Fw: Copy of FDA speech of Lynda Roth of COSS

[Guest guest]

Dearest Friends:

I was going through my old mail and I found this. Lynda is a darling and

she has done so much for our cause. Thank you Lynda and have a wonderful

holiday. Sorry that I could not clean this before I sent it. We have friends

who will be taking our hot tub out this morning.

Wishing all better health soon...love always.......Lea

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Subject: Fw: Copy of FDA speech of Lynda Roth of COSS

> Sent: Tuesday, February 29, 2000 5:39 PM

> Subject: Copy of FDA speech of Lynda Roth of COSS

>

>

> >

> > 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

> >

> >

>

>

>

>