Re: look what I found onlne

December 30, 2007

Copy of FDA speech of Lynda Roth of COSS

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

From: Lynda 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

December 30, 2007