Fw: Raising Health Awareness Through Examining Benign Brain Tumor Cancer, Alpha One and Breast Implant Issues ~ The Committee on Energy and Commerce ~ 11/15/01

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Subject: Raising Health Awareness Through Examining Benign Brain Tumor

Cancer, Alpha One and Breast Implant Issues ~ The Committee on Energy and

Commerce ~ 11/15/01

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http://energycommerce.house.gov/107/hearings/11152001Hearing428/hearing.htm

Committee Hearing

The Committee on Energy and Commerce

W.J. " " Tauzin,Ý Chairman

Raising Health Awareness Through Examining Benign Brain Tumor Cancer,

Alpha One and Breast Implant Issues.

Subcommittee on Health

November 15, 2001

2:00 PM

2123 Rayburn House Office Building

~~~~~~~~

http://www.breastimplantinfo.org/hr1961pam.html

Testimony of Pamela Noonan-Saraceni

before the

House Energy and Commerce Committee

Subcommittee on Health

November 15, 2001

Mr. Chairman and Members of this Committee: My name is Pam

Noonan-Saraceni. As a breast cancer survivor who continues to endure the

painful physical side-effects of silicone breast implants, I am pleased to

have the opportunity to take part in this hearing.

Many of you here today may think the scientific and safety debate on

breast implants is over and are wondering why breast implants are part of

today¼s hearing. You believe this issue has reached its saturation point.

But, breast implants remain a classic example of " what we don¼t know can

hurt us. "

Consider the number of women who have breast implants. The Institute of

Medicine estimates that by 1997, 1.5 to 1.8 million American women had

breast implants with nearly one third of these women being breast cancer

survivors. In 1999 alone, nearly 83,000 women received implants following

a mastectomy. In 2000, over 200,000 women received breast implants for

cosmetic reasons.

Yet, in 1999, the Institute of Medicine concluded:

* First, reoperations and local complications are frequent enough to be a

cause for concern and to justify the conclusion that they are the primary

safety issue with silicone breast implants;

* Second, risks accumulate over the lifetime of the implant, but

quantitative data on this point are lacking for modern implants and

deficient historically;

* Third, information concerning the nature and relatively high frequency

of local complications and reoperations is an essential element of

adequate informed consent for women undergoing breast implantation.

And in 1997, the Mayo Clinic found that one in four women required

additional surgeries within five years of implantation because of problems

related to the implants. The rate was higher for mastectomy patients: one

in three women.

Despite over thirty years of use, the Food and Drug Administration has

never approved silicone implants and just recently approved saline

implants for the first time. Little is known about the long term effects

of silicone and even less is known about saline. Yet their popularity is

growing with a new generation of young women who, in spite of the past

controversy, are being led to believe that improvements have been made to

these implants, and therefore, they are now safe.

I believe breast implants should be an option for women. But, a safe

option. Therefore, the role of the government cannot be overlooked. There

are a number measures that the federal government could implement to

better protect women and preserve their health and their quality of life.

These measures are encompassed in the legislation introduced by

Representatives Roy Blunt and Gene Green. H.R. 1961, " The Breast Implant

Research and Information Act, " calls upon the FDA to strengthen informed

consent documents given to patients in clinical trials for breast

implants; directs the National Institute of Health to conduct independent

research desperately needed on breast implant recipients; and ensures

better FDA oversight of device manufacturers.

In order to better understand the need for this legislation, I would like

to tell you a little bit about my personal experience. I was diagnosed

with breast cancer and had a radical mastectomy in 1978. I was just 25

years old at the time. I waited 5 years before I decided to have

reconstructive surgery. I was an active person. I played tennis, taught

aerobics, and jogged. I had grown tired of the inconvenience of the

prosthesis shifting and falling out when I perspired. I thought I had done

my homework on breast implants prior to choosing the plastic surgeon to do

my reconstruction. However, I was never advised of any of the health risks

associated with the implants. In fact I was told repeatedly that they

would " last a lifetime " and that " complications " were rare. Within 3

months of the initial reconstruction, I was back in the operating room. My

body had formed a capsule around the implant and the implant had shifted

up toward the collarbone. My symptoms of physical illness began slowly. In

the summer of 1990 I began to experience joint pain and chronic fatigue.

This was six years after my being implanted. I have been to various

doctors and specialists and have a list of various diagnoses. Before I had

the implant removed in June of 1994 (10 years after the initial

reconstruction), I had to wear a partial prosthesis over the implant.

Capsular contracture had again become a problem and I was misshapen and

lopsided. The explantation was the 5th surgery at my breast site.

To date, my out of pocket medical expenses total almost $35,000. My

husband and I are self-insured. The insurance policy that we took out in

1991 had an exclusion. I was not covered for any illness or disabilities

related to the reconstructive surgery. Apparently, the insurance companies

understood the health risks breast implants pose for women and were not

willing to bear the financial costs.

I believe there are several areas that need improvement in order to

protect women considering breast implants. The Breast Implant Research and

Information Act, introduced by Congressmen Gene Green and Roy Blunt, is a

tremendous step forward to safeguarding American women.

First: Informed Consent Must Be Strengthened

Insufficient and inaccurate information has posed many problems for women

in breast implant trials. Even the Institute of Medicine recognized that

women are not being adequately warned of rupture, painful local

complications and multiple surgeries.

The informed consent agreement drawn up by the breast implant

manufacturers is the only required information women receive about the

implants and the study prior to surgery. This document contains inaccurate

data on rupture and contracture rates, the efficacy of the implants, the

risks and complications, and the need for future reoperations. It

understates the FDA¼s concern about the safety of silicone breast

implants, which first led to the 1992 moratorium, and makes many

misleading statements about the rate of complications following

implantation.

Furthermore, the informed consent agreement does not mention the effects

of breast implants on future mammography. This is probably not a concern

most cosmetic patients even consider. Yet, over 30% of the breast tissue

can be obscured by the implant, which can delay the detection of cancer.

Until independent research is able to answer the long-term safety

questions surrounding breast implants, women, at the very least, need to

be informed about what we DO know:

* chronic pain, breast hardening, infections and breast deformity;

* the high rate of reoperations;

* the high rate of ruptures;

* problems associated with insurance coverage;

* the fact that implants do not last a lifetime and will have to be

replaced every 8-10 years;

* inaccurate mammography.

Second: The Need for Long-Term Studies

The Breast Implant Research and Information Act directs the National

Institutes of Health to conduct the independent research that is so

desperately needed in this area. The lack of convincing data submitted by

the manufacturers or the plastic surgeons on the incidence of device

failure, implant rupture or gel bleed was of concern to the FDA in the

early 1980s Bso much of a concern that an FDA panel headed by Dr. Norm

recommended that silicone breast implants remain a Class III

device, meaning their safety and efficacy was not proven.

Once product liability cases involving silicone breast implants became

more and more common, the manufacturers began to pour money into new

scientific research on breast implant safety. Dr. implored the

manufacturers to put their money into an independent fund so that

impartial scientists could decide which issues should be examined. His

wish was not granted, and the ensuing research in large part ignored long

term outcomes, incidence of device failure, the consequences of implant

rupture, and the causes for tissue pain.

The latency period for breast implant complications and ruptures has been

widely recognized in scientific circles. I had my implants for six years

before my symptoms began to appear. But, the FDA only required

manufacturers to follow women in saline implant trials for three years,

and the agency recently announced that manufacturers of silicone breast

implants will only be required to follow patients for 2 years in order to

glean data for market approval. These studies will not provide meaningful

data on the long-term safety and efficacy of the implant, and will do

little to protect American women in the long run.

In its review of breast implant studies, the Institute of Medicine also

concluded, " risks accumulate over the lifetime of the implant, but

quantitative data on this point are lacking for modern implants and are

deficient historically. "

In May of 1999, University of Florida researchers published their analysis

of more than 35 studies, which examined more than 8,000 implants.

According to this analysis, silicone breast implant rupture rates were

found to be 30% at 5 years, 50% at 10 years and 70% at 17 years. According

to the researchers, past studies that have been cited in support of

silicone breast implant safety have " paid almost no attention to the

health consequences of local complications of pain, capsular contracture,

disfigurement, chronic inflammation, rupture, silicone migration, and

frequent surgical revisions. " They conclude that the longer women have

these devices in their bodies, the greater the risk of failure and

numerous complications.

This study and the IOM review reinforce the need to study women for a long

period to accurately assess the health effects of breast implants.

Furthermore, almost no research has been done to track mastectomy patients

who suffer from local complications at a higher rate than other breast

implant recipients.

I hope one day there is a cure for breast cancer. But until that day, the

National Institutes of Health should be obligated to conduct the

independent research so badly needed on breast implants. No woman should

be put in a position of surviving breast cancer only to experience chronic

pain, infections, or deformities from breast implants.

Conclusion

When I opted for reconstructive surgery using breast implants, I thought I

had made an informed decision. I asked questions of my doctors; I read as

much information as was available in 1983. I thought I was making a safe

choice for myself. Almost immediately, I was back in the operating room.

It took six years before I began to experience unusual and chronic pain in

my joints. A series of doctors diagnosed me with several different

illnesses, and I underwent two additional surgeries. Finally, ten years

after my initial implantation, I had the implants removed and my symptoms

began to improve.

Despite the breast implant manufacturers advertisements, breast

reconstruction is not an essential part of the recovery process; being

cancer free and feeling physically well enough to return to a normal life

is. Had I known the additional physical, emotional and financial hurdles I

would have to overcome due to breast implants, I would have made a

different decision. I would have never chosen implants.

My personal story and what I¼ve learned from the experiences of women like

me across the country and around the world is my only breast implant

expertise. I am grateful for the friendship and camaraderie of other

implant women who have helped bring this message to Capitol Hill. I would

like to acknowledge those who are attending today¼s hearing: Anne Stansell

from New Mexico, Keeling from Texas, McDonough from

California, and Hickey from Arizona. We all feel a tremendous

responsibility to increase awareness about the unanswered safety questions

that still surround breast implants. My hope is that other women, when

faced with the same choices, can make their decisions based upon better

informed consent and independent research. Please support the passage of

H.R. 1961.

Pamela Noonan-Saraceni

New Fairfield, CT

pamracey@...

Implant Information Project

National Center For Policy Research (CPR) For Women & Families

1444 Eye St NW, Suite 900, Washington, DC 20005. (202) 216-9507

~~~~~~~

http://www.breastimplantinfo.org/hr1961kim.html

Ý Ý Ý Ý Ý Ý

Testimony of Kim Hoffman

before the

House Energy and Commerce Committee

Subcommittee on Health

November 15, 2001

Ý

Mr. Chairman and Members of this Committee: thank you for giving me the

opportunity to testify. My name is Kim Hoffman. I am a breast implant

recipient from Missouri.

As the watchdog of public safety for food, drugs and medical devices, the

FDA has failed specifically in its duties, by allowing a medical device

with high complication rates to be marketed to American women by companies

with dubious manufacturing practices.

Like Pam, who is here today, and thousands of other women, I experienced

numerous debilitating problems immediately after receiving my textured,

silicone breast implants, manufactured by Mentor Corporation, in 1995. To

receive silicone implants after the moratorium in 1992, I was required to

participate in a clinical study. Because data collected in this study

could effect FDA's decision as to whether the agency should approve the

wide spread availability of the product, I recognized the importance of

accurately documenting my problems and including them in the study.

I reported my problems to my surgeon. He ignored me. I obtained a copy of

the study protocol and realized a number of study rules had been violated.

I reported the violations, and my physical problems to the manufacturer,

who was the sponsor of the study and to the FDA; again, I was ignored.

After numerous attempts to report my complications as a study participant,

I received a form from my file at the manufacturer; it read, " patient has

no complaint. "

Astonished by the apathetic responses I'd received, and being from the

show me state, I began my own investigation. I interviewed several other

study participants and found problems with their cases as well. I was able

to talk to people who worked for the manufacturers and even a couple of

industry whistle-blowers. From them I learned that not only were there

problems with the study and the documentation of problems experienced by

patients, but the companies were having major problems with quality

control issues and were violating good manufacturing practices. These

problems had gone on for years.

These individuals alleged that there were problems with the implant design

and gel suppliers; there were defects with the implants, valves, and outer

shell; and there were inconsistencies in the gel used to fill implants. It

appeared many of these problems had been concealed from the FDA. I

reported this information to the FDA, several people at the FDA, but there

was no apparent action.

Disturbed by the lack of responsiveness at the FDA, in the summer of 1998

I put all of the information together, information about the clinical

trials and the manufacturing problems alleged by industry employees, and

gave it to Congressman Green, the FDA, the House Energy and Commerce

Committee, and eventually to Congressman Blunt.

The FDA's copy was given to Austin Templer, a FDA compliance officer

who oversaw Mentor Corporation, the manufacturer I had gathered the most

data about. Mr. Templer referred the information to the FDA's Office of

Criminal Investigations, and in 1998 a criminal investigation was opened.

Throughout 1999, I continued to receive alarming information, which was

given to Mr. Templer and then forwarded to the FDA's criminal

investigators. Unfortunately, little was done, in spite of the shocking

information that was uncovered and Mr. Templer's efforts to push the

investigation forward. It became obvious to both of us that there were

significant problems with the medical devices and the integrity of the

manufacturing process. Furthermore, it appeared internal problems at the

FDA were undermining consumer protection.

The situation became critical in 2000. The FDA had announced that saline

breast implants would be considered for market approval in the spring, and

Mentor Corporation would be submitting a pre-market application (PMA) for

approval of their products. The criminal investigation had gone nowhere

and regulatory actions had been put on hold because of the criminal

investigation. In January 2000, in frustration and out of a concern for

American consumers, Mr. Templer tendered his resignation from a

twelve-year career at the FDA. He hoped his resignation would get the

attention of the agency. In his resignation letter to the commissioner,

he, among other things, urged the agency to conduct a thorough

investigation of the allegations, which had been made about the

manufacturer and the study, prior to the agency's approval of saline

breast implants. Unfortunately, the FDA again chose to look the other way.

In May 2000, the FDA approved saline breast implants. The approval came in

spite of Mr. Templer's recommendation, in spite of complications rates as

high as 43% for cosmetic patients and complication rates of over 70% for

reconstruction patients (in the first 3 years), and in spite of an ongoing

open criminal investigation into one of the manufacturers, which remains

open even today.

Sadly, consumers believe " FDA approval " of a product means that the

product has been adequately studied and has been found to be safe and

effective for it's intended use. I'm not sure this should be concluded

with this device. Unfortunately, the average consumer who might purchase

this product will not have access to the information the FDA has ignored

during the approval process, resulting in an inappropriate assumption of

safety and effectiveness.

It is my fear that by ignoring the regulatory problems, the criminal

allegations, the high complication rates and the recommendation of the

FDA's own staff, the agency has lowered the bar for what is considered a

safe and effective medical device. Additionally, the ramifications of the

FDA's decision could be widespread and ultimately effect other products

and many American consumers.

It was this concept which disturbed Mr. Templer and me so deeply. Mr.

Templer couldn't be here today, however, he asked me to advise the

committee of his professional opinion regarding this topic.

Mr. Templer writes, " Based upon information I was aware of as an FDA

official it does not surprise me that breast implant recipients are

experiencing significant health consequences. I was aware of many quality

control issues as well as situations where FDA employees illegally

assisted an implant manufacturer. I reported these issues, but the FDA

wanted to sweep the matter under the rug. In my opinion, the FDA has not

adequately monitored or investigated the safety of breast implants, and in

fact, they have looked the other way when credible allegations of criminal

conduct have been made. I urge the committee to take the actions necessary

to protect the public health, because the FDA has clearly failed to do

so. "

I agree with Mr. Templer: it will take an act of Congress to get to the

bottom of the breast implant debacle. However, Congress must insist that

our country's watchdogs are doing their jobs. The passing of this bill is

a great first step. H.R. 1961 will ensure the FDA has full oversight and

will provide accountability. The passing of this bill will ultimately

benefit women's health and could also impact FDA¼s oversight of all

medical devices.

I want to thank Congressman Gene Green for his steadfast leadership on

this issue, and I would also like to thank my Congressman, Roy Blunt, for

his support. I would also like to thank members of this panel who have

co-sponsored H.R. 1961. We are grateful for the support of Representatives

Sherrod Brown, Ed , Burr, Pallone Ted Strickland and

.

Thank you for your time today and I urge you to make it a goal to pass

this bill in this Congress. Breast implants have been put in women's

bodies for over 30 years; it's high time we understand the long-term

effects of this product and insist that they be manufactured with

integrity and in accordance with good manufacturing practices.

Kim Hoffman

Niangua, Missouri

krhoffman@...

Implant Information Project

National Center For Policy Research (CPR) For Women & Families

1444 Eye St NW, Suite 900, Washington, DC 20005. (202) 216-9507

~~~~~

http://www.breastimplantinfo.org/hr1961dz.html

Testimony of Zuckerman, Ph.D.

Before the Subcommittee on Health

Of the House Committee on Energy and Commerce

November 15, 2001

My name is Dr. Zuckerman and I am president of the National Center

for Policy Research for Women & Families. Our organization is a nonprofit

think tank dedicated to improving the lives of women and families by

explaining and disseminating medical and scientific research information.

I am honored to be on this panel with these courageous women, to talk

about the need for H.R. 1961, a bill that will help to ensure and protect

women¼s health and well-being.

The Breast Implant Research and Information Act calls for more research on

breast implants. I am here to tell you why this bill is so essential.

Breast implants have been sold in this country for almost 40 years, but we

still know very little about their long-term health risks. In fact, almost

a million women had breast implants before the first epidemiological study

was published about health risks. Before then, there were just a few

studies of rats and dogs, but no published studies of human beings.

In 1990, as a scientist working on what is now the House Committee on

Government Reform, I started an investigation of the FDA¼s regulation of

breast implants. We found that the FDA had ignored the concerns of its own

scientists by allowing the sale of breast implants without requiring that

the manufacturers prove that implants were safe. As a result of our

hearing, the FDA finally required the manufacturers to submit studies of

silicone gel implants. Unfortunately, those studies were so badly designed

that they could not prove whether or not implants were safe.

In response to pressure on both sides, the FDA did something they almost

never do , they refused to approve implants but allowed them to stay on

the market as a " public health need. " I think the last two months have

shown us what a true public health need is , and breast augmentation does

not qualify. But, at the time, there were fewer options for breast cancer

patients than there are today, and the FDA was reluctant to make a

different standard for augmentation patients , who comprise 80% of implant

patients. Congress went along with the FDA decision, but required the NIH

to conduct long-term research.

There were no studies of women with implants in 1990, but quite a few

epidemiological studies have been conducted since then. I have carefully

studied all of them. Despite what you may have heard in the media, the

research and the report by the Institute of Medicine does not conclude

that implants are safe , to the contrary, they show many serious problems

related to implants, such as infections and the need for multiple

surgeries.

And, just a few months ago, three major new studies reported that women

who have breast implants are at significant risk for several debilitating

and fatal diseases.

One study, conducted by researchers at the National Cancer Institute (NCI)

reported that women with implants were likely to die from brain cancer,

lung cancer, other respiratory diseases, and suicide compared to other

plastic surgery patients.

A second study, also by NCI, reported that women with breast implants are

more likely to develop cancer compared to other women their age.

Both of these studies were of women who had either silicone or saline

breast implants for at least 8 years. In contrast, the studies that have

shown no increase in disease for women with implants included many women

who had implants for very short periods of time , even as short as one

month. Obviously, cancer and autoimmune diseases do not develop that

quickly.

A third study, conducted by scientists at the FDA, found that women with

leaking silicone gel breast implants are more likely to have several

painful and potentially fatal autoimmune diseases. Implants were found to

be increasingly likely to break as they got older, and most implants were

broken by the time there were 10-15 years old. This study may provide an

important clue: It is possible that illnesses reported by women with

implants are a result of leaking implants , which would explain why most

women do not have systemic health problems until after they have had

implants for several years.

At the same time that these new studies were released, the plastic surgery

organizations announced that almost 300,000 American women got breast

implants last year, most of them for augmentation. Although they don¼t

boast about it, these statistics also show that the number of teenage

girls getting implants has more than doubled in the last 3 years.

These three new studies remind us that, although relatively few women

become ill after having implants for a year or two, we need to be

concerned about the long-term dangers. Women who are considering implants

deserve to be accurately informed about the risks , what is known, and

what is not known. And yet, hundreds of thousands of women are deciding to

get implants because they mistakenly believe that implants are proven safe

for long-term use.

The two studies conducted by NCI were mandated by Congress. They were

designed to answer two essential questions:

1. do breast implants have health risks and

2. do women with implants die at a younger age than they otherwise would

have?

These are still the essential questions and that is the purpose of H.R.

1961. I am especially pleased that this legislation requires studies of

women with implants after mastectomies. It is unfortunately true that not

one single breast cancer patient was included in the studies that the

federal government has conducted thus far. I want you to know that

Congress requested that mastectomy patients be included in those studies,

but the head of the NIH at the time, Dr. Bernadine Healy, refused. It¼s

too late to fix those studies, but it is absolutely essential that studies

of reconstruction patients be conducted as soon as possible. At this

point, most of what we know is based on the manufacturers¼ own studies,

which show that more than 70 percent of reconstruction patients have at

least one serious complication within three years of getting saline

implants, and one in four reconstruction patients need to have at least

one additional surgery within the first three years. We need to know what

happens after three years, and we need to tell breast cancer patients

about these complications so that they can make an informed decision about

what would be best for them.

In addition to new studies, it would be very cost-effective for the NIH to

continue to study the breast augmentation patients in the NCI and FDA

studies that I described a few minutes ago. At the time the NCI studied

the women¼s medical records, they had implants for at least 8 years. They

have now had implants for at least 11 years, so it is important to study

what has happened , whether the cancer rates, autoimmune diseases, and

death rates of women with implants have increased or decreased in the last

three years.

Although I am especially concerned about the lack of information about the

long-term safety of reconstruction, I am also concerned about the

thousands of teenage girls that are getting breast implants every year. We

don¼t know what will happen to those girls, and unfortunately neither they

nor their parents realize how little is known about long-term risks. It is

time we answered that question. And H.R. 1961 would help ensure that

patients , and teenage patients¼ parents , know what the risks are before

they decide whether or not to get implants.

In conclusion, I want to thank the Committee for holding this hearing, and

especially thank Congressman Blunt and Congressman Gene Green, and their

wonderful staff, for their leadership on these issues. And, I thank the

Committee members, and their staff, who have supported this legislation

and shown respect and support for constituents who have courageously

shared their personal experiences with implants. Our nonprofit

organization hears from thousands of consumers, and I can assure you that

there are many implant patients who are grateful for this hearing, and

waiting to see what happens next. We need your continued help. If Congress

doesn¼t required that these important studies be conducted by NIH, it is

unlikely that they ever will be. And so, we¼re counting on this Committee

to make sure that NIH moves forward as quickly as possible.

I hope the Committee will also undertake a careful review of the role of

the FDA regarding the lack of long-term safety data on breast implants.

Breast implants have been sold for almost 40 years, and yet the FDA has

never required long-term safety data. They have not required that patients

be informed of the risk of implants. Meanwhile, more than 127,000 adverse

reactions have been reported regarding silicone gel implants and more than

65,000 for saline-filled implants , and yet the FDA has not even bothered

to examine them. As this Committee considers legislation to reform the FDA

in the coming year, I urge you to include a provision requiring long-term

safety data for implanted medical devices that are already on the market.

This is not like a new medical product: women who have had implants for

many years are available to be studied, and the FDA should be mandated to

do so.

I would be glad to answer any questions, and I invite you and your staff

to go to our website, www.center4policy.org, to read some of the medical

and lay articles that we have written on the topic, and to link to FDA¼s

consumer materials about breast implants.

Implant Information Project

National Center For Policy Research (CPR) For Women & Families

1444 Eye St NW, Suite 900, Washington, DC 20005. (202) 216-9507