Jump to content
RemedySpot.com

Re: Re: look what I found onlne

Rate this topic


Guest guest

Recommended Posts

Ya Lynda, it was long ago,

and they are all still the same

greedy, self absorbed......

" Rectal Cranial Inversions "

Hugs DedeSee AOL's top rated recipes and easy ways to stay in shape for winter.

Link to comment
Share on other sites

Ya Lynda, it was long ago,

and they are all still the same

greedy, self absorbed......

" Rectal Cranial Inversions "

Hugs DedeSee AOL's top rated recipes and easy ways to stay in shape for winter.

Link to comment
Share on other sites

Dede,

Look how long ago that was. Nothing has

changed. Big business still runs this country.

Lynda

At 12:19 PM 12/30/2007, you wrote:

>This is awesome Lynda !

>Love Dede

>

>

>

>

>----------

>See AOL's

><http://food.aol.com/top-rated-recipes?NCID=aoltop00030000000004>top

>rated recipes and

><http://body.aol.com/fitness/winter-exercise?NCID=aoltop00030000000003>easy

>ways to stay in shape for winter.

>

Link to comment
Share on other sites

Dede,

Look how long ago that was. Nothing has

changed. Big business still runs this country.

Lynda

At 12:19 PM 12/30/2007, you wrote:

>This is awesome Lynda !

>Love Dede

>

>

>

>

>----------

>See AOL's

><http://food.aol.com/top-rated-recipes?NCID=aoltop00030000000004>top

>rated recipes and

><http://body.aol.com/fitness/winter-exercise?NCID=aoltop00030000000003>easy

>ways to stay in shape for winter.

>

Link to comment
Share on other sites

  • 2 weeks later...

Hi Lea,

I think Ilena has it on her site.

Hope you are doing better.

I have to go for a CT Scan tomorrow, they found something they did

not like in my lung when they did a chest X-ray. Darn, I do not need

any more health problems ever, ever, ever.

Lynda

At 10:02 AM 1/10/2008, you wrote:

>Thank you for this great speech to the FDA. You are wonderful.

>

>Love always......Lea

>~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~`````

> Re: look what I found onlne

>

>

>Copy of FDA speech of Lynda Roth of COSS

>

>Date: Tue, 29 Feb 2000 16:05:20 -0700

>

>From: Lynda <mailto:coss@...>coss@... (by way of ilena rose)

>

>Lynda Roth

>

>2739 W. 23rd St.

>

>Greeley, CO 80634

>

>(970) 506-9288

>

>Ladies and Gentlemen of the Panel,

>

>I am a social worker (MSW) and the leader of a support network for

>women with breast implants. I am here today to represent the many

>women who are unable to come. There are numerous reasons for their

>absence, among them the inability to afford a trip, illness, and

>their feelings that they could not speak eloquently enough to get

>their points across. Many fear the publicity of dealing with a

>private medical matter in such a public forum. Many are embarrassed

>that they made this medical decision only to become ill and become a

>burden to their families and friends. They hide their shame. Some

>fear the legal repercussions of being public while legalities still

>exist over these devices.

>

>I am here today to tell you my experiences with these women and with

>saline filled silicone breast implants. Our network has existed since

>1990 and has about 5500 members; about 25% being women who have had

>only saline filled silicone implants. A few of these women do not

>have problems, but are concerned. The vast majority have medical

>problems caused by their implants. As saline filled silicone implants

>become more popular, the percentage of calls coming from women with

>these breast implants has mushroomed. In the last three years, our

>calls have consisted of more and more saline implantees, nearing 50%

>today. Our network provides information free of charge throughout the

>world to those who cannot afford to pay for it and we do provide a

>newsletter for $25 annually. We are incorporated as a 501c3

>non-profit organization. I have traveled many places in the world to

>arrange conferences, meetings, and to impart information on breast implants.

>

>Silicone is not biologically inert, although it may be chemically

>inert. The silicone in the shell contains many chemicals which react

>when placed in a biological setting. Some of these chemicals are

>known to be harmful to the body. I am sure you have a list of all the

>contents of the shell of these devices. I urge you to read about the

>harmful effects of each. These are not inert devices. Bio-chemical

>reactions can and do occur. When implants are removed, often scar

>tissue remains. Some of these harmful chemicals that slough off the

>shell will remain in the chest causing further reactions. Foreign

>bodies are known to cause reactions. The calcium deposits that form

>in scar tissue resemble cancerous tissue on mammograms. Screening for

>cancer is much more difficult with any implant.

>

>Women who have had cancer are known to have a suppressed immune

>system. I am one such woman, and, although at the time the implant

>seemed like a great idea, it was probably the biggest mistake of my

>life. It almost cost me my life. Women who have suppressed immune

>systems should not be exposed to products that are known immune

>system suppressants.

>

>The manufacturers of saline (that goes into these implants) are on

>record as stating that their solution is not meant for long-term

>implantation into the human body. It is a dated solution, and one

>that can not be guaranteed to remain sterile. Generally the date is

>less than a year from the time of implantation. Sterility is only as

>good as the conditions of the operating room and the cleanliness of

>the medical persons involved. In addition, sterility is never 100%,

>even with all the modern ways we have to sterilize medical devices.

>Implants are micro-porous; they exchange fluid with the body.

>Anything in the implants can get into the body, and vice versa. We

>all have bacteria and fungi in our bodies. This leads to the

>incubation of nightmarish microbes that cause serious damage. Saline

>implants can and do rupture, often. Besides the risks of the original

>surgery, women are exposed to repeated surgeries for years to come.

>The FDA reportedly has over 25,000 claims of injury from these

>saline-filled silicone devices. We have heard that our government is

>here to protect us. What have they done about these claims?

>

>Some of the most common problems reported to us are: Deflation of the

>implant, often within a few weeks, hard and painful breasts, shifting

>of the implant so that it has to be surgically moved back where it

>belongs, body aches and joint pains, loss of energy, unexplained

>rashes (often on the chest and neck), burning , twitching and

>weakness of the muscles, and short-term memory loss. Many women

>report significant hair loss all over their bodies, including

>eyebrows and eyelashes, and this problem usually reverses with

>implant removal. Women also report skin and nipple necrosis. Testing

>often reveals antibodies to silicone.

>

>I would like to specifically address the studies that the

>manufacturers have conducted, the so-called five-year studies. First

>I want to mention the lack of informed consent. Product label inserts

>are not often given to the women. Women often have these implants

>placed without hearing a word about possible problems. They report

>being given papers to sign when they have been prepped for surgery

>and have been given a sedative. They report being given papers to

>sign after the surgery before they are fully

>

>recovered from anesthesia. I have heard from more than a dozen

>symptomatic women in the last 3 years who have never been contacted

>by their plastic surgeon after implantation with saline implants,

>despite the fact that they were told they were in a study about the

>safety of these devices. These women's symptoms remain unreported. If

>I have heard from this many (and other group leaders have heard from

>at least this many), how many others remain unreported.

>

>These women are all part of a study being done by McGhan and Mentor.

>The plastic surgeons that insert the implants are collecting this

>data. This greatly reduces or eliminates any scientific validity of

>this study.

>

>Another problem is that a study that only goes for 5 years can hardly

>define risks that may take 20-30 years to discover, as in the case of

>asbestos. We know for a certainty that women with silicone implants

>often do not show symptoms for at least 6-8 years. For some it is 15

>years or more. What possible value can a biased study, one in which

>not all the plastic surgeons follow up with patients and that only

>goes for 5 years, have? This certainly calls into question the

>accuracy of the data from these studies that you will hear at this

>PMA meeting. These saline-filled silicone implants studies need to be

>followed by unbiased researchers for at least 20 years before we can

>know what damage they will do to many of the recipients.

>

>I have heard doctors joking about these " studies " , stating that they

>are a study in name only. I seriously doubt that any of these

>doctors, who make money from placing implants, are going to come here

>and admit that these studies are not scientifically valid. A survey

>of all women implanted should be done to find out how many had

>problems and how many have reported these to their plastic surgeons.

>This should not be done by the manufacturers of implants or the

>plastic surgeons. The FDA should closely monitor these studies and

>check the accuracy of the information provided regarding these.

>

>Women call our network with illnesses a few years after implantation,

>stating that they have never heard from their plastic surgeons. When

>they do finally call their surgeon, complaining of symptoms, they are

>told that these symptoms could not possibly be from their implants. I

>heard from one of these women again recently, and after almost 4

>years, she had not once heard from her California plastic surgeon,

>despite the fact that she was told that she was enrolled in a study.

>She finally called his office to report problems and was told that

>her problems are not of the type implants cause. I am including the

>e-mail of one woman who contacted me less than three weeks ago. She

>had her saline implants for 4 months and was already symptomatic.

>When she contacted her plastic surgeon, he told her it was not due to

>the implants. She has persisted and he has removed them, but with

>great reluctance. I am sure he will not report that her medical

>problems are related to her implants. I do not believe that is in an

>uncommon problem. From the reports I get from women and other support

>group leaders, this is an extremely common situation. Complaints are

>being brushed off as merely inconsequential problems not related to

>saline breast implants. Those of us who speak out are called

>fanatical, hysterical women. I am a serious, practical, intelligent

>and educated woman. I am dedicated to informing people on this issue

>that harms more than just the women of our society.

>

>I have seen the pictures of the horrible fungi and bacteria that grow

>in implants. I have one here with me. I have known the women from

>whose bodies these implants were removed. I have seen their

>disastrous health problems. Studies must be done to determine what

>happens to women with saline implants that have bacteria and mold

>growing in them, especially when they rupture inside the women's

>bodies. These need to be longer than 1,3, or 5 years. After 6-7

>years, the incidence of rupture dramatically increases. We are asking

>you to advise the FDA to protect us from these dangerous products and

>their side effects. I am sure you are privy to Health and Human

>Services' list of concerns about the autoimmune problems caused by

>saline-filled implants. I have included a copy with this testimony.

>

>If this meeting is not a serious effort to evaluate the safety of

>saline implants, but instead a rubber stamp to please the

>manufacturers by approving their products, then I ask that you make

>absolutely certain that all women are, at least a week before the

>surgical, given the important information about side effects. They

>need to be informed of the wealth of information available. They need

>to be given this without bias or comments by the physician. Often

>concerns are just waved away with a sweep of the hand and a statement

>that we don't have any problems with these. My group members report

>this same paternalistic response from their plastic surgeons.

>land is a good example. The state has an excellent policy of

>informed consent regarding implants, but the policy is more

>impressive on paper than in reality. This informed consent itself

>would save many lives and much heartache for years to come, but

>unfortunately, many of the doctors reportedly ignore the law and fail

>to comply.

>

>There is an increasing problem with younger and younger women

>desiring and getting breast implants. The age range from 13-17 is not

>unusual. Although some (few) plastic surgeons refuse to implant women

>so young, most can and do take these young women (children) as

>patients. They are not yet old enough to understand the lifetime of

>surgeries and problems that may occur. They just want to feel good

>about their bodies and want to fit into their peer groups. Ethically

>and morally, these women should not be candidates for surgery, yet

>they are being given breast implants. Their parents need to be truly

>informed of all the problems at least a week prior to surgery so that

>they can make better decisions. Often these young women's bodies are

>not finished with development, yet they are being exposed to surgeries.

>

>We have heard about the social aspects, the self-esteem issues, the

>self-worth issues, the feel good about myself now reports. There are

>many social aspects that are just the opposite. The families of women

>who suffer from these devices also suffer. The children suffer when

>their mother is unwell. The whole family often unravels. The

>emotional costs are tremendously high. Some women commit suicide to

>escape the very real pain, not just the physical pain caused by their

>implants. These women simply can no longer face their indifferent

>doctors and their families who are tired of dealing with the medical

>problems that implantees suffer from.

>

>Aside from this, women in increasing numbers are being granted

>disability for their breast implant problems. This certainly includes

>saline implant women. In fact, women who have had long term saline

>implants are often worse off medically than their silicone sisters

>are. Women who were implanted with saline implants in the 70's are

>often quite ill today. I know quite a few of these women. I am often

>grateful that I am not in their shoes. Many have lost their husbands

>due to their illness. Taxpayers are picking up the burden of these

>very ill women. They are often of SSD and on Medicaid. When women are

>on disability, their children also get checks. Having women ill,

>besides being economically devastating to their families, it is also

>an issue that costs all of us. We ignore the fact that many people

>are needlessly being made ill and will, in the future, cost us even more.

>

>Women must now sign away their rights to sue for damages if these

>devices injure them. Before they can receive the implants, they have

>to agree to never sue the manufacturer; otherwise they will not be

>given the implants. This seems to fly in the face of reason. If they

>are being told that these devices are safe and FDA approved, then

>they should not be restricted from suing for damages. The

>manufacturers know these devices are not safe.

>

>In conclusion, I thank this panel for your time and hope that you

>make a decision to require more study on saline implants before any

>approval so that the women of this country and, indeed, the world

>will benefit from this hearing.

>

>Lynda Roth

>

>Coalition of Silicone Survivors

>

>

><http://promos.hotbar.com/promos/promodll.dll?RunPromo & El= & SG= & RAND=25087 & partn\

er=hotbar>

>Upgrade Your Email - Click here!

>

>

>

Link to comment
Share on other sites

Hi Lea,

I think Ilena has it on her site.

Hope you are doing better.

I have to go for a CT Scan tomorrow, they found something they did

not like in my lung when they did a chest X-ray. Darn, I do not need

any more health problems ever, ever, ever.

Lynda

At 10:02 AM 1/10/2008, you wrote:

>Thank you for this great speech to the FDA. You are wonderful.

>

>Love always......Lea

>~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~`````

> Re: look what I found onlne

>

>

>Copy of FDA speech of Lynda Roth of COSS

>

>Date: Tue, 29 Feb 2000 16:05:20 -0700

>

>From: Lynda <mailto:coss@...>coss@... (by way of ilena rose)

>

>Lynda Roth

>

>2739 W. 23rd St.

>

>Greeley, CO 80634

>

>(970) 506-9288

>

>Ladies and Gentlemen of the Panel,

>

>I am a social worker (MSW) and the leader of a support network for

>women with breast implants. I am here today to represent the many

>women who are unable to come. There are numerous reasons for their

>absence, among them the inability to afford a trip, illness, and

>their feelings that they could not speak eloquently enough to get

>their points across. Many fear the publicity of dealing with a

>private medical matter in such a public forum. Many are embarrassed

>that they made this medical decision only to become ill and become a

>burden to their families and friends. They hide their shame. Some

>fear the legal repercussions of being public while legalities still

>exist over these devices.

>

>I am here today to tell you my experiences with these women and with

>saline filled silicone breast implants. Our network has existed since

>1990 and has about 5500 members; about 25% being women who have had

>only saline filled silicone implants. A few of these women do not

>have problems, but are concerned. The vast majority have medical

>problems caused by their implants. As saline filled silicone implants

>become more popular, the percentage of calls coming from women with

>these breast implants has mushroomed. In the last three years, our

>calls have consisted of more and more saline implantees, nearing 50%

>today. Our network provides information free of charge throughout the

>world to those who cannot afford to pay for it and we do provide a

>newsletter for $25 annually. We are incorporated as a 501c3

>non-profit organization. I have traveled many places in the world to

>arrange conferences, meetings, and to impart information on breast implants.

>

>Silicone is not biologically inert, although it may be chemically

>inert. The silicone in the shell contains many chemicals which react

>when placed in a biological setting. Some of these chemicals are

>known to be harmful to the body. I am sure you have a list of all the

>contents of the shell of these devices. I urge you to read about the

>harmful effects of each. These are not inert devices. Bio-chemical

>reactions can and do occur. When implants are removed, often scar

>tissue remains. Some of these harmful chemicals that slough off the

>shell will remain in the chest causing further reactions. Foreign

>bodies are known to cause reactions. The calcium deposits that form

>in scar tissue resemble cancerous tissue on mammograms. Screening for

>cancer is much more difficult with any implant.

>

>Women who have had cancer are known to have a suppressed immune

>system. I am one such woman, and, although at the time the implant

>seemed like a great idea, it was probably the biggest mistake of my

>life. It almost cost me my life. Women who have suppressed immune

>systems should not be exposed to products that are known immune

>system suppressants.

>

>The manufacturers of saline (that goes into these implants) are on

>record as stating that their solution is not meant for long-term

>implantation into the human body. It is a dated solution, and one

>that can not be guaranteed to remain sterile. Generally the date is

>less than a year from the time of implantation. Sterility is only as

>good as the conditions of the operating room and the cleanliness of

>the medical persons involved. In addition, sterility is never 100%,

>even with all the modern ways we have to sterilize medical devices.

>Implants are micro-porous; they exchange fluid with the body.

>Anything in the implants can get into the body, and vice versa. We

>all have bacteria and fungi in our bodies. This leads to the

>incubation of nightmarish microbes that cause serious damage. Saline

>implants can and do rupture, often. Besides the risks of the original

>surgery, women are exposed to repeated surgeries for years to come.

>The FDA reportedly has over 25,000 claims of injury from these

>saline-filled silicone devices. We have heard that our government is

>here to protect us. What have they done about these claims?

>

>Some of the most common problems reported to us are: Deflation of the

>implant, often within a few weeks, hard and painful breasts, shifting

>of the implant so that it has to be surgically moved back where it

>belongs, body aches and joint pains, loss of energy, unexplained

>rashes (often on the chest and neck), burning , twitching and

>weakness of the muscles, and short-term memory loss. Many women

>report significant hair loss all over their bodies, including

>eyebrows and eyelashes, and this problem usually reverses with

>implant removal. Women also report skin and nipple necrosis. Testing

>often reveals antibodies to silicone.

>

>I would like to specifically address the studies that the

>manufacturers have conducted, the so-called five-year studies. First

>I want to mention the lack of informed consent. Product label inserts

>are not often given to the women. Women often have these implants

>placed without hearing a word about possible problems. They report

>being given papers to sign when they have been prepped for surgery

>and have been given a sedative. They report being given papers to

>sign after the surgery before they are fully

>

>recovered from anesthesia. I have heard from more than a dozen

>symptomatic women in the last 3 years who have never been contacted

>by their plastic surgeon after implantation with saline implants,

>despite the fact that they were told they were in a study about the

>safety of these devices. These women's symptoms remain unreported. If

>I have heard from this many (and other group leaders have heard from

>at least this many), how many others remain unreported.

>

>These women are all part of a study being done by McGhan and Mentor.

>The plastic surgeons that insert the implants are collecting this

>data. This greatly reduces or eliminates any scientific validity of

>this study.

>

>Another problem is that a study that only goes for 5 years can hardly

>define risks that may take 20-30 years to discover, as in the case of

>asbestos. We know for a certainty that women with silicone implants

>often do not show symptoms for at least 6-8 years. For some it is 15

>years or more. What possible value can a biased study, one in which

>not all the plastic surgeons follow up with patients and that only

>goes for 5 years, have? This certainly calls into question the

>accuracy of the data from these studies that you will hear at this

>PMA meeting. These saline-filled silicone implants studies need to be

>followed by unbiased researchers for at least 20 years before we can

>know what damage they will do to many of the recipients.

>

>I have heard doctors joking about these " studies " , stating that they

>are a study in name only. I seriously doubt that any of these

>doctors, who make money from placing implants, are going to come here

>and admit that these studies are not scientifically valid. A survey

>of all women implanted should be done to find out how many had

>problems and how many have reported these to their plastic surgeons.

>This should not be done by the manufacturers of implants or the

>plastic surgeons. The FDA should closely monitor these studies and

>check the accuracy of the information provided regarding these.

>

>Women call our network with illnesses a few years after implantation,

>stating that they have never heard from their plastic surgeons. When

>they do finally call their surgeon, complaining of symptoms, they are

>told that these symptoms could not possibly be from their implants. I

>heard from one of these women again recently, and after almost 4

>years, she had not once heard from her California plastic surgeon,

>despite the fact that she was told that she was enrolled in a study.

>She finally called his office to report problems and was told that

>her problems are not of the type implants cause. I am including the

>e-mail of one woman who contacted me less than three weeks ago. She

>had her saline implants for 4 months and was already symptomatic.

>When she contacted her plastic surgeon, he told her it was not due to

>the implants. She has persisted and he has removed them, but with

>great reluctance. I am sure he will not report that her medical

>problems are related to her implants. I do not believe that is in an

>uncommon problem. From the reports I get from women and other support

>group leaders, this is an extremely common situation. Complaints are

>being brushed off as merely inconsequential problems not related to

>saline breast implants. Those of us who speak out are called

>fanatical, hysterical women. I am a serious, practical, intelligent

>and educated woman. I am dedicated to informing people on this issue

>that harms more than just the women of our society.

>

>I have seen the pictures of the horrible fungi and bacteria that grow

>in implants. I have one here with me. I have known the women from

>whose bodies these implants were removed. I have seen their

>disastrous health problems. Studies must be done to determine what

>happens to women with saline implants that have bacteria and mold

>growing in them, especially when they rupture inside the women's

>bodies. These need to be longer than 1,3, or 5 years. After 6-7

>years, the incidence of rupture dramatically increases. We are asking

>you to advise the FDA to protect us from these dangerous products and

>their side effects. I am sure you are privy to Health and Human

>Services' list of concerns about the autoimmune problems caused by

>saline-filled implants. I have included a copy with this testimony.

>

>If this meeting is not a serious effort to evaluate the safety of

>saline implants, but instead a rubber stamp to please the

>manufacturers by approving their products, then I ask that you make

>absolutely certain that all women are, at least a week before the

>surgical, given the important information about side effects. They

>need to be informed of the wealth of information available. They need

>to be given this without bias or comments by the physician. Often

>concerns are just waved away with a sweep of the hand and a statement

>that we don't have any problems with these. My group members report

>this same paternalistic response from their plastic surgeons.

>land is a good example. The state has an excellent policy of

>informed consent regarding implants, but the policy is more

>impressive on paper than in reality. This informed consent itself

>would save many lives and much heartache for years to come, but

>unfortunately, many of the doctors reportedly ignore the law and fail

>to comply.

>

>There is an increasing problem with younger and younger women

>desiring and getting breast implants. The age range from 13-17 is not

>unusual. Although some (few) plastic surgeons refuse to implant women

>so young, most can and do take these young women (children) as

>patients. They are not yet old enough to understand the lifetime of

>surgeries and problems that may occur. They just want to feel good

>about their bodies and want to fit into their peer groups. Ethically

>and morally, these women should not be candidates for surgery, yet

>they are being given breast implants. Their parents need to be truly

>informed of all the problems at least a week prior to surgery so that

>they can make better decisions. Often these young women's bodies are

>not finished with development, yet they are being exposed to surgeries.

>

>We have heard about the social aspects, the self-esteem issues, the

>self-worth issues, the feel good about myself now reports. There are

>many social aspects that are just the opposite. The families of women

>who suffer from these devices also suffer. The children suffer when

>their mother is unwell. The whole family often unravels. The

>emotional costs are tremendously high. Some women commit suicide to

>escape the very real pain, not just the physical pain caused by their

>implants. These women simply can no longer face their indifferent

>doctors and their families who are tired of dealing with the medical

>problems that implantees suffer from.

>

>Aside from this, women in increasing numbers are being granted

>disability for their breast implant problems. This certainly includes

>saline implant women. In fact, women who have had long term saline

>implants are often worse off medically than their silicone sisters

>are. Women who were implanted with saline implants in the 70's are

>often quite ill today. I know quite a few of these women. I am often

>grateful that I am not in their shoes. Many have lost their husbands

>due to their illness. Taxpayers are picking up the burden of these

>very ill women. They are often of SSD and on Medicaid. When women are

>on disability, their children also get checks. Having women ill,

>besides being economically devastating to their families, it is also

>an issue that costs all of us. We ignore the fact that many people

>are needlessly being made ill and will, in the future, cost us even more.

>

>Women must now sign away their rights to sue for damages if these

>devices injure them. Before they can receive the implants, they have

>to agree to never sue the manufacturer; otherwise they will not be

>given the implants. This seems to fly in the face of reason. If they

>are being told that these devices are safe and FDA approved, then

>they should not be restricted from suing for damages. The

>manufacturers know these devices are not safe.

>

>In conclusion, I thank this panel for your time and hope that you

>make a decision to require more study on saline implants before any

>approval so that the women of this country and, indeed, the world

>will benefit from this hearing.

>

>Lynda Roth

>

>Coalition of Silicone Survivors

>

>

><http://promos.hotbar.com/promos/promodll.dll?RunPromo & El= & SG= & RAND=25087 & partn\

er=hotbar>

>Upgrade Your Email - Click here!

>

>

>

Link to comment
Share on other sites

Lynda, I am happy that your speech is on Ilena's site...it is wonderful. You are a very brave lady.

Honey, it could be a shadow in your lung, because that is what happened to a year ago. The doctors saw something that turned out to be a shadow. We hope that there is nothing in your lungs, you have had more health problems in the last several months than you need.

Honey, we will continue to pray for you....love you....Lea

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

Re: look what I found onlne>>>Copy of FDA speech of Lynda Roth of COSS>>Date: Tue, 29 Feb 2000 16:05:20 -0700>>From: Lynda <mailto:cossprivatei>cossprivatei (by way of ilena rose)>>Lynda Roth>>2739 W. 23rd St.>>Greeley, CO 80634>>(970) 506-9288>>Ladies and Gentlemen of the Panel,>>I am a social worker (MSW) and the leader of a support network for>women with breast implants. I am here today to represent the many>women who are unable to come. There are numerous reasons for their>absence, among them the inability to afford a trip, illness, and>their feelings that they could not speak eloquently enough to get>their points across. Many fear the publicity of dealing with a>private medical matter in such a public forum. Many are embarrassed>that they made this medical decision only to become ill and become a>burden to their families and friends. They hide their shame. Some>fear the legal repercussions of being public while legalities still>exist over these devices.>>I am here today to tell you my experiences with these women and with>saline filled silicone breast implants. Our network has existed since>1990 and has about 5500 members; about 25% being women who have had>only saline filled silicone implants. A few of these women do not>have problems, but are concerned. The vast majority have medical>problems caused by their implants. As saline filled silicone implants>become more popular, the percentage of calls coming from women with>these breast implants has mushroomed. In the last three years, our>calls have consisted of more and more saline implantees, nearing 50%>today. Our network provides information free of charge throughout the>world to those who cannot afford to pay for it and we do provide a>newsletter for $25 annually. We are incorporated as a 501c3>non-profit organization. I have traveled many places in the world to>arrange conferences, meetings, and to impart information on breast implants.>>Silicone is not biologically inert, although it may be chemically>inert. The silicone in the shell contains many chemicals which react>when placed in a biological setting. Some of these chemicals are>known to be harmful to the body. I am sure you have a list of all the>contents of the shell of these devices. I urge you to read about the>harmful effects of each. These are not inert devices. Bio-chemical>reactions can and do occur. When implants are removed, often scar>tissue remains. Some of these harmful chemicals that slough off the>shell will remain in the chest causing further reactions. Foreign>bodies are known to cause reactions. The calcium deposits that form>in scar tissue resemble cancerous tissue on mammograms. Screening for>cancer is much more difficult with any implant.>>Women who have had cancer are known to have a suppressed immune>system. I am one such woman, and, although at the time the implant>seemed like a great idea, it was probably the biggest mistake of my>life. It almost cost me my life. Women who have suppressed immune>systems should not be exposed to products that are known immune>system suppressants.>>The manufacturers of saline (that goes into these implants) are on>record as stating that their solution is not meant for long-term>implantation into the human body. It is a dated solution, and one>that can not be guaranteed to remain sterile. Generally the date is>less than a year from the time of implantation. Sterility is only as>good as the conditions of the operating room and the cleanliness of>the medical persons involved. In addition, sterility is never 100%,>even with all the modern ways we have to sterilize medical devices.>Implants are micro-porous; they exchange fluid with the body.>Anything in the implants can get into the body, and vice versa. We>all have bacteria and fungi in our bodies. This leads to the>incubation of nightmarish microbes that cause serious damage. Saline>implants can and do rupture, often. Besides the risks of the original>surgery, women are exposed to repeated surgeries for years to come.>The FDA reportedly has over 25,000 claims of injury from these>saline-filled silicone devices. We have heard that our government is>here to protect us. What have they done about these claims?>>Some of the most common problems reported to us are: Deflation of the>implant, often within a few weeks, hard and painful breasts, shifting>of the implant so that it has to be surgically moved back where it>belongs, body aches and joint pains, loss of energy, unexplained>rashes (often on the chest and neck), burning , twitching and>weakness of the muscles, and short-term memory loss. Many women>report significant hair loss all over their bodies, including>eyebrows and eyelashes, and this problem usually reverses with>implant removal. Women also report skin and nipple necrosis. Testing>often reveals antibodies to silicone.>>I would like to specifically address the studies that the>manufacturers have conducted, the so-called five-year studies. First>I want to mention the lack of informed consent. Product label inserts>are not often given to the women. Women often have these implants>placed without hearing a word about possible problems. They report>being given papers to sign when they have been prepped for surgery>and have been given a sedative. They report being given papers to>sign after the surgery before they are fully>>recovered from anesthesia. I have heard from more than a dozen>symptomatic women in the last 3 years who have never been contacted>by their plastic surgeon after implantation with saline implants,>despite the fact that they were told they were in a study about the>safety of these devices. These women's symptoms remain unreported. If>I have heard from this many (and other group leaders have heard from>at least this many), how many others remain unreported.>>These women are all part of a study being done by McGhan and Mentor.>The plastic surgeons that insert the implants are collecting this>data. This greatly reduces or eliminates any scientific validity of >this study.>>Another problem is that a study that only goes for 5 years can hardly>define risks that may take 20-30 years to discover, as in the case of>asbestos. We know for a certainty that women with silicone implants>often do not show symptoms for at least 6-8 years. For some it is 15>years or more. What possible value can a biased study, one in which>not all the plastic surgeons follow up with patients and that only>goes for 5 years, have? This certainly calls into question the>accuracy of the data from these studies that you will hear at this>PMA meeting. These saline-filled silicone implants studies need to be>followed by unbiased researchers for at least 20 years before we can>know what damage they will do to many of the recipients.>>I have heard doctors joking about these "studies", stating that they>are a study in name only. I seriously doubt that any of these>doctors, who make money from placing implants, are going to come here>and admit that these studies are not scientifically valid. A survey>of all women implanted should be done to find out how many had>problems and how many have reported these to their plastic surgeons.>This should not be done by the manufacturers of implants or the>plastic surgeons. The FDA should closely monitor these studies and>check the accuracy of the information provided regarding these.>>Women call our network with illnesses a few years after implantation,>stating that they have never heard from their plastic surgeons. When>they do finally call their surgeon, complaining of symptoms, they are>told that these symptoms could not possibly be from their implants. I>heard from one of these women again recently, and after almost 4>years, she had not once heard from her California plastic surgeon,>despite the fact that she was told that she was enrolled in a study.>She finally called his office to report problems and was told that>her problems are not of the type implants cause. I am including the>e-mail of one woman who contacted me less than three weeks ago. She>had her saline implants for 4 months and was already symptomatic.>When she contacted her plastic surgeon, he told her it was not due to>the implants. She has persisted and he has removed them, but with>great reluctance. I am sure he will not report that her medical>problems are related to her implants. I do not believe that is in an>uncommon problem. From the reports I get from women and other support>group leaders, this is an extremely common situation. Complaints are>being brushed off as merely inconsequential problems not related to>saline breast implants. Those of us who speak out are called>fanatical, hysterical women. I am a serious, practical, intelligent>and educated woman. I am dedicated to informing people on this issue>that harms more than just the women of our society.>>I have seen the pictures of the horrible fungi and bacteria that grow>in implants. I have one here with me. I have known the women from>whose bodies these implants were removed. I have seen their>disastrous health problems. Studies must be done to determine what>happens to women with saline implants that have bacteria and mold>growing in them, especially when they rupture inside the women's>bodies. These need to be longer than 1,3, or 5 years. After 6-7>years, the incidence of rupture dramatically increases. We are asking>you to advise the FDA to protect us from these dangerous products and>their side effects. I am sure you are privy to Health and Human>Services' list of concerns about the autoimmune problems caused by>saline-filled implants. I have included a copy with this testimony.>>If this meeting is not a serious effort to evaluate the safety of>saline implants, but instead a rubber stamp to please the>manufacturers by approving their products, then I ask that you make>absolutely certain that all women are, at least a week before the>surgical, given the important information about side effects. They>need to be informed of the wealth of information available. They need>to be given this without bias or comments by the physician. Often>concerns are just waved away with a sweep of the hand and a statement>that we don't have any problems with these. My group members report>this same paternalistic response from their plastic surgeons.>land is a good example. The state has an excellent policy of>informed consent regarding implants, but the policy is more>impressive on paper than in reality. This informed consent itself>would save many lives and much heartache for years to come, but>unfortunately, many of the doctors reportedly ignore the law and fail>to comply.>>There is an increasing problem with younger and younger women>desiring and getting breast implants. The age range from 13-17 is not>unusual. Although some (few) plastic surgeons refuse to implant women>so young, most can and do take these young women (children) as>patients. They are not yet old enough to understand the lifetime of>surgeries and problems that may occur. They just want to feel good>about their bodies and want to fit into their peer groups. Ethically>and morally, these women should not be candidates for surgery, yet>they are being given breast implants. Their parents need to be truly>informed of all the problems at least a week prior to surgery so that>they can make better decisions. Often these young women's bodies are>not finished with development, yet they are being exposed to surgeries.>>We have heard about the social aspects, the self-esteem issues, the>self-worth issues, the feel good about myself now reports. There are>many social aspects that are just the opposite. The families of women>who suffer from these devices also suffer. The children suffer when>their mother is unwell. The whole family often unravels. The>emotional costs are tremendously high. Some women commit suicide to>escape the very real pain, not just the physical pain caused by their>implants. These women simply can no longer face their indifferent>doctors and their families who are tired of dealing with the medical>problems that implantees suffer from.>>Aside from this, women in increasing numbers are being granted>disability for their breast implant problems. This certainly includes>saline implant women. In fact, women who have had long term saline>implants are often worse off medically than their silicone sisters>are. Women who were implanted with saline implants in the 70's are>often quite ill today. I know quite a few of these women. I am often>grateful that I am not in their shoes. Many have lost their husbands>due to their illness. Taxpayers are picking up the burden of these>very ill women. They are often of SSD and on Medicaid. When women are>on disability, their children also get checks. Having women ill,>besides being economically devastating to their families, it is also>an issue that costs all of us. We ignore the fact that many people>are needlessly being made ill and will, in the future, cost us even more.>>Women must now sign away their rights to sue for damages if these>devices injure them. Before they can receive the implants, they have>to agree to never sue the manufacturer; otherwise they will not be>given the implants. This seems to fly in the face of reason. If they>are being told that these devices are safe and FDA approved, then>they should not be restricted from suing for damages. The>manufacturers know these devices are not safe.>>In conclusion, I thank this panel for your time and hope that you>make a decision to require more study on saline implants before any>approval so that the women of this country and, indeed, the world>will benefit from this hearing.>>Lynda Roth>>Coalition of Silicone Survivors>>><http://promos.hotbar.com/promos/promodll.dll?RunPromo & El= & SG= & RAND=25087 & partner=hotbar>>Upgrade Your Email - Click here!>>>

Link to comment
Share on other sites

Lynda, I am happy that your speech is on Ilena's site...it is wonderful. You are a very brave lady.

Honey, it could be a shadow in your lung, because that is what happened to a year ago. The doctors saw something that turned out to be a shadow. We hope that there is nothing in your lungs, you have had more health problems in the last several months than you need.

Honey, we will continue to pray for you....love you....Lea

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

Re: look what I found onlne>>>Copy of FDA speech of Lynda Roth of COSS>>Date: Tue, 29 Feb 2000 16:05:20 -0700>>From: Lynda <mailto:cossprivatei>cossprivatei (by way of ilena rose)>>Lynda Roth>>2739 W. 23rd St.>>Greeley, CO 80634>>(970) 506-9288>>Ladies and Gentlemen of the Panel,>>I am a social worker (MSW) and the leader of a support network for>women with breast implants. I am here today to represent the many>women who are unable to come. There are numerous reasons for their>absence, among them the inability to afford a trip, illness, and>their feelings that they could not speak eloquently enough to get>their points across. Many fear the publicity of dealing with a>private medical matter in such a public forum. Many are embarrassed>that they made this medical decision only to become ill and become a>burden to their families and friends. They hide their shame. Some>fear the legal repercussions of being public while legalities still>exist over these devices.>>I am here today to tell you my experiences with these women and with>saline filled silicone breast implants. Our network has existed since>1990 and has about 5500 members; about 25% being women who have had>only saline filled silicone implants. A few of these women do not>have problems, but are concerned. The vast majority have medical>problems caused by their implants. As saline filled silicone implants>become more popular, the percentage of calls coming from women with>these breast implants has mushroomed. In the last three years, our>calls have consisted of more and more saline implantees, nearing 50%>today. Our network provides information free of charge throughout the>world to those who cannot afford to pay for it and we do provide a>newsletter for $25 annually. We are incorporated as a 501c3>non-profit organization. I have traveled many places in the world to>arrange conferences, meetings, and to impart information on breast implants.>>Silicone is not biologically inert, although it may be chemically>inert. The silicone in the shell contains many chemicals which react>when placed in a biological setting. Some of these chemicals are>known to be harmful to the body. I am sure you have a list of all the>contents of the shell of these devices. I urge you to read about the>harmful effects of each. These are not inert devices. Bio-chemical>reactions can and do occur. When implants are removed, often scar>tissue remains. Some of these harmful chemicals that slough off the>shell will remain in the chest causing further reactions. Foreign>bodies are known to cause reactions. The calcium deposits that form>in scar tissue resemble cancerous tissue on mammograms. Screening for>cancer is much more difficult with any implant.>>Women who have had cancer are known to have a suppressed immune>system. I am one such woman, and, although at the time the implant>seemed like a great idea, it was probably the biggest mistake of my>life. It almost cost me my life. Women who have suppressed immune>systems should not be exposed to products that are known immune>system suppressants.>>The manufacturers of saline (that goes into these implants) are on>record as stating that their solution is not meant for long-term>implantation into the human body. It is a dated solution, and one>that can not be guaranteed to remain sterile. Generally the date is>less than a year from the time of implantation. Sterility is only as>good as the conditions of the operating room and the cleanliness of>the medical persons involved. In addition, sterility is never 100%,>even with all the modern ways we have to sterilize medical devices.>Implants are micro-porous; they exchange fluid with the body.>Anything in the implants can get into the body, and vice versa. We>all have bacteria and fungi in our bodies. This leads to the>incubation of nightmarish microbes that cause serious damage. Saline>implants can and do rupture, often. Besides the risks of the original>surgery, women are exposed to repeated surgeries for years to come.>The FDA reportedly has over 25,000 claims of injury from these>saline-filled silicone devices. We have heard that our government is>here to protect us. What have they done about these claims?>>Some of the most common problems reported to us are: Deflation of the>implant, often within a few weeks, hard and painful breasts, shifting>of the implant so that it has to be surgically moved back where it>belongs, body aches and joint pains, loss of energy, unexplained>rashes (often on the chest and neck), burning , twitching and>weakness of the muscles, and short-term memory loss. Many women>report significant hair loss all over their bodies, including>eyebrows and eyelashes, and this problem usually reverses with>implant removal. Women also report skin and nipple necrosis. Testing>often reveals antibodies to silicone.>>I would like to specifically address the studies that the>manufacturers have conducted, the so-called five-year studies. First>I want to mention the lack of informed consent. Product label inserts>are not often given to the women. Women often have these implants>placed without hearing a word about possible problems. They report>being given papers to sign when they have been prepped for surgery>and have been given a sedative. They report being given papers to>sign after the surgery before they are fully>>recovered from anesthesia. I have heard from more than a dozen>symptomatic women in the last 3 years who have never been contacted>by their plastic surgeon after implantation with saline implants,>despite the fact that they were told they were in a study about the>safety of these devices. These women's symptoms remain unreported. If>I have heard from this many (and other group leaders have heard from>at least this many), how many others remain unreported.>>These women are all part of a study being done by McGhan and Mentor.>The plastic surgeons that insert the implants are collecting this>data. This greatly reduces or eliminates any scientific validity of >this study.>>Another problem is that a study that only goes for 5 years can hardly>define risks that may take 20-30 years to discover, as in the case of>asbestos. We know for a certainty that women with silicone implants>often do not show symptoms for at least 6-8 years. For some it is 15>years or more. What possible value can a biased study, one in which>not all the plastic surgeons follow up with patients and that only>goes for 5 years, have? This certainly calls into question the>accuracy of the data from these studies that you will hear at this>PMA meeting. These saline-filled silicone implants studies need to be>followed by unbiased researchers for at least 20 years before we can>know what damage they will do to many of the recipients.>>I have heard doctors joking about these "studies", stating that they>are a study in name only. I seriously doubt that any of these>doctors, who make money from placing implants, are going to come here>and admit that these studies are not scientifically valid. A survey>of all women implanted should be done to find out how many had>problems and how many have reported these to their plastic surgeons.>This should not be done by the manufacturers of implants or the>plastic surgeons. The FDA should closely monitor these studies and>check the accuracy of the information provided regarding these.>>Women call our network with illnesses a few years after implantation,>stating that they have never heard from their plastic surgeons. When>they do finally call their surgeon, complaining of symptoms, they are>told that these symptoms could not possibly be from their implants. I>heard from one of these women again recently, and after almost 4>years, she had not once heard from her California plastic surgeon,>despite the fact that she was told that she was enrolled in a study.>She finally called his office to report problems and was told that>her problems are not of the type implants cause. I am including the>e-mail of one woman who contacted me less than three weeks ago. She>had her saline implants for 4 months and was already symptomatic.>When she contacted her plastic surgeon, he told her it was not due to>the implants. She has persisted and he has removed them, but with>great reluctance. I am sure he will not report that her medical>problems are related to her implants. I do not believe that is in an>uncommon problem. From the reports I get from women and other support>group leaders, this is an extremely common situation. Complaints are>being brushed off as merely inconsequential problems not related to>saline breast implants. Those of us who speak out are called>fanatical, hysterical women. I am a serious, practical, intelligent>and educated woman. I am dedicated to informing people on this issue>that harms more than just the women of our society.>>I have seen the pictures of the horrible fungi and bacteria that grow>in implants. I have one here with me. I have known the women from>whose bodies these implants were removed. I have seen their>disastrous health problems. Studies must be done to determine what>happens to women with saline implants that have bacteria and mold>growing in them, especially when they rupture inside the women's>bodies. These need to be longer than 1,3, or 5 years. After 6-7>years, the incidence of rupture dramatically increases. We are asking>you to advise the FDA to protect us from these dangerous products and>their side effects. I am sure you are privy to Health and Human>Services' list of concerns about the autoimmune problems caused by>saline-filled implants. I have included a copy with this testimony.>>If this meeting is not a serious effort to evaluate the safety of>saline implants, but instead a rubber stamp to please the>manufacturers by approving their products, then I ask that you make>absolutely certain that all women are, at least a week before the>surgical, given the important information about side effects. They>need to be informed of the wealth of information available. They need>to be given this without bias or comments by the physician. Often>concerns are just waved away with a sweep of the hand and a statement>that we don't have any problems with these. My group members report>this same paternalistic response from their plastic surgeons.>land is a good example. The state has an excellent policy of>informed consent regarding implants, but the policy is more>impressive on paper than in reality. This informed consent itself>would save many lives and much heartache for years to come, but>unfortunately, many of the doctors reportedly ignore the law and fail>to comply.>>There is an increasing problem with younger and younger women>desiring and getting breast implants. The age range from 13-17 is not>unusual. Although some (few) plastic surgeons refuse to implant women>so young, most can and do take these young women (children) as>patients. They are not yet old enough to understand the lifetime of>surgeries and problems that may occur. They just want to feel good>about their bodies and want to fit into their peer groups. Ethically>and morally, these women should not be candidates for surgery, yet>they are being given breast implants. Their parents need to be truly>informed of all the problems at least a week prior to surgery so that>they can make better decisions. Often these young women's bodies are>not finished with development, yet they are being exposed to surgeries.>>We have heard about the social aspects, the self-esteem issues, the>self-worth issues, the feel good about myself now reports. There are>many social aspects that are just the opposite. The families of women>who suffer from these devices also suffer. The children suffer when>their mother is unwell. The whole family often unravels. The>emotional costs are tremendously high. Some women commit suicide to>escape the very real pain, not just the physical pain caused by their>implants. These women simply can no longer face their indifferent>doctors and their families who are tired of dealing with the medical>problems that implantees suffer from.>>Aside from this, women in increasing numbers are being granted>disability for their breast implant problems. This certainly includes>saline implant women. In fact, women who have had long term saline>implants are often worse off medically than their silicone sisters>are. Women who were implanted with saline implants in the 70's are>often quite ill today. I know quite a few of these women. I am often>grateful that I am not in their shoes. Many have lost their husbands>due to their illness. Taxpayers are picking up the burden of these>very ill women. They are often of SSD and on Medicaid. When women are>on disability, their children also get checks. Having women ill,>besides being economically devastating to their families, it is also>an issue that costs all of us. We ignore the fact that many people>are needlessly being made ill and will, in the future, cost us even more.>>Women must now sign away their rights to sue for damages if these>devices injure them. Before they can receive the implants, they have>to agree to never sue the manufacturer; otherwise they will not be>given the implants. This seems to fly in the face of reason. If they>are being told that these devices are safe and FDA approved, then>they should not be restricted from suing for damages. The>manufacturers know these devices are not safe.>>In conclusion, I thank this panel for your time and hope that you>make a decision to require more study on saline implants before any>approval so that the women of this country and, indeed, the world>will benefit from this hearing.>>Lynda Roth>>Coalition of Silicone Survivors>>><http://promos.hotbar.com/promos/promodll.dll?RunPromo & El= & SG= & RAND=25087 & partner=hotbar>>Upgrade Your Email - Click here!>>>

Link to comment
Share on other sites

Lea,

Definitely not a shadow, it is a pleural effusion, which I guess will

have to be drained. I will have to go into the hospital and have a

needle put in between my ribs and have the fluid drained.

Probably next week, early.

I am not happy.

Lynda

At 09:30 AM 1/11/2008, you wrote:

>Lynda, I am happy that your speech is on Ilena's site...it is

>wonderful. You are a very brave lady.

>

>Honey, it could be a shadow in your lung, because that is what

>happened to a year ago. The doctors saw something that turned

>out to be a shadow. We hope that there is nothing in your lungs, you

>have had more health problems in the last several months than you need.

>

>Honey, we will continue to pray for you....love you....Lea

>~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~````````

> Re: look what I found onlne

> >

> >

> >Copy of FDA speech of Lynda Roth of COSS

> >

> >Date: Tue, 29 Feb 2000 16:05:20 -0700

> >

> >From: Lynda

> <mailto:coss@...><mailto:coss@...>coss@...

> m (by way of ilena rose)

> >

> >Lynda Roth

> >

> >2739 W. 23rd St.

> >

> >Greeley, CO 80634

> >

> >(970) 506-9288

> >

> >Ladies and Gentlemen of the Panel,

> >

> >I am a social worker (MSW) and the leader of a support network for

> >women with breast implants. I am here today to represent the many

> >women who are unable to come. There are numerous reasons for their

> >absence, among them the inability to afford a trip, illness, and

> >their feelings that they could not speak eloquently enough to get

> >their points across. Many fear the publicity of dealing with a

> >private medical matter in such a public forum. Many are embarrassed

> >that they made this medical decision only to become ill and become a

> >burden to their families and friends. They hide their shame. Some

> >fear the legal repercussions of being public while legalities still

> >exist over these devices.

> >

> >I am here today to tell you my experiences with these women and with

> >saline filled silicone breast implants. Our network has existed since

> >1990 and has about 5500 members; about 25% being women who have had

> >only saline filled silicone implants. A few of these women do not

> >have problems, but are concerned. The vast majority have medical

> >problems caused by their implants. As saline filled silicone implants

> >become more popular, the percentage of calls coming from women with

> >these breast implants has mushroomed. In the last three years, our

> >calls have consisted of more and more saline implantees, nearing 50%

> >today. Our network provides information free of charge throughout the

> >world to those who cannot afford to pay for it and we do provide a

> >newsletter for $25 annually. We are incorporated as a 501c3

> >non-profit organization. I have traveled many places in the world to

> >arrange conferences, meetings, and to impart information on breast implants.

> >

> >Silicone is not biologically inert, although it may be chemically

> >inert. The silicone in the shell contains many chemicals which react

> >when placed in a biological setting. Some of these chemicals are

> >known to be harmful to the body. I am sure you have a list of all the

> >contents of the shell of these devices. I urge you to read about the

> >harmful effects of each. These are not inert devices. Bio-chemical

> >reactions can and do occur. When implants are removed, often scar

> >tissue remains. Some of these harmful chemicals that slough off the

> >shell will remain in the chest causing further reactions. Foreign

> >bodies are known to cause reactions. The calcium deposits that form

> >in scar tissue resemble cancerous tissue on mammograms. Screening for

> >cancer is much more difficult with any implant.

> >

> >Women who have had cancer are known to have a suppressed immune

> >system. I am one such woman, and, although at the time the implant

> >seemed like a great idea, it was probably the biggest mistake of my

> >life. It almost cost me my life. Women who have suppressed immune

> >systems should not be exposed to products that are known immune

> >system suppressants.

> >

> >The manufacturers of saline (that goes into these implants) are on

> >record as stating that their solution is not meant for long-term

> >implantation into the human body. It is a dated solution, and one

> >that can not be guaranteed to remain sterile. Generally the date is

> >less than a year from the time of implantation. Sterility is only as

> >good as the conditions of the operating room and the cleanliness of

> >the medical persons involved. In addition, sterility is never 100%,

> >even with all the modern ways we have to sterilize medical devices.

> >Implants are micro-porous; they exchange fluid with the body.

> >Anything in the implants can get into the body, and vice versa. We

> >all have bacteria and fungi in our bodies. This leads to the

> >incubation of nightmarish microbes that cause serious damage. Saline

> >implants can and do rupture, often. Besides the risks of the original

> >surgery, women are exposed to repeated surgeries for years to come.

> >The FDA reportedly has over 25,000 claims of injury from these

> >saline-filled silicone devices. We have heard that our government is

> >here to protect us. What have they done about these claims?

> >

> >Some of the most common problems reported to us are: Deflation of the

> >implant, often within a few weeks, hard and painful breasts, shifting

> >of the implant so that it has to be surgically moved back where it

> >belongs, body aches and joint pains, loss of energy, unexplained

> >rashes (often on the chest and neck), burning , twitching and

> >weakness of the muscles, and short-term memory loss. Many women

> >report significant hair loss all over their bodies, including

> >eyebrows and eyelashes, and this problem usually reverses with

> >implant removal. Women also report skin and nipple necrosis. Testing

> >often reveals antibodies to silicone.

> >

> >I would like to specifically address the studies that the

> >manufacturers have conducted, the so-called five-year studies. First

> >I want to mention the lack of informed consent. Product label inserts

> >are not often given to the women. Women often have these implants

> >placed without hearing a word about possible problems. They report

> >being given papers to sign when they have been prepped for surgery

> >and have been given a sedative. They report being given papers to

> >sign after the surgery before they are fully

> >

> >recovered from anesthesia. I have heard from more than a dozen

> >symptomatic women in the last 3 years who have never been contacted

> >by their plastic surgeon after implantation with saline implants,

> >despite the fact that they were told they were in a study about the

> >safety of these devices. These women's symptoms remain unreported. If

> >I have heard from this many (and other group leaders have heard from

> >at least this many), how many others remain unreported.

> >

> >These women are all part of a study being done by McGhan and Mentor.

> >The plastic surgeons that insert the implants are collecting this

> >data. This greatly reduces or eliminates any scientific validity of

> >this study.

> >

> >Another problem is that a study that only goes for 5 years can hardly

> >define risks that may take 20-30 years to discover, as in the case of

> >asbestos. We know for a certainty that women with silicone implants

> >often do not show symptoms for at least 6-8 years. For some it is 15

> >years or more. What possible value can a biased study, one in which

> >not all the plastic surgeons follow up with patients and that only

> >goes for 5 years, have? This certainly calls into question the

> >accuracy of the data from these studies that you will hear at this

> >PMA meeting. These saline-filled silicone implants studies need to be

> >followed by unbiased researchers for at least 20 years before we can

> >know what damage they will do to many of the recipients.

> >

> >I have heard doctors joking about these " studies " , stating that they

> >are a study in name only. I seriously doubt that any of these

> >doctors, who make money from placing implants, are going to come here

> >and admit that these studies are not scientifically valid. A survey

> >of all women implanted should be done to find out how many had

> >problems and how many have reported these to their plastic surgeons.

> >This should not be done by the manufacturers of implants or the

> >plastic surgeons. The FDA should closely monitor these studies and

> >check the accuracy of the information provided regarding these.

> >

> >Women call our network with illnesses a few years after implantation,

> >stating that they have never heard from their plastic surgeons. When

> >they do finally call their surgeon, complaining of symptoms, they are

> >told that these symptoms could not possibly be from their implants. I

> >heard from one of these women again recently, and after almost 4

> >years, she had not once heard from her California plastic surgeon,

> >despite the fact that she was told that she was enrolled in a study.

> >She finally called his office to report problems and was told that

> >her problems are not of the type implants cause. I am including the

> >e-mail of one woman who contacted me less than three weeks ago. She

> >had her saline implants for 4 months and was already symptomatic.

> >When she contacted her plastic surgeon, he told her it was not due to

> >the implants. She has persisted and he has removed them, but with

> >great reluctance. I am sure he will not report that her medical

> >problems are related to her implants. I do not believe that is in an

> >uncommon problem. From the reports I get from women and other support

> >group leaders, this is an extremely common situation. Complaints are

> >being brushed off as merely inconsequential problems not related to

> >saline breast implants. Those of us who speak out are called

> >fanatical, hysterical women. I am a serious, practical, intelligent

> >and educated woman. I am dedicated to informing people on this issue

> >that harms more than just the women of our society.

> >

> >I have seen the pictures of the horrible fungi and bacteria that grow

> >in implants. I have one here with me. I have known the women from

> >whose bodies these implants were removed. I have seen their

> >disastrous health problems. Studies must be done to determine what

> >happens to women with saline implants that have bacteria and mold

> >growing in them, especially when they rupture inside the women's

> >bodies. These need to be longer than 1,3, or 5 years. After 6-7

> >years, the incidence of rupture dramatically increases. We are asking

> >you to advise the FDA to protect us from these dangerous products and

> >their side effects. I am sure you are privy to Health and Human

> >Services' list of concerns about the autoimmune problems caused by

> >saline-filled implants. I have included a copy with this testimony.

> >

> >If this meeting is not a serious effort to evaluate the safety of

> >saline implants, but instead a rubber stamp to please the

> >manufacturers by approving their products, then I ask that you make

> >absolutely certain that all women are, at least a week before the

> >surgical, given the important information about side effects. They

> >need to be informed of the wealth of information available. They need

> >to be given this without bias or comments by the physician. Often

> >concerns are just waved away with a sweep of the hand and a statement

> >that we don't have any problems with these. My group members report

> >this same paternalistic response from their plastic surgeons.

> >land is a good example. The state has an excellent policy of

> >informed consent regarding implants, but the policy is more

> >impressive on paper than in reality. This informed consent itself

> >would save many lives and much heartache for years to come, but

> >unfortunately, many of the doctors reportedly ignore the law and fail

> >to comply.

> >

> >There is an increasing problem with younger and younger women

> >desiring and getting breast implants. The age range from 13-17 is not

> >unusual. Although some (few) plastic surgeons refuse to implant women

> >so young, most can and do take these young women (children) as

> >patients. They are not yet old enough to understand the lifetime of

> >surgeries and problems that may occur. They just want to feel good

> >about their bodies and want to fit into their peer groups. Ethically

> >and morally, these women should not be candidates for surgery, yet

> >they are being given breast implants. Their parents need to be truly

> >informed of all the problems at least a week prior to surgery so that

> >they can make better decisions. Often these young women's bodies are

> >not finished with development, yet they are being exposed to surgeries.

> >

> >We have heard about the social aspects, the self-esteem issues, the

> >self-worth issues, the feel good about myself now reports. There are

> >many social aspects that are just the opposite. The families of women

> >who suffer from these devices also suffer. The children suffer when

> >their mother is unwell. The whole family often unravels. The

> >emotional costs are tremendously high. Some women commit suicide to

> >escape the very real pain, not just the physical pain caused by their

> >implants. These women simply can no longer face their indifferent

> >doctors and their families who are tired of dealing with the medical

> >problems that implantees suffer from.

> >

> >Aside from this, women in increasing numbers are being granted

> >disability for their breast implant problems. This certainly includes

> >saline implant women. In fact, women who have had long term saline

> >implants are often worse off medically than their silicone sisters

> >are. Women who were implanted with saline implants in the 70's are

> >often quite ill today. I know quite a few of these women. I am often

> >grateful that I am not in their shoes. Many have lost their husbands

> >due to their illness. Taxpayers are picking up the burden of these

> >very ill women. They are often of SSD and on Medicaid. When women are

> >on disability, their children also get checks. Having women ill,

> >besides being economically devastating to their families, it is also

> >an issue that costs all of us. We ignore the fact that many people

> >are needlessly being made ill and will, in the future, cost us even more.

> >

> >Women must now sign away their rights to sue for damages if these

> >devices injure them. Before they can receive the implants, they have

> >to agree to never sue the manufacturer; otherwise they will not be

> >given the implants. This seems to fly in the face of reason. If they

> >are being told that these devices are safe and FDA approved, then

> >they should not be restricted from suing for damages. The

> >manufacturers know these devices are not safe.

> >

> >In conclusion, I thank this panel for your time and hope that you

> >make a decision to require more study on saline implants before any

> >approval so that the women of this country and, indeed, the world

> >will benefit from this hearing.

> >

> >Lynda Roth

> >

> >Coalition of Silicone Survivors

> >

> >

> ><<http://promos.hotbar.com/promos/promodll.dll?RunPromo & El= & SG= & RAN

>

D=25087 & partner=hotbar>http://promos.hotbar.com/promos/promodll.dll?RunPromo & El=\

& SG= & RAND=25087 & partner=hotbar>

> >Upgrade Your Email - Click here!

> >

> >

> >

>

>

><http://promos.hotbar.com/promos/promodll.dll?RunPromo & El= & SG= & RAND=65430 & partn\

er=hotbar>

>Upgrade Your Email - Click here!

>

>

>

Link to comment
Share on other sites

Join the conversation

You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.

Guest
Reply to this topic...

×   Pasted as rich text.   Paste as plain text instead

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

Loading...
×
×
  • Create New...