Fw: SENATE Committee on Commerce and Labor on Breast Implants

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Subject: SENATE Committee on Commerce and Labor on Breast Implants

EXCERPT:

Morton Hyson, M.D., Concerned Citizen, stated he is a board certified

neurologists, and has been in practice for 18 years, 10 of those years in

LasVegas, and he is an assistant clinical professor at the University of

Nevada, LasVegas, School of Medicine. He testified he has seen many

women with the silicone breast implants syndrome, and he is firmly

convinced it is a serious and bona fide syndrome. He explained, the

women¼s symptoms are very stereotypical. He stated he has seen many women

suffering from headaches, skin rash, diffused incapacitating pain, memory

problems, cognitive dysfunction, dry mouth, dry eyes, weakness, shortness

of breath, nausea, and visual problems. He asserted there is no doubt the

body recognizes these implants as a foreign body. He said this is a

well-known inflammatory reaction called a capsule around the implants,

which is found when they are explanted (removed). He said leakage is well

known not only of silicone, but also of platinum and other heavy metals

that are part of the contents of the bags; even the saline implants have

silicone in their envelopes. He pointed out all of this material becomes

a breeding ground for bacteria and fungi. He attributed the death of some

patients to this. He maintained he has no doubt this is a true syndrome.

Dr. Hyson stated just because there is no simple laboratory test to

diagnose it, does not mean it does not exist; all it means is that it is

not some other disease, and it is the fault of medical science that we

have not devised a means to properly identify it. He said if everyone has

to compare this to something, then he would like to compare it to another

syndrome also predominately affecting women, causing headaches, cognitive

dysfunction, visual loss, and nausea and almost always has normal tests.

He said some say it does not exist, or that these women are hysterical or

malingering, but others call it migraine.

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

http://www.leg.state.nv.us/71st/Minutes/Senate/CL/Final/1527.html

MINUTES OF THE

SENATE Committee on Commerce and Labor

Seventy-First Session

May 30, 2001

The Senate Committee on Commerce and Laborwas called to order by Chairman

Randolph J. Townsend, at 8:05 a.m., on Wednesday, May 30, 2001, in Room

2135 of the Legislative Building, Carson City, Nevada. The meeting was

video conferenced to the Grant Sawyer Office Building, Room 4406, 555 East

Washington Avenue, Las Vegas, Nevada. ExhibitA is the Agenda. ExhibitB

is the Attendance Roster. All exhibits are available and on file at the

Research Library of the Legislative Counsel Bureau.

COMMITTEE MEMBERS PRESENT:

Senator Randolph J. Townsend, Chairman

Senator Ann O¼Connell, Vice Chairman

Senator Dean A. Rhoads

Senator Mark Amodei

Senator C. Shaffer

Senator A. (Mike) Schneider

Senator Maggie Carlton

GUEST LEGISLATORS PRESENT:

Dennis Nolan, County Assembly District No. 13

Ellen Marie Koivisto, County Assembly District No. 14

STAFF MEMBERS PRESENT:

Young, Committee Policy Analyst

Adler, Committee Secretary

OTHERS PRESENT:

Morton Hyson, M.D., Concerned Citizen

Geoffrey White, Esquire, Concerned Citizen

Roy Cannon, Esquire, Concerned Citizen

Lee Randle, Concerned Citizen

Gaylene Ausem, Concerned Citizen

Glenda , Concerned Citizen

Diep T. Woodard, Concerned Citizen

Patty , Concerned Citizen

Ed Wood, Concerned Citizen

Toni , Concerned Citizen

ASSEMBLY BILL 667: Revives for limited time certain causes of action

based on effects of silicone injected or implanted into body. (BDR2-1559)

Dennis Nolan, County Assembly District No. 13, stated he considered

himself one of the most unlikely people to bring this item forward. He

said he had received many communications from women and thought there was

nothing he could do, until a retired fireman friend of his related a

personal story. He said he was apprehensive about introducing a bill that

would extend or toll the statute of limitations on any issue, and dropped

the bill draft request in favor of the Assembly having a joint hearing to

make that determination. The select committee was the result, he said.

He conveyed it was estimated there have been 40,000 breast implants done

in this country, of which approximately 20,000 were done in Nevada, mostly

to Nevada residents. No one is sure how many women have experienced ill

effect from this he pointed out. He said it is estimated from 200 to,

perhaps, several thousand.

Continuing, Assemblyman Nolan stated legal counsel is present to explain

the chronological order of the Dow Corning lawsuit and the settlement. He

said the genesis is, there were several hundred women precluded from being

involved in the Dow Corning lawsuit, who have become very sick from

silicone leakage or injections. He explained that some of the women are

so sick they are " on disability with the state.¾ Projecting ahead, he

said, it is difficult to estimate how many will eventually end up on state

rolls, because they have become uninsurable. He contended it is a double

issue of health care and a fiscal issue for the state.

Assemblyman Nolan emphasized, after further examination, he is convinced

this is a life or death issue for many woman. He conveyed that many women

have become destitute and dependent on family to care for them, because

they have become so ill. He noted, without opening the statute of

limitations, many of these woman have no recourse and no hope.

Assemblyman Nolan averred, Dow Corning was not initially represented at

the hearing, but by the end, Dow Corning had secured lobbyists and a

high-profile law firm to represent them at the Legislature. He expounded

the opposition contends action on Assembly Bill (A.B.) 667 would toll the

statute of limitations on every other issue. Their position, he said, is

this would be the proverbial " camel¼s nose under the tent.¾ He

articulated every bill the legislature passes, has the potential to set

precedence.

Ellen Marie Koivisto, County Assembly District No. 14, stated A.B.

667 is an emergency bill, passed unanimously by the select committee, and

passed unanimously by the Assembly. She clarified the bill was amended to

limit the window of opportunity to 1 year and limit the action to the

manufacturers of the substance. She noted the prepared packet of

information (Exhibit C) contains historical backgrounds, studies from

scientific journals, information from university websites, and a copy of

the Breast Implant Research and Information Act (BIRIA), introduced May

24, 2001, in the United States House of Representatives; as well as

statements and testimony from victims of silicone-induced disease.

Assemblywoman Koivisto elucidated the majority of silicone breast implants

and silicone breast injections were done in California and Nevada, with,

probably, more than half of the procedures done in Nevada, so it really is

a Nevada problem. She emphasized the importance of considering what could

be done for these ladies and their families.

Morton Hyson, M.D., Concerned Citizen, stated he is a board certified

neurologists, and has been in practice for 18 years, 10 of those years in

LasVegas, and he is an assistant clinical professor at the University of

Nevada, LasVegas, School of Medicine. He testified he has seen many

women with the silicone breast implants syndrome, and he is firmly

convinced it is a serious and bona fide syndrome. He explained, the

women¼s symptoms are very stereotypical. He stated he has seen many women

suffering from headaches, skin rash, diffused incapacitating pain, memory

problems, cognitive dysfunction, dry mouth, dry eyes, weakness, shortness

of breath, nausea, and visual problems. He asserted there is no doubt the

body recognizes these implants as a foreign body. He said this is a

well-known inflammatory reaction called a capsule around the implants,

which is found when they are explanted (removed). He said leakage is well

known not only of silicone, but also of platinum and other heavy metals

that are part of the contents of the bags; even the saline implants have

silicone in their envelopes. He pointed out all of this material becomes

a breeding ground for bacteria and fungi. He attributed the death of some

patients to this. He maintained he has no doubt this is a true syndrome.

Dr. Hyson stated just because there is no simple laboratory test to

diagnose it, does not mean it does not exist; all it means is that it is

not some other disease, and it is the fault of medical science that we

have not devised a means to properly identify it. He said if everyone has

to compare this to something, then he would like to compare it to another

syndrome also predominately affecting women, causing headaches, cognitive

dysfunction, visual loss, and nausea and almost always has normal tests.

He said some say it does not exist, or that these women are hysterical or

malingering, but others call it migraine.

Geoffrey White, Esquire, Concerned Citizen, stated to better address the

situation and anticipate questions, he prepared and sent a letter to all

the committee members (Exhibit D). He articulated there are two elements

to silicone implants. First is the physical scarring and deformation

occasioned by ruptures. The rupture is equivalent to a silicone injection

into the body migrating into the organs and tissue; and there is medical

evidence to support that. He noted a book, Silicone Spills, Breast

Implants on Trial, by Professor White , a professor at the

University of Nevada, Reno (UNR). Mr.White disclosed the author is his

sister, and claimed she wrote the book independent of the litigation,

based on the references in the book. He pointed out there were between

200 and 300 references dealing with the various medical consequences of

silicone in the particular controversy.

Continuing, Mr. White said the second element is the disease claims. He

elucidated many women have lupus, fibromyalgia, and severe disease, all

resulting from silicone. He stated that in 1968 [sic] the Legislature was

so outraged it made silicone injections a felony. He noted there was no

controversy then, but there is now, and it is because of the

manufacturers¼ campaign to engineer testimony to say silicone gel breast

implants are safe, when, in fact, they are not safe. He averred many

women have been successful in obtaining awards and getting judgments, but

there is still a percentage, mostly in Nevada, who have not. This 5 to 10

percent of woman who could not or did not file within the 2 years allotted

under the statute of limitations, mostly because the implants had not

ruptured or many believed the manufacturer¼s propaganda that the released

silicone was harmless to their systems. Further, he said, the most recent

study by the National Institute of Health as sponsored by the Food and

Drug Administration (FDA) is a study the manufacturers have been trying to

keep quiet for the past 3 to 4 years. He noted this particular study

shows the most common complaint from women with ruptured silicone breast

implants is fibromyalgia, which is a much higher incidence than in the

average population. He contended if the studies supported by the

manufacturers showing no correlation between silicone and these women¼s

illnesses, then the manufacturers should have no concern about the passage

of A.B. 667. He emphasized, at the very least, the bill would give these

women a chance at their day in court.

Senator O'Connell queried, since silicone breast implants became a felony

in 1968, whether these 5 to 10 percent of women had their implants prior

to that date.

Mr. White explained the felony law addressed only the injection of

silicone directly into the breast tissue using a needle. He added, a lot

of Las Vegas showgirls, cocktail waitresses, and others had the procedure

done, mostly to keep jobs or to get jobs. He insisted the bill does not

have impact on any Nevada employer interests or against doctors; it is

only directed at the manufacturers of these products, because it was the

manufacturers who represented product safety to the doctors. He

elucidated, to get around the felony law against injections, manufacturers

developed the plastic bag to contain the silicone. He continued,

unfortunately the bags can deteriorate, or an accident can cause the bags

to rupture, and the contents act just like a silicone injection, but a

ruptured bag is not a felony.

Senator O'Connell surmised then the doctor holds no responsibility for

passing on the information or for performing the implant surgery.

Mr. White answered the doctor could not be held beyond the statute of

limitations, as the bill is presently drafted. He explained the reason is

the manufacturers misled the doctors.

Senator O'Connell wanted to know what was the federal government¼s

responsibility in all of this.

Mr. White replied, on April 16, 1992, the federal government successfully

banned silicone gel breast implants into women in this country. He added

in the ensuing years, the FDA has not lifted the ban.

Senator O'Connell asked to clarify whether the 5 to 10 percent of women

had their implants prior to the ban.

Mr. White acknowledged that was correct. He added most of them had their

implants done in 1990 or earlier. He pointed out most implants do not

rupture until 7 to 10 years afterwards, and many of them are rupturing

now. He stated A.B. 667 would address the issue of women who are now

experiencing the effects of silicone leaking into their bodies from

ruptured implants.

Senator O'Connell inquired if the doctors required a paper to be signed by

these women in order for the doctors to protect themselves.

Mr. White responded some did and some did not. He said many doctors had

informed consents, but many of the informed consents did not cover

autoimmune disease, because many of the doctors believed the silicone was

not capable of causing autoimmune disease, such as fibromyalgia.

Senator O'Connell emphasized it was said the doctors have no

responsibility whatsoever.

Mr. White conveyed, most of the doctors involved with implants do not

share responsibility with the manufacturers. He acknowledged there are

some women who would disagree with that assessment. But, again, he held

that the manufacturers misled the doctors, and he said the manufacturers

were clear to not blame the doctors for the catastrophe.

Senator O'Connell contended it was hard for her to believe a doctor

putting something foreign into a body would not want to have more

information or education on that issue than just what the manufacturer

provided. She emphasized she could not " connect¾ with that.

Mr. White said there are a lot of women who would concur with her. But in

Nevada, the most logical and liable defendant in this particular case,

would be the manufacturer of the substance, who engaged in a concerted,

proven, campaign to say the implants would last a lifetime, and never

cause disease or harm.

Senator O'Connell inquired what responsibility the federal government has

in giving its approval to this procedure. Mr. White answered the FDA was

completely misled by the manufacturers in this particular process.

Senator O'Connell asked whether the FDA did any testing of its own.

Mr. White replied it was incumbent on the manufacturers to demonstrate the

safety of their implants. However, because of a grandfather position on

products that were enacted before the FDA enacted its legislation, which

required manufacturers to prove safety, the breast implant manufacturers

did not have to demonstrate safety at the time the implants were first

approved. He continued, it was only later when it was insisted that

manufacturers demonstrate safety, and they could not, that silicone breast

implants were banned by the FDA for most purposes and allowed only for

limited exceptions.

Roy Cannon, Esquire, Concerned Citizen, stated he represents victims of

silicone injections given during the 1960s. He elucidated the 1995

lawsuit he was involved in was made part of Dow Corning¼s bankruptcy

filing. He explained silicone was never approved by the FDA for the

purpose of injection. He stated Dow Corning had elected to treat silicon

injections as a device rather than as a drug, because they contended that

silicone was inert, safe, and would not migrate within the body. He

explained that, for the most part, his clients¼ claims are barred by the

statute of limitations due to the early onset of symptoms. He noted not

all the people were women, and other body parts were also injected. He

expounded, when silicone was injected, in most cases, there was almost an

immediate reaction. The reactions included formation of lumps and

encapsulation pain.

Mr. White said Nevada is a " discovery state,¾ for purposes of the statute

of limitations. He explained this means the time starts running either

when the event takes place, such as a motor vehicle accident, or in these

cases, the time starts when the individual knew or should have known there

was an injury. He stated many courts have held the knowledge was there at

the time the lumps formed or when the individual starts experiencing

pain. He said since this occurred in the 1960s, the statute has run out

in most cases. He averred most of the women who had silicone breast

injections have also had double mastectomies for removal of the silicone,

and received silicone breast implants. He added there are reports that

say not all of the women who have had silicone breast injections are sick,

but all of the " 200 plus¾ women he has interviewed are sick.

Continuing, Mr. Cannon stated that over the years of continued

investigation, it has come out Dow Corning knew back in the 1960s silicone

was not safe, was not inert, and did migrate to all the organs of the

body, and they did not report this to anyone. He pointed out, at that

time, there were no independent studies required or performed; the FDA

required manufacturers to only report the results of completed studies.

Subsequently, he said, it has been discovered when a study was not going

the manufacturers¼ way, they terminated the study, and so never completed

or reported on it.

Mr. Cannon pointed out the women initially believed they were going to be

covered by the various global proposals brought forth by the various

manufacturers offering compensation to victims of silicone. He said on

the early claim forms Dow Corning sent out, the only place for those who

had silicone injections to check off was labeled " breast implants.¾ He

told the committee, it wasn¼t until the third revised plan in 1999 these

women realized they were excluded. Mr. Cannon emphasized many of the

women are " on disability and welfare,¾ and A.B. 667 would help them remedy

their situations, get the care they need, and reduce the burden on public

funds. He pointed out one of the biggest beneficiaries to the Dow Corning

settlement would be the federal government, which is seeking recovery of

medical benefits paid on over 15,000 identified recipients.

Mr. Cannon mentioned passage of the bill would have no impact on Nevada¼s

courts, since everything would go through the federal courts.

Additionally, he said, it would not have a substantial impact on business

perception in Nevada. He claimed the bill has a very limited scope. For

example, in the State of New York, there were not huge numbers of cases

nor many people from outside the state coming to litigate their cases. He

noted the California bill was overwhelmingly approved by both houses, then

vetoed by Governor Pete , because he believed the women would

receive an adequate remedy under the manufacturers¼ plan. However, he

said, that plan came out after the veto, and did not provide a remedy. He

noted the bill does not change Nevada tort law with respect to injury or

causation; it just gives these women a chance at their day in court.

Senator O'Connell inquired how Dow Corning could sell something to doctors

without the endorsement of the FDA.

Mr. Cannon replied proof of rigorous testing was not required at that

time. He added, to this day, many people have a misconception of the role

of the FDA. He said many people think if a product is on the market, the

FDA has approved it. He conveyed the FDA¼s primary responsibility lies

with pharmaceuticals, and often a product is approved for one purpose, and

then used for another. For example, he said, pedicle screws were

developed for orthopedic injuries, and then used in the back, which was

not an FDA approved use for the device, but it was held that the device

itself had been approved so it could be used in that manner.

Senator O'Connell questioned how anything invasive or internalized by the

body would not have to be approved.

Mr. Cannon answered, it would depend on the circumstances. He stressed

any device would have to be approved with respect to a particular

purpose. He clarified their situation was dealing with the law as it

applied in the early sixties, and that was a completely different

situation.

Mr. White stated one of the arguments that will be raised regarding

silicone breast implants versus silicone breast injections, is that, under

the national settlement program, they still have a remedy. However, he

said, it is very clear if people are late registrants under the revised

global settlement, they do not get to have the implants removed, medical

bills paid, or disease compensation. Only about one-tenth of one percent

of the late registrants would get any benefits at all from the

manufacturers¼ settlement program, he added.

Lee Randle, Concerned Citizen, stated she has been a Nevada resident for

12years, has had breast implants for 16 years, and this is her fourth set

of implants. She said since her implants ruptured 10 months ago, the most

significant effect has been transient blindness. She said she wanted to

correct Mr.White¼s statement that women are no longer being injected with

silicone. She explained when she saw her doctor about the rupture, he

offered to replace it by injecting her with silicone. So, it is still

being done on a regular basis in Las Vegas by one very busy surgeon in

particular. She explained, within a year, possibly 2 years at the most,

she will be destitute and she and her children will have to depend on the

state for assistance. She insisted it would not be the case if she could

prove in court the silicone manufacturers are responsible for her

illnesses.

Gaylene Ausem, Concerned Citizen, stated she¼s been a resident of Nevada

since 1960 and is 51 years old. She said she has neurological,

gastrointestinal, autoimmune, thyroid, and colon problems, to name just a

few. She elucidated conditions such as hers have been a part of studies

recently released. These are highly credited studies linking silicone to

diseases. She claimed it took some people over 30 years of exposure to

reach their present conditions. She emphasized silicone is a slowly

progressive, toxic poison. She pointed out about three-quarters of the

women who have had injections and/or implants are now on disability. She

stated it is becoming increasingly difficult to get insurance, and more

and more insurance company questionnaires are asking if a person has now

or ever had silicone in his or her body. She noted silicone is made from

39 toxic chemicals, such as vinyl chloride, epoxy resin, and tuline; many

bearing the warning labels of " do not inhale¾ or " do not ingest,¾ because

it may result in death. She said there are no warning labels accompanying

the silicone, and the medical profession has assured women it is a safe

product. She stressed there have been no warnings about the effects to

newborns or in nursing a baby.

Senator O'Connell queried whether, at the time of the surgery, Ms. Ausem¼s

doctor gave her no warning about breast-feeding.

Ms. Ausem replied, in less than 3 years after receiving her injections,

she had a hysterectomy and then had implants. Both those times she was

given no information about the product¼s use, contents or warnings.

Senator O'Connell asked if any of the paperwork required before surgery

contained any warnings or information.

Ms. Ausem stated there were no warnings at all, and she has copies of her

medical records. She expounded that she was first injected in 1971,

implanted in 1974, and implanted in 1988. She added, there is evidence of

genetic changes, and even generational. She claimed no one in support of

A.B. 667 is there to judge, but only to " ask for their day in court,¾ so

the manufacturers can be held responsible for their actions, and pay for

the human suffering they have caused, instead of having Nevada shoulder

the costs.

Glenda , Concerned Citizen, stated she has lived in Las Vegas for

over 20 years and is a breast implant survivor. She stated she has been

living the effects of silicone leaking into her body for 24 years, and did

not know why she was getting sicker, and for a long time neither did the

doctors. She asserted she is asking for approval of the bill so these

companies can no longer commit fraud on an unsuspecting, and trusting

public.

Diep T. Woodard, Concerned Citizen, stated she has been a 25-year resident

in Las Vegas, and for the past 10 years she has been very ill. She

insisted she could not find a lawyer to take her case, and this bill is

the only hope she has of getting help.

Patty , Concerned Citizen, stated she became very ill from her

saline implants after only 8 months. She said the shell of the saline

implants is made of silicone. Her blood test showed an elevated

rheumatoid factor, but after having the implants removed, her rheumatoid

factor has gone down to almost normal. She contended that was proof

enough the silicone in her implants was the cause of her problems. She

posited she now operates a website to inform women saline implants are not

safe because the saline is in a silicone package. She said she also

offers counseling and guidance for women who have nowhere else to turn.

Ed Wood, Concerned Citizen, stated he was the retired fireman

AssemblymanNolan had mentioned. He said he and his wife were long-time

Nevadans. He said his wife had silicone injections before they met and

married in 1967. He averred that throughout the years, they just gritted

their teeth and dealt with his wife¼s medical problems, never making the

connection until last year while on the Internet. Now they know, and now,

more than ever, he said, something needs to be done to address this

problem through A.B.667.

Toni , Concerned Citizen, stated she has waited a long time for the

opportunity for her turn. She said she had injections in 1967, and her

medical problems began in 1980 when she breast-fed her son, who died at 3

months. She has her son¼s autopsy report linking his death to the

silicone in her body. She said she then came down with multiple sclerosis

(MS) symptoms. Sheasserted, in 1982 her other children began to show

physical problems. She maintained in 1993 she saw a television program

featuring women telling their silicone injection and implant stories, and

realized they were talking about the same problems she and her family were

experiencing. She emphasized she tried in the 1990s to get her day in

court, and she was still trying.

Assemblyman Nolan stated during earlier testimony, they heard from women

so affected they had to be helped to get around. He noted those

testifying today were just a small number of the persons providing the

testimony they heard. He elucidated, during testimony, one of the women

bared her chest to show the nodules that had formed as a result of the

different toxins and poisons resulting from the silicone. He conveyed the

only precedents that would be set by the passage of A.B. 667, is that

other states may follow. He contended the manufacturer has the

wherewithal to hire every lobbyist in this building for its cause, and he

thinks it would do that. He concluded Nevada has the determination and

the pioneering spirit to lead the way and take action.

Senator Townsend noted the opposition to A.B. 667 would be heard another

day, and closed the hearing on A.B. 667. The meeting was adjourned at

9:17a.m.

RESPECTFULLY SUBMITTED:

Adler,

Committee Secretary

APPROVED BY:

Senator Randolph J. Townsend, Chairman

DATE: