gel migration. Research at the National Institutes

of Environmental Health Sciences and published research by the FDA has demonstrated the presence of immunological responses to silicone gel-filled breast implants including a significant association with fibromyalgia. [2][2]

Given the decades-long availability of silicone gel-filled breast implants despite never having been approved, it is imperative that the FDA complete a thorough assessment of the long-term safety of these devices prior to approval. Recent research suggests that complications often have a delayed onset. The ongoing and loosely monitored adjunct “study” is not a sufficient substitute for long-term safety data collected through rigorous core clinical trials. Therefore, we request that the FDA delay the review of the current trials in order to collect long-term data and fully assess the risks of silicone

gel-filled breast implants. It is vital to ensure that the health of future generations of women is not put in jeopardy by a device whose long-term risks far outweigh the long-term benefits.

We also request a meeting with you on or prior to September 30, 2003 to discuss these outstanding issues.

Sincerely,

Gene Green

Member of Congress

GG:sgs

[1][1] Brown SL, MS Middleton, WA Berg, MS Soo, G Pennello. Presence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama. American Journal of Roentgeonology; 175: 1057-1064, 2000.

[2][2] Brown SL, Duggirala HJ, Pennello G. An Association of Silicone-Gel Breast Implant Rupture and Fibromyalgia. Current Rheumatology Reports, 2002; 4:293-298.

[Guest guest]

Kay,

You are right--nothing much ever happens. And I can understand your anger completely. But look at the alternative....do we stay silent? Do we stop writing? Do we let everyone think we are just going to run away with our tails between our legs because we aren't being acknowledged? Or just die off without raising a fight?

As little a difference it seems to make, please have faith that others do hear when we speak out. As long as the letters are being written and our voices are not staying silent, others will hear and they will know that something is wrong. Our silence would give them all the ammunition they need to tell the world that women are not getting sick.

The manufacturer's and the FDA think that if they can put out studies showing implants don't cause disease, that the world will believe it. There is a huge amount of deceit going on, and they are spending huge amounts of money on public relations. But there is one thing they don't seem to realize. As long as women are getting sick, and speaking out, there will be a fight. They would like to think we will eventually go away. That is their hope. That is what they are trying to do--get everyone to think that women are not getting sick from implants, so that this "myth" will be put to rest and we will all just shut up. But there is only one problem. It isn't a "myth". We aren't going to go away, because women ARE sick from implants. We not only won't go away....we can't. We MUST continue to speak out, so that everyone will see that the truth is being covered up by those with the money--the deep pockets.

If this were true that women were NOT getting ill from implants, then you would think that after 40 years of this crap there would be some answers as to just what is happening to women--some clue as to these "mystery" diseases. But they can't come up with the right answers because they don't want to--it would hurt them too much.

I have faith that God will take care of those who look to him for help, and I believe this is totally an individual experience. I believe also that this world is so deceived by evil lusts of the flesh that God has allowed us to reap the consequences of our foolishness--hear me--I don't believe he is punishing us--but I do believe He has given us freedom of choice and we reap what we sow. There is salvation, and we know that God's Word tells us we are free in Christ. He will be here for us through all of our trials. We can stay silent if we so choose, but I believe that in the name of TRUTH, He will give us the courage and stamina to fight for that which is right. And that is what needs to be done. Don't give up.

"Blessed are those who hunger and thirst for righteousness, for they will be filled."

5:6

Bless you Kay.

----- Original Message -----

From: kay varni

Sent: Saturday, October 04, 2003 1:01 PM

Subject: Re: Fw: Letter to the FDA from your Senator or Congressman

Patty

Maybe I am a bit confused, What letter do you think The Senator, Congressman will need to benefit us. I have been sending letters daily. I fail to see any benefits. I still am unable to get any benefit of having consent forms IN MY HANDS THAT WERE SENT 16 MONTHS AFTER MY SURGERY. I fail to see any benefit, I keep plugging away, I am so damm tired of being ignored, this is becoming a assinite situation. Tell me ? Everyone talks about remidies of getting better. Well I am damm broke spent thousands, Just left my Husband and am real pissed off right now. No one writes me back, . I still am unable to get a Attorney to take my case, The Doctors want their money Well they can kiss my ----..

I am tired, Dr Joiner is an A--------. The FDA S---K, I had Silicone 14 YEARS, I wrote the damm Suicide Letters. I lost my Business to debts now. And I keep writing Letters, People keep saying They will Help, B--------T. I am really P-------O----Now. He not only Put me in a experiment and sent the papers to sign after, He did'nt clean out the old shit, And to top it off they were Textured, LIES,LIES, Even my California Bill of Rights, Inside the package ignored. Five Hours of Surgery, They Still left One Piece, too close to the Heart to remove. Yes I'll keep writing , Just to Whom? .The PS said this is still in my blood, I still get very sick. I know it takes time, After 14 years.

I am angry, And Yes I pray, Yes I am Positive, And tired of people in this group telling me to keep Positive I am damm positive. I have been working on this Silicone Poison For months, It gives me the energy to get well, I don't STOP. If you have any one that wants to tell me about the So Called Study Of Silicone, Than where the Hell is it. No one has showed it to me I' have wrote Ps, Attorneys, News Media, Authors, FDA, Doctors, Congress, Even the Damm White House, all they do is ignore,ignore, or say Oh I am so sorry, You better hurry up and get an attorney ,You definitely have a case but, time is running out. No Shit! Not for them for me.

I feel like I am tired of casting pearls amongst the swine, (our government) I truly believe that this nation has been turned over to Satan.

I've signed the petitions, Even voulenteered to give my statement in Washington, before the FDA board, Still no answer. I have called the attorneys that are on our side. Still no answer. How much more proof do they Want. There is no Silicone Study....If so than will someone show me these statistics they keep talking about.

Please No one tell me to keep the faith, Pray, Be Positive, I am and I do. This is a battle not just a prayer group. I am here to fight the Fight. Prayer with action, God will not do it for us. We must do it through Him, He uses us to do his work.

Yes, I am expressing Anger, This is the time for me to do this. Those that keep asking for women that have, or had Silicone for over 10 years write. I DID,DO, Still nothing. I wonder if this is just a big stupid waste of time. My body looks so ugly now, I have lost so much weight, am unable to eat, 5'6" maybe 110 lbs, My hair is falling out I feel like an upside down MOP. My breasts are gone, now sunk in, Theres still little hard lumps, It's so hard to breath, Very stressed out. I just feel Like I dont care anymore. Now my parents don't talk to me, Oh of course this is ALL my fault, So Be It.

I have been called Sunshine. I don't feel the Sun Shining.

My intent is not to hurt anyones feelings in this group. I know so many feel the anger. I needed a safe Haven to express my feelings. This Silicone has ruined My Life, and The places that want me to write to help. Dont Help! Dont Return Letters, Dont Call Back, Dont Care.

Kay L Varni.