[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]




 RAISING HEALTH AWARENESS THROUGH EXAMINING BENIGN BRAIN TUMOR CANCER, 
                  ALPHA ONE, AND BREAST IMPLANT ISSUES

=======================================================================

                                HEARING

                               before the

                         SUBCOMMITTEE ON HEALTH

                                 of the

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS

                             FIRST SESSION

                               __________

                           NOVEMBER 15, 2001

                               __________

                           Serial No. 107-75

                               __________

       Printed for the use of the Committee on Energy and Commerce


 Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                 house

                                _______

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                    COMMITTEE ON ENERGY AND COMMERCE

               W.J. ``BILLY'' TAUZIN, Louisiana, Chairman

MICHAEL BILIRAKIS, Florida           JOHN D. DINGELL, Michigan
JOE BARTON, Texas                    HENRY A. WAXMAN, California
FRED UPTON, Michigan                 EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida               RALPH M. HALL, Texas
PAUL E. GILLMOR, Ohio                RICK BOUCHER, Virginia
JAMES C. GREENWOOD, Pennsylvania     EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California          FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia                 SHERROD BROWN, Ohio
STEVE LARGENT, Oklahoma              BART GORDON, Tennessee
RICHARD BURR, North Carolina         PETER DEUTSCH, Florida
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
GREG GANSKE, Iowa                    ANNA G. ESHOO, California
CHARLIE NORWOOD, Georgia             BART STUPAK, Michigan
BARBARA CUBIN, Wyoming               ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois               TOM SAWYER, Ohio
HEATHER WILSON, New Mexico           ALBERT R. WYNN, Maryland
JOHN B. SHADEGG, Arizona             GENE GREEN, Texas
CHARLES ``CHIP'' PICKERING,          KAREN McCARTHY, Missouri
Mississippi                          TED STRICKLAND, Ohio
VITO FOSSELLA, New York              DIANA DeGETTE, Colorado
ROY BLUNT, Missouri                  THOMAS M. BARRETT, Wisconsin
TOM DAVIS, Virginia                  BILL LUTHER, Minnesota
ED BRYANT, Tennessee                 LOIS CAPPS, California
ROBERT L. EHRLICH, Jr., Maryland     MICHAEL F. DOYLE, Pennsylvania
STEVE BUYER, Indiana                 CHRISTOPHER JOHN, Louisiana
GEORGE RADANOVICH, California        JANE HARMAN, California
CHARLES F. BASS, New Hampshire
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska

                  David V. Marventano, Staff Director

                   James D. Barnette, General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

                         Subcommittee on Health

                  MICHAEL BILIRAKIS, Florida, Chairman

JOE BARTON, Texas                    SHERROD BROWN, Ohio
FRED UPTON, Michigan                 HENRY A. WAXMAN, California
JAMES C. GREENWOOD, Pennsylvania     TED STRICKLAND, Ohio
NATHAN DEAL, Georgia                 THOMAS M. BARRETT, Wisconsin
RICHARD BURR, North Carolina         LOIS CAPPS, California
ED WHITFIELD, Kentucky               RALPH M. HALL, Texas
GREG GANSKE, Iowa                    EDOLPHUS TOWNS, New York
CHARLIE NORWOOD, Georgia             FRANK PALLONE, Jr., New Jersey
  Vice Chairman                      PETER DEUTSCH, Florida
BARBARA CUBIN, Wyoming               ANNA G. ESHOO, California
HEATHER WILSON, New Mexico           BART STUPAK, Michigan
JOHN B. SHADEGG, Arizona             ELIOT L. ENGEL, New York
CHARLES ``CHIP'' PICKERING,          ALBERT R. WYNN, Maryland
Mississippi                          GENE GREEN, Texas
ED BRYANT, Tennessee                 JOHN D. DINGELL, Michigan,
ROBERT L. EHRLICH, Jr., Maryland       (Ex Officio)
STEVE BUYER, Indiana
JOSEPH R. PITTS, Pennsylvania
W.J. ``BILLY'' TAUZIN, Louisiana
  (Ex Officio)

                                  (ii)


                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Hoffman, Kim.................................................    15
    Howell, Dwayne, President and CEO, Leukemia and Lymphoma 
      Society....................................................    26
    Johnson, Jacqueline L., Executive Director, National Congress 
      of American Indians........................................    29
    Morgan, Lloyd, Board of Directors, Central Brain Tumor 
      Registry of the United States and the North American Brain 
      Tumor Coalition............................................    23
    Noonan-Saraceni, Pamela......................................    19
    Zuckerman, Diana, Executive Director, National Center for 
      Policy Research for Women and Families.....................    11
Material submitted for the record by:
    Conway, Christopher, President, Mentor Corporation, prepared 
      statement of...............................................    40
    Udall, Hon. Tom, a Representative in Congress from the State 
      of New Mexico, Hon. J.D. Hayworth, a Representative in 
      Congress from the State of Arizona, and Hon. J.C. Watts, 
      Jr., a Representative in Congress from the State of 
      Oklahoma, joint statement of...............................    40

                                 (iii)

  

 
 RAISING HEALTH AWARENESS THROUGH EXAMINING BENIGN BRAIN TUMOR CANCER, 
                  ALPHA ONE, AND BREAST IMPLANT ISSUES

                              ----------                              


                      THURSDAY, NOVEMBER 15, 2001

                  House of Representatives,
                  Committee on Energy and Commerce,
                                    Subcommittee on Health,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 2 p.m., in 
room 2123, Rayburn House Office Building, Hon. Michael 
Bilirakis (chairman) presiding.
    Members present: Representatives Bilirakis, Wilson, Brown, 
Strickland, Barrett, Pallone, and Green.
    Also present: Representatives Blunt and Lee.
    Staff present: Brent Del Monte, majority counsel; Nolty 
Theriot, legislative clerk; John Ford, minority counsel; and 
Nicole Kenner, minority resident assistant.
    Mr. Bilirakis. I call to order this hearing and, again, 
formally apologize to the panel and to the folks out there who 
are interested, but we just didn't really have any choice in 
the matter.
    This is a hearing on raising health awareness through 
examining benign brain tumor cancer, breast implant health 
issues, hematological cancer research and access to breast 
cancer treatment for women receiving care through the Indian 
Health Service.
    I would like to thank, again, all of our witnesses for 
coming today and for being so understanding and considerate. 
Their expertise on these important health issues are so very 
important. Two of the issues that we are discussing today focus 
on strengthening certain areas of the National Institutes of 
Health research programs. We will hear testimony highlighting 
the need for more research into the safety of breast implants. 
As we have all heard, many women have received breast implants 
and unfortunately suffer debilitating diseases that may have 
been linked to the procedure.
    Testimony will also be presented on the need to improve our 
research efforts into leukemia and lymphoma cancers. Current 
Federal research into these deadly cancers falls well below the 
level that is afforded to other cancers, even though leukemia 
and lymphoma cancers will claim the lives of 60,000 people.
    We will also learn about the lacking infrastructure for 
tracking benign brain tumors. Many brain tumors are diagnosed 
as benign. However, these tumors can and do have terrible 
health consequences for those who suffer from such illnesses. 
As we learned this morning, surveillance is an important 
component in protecting the public's health, and I look forward 
to learning more about this issue.
    Finally, we will hear testimony on an issue with respect to 
treatment for breast and cervical cancer. As many of you know, 
our subcommittee worked in the previous Congress to pass the 
Breast and Cervical Cancer Prevention and Treatment Act. I was 
pleased to support this effort and its enactment into law. A 
concern has been raised with implementation of the act. 
Specifically, women receiving care through the Indian Health 
Service may be excluded, something we certainly did not intend.
    I look forward to hearing all the testimony today, and, 
again, would like to thank all the witnesses for appearing here 
today. And now I gladly yield to my good friend from Ohio, the 
ranking member of this subcommittee, Mr. Brown.
    Mr. Brown. Well, thank you, Mr. Chairman. Today's hearing 
will address--and welcome all of you as witnesses, thank you 
for your patience and sticking around and putting up with the 
idiosyncrasies of this institution. Today's hearing will 
address a number of important issues: a cancer registry for 
benign brain tumors and the need for additional research 
focused on breast implants as well as blood cancers. We are 
going to discuss the need for technical change to the Breast 
and Cervical Cancer Treatment Act we passed last year, which 
inadvertently omitted Native American women.
    It is estimated that 35,000 individuals are diagnosed with 
malignant and benign brain tumors each year. Most registries 
collect data on malignant brain tumors but not on benign 
tumors. It might seem superfluous to collect data on people 
diagnosed with a non-lethal tumor, but experts contend that in 
order to understand this complex cancer, they must be able to 
track it in all forms--malignant as well as benign.
    Because the causes of brain tumors are not well understood, 
studying ideology of benign brain tumors may improve our 
understanding of malignant tumors. My colleague, Congresswoman 
Lee, who just walked in, has introduced a Benign Brain Tumor 
Cancer Registries Amendment Act, H.R. 239, which will require 
all registries funded by the Government to collect both benign 
and malignant brain tumor data. And it is my understanding, Mr. 
Chairman, that once I am finished, that Ms. Lee would like to 
introduce the panelist from her--whom she knows.
    The death of our colleague, Joe Moakley, earlier this year 
certainly raised the profile of leukemia and other blood 
cancers for those of us in Congress. An estimated 109,000 
people in the U.S. will be diagnosed with blood cancers this 
year. These diseases will be the cause of death for an 
estimated 60,000 Americans in 2001, meaning that a child or an 
adult dies from a blood cancer every 9 minutes.
    Our colleague, Mr. Crane, introduced legislation to expand 
and intensify NIH research on blood cancers and to establish a 
public information program in collaboration with the Centers 
for Disease Control and Prevention specifically for patients 
and their families. I am pleased our subcommittee is 
considering Mr. Crane's bill in honor of Joe.
    I want to thank my colleague, Mr. Green, for his work 
developing legislation to heighten research in the area of 
breast implants. I am pleased to be a co-sponsor of that. This 
bill would recommend further studies into the risks of breast 
implants, providing women with more accurate and more complete 
information.
    As you know, thousands of young women are getting implants 
each year. That number is expected to rise, yet neither they 
nor their parents have the information oftentimes that they 
need to fully assess the associated risks. This bill would 
require the study of a population not included in past studies: 
Breast cancer survivors who are seeking reconstructive surgery.
    I have worked with the breast cancer community a great deal 
on the breast and cervical cancer issue, both enactment here 
and implementation in my State of Ohio, and recognize that for 
many women who have successfully beaten their cancer, the 
option of reconstructive surgery is a very important one. The 
least we can do is provide women with the most accurate 
information about the risks, so the decisions they make don't 
put their lives at risk a second time.
    The last thing I wanted to briefly mention is a bill that 
my colleague, Tom Udall, has been working on to make a 
technical change to the Cancer and Cancer Treatment Act, to 
include this treatment service for Native American women. I 
hope the chairman and I can work together to bring this bill to 
the attention of leadership and bring it to the floor for a 
vote. These women should not have been excluded last year, and 
we should correct this anomaly as soon as possible. I thank the 
chairman.
    Mr. Bilirakis. I thank the gentleman, and would the 
gentleman like to yield to Ms. Lee for her introduction?
    Ms. Lee. Thank you, Mr. Chairman.
    Mr. Bilirakis. I might add that you are more than welcome 
to remain on the panel here and listen to the testimony if 
you'd like.
    Ms. Lee. Thank you, Mr. Chairman. And I just want to thank 
you very much for holding this hearing and also for the 
committee's work on this very important issue. I would like to 
take this opportunity to introduce a constituent from Berkeley, 
California, Mr. Lloyd Morgan.
    Now, Mr. Morgan will be testifying on the importance of 
H.R. 239, the Benign Brain Tumor Cancer Registries Amendment 
Act, which I am very proud to have sponsored. Mr. Morgan is an 
electrical engineer as well as a member of the North American 
Brain Tumor Coalition.
    Mr. Chairman, let me just mention how I learned about this 
very important health issue. Mr. Morgan attended one of my town 
hall meetings in California where he had the opportunity to 
discuss this issue, not only with me but with those who were in 
the town meeting. He ask that I introduce a bill to address the 
problem of benign brain tumors not being included in the 
National Program of Cancer Registries, as his representative. 
And, Mr. Chairman, I think this is quite an example of how our 
democracy works.
    We looked into it, we conducted our research, your staff 
has been very helpful, the entire committee has been helpful in 
assisting us to make sure that we were able to bring this 
amendment to you today. So I agreed to introduce this bill in 
order to help the medical system, including public health 
agencies, scientific research labs and health system public 
policy groups, as well as patients with brain tumors.
    Mr. Morgan will take the opportunity today to share his 
story as a survivor of benign brain tumor with the 
subcommittee. So I want thank you again, Mr. Chairman, for 
holding this hearing on the Benign Brain Tumor Cancer 
Registries Amendment Act. Thank you very much, and it is great 
to be here.
    Mr. Bilirakis. I thank the gentlelady and thank her on 
behalf of all of us for your interest in this subject. And now 
I would yield to the gentlelady from New Mexico, Mrs. Wilson.
    Ms. Wilson. Thank you, Mr. Chairman, and I appreciate your 
holding this hearing today and inviting testimony about breast 
implants. I wanted to thank one of my constituents who is here 
in the audience today, Anne Stansell, who brought to my 
attention this problem in this bill. And she survived cancer 
only to become seriously ill with symptoms attributed to her 
breast implants. And she has been a leader in New Mexico and 
across the country helping other women through breast cancer. I 
wanted to thank her for her work in helping women and also 
helping to educate me about the lack of information and the 
research that needs to be done.
    I think the important message of this hearing today--and I 
thank all of you for your patience, as you've waited through a 
very long day and a prior testimony in this room--I think the 
important message is that women need more awareness about the 
possible side effects and the risks involved. No surgery or 
medical device is 100 percent risk-free, and no product is 
completely safe, because it is in high demand or because it is 
marketed effectively. People need to know what the risks are 
before they make a decision about whether to have implants.
    I am very disappointed that we don't have anyone from FDA 
here, and I am not sure that the current FDA processes give an 
accurate picture of those risks. And I look forward to asking 
some questions of the FDA at a later time. Again, Mr. Chairman, 
I thank you very much for holding this hearing.
    Mr. Bilirakis. I thank the gentlelady and thank her for 
being here. The members will be in and out; it is kind of, 
again, our way of life here. Mr. Pallone for an opening 
statement.
    Mr. Pallone. Thank you, Mr. Chairman. I wanted to speak in 
support of H.R. 1383, the Native American Breast and Cervical 
Cancer Treatment Technical Amendment Act of 2001. As was 
mentioned, this legislation makes a simple but extremely 
important technical change to the Breast and Cervical Cancer 
Treatment and Prevention Act to improve the coverage of breast 
and cervical cancer treatment for American Indian and Alaska 
native women.
    Under the Health Insurance Portability and Accountability 
Act of 1996, HIPAA, credible coverage includes a reference to 
the Medical Care Program of the Indian Health Service. The 
reference to credible coverage in the law effectively excludes 
Indian women from receiving Medicaid breast and cervical cancer 
treatment, as provided under this act.
    The Indian health reference to IHS tribal care was 
originally included in HIPAA so that members of Indian tribes 
eligible for IHS would not be treated as having a break in 
coverage simply because they received care through Indian 
health programs, rather than through a conventional health 
insurance program. Thus in the HIPAA context, the inclusion of 
the IHS tribal provision was intended to benefit American 
Indians and Alaska natives, not penalize them. However, use of 
the HIPAA definition in the recent Breast and Cervical 
Treatment and Prevention Act has the exact opposite effect. In 
fact, the many Indian women who rely on IHS tribal programs for 
basic health care are excluded from the new law's eligibility 
for Medicaid. This not only denies coverage to Indian women, 
but the provision runs counter to the general Medicaid rule 
treating IHS facilities as full Medicaid providers.
    While American Indian and Alaska native women have a higher 
incidence of breast and cervical cancer than the U.S. 
population generally, many Indian women with these conditions 
will be left with fewer resources to fight breast and cervical 
cancer because of their exclusion from the new Medicaid 
coverage option. The bill would resolve these problems by 
clarifying the term ``credible coverage'' that it shall not 
include--well, I am not going to go into all the details.
    I just wanted to say that since a number of States are 
currently moving forward to provide Medicaid coverage under the 
State option, the need for this legislation is immediate to 
ensure that American Indian and Alaska native women are not 
denied from receiving life-saving breast and cervical cancer 
treatment. And I appreciate the fact that we are bringing this 
up today and hopefully can move it soon to the full House. 
Thank you, Mr. Chairman.
    Mr. Bilirakis. I thank the gentleman. Mr. Green, for an 
opening statement.
    Mr. Green. Thank you, Mr. Chairman. First of all, I 
appreciate you for calling this hearing on a number of bills, 
but particularly the issue of breast implant safety. As an 
original co-sponsor of the bill, along with Congressman Blunt, 
of H.R. 1961, I strongly believe that the Federal Government 
should do more to study the safety and efficacy of breast 
implants and to ensure that women have the facts they need to 
make informed decisions about implants.
    I have been working on this issue now for 4 years, and it 
was brought to my attention by my constituent, Marlene Keeling, 
who is here today. Marlene has been a driven and tireless 
advocate for this cause and has done so much to raise the 
awareness about the potential dangers of breast implants. I 
would like to thank her for her hard work and for educating me 
on this important issue. I would also like to thank my 
colleague, Congressman Roy Blunt, who learned of this issue 
from his constituent, one of our panelists, Kim Hoffman.
    Most people don't usually think of breast implants as a 
public health issue, but this is a serious issue that needs to 
be seriously examined. Silicone breast implants were never 
approved by the Food and Drug Administration, have significant 
complication rates. Women with implants often soften suffer 
hardening of the breast tissue, discomfort, scarring and 
disfigurement. Even more troubling, studies have shown that 
women with breast implants have higher rates of brain cancer, 
lung cancer, fibromyalgia, joint pain, fatigue and other 
symptoms.
    Despite popular misconceptions, saline implants are not 
necessarily any safer. Saline implants, which consist of saline 
solution injected in a silicone envelope, were approved by the 
agency in 2000 despite alarmingly high complication and 
reoperation rates. In fact, from 1985 until January 2000, the 
FDA received 127,770 adverse reaction reports on silicone-gel-
filled breast implants and 65,720 adverse reaction reports on 
saline-filled implants.
    While these are startling statistics, there is still a 
great deal we don't know about the long-term safety of 
implants. That is because there haven't been many objective and 
comprehensive studies into the issue. As we will hear from one 
of our witnesses today, there is almost no research being 
performed on women who have implants for reconstruction 
following a mastectomy.
    Mr. Chairman, I know there are many women in the breast 
cancer community who feel strongly that they need implants as 
part of their recovery process. And I don't believe they should 
be restricted from having that access, but we must ask how 
these implants are affecting mastectomy patients and whether 
there are higher rates of complications, problems detecting 
additional cancers or any other issues that women must know 
before they opt for implants. Mr. Chairman, these are very 
serious issues, and I am glad that--again, thank you for 
calling this hearing today, and I hope my colleagues will 
consider co-sponsoring H.R. 1961. I look forward to our 
committee hearing today.
    Mr. Bilirakis. And the Chair thanks the gentleman. Mr. 
Blunt for an opening statement and to introduce Ms. Hoffman.
    Mr. Blunt. Thank you, Mr. Chairman. I want to thank you 
particularly for your leadership and joining with me and our 
fellow Commerce Committee member and our good friend, Gene 
Green, to bring this act, the Breast Implant Research and 
Information Act, before the Health Subcommittee for a hearing. 
Members of Congress are routinely inundated with statistics, 
and the topic of this bill generates its own list. More than 
40,000 women are expected to die this year because of breast 
cancer, the second ranking cause of cancer deaths. It is 
estimated that 83,000 women had breast reconstruction following 
mastectomies last year, and almost 200,000 adverse reactions to 
implants have been reported to the FDA.
    These are pretty big numbers, Mr. Chairman, but more 
importantly, behind each number is a face, a family, a friend 
and a fractured life. It is easy to be overwhelmed by such 
numbers. We can allow ourselves to become numb to just how big 
this problem really is. It is not so easy when we come face to 
face with people who these statistics represent.
    Today, you will hear and I will and we will hear in this 
hearing from Kim Hoffman, from Southwest Missouri, who came to 
my office 3 years ago and shared her tragic experience of going 
from a successful business owner to a disabled person in a 
matter of months because of implants. She underwent six 
surgeries in 2 years, eventually lost her business, her home, 
her health, her pride because of what she believed at the time 
she made the decision was a routine medical decision. You will 
hear from Pam Noonan-Saraceni, who survived the trauma of 
cancer and the treatment that followed only to fall victim, 
ironically, to the implants she had hoped would allow her to 
return to a normal life. These women are but two of the faces 
behind these huge numbers of women affected by this particular 
devastating problem.
    There are many others who could share similar and tragic 
stories. Some of those are in the hearing room today, including 
actress Mary McDonough, who may be better known to many of us 
as Erin Walton on the TV series, ``The Waltons.'' Mary is in 
the front row there, and you will all recognize her as you try 
to figure out who that might be from not only the Waltons but 
from appearances on ``ER,'' ``Ally McBeal,'' ``Diagnosis 
Murder,'' ``Walker, Texas Ranger.'' Her career was interrupted 
by lupus, which she attributes to implants.
    You will also hear today from Dr. Diana Zuckerman, an 
academician with credentials from Yale, Harvard and George 
Washington University, who also worked as a staffer on Capitol 
Hill for over a decade to forge stronger programs on women's 
health. She brings a unique perspective on the Food and Drug 
Administration's oversight role in improving implants even when 
the agency found complication rates as high as 73 percent after 
only 3 years.
    Mr. Chairman, the Breast Implant Research and Information 
Act improves women's health options in three critical areas. 
One is informed consent. This bill doesn't attempt to stop 
physicians from prescribing implants or from women seeking 
them. What it does do is to ensure that a women and perhaps 
other significant loved ones in her life make the decision to 
get implants, she has the best and most recent scientific 
research available to her. I have heard from woman after woman 
that has shared her decision on--that has based her decision, 
rather, on inaccurate information and general assurances, not 
on sound sciences. Individuals considering this surgery need to 
know about complication rates and the fact that these devices 
have been replaced periodically. Our medical community needs to 
do a better job in this area.
    In light of the controversy surrounding implants, 2 years 
ago, the State of Missouri became the first State to require 
informed consent prior to implant surgery, including a 5-day 
waiting period and specific State-approved materials be given 
to the patient. Rather than creating a conflicting patchwork of 
State regulations, Congress can work to ensure that accurate 
portrayal of the risks associated with these implants, 
regardless of where the patient lives, are known to the 
patient.
    Post-market research is the second this that this bill 
requires. When the FDA's Advisory Panel recommends approval of 
drugs or devices to the agency, they often do so with carefully 
worded conditions on follow-up studies. The truth is that the 
post-market research is rarely, if ever, reviewed to determine 
whether it is completed and whether the additional research 
reveals additional problems. When the pre-market panel improved 
saline implants, they also required continuing studies. This 
bill would require the FDA to report on the status of those 
recommendations every 6 months for 2 years after this bill is 
enacted.
    The follow-up research conducted by the companies on their 
products deserves the same FDA scrutiny, which is paid to the 
research conducted on the initial approval of this device or 
other devices. Post-market research is especially important 
since there is increasing anecdotal evidence showing that 
significant implant problems did not appear until the patient 
has had the implants for 6 years or more.
    Coordinated activity is the third thing this bill does, as 
it utilizes the existing resources within the National 
Institutes of Health to bring together the work being done by 
seven different institutes and offices. Once lines of 
communications are open between the units, we expect there to 
be improved interdisciplinary research, either within the NIH 
itself or through outside research.
    Mr. Chairman, women who are facing the trauma of breast 
cancer and mastectomy do not need to made a victim a third time 
because of inadequate information to make a decision, 
inadequate follow-up on the research and inadequate focus 
within the Government's own health agency. That is why this is 
so important, that is why Representative Green and I have 
responded to the stories we have heard and the constituents we 
have talked to and why we are so appreciative that you have 
decided to have this hearing today.
    [The prepared statement of Hon. Roy Blunt follows:]

Prepared Statement of Hon. Roy Blunt, a Representative in Congress from 
                         the State of Missouri

    Mr. Chairman: I want to thank you for your leadership in joining 
with me and fellow Commerce Committee member Gene Green to bring the 
Breast Implant Research and Information Act before the Health 
Subcommittee for a hearing.
    Members of Congress are routinely inundated with statistics and the 
topic of this bill generates its own list. More than 40,000 women are 
expected to die this year because of breast cancer, the second ranking 
cause of cancer deaths. It is estimated that 83,000 women had breast 
reconstruction following mastectomies last year, and almost 200,000 
adverse reactions to implants have been reported to the FDA. Those are 
significant numbers, but more importantly behind each number is face, a 
family and a fractured life.
    It is easy to be overwhelmed by such numbers. We can allow 
ourselves to become numb to the enormity of the problem. It is not so 
easy when we come face to face with the people those statistics 
represent.
    Today you will hear from Kim Hoffman from Southwest Missouri who 
came to my office three years ago and shared her tragic experience of 
going from a successful business owner to a disabled person in a matter 
of months because of implants. She underwent six surgeries in two years 
and eventually lost her business, her home, her health and her pride 
because of what she believed was a routine medical decision.
    You will hear from Pam Noonan-Saraceni who survived the trauma of 
cancer and the treatment that followed, only to fall victim ironically 
to the implants that she hoped would allow her to return to a normal 
life.
    These women are but two faces behind the numbers. There are many 
others who could share similar tragic stories. Some of those are in 
this hearing room today including actress Mary McDonough, who may be 
better known by many of us as Erin Walton on the TV series the Waltons 
but who has also appeared on E.R., Ally McBeal, Diagnosis Murder and 
Walker-Texas Ranger. Her career was interrupted by Lupus which she 
attributes to implants.
    You will also hear today from Dr. Diana Zuckerman, an academician 
with credentials from Yale, Harvard and George Washington University 
who also worked as a staffer on Capitol Hill for over a decade to forge 
stronger programs on women's health. She brings a unique perspective on 
the Food and Drug Administration's oversight role in approving implants 
even when the agency found complication rates as high as 73% after only 
three years.Mr. Chairman, the Breast Implant Research and Information 
Act improves women's health options in three critical areas:
    Informed Consent: This bill does not attempt to stop physicians 
from prescribing implants or from women seeking them. What it does do 
is to insure that when a woman, and perhaps other significant loved 
ones in her life, make the decision to get implants, she has the best 
and most recent scientific research available to her. I have heard from 
woman after woman that she based her decision on inaccurate information 
and general assurances, not on sound science. Individuals considering 
this surgery need to know about complication rates and the fact that 
these devices have to be replaced periodically. Our medical community 
must do better.
    In light of the controversy surrounding implants, two years ago the 
State of Missouri became the first state to require informed consent 
prior to implant surgery including a 5-day waiting period and specific 
state approved materials to be given to the patient. Rather than 
creating a conflicting patchwork of state regulations, Congress can 
work to ensure an accurate portrayal of the risks associated with these 
implants, regardless of where the patient lives.
    Post Market Research: When the FDA's advisory panel recommends 
approval of drugs or devices to the agency, they often do so with 
carefully worded conditions on follow-up studies. The truth is that the 
post market research is rarely, if ever, reviewed to determine whether 
it is completed and whether the additional research reveals additional 
problems. When the pre-market panel approved saline implants, they also 
required continuing studies. This bill will require the FDA to report 
on the status of those recommendations every six months for two years 
after this bill is enacted.
    The follow-up research conducted by the companies on their products 
deserves the same FDA scrutiny which was paid to the research conducted 
for the initial approval of their device.
    Post market research is especially important since there is 
increasing anecdotal data showing that significant implant problems do 
not appear until the patient has had the implants for six years or 
more.
    Coordinated Activity: This bill also utilizes the existing 
resources within the National Institutes of Health to bring together 
the work being done by seven different institutes and offices. Once 
lines of communication are opened between the units, we expect there to 
be improved interdisciplinary research either within the NIH itself or 
through outside research.
    Mr. Chairman, women who are facing the trauma of breast cancer and 
mastectomy do not need to be made a victim for a third time because of 
inadequate information to make a decision, inadequate follow-up on 
research and inadequate focus within the government's own health 
agency. This bill will insure that our mothers, our wives, our sisters 
and our daughters will have the necessary information to make wise life 
changing medical decisions.

    Mr. Bilirakis. And you can rest assured that I will 
continue to support that legislation, and hopefully move it 
through the process. Mr. Barrett for an opening statement? 
Thank you. Thank you for coming, Tom. As per usual, the opening 
statements of all members of the subcommittee will be made a 
part of the record.
    [Additional statements submitted for the record follow:]

Prepared Statement of Hon. Robert L. Ehrlich, Jr., a Representative in 
                  Congress from the State of Maryland

    Mr. Chairman, thank you for holding this important hearing on 
legislative measures designed to address certain serious health 
conditions. I want to specifically call the Subcommittee's attention to 
benign brain tumors and the misnomer ``benign'' represents in this 
case.
    There are several kinds of benign brain tumors, including 
meningiomas, a tumor of the lining of the brain; acoustic neuromas, 
affecting the acoustic nerve, often resulting in deafness; pituitary 
adenoma, affecting the pituitary gland; and pineal tumors, affecting 
the pineal gland.
    These kinds of benign brain tumors and several others together 
represent about half of all brain tumors. Approximately 21% of 
children's brain tumors are benign, yet many of these are deadly. 
Today, there are an estimated 267,000 people with benign brain tumors 
across the United States, and many in Maryland.
    Mr. Chairman, I first became aware of this issue when a Maryland 
resident, Mrs. Karen Wichman, of Ellicott City, came to me this summer 
in grief over the loss of her son, Nick, who passed away earlier this 
year. Nick Wichman was a healthy young boy who suddenly took ill, was 
diagnosed with an untreatable benign brain tumor, and died shortly 
thereafter. He received some of the best medical attention possible in 
the United States right in Maryland. Despite everything Nick had going 
for him, he was not able to defeat his benign brain tumor.
    As a result of meeting Karen Wichman and hearing about Nick, I 
cosponsored H.R. 239, the Benign Brain Tumor Cancer Registries 
Amendment Act. This legislation will amend the Cancer Registry Act to 
include data collection of benign brain tumors. This data is important 
for our scientific community to collect, analyze, and understand in 
order to research ways to reduce the incidence of benign brain tumors 
and effectively treat them once they occur. The data from this registry 
may one day be used to save lives.
    As a member of the Speaker's Corrections Day Advisory Committee, 
chaired by Congressman Dave Camp (R-MI), I was pleased to see that it 
favorably recommended this legislation for the Corrections Calender 
this summer, and I understand that Congress may be expediting this 
legislation in this way in the near future.
    I want to thank our witnesses who are here today to testify 
regarding all the important matters before us, and especially Mr. Lloyd 
Morgan, to discuss benign brain tumors and the need for this 
legislation. The passage of H.R. 239 won't save Nick Wichman, but it 
may help save others.
    In closing, I ask all my colleagues to support H.R. 239, and to 
support the families and children who must wake up every day to face 
life-threatening benign brain tumors. Thank you.
                                 ______
                                 
    Prepared Statement of Hon. John D. Dingell, a Representative in 
                  Congress from the State of Michigan

    Thank you, Mr. Chairman, for holding today's hearing. In the 
present climate in which issues of bioterrorism and public health 
surveillance are at the forefront of everyone's mind, it is important 
to also press ahead with less prominent, but no less important, health 
care concerns. We will examine four health issues today: breast and 
cervical cancer in the Native American community; breast implants; 
benign brain tumors; and blood cancers. As many of the witnesses today 
will testify, these issues have received inadequate attention from the 
government, scientific researchers, and the medical community. The 
legislation that we consider today will potentially improve the health 
and well being of thousands of Americans each year.
    H.R. 239 mandates the inclusion of benign brain tumors in cancer 
registries. Cancer surveillance conducted through state-based 
registries is designed to determine cancer patterns among various 
populations, monitor cancer trends over time, guide planning and 
evaluation of cancer control programs, help allocate health resources, 
advance health services research, and serve as the basis for an 
aggregated and centralized database of cancer incidence in the United 
States. Ignoring benign tumors may underestimate the occurrence of all 
brain tumors by at least 50 percent. Adding this important data will 
only increase data collection costs by one percent. This is a small 
price to pay for more accurate information.
    H.R. 2629 will increase research and education for leukemia, 
lymphoma, and multiple myeloma to assure advances in the treatment and, 
we hope ultimately, a cure for those blood cancers. Blood cancers are 
responsible for 11 percent of all cancer deaths in the U.S. I am 
particularly pleased to note that this bill establishes the Joe Moakley 
Cancer Education Program within the Department of Health and Human 
Services. This program will be a most fitting tribute to our former 
colleague, who lost his gallant fight against leukemia earlier this 
year.
    H.R. 1383, the Native American Breast and Cervical Cancer Treatment 
Technical Amendment Act of 2001, simply corrects the inadvertent 
exclusion of Native American women from Medicaid breast and cervical 
cancer treatment. The Health Insurance Portability and Accountability 
Act of 1996 unintentionally excluded them from receiving this life-
saving care. This fix is overdue.
    H.R. 1961, the ``Breast Implant Research and Information Act,'' 
requires the National Institutes of Health (NIH) to report on the 
status of the existing breast implant research funded by such 
Institutes; the appointment of a coordinator regarding breast implant 
research; the establishment of either a study section or special 
emphasis panel for NIH to review breast implant research grant 
applications for quality control; and the conduct or support of 
research to expand the understanding of the health implications of both 
saline and silicone breast implants. It also requires the Food and Drug 
Administration to evaluate and report on postmarket evaluations of 
saline implant manufacturers' data, and to assist women in receiving 
accurate and complete information about the risks of such implants.
    I look forward to working with my colleagues on these four bills 
and to hearing from the witnesses before us today.

    Mr. Bilirakis. The witness list consists of Dr. Diana 
Zuckerman, Executive Director of the National Center for Policy 
Research for Women and Families; Ms. Kim Hoffman of Nangua, 
Missouri. Is that right?
    Ms. Hoffman. Nangua.
    Mr. Bilirakis. Close. Pamela Noonan-Saraceni from New 
Fairfield, Connecticut; Mr. Lloyd Morgan, the Board of 
Directors, Central Brain Tumor Registry of the United States 
and North American Brain Tumor Coalition; Dr. Dwayne Howell, 
President and CEO, Leukemia and Lymphoma Society; and Ms. 
Jacqueline L. Johnson, Executive Director of the National 
Congress of American Indians.
    Ladies and gentlemen, I set the clock at 5 minutes. I 
certainly won't cut you off if you go past that, but I would 
hope that you would stay as close to it as you can. Your 
written statement is already a matter of the record, and so, 
consequently, we would hope you would complement it more than 
anything else. That being the case, we will start off with Dr. 
Zuckerman. Thank you and welcome.

  STATEMENTS OF DIANA ZUCKERMAN, EXECUTIVE DIRECTOR, NATIONAL 
CENTER FOR POLICY RESEARCH FOR WOMEN AND FAMILIES; KIM HOFFMAN; 
   PAMELA NOONAN-SARACENI; LLOYD MORGAN, BOARD OF DIRECTORS, 
CENTRAL BRAIN TUMOR REGISTRY OF THE UNITED STATES AND THE NORTH 
 AMERICAN BRAIN TUMOR COALITION; DWAYNE HOWELL, PRESIDENT AND 
CEO, LEUKEMIA AND LYMPHOMA SOCIETY; AND JACQUELINE L. JOHNSON, 
   EXECUTIVE DIRECTOR, NATIONAL CONGRESS OF AMERICAN INDIANS

    Ms. Zuckerman. Thank you very much, Mr. Chairman. Is this a 
good distance? It is working? I am Dr. Diana Zuckerman, 
President of the National Center for Policy Research----
    Mr. Bilirakis. You might pull it closer. It is on? The 
light is not on, is it.
    Ms. Zuckerman. Okay. Is that working now?
    Mr. Bilirakis. Yes.
    Ms. Zuckerman. Okay. Thank you. I am Dr. Diana Zuckerman, 
president of the National Center for Policy Research for Women 
and Families. I am especially grateful to have the opportunity 
to be here today, because 11 years ago, I was in a similar 
hearing room, only I was on that side of the table. Actually, 
it is a little easier on this side. Well, it wasn't even this 
room, but I was staffing the first congressional hearing on 
breast implants.
    And on that day, I listened to courageous women talk about 
their terrible experiences with breast implants, and I wondered 
if their stories could possibly be true. At that point, about a 
million women had breast implants, but there was no research to 
tell us how often these implants caused health problems. There 
were just a few studies of rats and other animals, none of 
humans.
    Eleven years later, there are studies of women, and it is 
now established that implants can cause serious complications, 
such as infections, which can sometimes be fatal, and the much 
more common problem of rupture and the need for additional 
surgery. And just a few months ago, two major new studies, 
conducted by the National Cancer Institute, reported that women 
who have silicone or saline breast implants are at increased 
risk of some kinds of cancer and at increased risk of death 
from brain cancer, lung cancer and other respiratory diseases. 
A third new study, conducted by the FDA, found that women with 
leaking silicon jell breast implants are more likely to have 
several painful and potentially fatal autoimmune diseases.
    These studies are very important, because unlike previous 
studies, every woman in these studies had implants for at least 
6 years. The studies that had been conducted that had found no 
increased health risks had usually included women who had 
implants for just a very short period of time, sometimes just a 
few months or a few years. And as we all know, it takes a lot 
longer than that for cancer or other serious diseases to 
develop. So the new NCI and FDA studies are not conclusive, but 
they raise frightening questions about the long-terms risks of 
both silicone and saline breast implants.
    The essential questions have not changed in the last 11 
years. There are two: Do breast implants increase health 
problems; and No. 2, do women with implants die at a younger 
age than they otherwise would? And we especially need to know 
what are the health risks for women who have reconstruction 
with implants after mastectomies and to provide informed 
consent to all patients before they have decided whether or not 
to undergo implant surgery. And that is why H.R. 1961, the 
Breast Implant Research and Information Act, is so very 
important.
    The number of American women and teenage girls that are 
getting implants for augmentation has more than doubled--more 
than doubled--in the last 3 years. Meanwhile, the FDA has not 
even bothered to look at the almost 200,000 adverse reaction 
reports that have been sent into them. And we are still 
listening to women with the courage to testify to Congress 
about their implant experiences. And many of the people in this 
room may still be wondering, can this be true what we are going 
to hear from them today? And if so, how often does this happen? 
It is time to stop wondering.
    The studies that were conducted by the NCI were mandated by 
Congress. They would not have been conducted at all, they never 
would have been conducted if it weren't for congressional 
pressure, but even so, they did not include a single mastectomy 
patient, not one. It is too late to fix those studies, but it 
is absolutely essential that we do start a new study that is a 
study of mastectomy patients. We have learned from experience 
that that study won't be conducted unless Congress makes that 
happen, and it looks like we need a law to require it.
    And, of course, all women, all women, mastectomy patients 
and augmentation patients, deserve informed consent. They 
deserve to know what the risks are when they are considering 
breast implants, and they especially deserve to know that there 
are these new NCI studies, the results of those studies and the 
FDA studies that show the potential of life-threatening 
diseases related to breast implants. So far that is not 
happening. Women today are not getting that kind of informed 
consent. And, again, it looks like it won't happen without your 
help.
    I have two other very brief suggestions, really brief. The 
NCI and the FDA studies that have already been published should 
be continued. Almost all the women in those studies have had 
implants for at least 11 years by now. It had been 8 years at 
the time they were analyzed; now it is 11 years of research. 
And so we can learn a lot more about the long-term risks of 
cancer and other diseases, and we can learn it for a lot less 
money just by continuing those studies. And, of course, because 
those studies don't include mastectomy patients, we still do 
need extra research on mastectomy patients.
    And I would just ask that 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. 
Breast implants and many other medical implants are not like 
other medical products. There are women who have had breast 
implants for many, many years already out there, and they are 
available to be studied, and the FDA should be mandated to do 
so. Since implants are forever, basically, they are implanted 
forever, the FDA approval should be based on long-term safety 
data, not just a year or 2 or 3 of safety data.
    In closing, I want to thank you for the privilege of 
testifying, and I especially want to thank Congressman Blunt 
and Congressman Green for their terrific staff and their 
terrific leadership on this issue. And I want to thank the 
other members of the committee and their staff--see, I was a 
staffer, you can tell--because you have listened to your 
constituents talking about these issues, and you have shown 
them great respect as they have described their implant 
problems.
    Our non-profit think tank thanks you on behalf of our 
organization and the thousands of consumers who have contacted 
us about health problems linked to implants and other medical 
devices. Thank you very much.
    [The prepared statement of Diana Zuckerman follows:]

 Prepared Statement of Diana Zuckerman, President National Center for 
                  Policy Research for Women & Families

    My name is Dr. Diana 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 Congressman Roy Blunt and 
these courageous women, to talk about the need for H.R. 1961, a bill 
that will help to ensure and protect women's 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 Reform and 
Oversight Committee, I started an investigation of the FDA's 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, 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 read 
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.
    In fact, 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 more 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 
showing no increase in disease for women with implants included many 
women who had implants for 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 they 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 
don't boast about it, their 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. And 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 increase health risks and
2) do women with implants die at a younger age than other women?
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 NIH at the time, Dr. Bernadine Healy, refused. 
It's 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 manufacturers' own 
studies, which show that one in four reconstruction patients need to 
have at least one additional surgery within the first three years after 
getting saline implants, and that other complication rates are also 
extremely high. 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 women's 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 don't know what will happen to those girls, but 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 patients' parents--know what the 
risks are well 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 for their essential work on this legislation. And, I thank the 
Committee members who have supported this legislation and shown respect 
and support for their constituents who have courageously shared their 
experiences with implants. We need your continued help. If Congress 
doesn't require that these important studies be conducted by NIH, it is 
unlikely that they ever will be. And so, we're 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 risks 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 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 FDA's 
consumer materials about breast implants.

    Mr. Bilirakis. Thank you very much, Doctor. Ms. Hoffman.

                    STATEMENT OF KIM HOFFMAN

    Ms. Hoffman. Mr. Chairman and members of this committee, 
thank you for giving me the opportunity to testify. My name is 
Kim Hoffman, and 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, 
in 1995, I experienced numerous debilitating problems 
immediately after receiving silicone breast implants, 
manufactured by Mentor Corporation. 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 to approve the widespread use 
of this product----
    Mr. Bilirakis. Kim, will you please pull that mike a little 
closer. I think it is important that we not miss any part of 
your story.
    Ms. Hoffman. Okay. Because the data collected in this 
study--is that better? Okay--could affect FDA's decision to 
approve the widespread use of this product, I recognized the 
importance of accurately documenting my problems and including 
them in the study.
    I reported my problems to my surgeon, but 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 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 had 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, but the companies were having major 
problems with quality control issues and were violating good 
manufacturing practices. These problems had gone on for years.
    Informants alleged that there were problems with the 
implant design and gel suppliers; there were defects with the 
implants, valves, outer shell and gel. It appeared many of 
these problems had been concealed from the FDA. I reported this 
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 and gave 
it to Congressman Gene Green, the FDA, the House Energy and 
Commerce Committee and eventually to Congressman Blunt. The 
FDA's copy was given to James Austin Templer, an FDA compliance 
officer who oversaw Mentor. He 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 which 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 approval application. 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 concern for American consumers, 
Mr. Templer tendered his resignation from a 12-year career at 
the FDA. He hoped his resignation would get the attention of 
the agency. In his resignation letter to the Commissioner, he 
urged the agency to conduct a thorough investigation of the 
allegations prior to the agency's approval of saline breast 
implants.
    Unfortunately, in May 2000, the FDA approved saline breast 
implants anyway. The approval came in spite of Mr. Templer's 
recommendation, in spite of complications rates of over 70 
percent for breast cancer patients in the first 3 years and in 
spite of an ongoing criminal investigation into Mentor, 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 its intended use. Clearly, this is 
not the case with this device. 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 affect 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. 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 the safety of breast implants nor have they 
investigated adequately the safety of breast implants. And in 
fact, they have looked the other way when credible allegations 
of criminal misconduct 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.''
    In conclusion, 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. This bill will ensure the FDA 
has full oversight and will provide accountability. This bill 
will ultimately benefit women's health and could also impact 
FDA's oversight of all medical devices.
    I want to thank Congressman Green and Congressman Blunt for 
their efforts and all the committee members who have supported 
H.R. 1961.
    [The prepared statement of Kim Hoffman follows:]

  Prepared Statement of Kim Hoffman, Patient Representative Regarding 
                            Breast Implants

    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 James 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 FDA's 
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 Bryant, Richard Burr, Frank 
Pallone Ted Strickland and Heather Wilson.
    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.

    Mr. Bilirakis. Thank you. Thank you so very much. Ms. 
Noonan-Saraceni?

               STATEMENT OF PAMELA NOONAN-SARACENI

    Ms. Noonan-Saraceni. Mr. Chairman and members of the 
committee, my name is Pamela Noonan-Saraceni. I am a breast 
cancer survivor who continues to endure the painful side 
effects from breast implants. I am very pleased to have this 
opportunity to be here with you today.
    Despite over 30 years of use, breast implants remain a 
classic example of, ``What we don't know can hurt us.'' The 
Institute of Medicine estimates by 1997 about 1.8 million 
American women had breast implants with nearly one-third of 
these women being breast cancer survivors. In 1999 alone, 
83,000 women received implants following mastectomies. In the 
year 2000, over 200,000 women received breast implants for 
cosmetic reasons.
    The FDA 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 were 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, so the role of the Government cannot be 
overlooked. The bill that has been introduced by 
representatives Roy Blunt and Gene Green, H.R. 1961, Breast 
Implant Research and Information Act, calls upon the FDA to 
strengthen the informed consent documents given to patients in 
breast implants clinical trials. It directs the NIH to conduct 
research desperately needed on breast implants recipients, and 
it ensures better FDA oversight of device manufacturers.
    To understand the need for this bill, I would like to tell 
you about my 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. At that time, I was active, I played 
tennis, I taught aerobics, and I 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, but I was never advised of any health risks 
associated with the implants; in fact, I was told they would 
last a lifetime, and the complications were rare.
    Within 3 months, I was back in the operating room. My body 
had formed a capsule around the implant, and the implant had 
shifted up to my collarbone. My symptoms began in the summer of 
1990 when I experienced joint pain and chronic fatigue. Various 
doctors gave me a list of diagnoses. Eventually, I again had to 
wear a prosthesis over the implant, because I was again 
misshapen and lopsided. Finally, in 1994, which was 10 years 
after my initial reconstruction, I had surgery for the fifth 
time; this time to remove the breast implant.
    My out-of-pocket medical expenses has totaled over $35,000. 
My husband and I are self-insured, and our insurance policy at 
the time carried an exclusion: I would not be covered for any 
illness or disability related to my reconstructive surgery. 
Apparently, the insurance company understood the health risk of 
breast implants, what they posed for women, and they were not 
willing to cover the costs.
    I believe there are improvements that need to protect women 
considering implants. This bill is a tremendous step forward in 
safeguarding American women. First, informed consent must be 
strengthened. The informed consent agreement, written by the 
implant manufacturers, is the only required information women 
receive prior to surgery. This document contains inaccurate and 
misleading information. Furthermore, the informed consent 
agreement does not mention the effects of breast implants on 
future mammography. This is probably not a concern to most 
cosmetic patients, yet over 30 percent of breast tissue can be 
obscured by an implant, which can delay the early detection of 
breast cancer.
    Until research is able to answer the long-term safety 
questions about breast implants, women, at the very least, need 
to be informed about what we do know: Chronic pain, hardening, 
infections and deformities, high rate of reoperations and 
ruptures, problems with insurance coverage, the fact that 
implants do not last a lifetime and will have to be replaced 
every 8 to 10 years and inaccurate mammography readings.
    Second is the need for long-term studies. I hope 1 day 
there will be a cure for breast cancer, but until then the NIH 
should be obligated to conduct long-term research so badly 
needed on breast implants. Almost no research has been done to 
track mastectomy patients who suffer with local complications 
at a higher rate than other breast implant recipients. No woman 
should survive breast cancer only to experience chronic pain, 
infections or deformities from implants. The latency period for 
complications and ruptures has been widely recognized in the 
scientific circles, but the FDA only required manufacturers to 
follow women in the saline implant trials for 3 years. The 
agency recently announced manufactures of silicone breast 
implants are required to study patients for only 2 years in 
order to glean data for their market approval. These studies 
will not provide meaningful data on a long-term safety and 
efficacy of the implant and will not protect American women.
    In conclusion, had I known the physical, emotional and 
financial hurdles I would have to overcome due to breast 
implants, I would have made a different decision. I would never 
have chosen implants. Despite the implant manufacturers' 
advertisements, breast reconstruction was not a part of my 
breast cancer recovery process; being cancer-free and feeling 
physically well enough to return to a normal life is. My 
experience and what I have learned from women across the 
country is my only breast implant expertise.
    I would like to acknowledge the women who helped to bring 
this message to Capitol Hill today. We have Anne Stansell from 
New Mexico, Marlene Keeling from Texas, Mary McDonough from 
California, Lisa Hickey from Arizona and Kim. We feel a 
tremendous responsibility to increase awareness about the 
safety questions which still surround breast implants, and we 
thank you for your support in the passage of H.R. 1961. Thank 
you.
    [The prepared statement of Pamela Noonan-Saraceni follows:]

 Prepared Statement of Pamela Noonan-Saraceni, Patient Representative 
                       Regarding Breast Implants

    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 today's hearing. You believe this issue has reached its 
saturation point. But, breast implants remain a classic example of 
``what we don't 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 FDA's 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, which is particularly 
worrisome for breast cancer survivors. We live in fear of finding 
reoccurring cancer. 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 Anderson 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. Anderson 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 
18 months 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 I've 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 today's hearing: 
Anne Stansell from New Mexico, Marlene Keeling from Texas, Mary 
McDonough from California, and Lisa 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.

    Mr. Bilirakis. Thank you very much for that great 
testimony. Mr. Morgan.

                    STATEMENT OF LLOYD MORGAN

    Mr. Morgan. Thank you, Honorable Chairman Michael Bilirakis 
and the whole Subcommittee on Health, 5 of whom are among the 
75 co-sponsors, and Honorable Representative Lee, the sponsor 
of H.R. 239, Benign Brain Tumor Cancer Registries Amendment 
Act, for allowing me to be here today.
    On April 28, 1995, I went to lunch with a colleague from 
work. Without warning or prior symptoms, I had a 45-minute 
grand mal seizure. My wife was told, ``You better get used to 
it, honey. He has between a few hours and a few days.'' I spent 
11 days, 8 in critical condition, at the hospital. The surgery 
took 12 hours; I was off work for 4 months. The reason? I had a 
peach-sized benign brain tumor. Unlike most benign brain tumor 
survivors, I escaped with only a minor deficit.
    Carla Brinegar had the same tumor. It was, like mine, 
completely removed by surgery. It has since reoccurred five 
times. She is now in a hospice in Sacramento, California, blind 
in one eye, unable to speak, unable to care for herself in 
anyway. This is a benign brain tumor. Jeff Licht had a pineal 
tumor in his brain completely removed. It has reoccurred twice. 
It is now inoperable and growing. He, too, has a benign brain 
tumor. The dictionary defines benign as harmless. All brain 
tumors are malignant by location.
    I am an electronic engineer. I am trained to use data in 
order to understand how the world behaves. I quickly learned 
that most SSate cancer registries, including California, where 
I live, did not collect data on benign brain tumors because 
they are not labeled as cancer. I am not a person who sits back 
when confronted with a challenge. Last year, California 
corrected this oversight with the passage of assembly bill 48. 
My Congresswoman, Barbara Lee, picked up our cause. As a 
result, H.R. 239 was introduced in the House.
    I am active in the North American Brain Tumor Coalition and 
I am a member of the Board of the Central Brain Tumor Registry 
of the United States. I attend several scientific conferences 
and patient symposiums each year. This week, I will be at the 
Society of Neuro-Oncology here in DC. But, please understand, I 
am here today, not as a member of any organization. I am here 
as a benign brain tumor survivor, and I am here on behalf of 
all brain tumor patients, especially those that have died from 
a benign brain tumor.
    H.R. 239 amends the Cancer Registry Act to include data 
collection of benign brain tumors. It is non-controversial, has 
widespread support from the cancer surveillance community, 
brain tumor researchers and clinicians, patients and their 
families. Its cost is very small, an estimated $923,520).
    The most common benign brain tumors are: Meningiomas, a 
tumor of the meninges, the lining of the brain. This is the 
tumor that I had and that Carla Brinegar has. Acoustic 
Neuromas, a tumor of the acoustic nerve. Often it results in 
deafness. Pituitary Adenoma, a tumor of the pituitary, or 
master, gland located within the brain. All too often it 
results in hormonal devastation. Pineal tumors, tumors of the 
pineal gland located within the brain. This is the type of 
tumor that Jeff Licht has. There are other benign brain tumors.
    Benign brain tumors are estimated to number about half of 
all brain tumors. Approximately 21 percent of children's brain 
tumors are benign. Since primary, that is benign and malignant, 
brain tumors are the leading cause of cancer death in children, 
cancer registries already collect most of these benign 
children's tumors. Collecting data on all benign brain tumors 
will amount to less than 3 percent of all data collected by 
cancer registries.
    For women, a meningioma, a benign brain tumor, is more 
deadly than breast cancer; 69 percent survival in 5 years 
compared to 84 percent for breast cancer. In Norway, where data 
is kept on benign brain tumors, the incidence rate for men has 
increased by 250 percent; for women 280 percent for 3 decades, 
between 1962 and 1992. Is this happening in the United States? 
We cannot know without data. Only with the data provided as a 
result of H.R. 239 will we have the ability to recognize 
trends, the full scope of the problem, the potential cause, the 
best treatment options, as is done with cancer.
    There are now an estimated 267,000 people with benign brain 
tumors, including Members of this Congress. I urge this 
subcommittee to pass H.R. 239. I urge the Energy and Commerce 
Committee to pass H.R. 239, and I certainly urge the House of 
Representatives to pass H.R. 239. I would also like to give a 
special thanks to Lynette Farhadian of Congressman Lee's staff 
for all the work she has done for us. Thank you so much. Do you 
have any questions?
    [The prepared statement of Lloyd Morgan follows:]

                   Prepared Statement of Lloyd Morgan

    Thank you Honorable Chairman, Michael Bilirakis and the whole 
Subcommittee on Health, 5 of whom are among the 75 cosponsors of HR239, 
the Benign Brain Tumor Cancer Registries Amendment Act, for allowing me 
to be here today.
    On April 28th 1995 I went to lunch with a colleague from work. 
Without warning or prior symptoms, I had a 45-minute grand mal brain 
seizure. My wife was told, ``You better get use to it, honey. He has 
between a few hours and a few days.'' I spent 11 days, 8 in critical 
condition, at the hospital. The surgery took 12 hours. I was off work 
for 4 months. The reason? I had a peach sized ``benign'' brain tumor! 
Unlike most ``benign'' brain tumor survivors, I escaped with only a 
minor deficit.
    Carla Brinegar had the same tumor. It was, like mine, completely 
removed by surgery. It has since reoccurred 5 times. She is now in a 
Hospice, blind in one eye, unable to speak, unable to care for herself 
in anyway. This is a ``benign'' brain tumor!
    Jeff Licht had a pineal tumor in his brain completely removed in 
1993. It has reoccurred twice. It is now inoperable and growing. He, 
too, has a ``benign'' brain tumor.
    The dictionary defines benign as harmless. All brain tumors are 
malignant by location.
    I am an electronic engineer. I am trained to use data in order to 
understand how the world behaves. As soon as I came home from the 
hospital I tried to find the data for ``benign'' brain tumors. I 
quickly learned that most state cancer registries, including 
California, where I live, did not collect data on ``benign'' brain 
tumors because they are not labeled as cancer. I am not a person who 
sits back when confronted with a challenge. Last year California 
corrected this oversight with the passage of AB 48. My Congresswoman, 
Barbara Lee picked up our cause. As a result HR 239 was introduced in 
the House.
    I am involved with various brain tumor organizations. I am active 
in the North American Brain Tumor Coalition (NABTC) and a member of the 
Board of the Central Brain Tumor Registry of the United States 
(CBTRUS). I attend several scientific conferences and patient 
symposiums each year (this week I will be at the Society of Neuro-
Oncology's meeting, here in DC). But, please understand, I'm here 
today, not as a member of any organization. I'm here as a ``benign'' 
brain tumor survivor.
HR 239: What it does
    HR 239 amends the Cancer Registry Act to include data collection of 
``benign'' brain tumors. HR 239 is an ideal bill for Congress to pass 
this year. It is non-controversial, has wide spread support from the 
cancer surveillance community, brain tumor researchers and clinicians, 
patients and their families. Its cost is very small (an estimated 
$923,520). It will provide an accurate description of brain tumors in 
our country so that we can fight this enemy offensively. I am sure you 
seldom get an opportunity to correct such a tragic oversight without 
either controversy or significant cost.
``Benign'' Brain Tumors
    The most common ``benign'' brain tumors are:

 Meningiomas: a tumor of the meninges, the lining of the brain. 
        This is the tumor that I had and that Carla Brinegar has.
 Acoustic Neuromas: a tumor of the acoustic nerve. Often it 
        results in deafness.
 Pituitary Adenoma: a tumor of the pituitary (or master) gland 
        located within the brain. All too often it results in hormonal 
        devastation.
 Pineal tumors: tumors of the pineal gland located within the 
        brain. This is the type of tumor that Jeff Licht has.
 There are other ``benign'' brain tumors.
``Benign'' Brain Tumor Statistics
    ``Benign'' brain tumors are estimated to number about half of all 
brain tumors. Approximately 21% of children's brain tumors are 
``benign''. Since primary (``benign'' and malignant) brain tumors are 
the leading cause of cancer death in children, cancer registries 
already collect most of these ``benign'' tumors. Collecting data on all 
``benign'' brain tumors will amount to less than 3% of all data 
collected by cancer registries.
    Meningiomas are 27% of all brain tumors, and 35% of all brain 
tumors in women. For women, this ``benign'' brain tumor is more deadly 
than breast cancer; 69% survival compared to 84%. In Norway, where data 
is kept on ``benign'' brain tumors, the incidence rate for men has 
increased by 250%; for women 280% for over three decades. Is this 
happening in the United States? We cannot know without data.
    While 21 states do collect ``benign'' brain tumor data, the 
remainder do not. HR239 will correct this oversight.
    There are now an estimated 267,000 people with ``benign'' brain 
tumors including members of this Congress.
    I urge this Subcommittee to pass HR239. I urge the Energy and 
Commerce Committee to pass HR239. I urge the House of Representatives 
to pass HR239.
    Thank you so much. Are there any questions?

    Mr. Bilirakis. Thank you, Mr. Morgan. Dr. Howell. And we 
will have questions.

                   STATEMENT OF DWAYNE HOWELL

    Mr. Howell. Good afternoon, Mr. Chairman and members of the 
committee. I appreciate the opportunity to testify today on the 
Hematological Cancer Research and Investment Act of 2001. I am 
Dwayne Howell, the president and CEO of The Leukemia & Lymphoma 
Society, and equally important, I am the parent of a child who 
died from leukemia in 1973, a time when research advances and 
the prospects for patient survival from a blood cancer were 
much more limited than they are today.
    The society is a voluntary health agency, and we fund 
research into blood cancers and help patients through our 59 
chapters around the country. We are, by far, the largest 
private funder of blood cancer research, with a budget this 
year of over $40 million.
    The burden of the hematological cancers is usually 
underestimated. People think of leukemia, lymphoma, myeloma, 
and Hodgkin's disease as separate entities, and they measure 
the prevalence and the incidence of those diseases separately. 
But when together, blood cancers represent the fourth most 
common form of cancer. In 2001, almost 700,000 people are 
living with leukemia, lymphoma and myeloma, and this year, 
110,000 people will be diagnosed with them and 60,000 will die 
from them.
    Patients, their families, friends and caregivers applaud 
the efforts of Representatives Phil Crane, Marge Roukema, Mike 
Ferguson, and Vic Snyder to develop legislation to focus the 
Nation's blood cancer research and education programs, and we 
also appreciate the willingness of the subcommittee to consider 
this bill in 2001. This is a time of great challenge and also 
tremendous opportunity for blood cancer research, and a 
coordinated and strengthened program is essential.
    The Federal Government currently makes a substantial 
investment in blood cancer research, an investment that is 
complemented by private funders, such as The Leukemia and 
Lymphoma Society. But despite the strong commitment of public 
and private funders, the research effort can be improved. The 
Hematological Cancer Research Investment and Education Act 
would make improvements in the existing research program to 
enhance the fundamental understanding of blood cancers and 
accelerate the development of new therapies.
    The act would also establish the Joe Moakley Cancer 
Education Program, an important educational initiative for 
patients and the public that would allow for coordination with 
existing private sector patient education and service programs. 
Patient service and education are a major focus of The Leukemia 
& Lymphoma Society, and we look forward to the Federal 
Government's involvement and collaboration in patient and 
public education.
    The Leukemia and Lymphoma Society would like to express its 
deep appreciation for your decision to focus on the 
hematological cancer research and education bill in the midst 
of the great pressures facing Congress. Your prompt action to 
evaluate the legislation is critically important to individuals 
living with blood cancers and their families and friends. The 
opportunity for research advances and the necessity for 
educating patients about those advances confront us now, and 
this act will help us respond to those challenges.
    We have reason to be hopeful. Our substantial investment in 
basic research has enhanced knowledge of the nature of these 
cancers and contributed to major advances in treatment. Genetic 
and molecular analyses of hematological cancers are identifying 
targets for drug development, and this work has yielded a 
groundbreaking new therapy for chronic myelogenous leukemia, or 
CML. We hope this new therapy, a signal transduction inhibitor 
called Gleevec, is the first of other similar drugs that are 
targeted to intercept a cellular malfunction that leads to 
cancer. There are other promising approaches to treatment of 
blood cancers, including cancer vaccines, employing 
immunotherapy, laboratory-designed monoclonal antibodies that 
target therapy to tumor antigens and leave the normal cells in 
tact, and the use of an antibody to carry a radioactive isotope 
or toxin to the cancer cells.
    The investment in research on the blood cancers will yield 
benefits beyond improvements in treatments for these cancers. 
The advances in understanding and treatment of blood cancers 
have also contributed to enhanced therapies for other forms of 
cancer. Chemotherapy drugs that were developed for treatment of 
leukemia, for example, are now saving the lives of individuals 
with solid tumors. Molecular therapies, such as Gleevec that I 
just mentioned, has also been beneficial and is saving the 
lives of patients with gastrointestinal tumors. Support for 
hematological cancers benefits all cancer research and has the 
potential to improve the lives of many cancer survivors.
    On behalf of the hundreds of thousands of leukemia, 
lymphoma and myeloma survivors and their families, friends and 
caregivers, we would like to thank you for your attention to 
hematological cancer research and education. We look forward to 
committee approval of this bill, and we approve your efforts to 
advance this bill. Thank you.
    [The prepared statement of Dwayne Howell follows:]

 Prepared Statement of Dwayne Howell, President & CEO, The Leukemia & 
                            Lymphoma Society

    Good afternoon, Mr. Chairman and Members of the Committee. I 
appreciate the opportunity to testify today on the Hematological Cancer 
Research Investment and Education Act of 2001. I am Dwayne Howell, the 
President and CEO of The Leukemia & Lymphoma Society. The Society is a 
voluntary health agency that raises funds to support research on the 
blood cancers and provides services to individuals with blood cancers 
and their families. In fiscal year 2001, we committed $36 million to 
hematological cancer research, including major grants to support 
specialized centers of research excellence in blood cancers, and we 
hope to fund research totaling almost $40 million in fiscal year 2002. 
Through our 59 chapters, we support patients and their families around 
the country.
    The burden of the hematological cancers, including leukemia, 
Hodgkin's disease, non-Hodgkin's lymphoma, and multiple myeloma, is 
often underestimated. However, if these diseases are taken together, 
they represent the fourth most common cancer. In 2001, almost 700,000 
are living with hematological malignancies. In this year, approximately 
110,000 individuals will be diagnosed with leukemia, lymphoma, and 
myeloma, and more than 60,000 will die from these cancers.
    These individuals, their families, friends, and caregivers applaud 
the efforts of Representatives Phil Crane, Marge Roukema, Mike 
Ferguson, and Vic Snyder to develop legislation to focus the nation's 
blood cancer research and education programs and we also appreciate the 
willingness of this Subcommittee to consider this bill in 2001. This is 
a time of great challenge and also tremendous opportunity for blood 
cancer research, and a coordinated and strengthened research program is 
essential. The obstacles of educating patients, their families, and the 
public regarding the blood cancers grow as our knowledge of the 
diseases deepens and the range of treatment options expands, and a 
public-private partnership in that educational effort is crucial.
    The Hematological Cancer Research Investment and Education Act of 
2001 authorizes an initiative to intensify and coordinate blood cancer 
research efforts at the National Institutes of Health (NIH) and the Joe 
Moakley Cancer Education Program within the Department of Health and 
Human Services. These programs will facilitate advances in the 
treatment of blood cancers and the education of patients and the public 
regarding blood cancers.
    The federal government currently makes a substantial investment in 
blood cancer research, an investment that is complemented by the 
research support of The Leukemia & Lymphoma Society and other private 
research organizations. Despite the strong commitment of public and 
private funders, the research effort can be improved with more funding 
and greater coordination. The Hematological Cancer Research Investment 
and Education Act would make improvements in the existing research 
program to enhance the fundamental understanding of blood cancers and 
accelerate the development of new therapies.
    The Act would also establish the Joe Moakley Cancer Education 
Program, an important educational initiative for patients and the 
public that would allow for coordination with existing private sector 
patient education and service programs. Patient service and education 
are major areas of focus for The Leukemia & Lymphoma Society, and we 
look forward to the federal government's involvement and collaboration 
in patient and public education.
    The Leukemia & Lymphoma Society appreciates the tremendous 
responsibilities and pressures that face the Congress as it attempts to 
respond to the events of September 11, and we would like to express our 
deep appreciation for your decision to focus on the hematological 
cancer research and education bill in the midst of these pressures. 
Your prompt action to evaluate this legislation is critically important 
to individuals living with blood cancers and their families and 
friends. The opportunity for research advances and the necessity for 
educating patients about those advances confront us NOW, and the 
Hematological Cancer Research Investment and Education Act will help us 
respond to those challenges.
    Over the last half-century, researchers have made impressive 
advances in the treatment of some forms of leukemia and Hodgkin's 
disease. In fact, many cite these diseases as success stories of cancer 
research. There has been much less progress in the treatment of non-
Hodgkin's lymphoma, multiple myeloma, and some forms of leukemia. 
Particularly troubling is the fact that the death rate for non-
Hodgkin's lymphoma has increased by 45% from the time period between 
1973 and 1998 and the death rate for multiple myeloma has increased by 
more than 32% in the same time period.
    Despite these troubling statistics, we have reason to be hopeful. 
Our substantial investment in basic research has yielded enhanced 
knowledge of the nature of hematological cancers and contributed to 
advances in treatment. Genetic and molecular analyses of hematological 
cancers are identifying targets for drug development, and this work has 
yielded a groundbreaking new therapy for chronic myelogenous leukemia, 
or CML. We hope this new therapy, a signal transduction inhibitor 
called Gleevec, is the first of other similar drugs that are targeted 
to intercept a cellular malfunction that leads to cancer. There are 
other promising approaches to treatment of blood cancers, including 
cancer vaccines employing immunotherapy to enhance the recognition and 
destruction of cancer cells; laboratory-designed monoclonal antibodies 
to use the specificity of an antibody directed against a tumor antigen 
to target therapy to the tumor, sparing normal cells; and the use of an 
antibody to carry a radioactive isotope or toxin to the cancer cells.
    The investment in research on the blood cancers will yield benefits 
beyond improvements in treatments for these cancers. The advances in 
the understanding and treatment of the hematological cancers have also 
contributed to enhanced therapies for other forms of cancer. 
Chemotherapy drugs that were developed for treatment of leukemia, for 
example, are now saving the lives of individuals with solid tumors. 
Support for hematological cancers benefits all cancer research and has 
the potential to improve the lives of many cancer survivors.
    To ensure that we realize the benefits of our investment in basic 
research and continue to make advances in the treatment of blood 
cancers, there must be a strong partnership between the private and 
public sectors. A special panel of researchers convened by the National 
Cancer Institute (NCI), called the Leukemia, Lymphoma, and Myeloma 
Progress Review Group (LLM PRG), has developed a comprehensive set of 
recommendations for hematological cancer research. This ambitious plan 
reflects lengthy deliberations of a group that included researchers, 
government officials, industry, and patient advocates and sets an 
aggressive course for hematological cancer research, with a special 
emphasis on partnerships between the private and public sectors. The 
Hematological Cancer Research Investment and Education Act will help us 
realize the goals of the PRG report, which are concentrated on 
accelerating the development of new therapies for leukemia, lymphoma, 
and myeloma.
    On behalf of the hundreds of thousands of leukemia, lymphoma, and 
myeloma survivors and their families, friends, and caregivers, we would 
like to thank you for your attention to hematological cancer research 
and education. We look forward to Committee approval of this bill, and 
we appreciate your efforts to advance this bill.

    Mr. Bilirakis. Thank you very much, sir. Ms. Johnson?

               STATEMENT OF JACQUELINE L. JOHNSON

    Ms. Johnson. I am honored to be here today on behalf of the 
National Congress of American Indians, which is the largest 
national organization of tribal governments in this Nation, to 
discuss with you an issue that is of great concern to our 
Health Committee. And at the last mid-year session of the 
National Congress of American Indians, we passed a resolution 
supporting the inclusion of the Native American women in the 
Native American Breast and Cervical Cancer Treatment Technical 
Amendment Act.
    I also would like to begin by thanking Mr. Udall of New 
Mexico and the co-sponsors of this act for taking the 
initiative to put forward this corrective action, and I might 
also note that there are written statements also in support of 
the inclusion of the Native American women by not only Tom 
Udall, J.D. Hayworth, J.C. Watts, American Cancer Society and 
the National Native American Indian Health Board.
    It is our--as we know, in the original passage of the act, 
the HIPAA Act, there was a reference to include Indian health 
care that was not originally included in the HIPAA Act so that 
members of the tribes that were eligible for Indian Health 
Service and not necessarily under insurance coverage could be 
considered eligible for this important provision, which also 
dealt with the fact that there are many times tribal members 
who have received health services under Indian Health were not 
necessarily--would not be subject of pre-existing conditions 
and long waiting periods when seeking health insurance.
    Thus, in the HIPAA context, the inclusion of the Indian 
health tribal provision was intended to benefit American 
Indians and Alaskan natives, and, unfortunately, as you heard 
earlier by Mr. Pallone and by the statement of the chairman, in 
fact the act had the opposite effect. And rather than in 
benefiting the American Indian women, it works to penalize them 
from receiving coverage under the Breast and Cervical Cancer 
Treatment and Prevention Act. In fact, many Indian women who 
rely on the Indian Health Service tribal programs for basic 
health are excluded within the new law eligibility for 
Medicaid. Not only does this definition deny coverage to Indian 
women, but also the provision runs counter to the general 
Medicaid rule that allow Indian Health Service facilities to be 
full medical providers.
    In summary, I would just like to also note that as a Native 
American woman whose family has breast cancer in their direct 
line and who all my family receives services under the Indian 
health care service provisions, I know that this is a deep 
concern to not only Native American women, Indian Health Board 
but certainly to my family, additionally. We support the 
technical amendment that clarifies, for the purposes of this 
Breast and Cervical Cancer Treatment and Prevention Act, that 
credible coverage shall not include the Indian Health Service 
funded care so that American Indians and Alaska native women 
can be covered by Medicaid for breast and cervical cancer 
treatment.
    And with that, I would like to thank you for your support 
in including the Native Americans to correct, which I am sure 
was not intentional but an oversight of the committee, and I am 
sure that the right things will be done. Thank you. Goonesh 
Shish.
    [The prepared statement of Jacqueline L. Johnson follows:]

Prepared Statement of Jacqueline Johnson, Executive Director, National 
                      Congress of American Indians

    Good Afternoon Chairman and distinguished committee members. It is 
an honor to be invited to provide testimony before the House Energy and 
Commerce Committee, Subcommittee on Health. I am Jacqueline Johnson, 
Executive Director of the National Congress of American Indians (NCAI). 
As the oldest and largest national Indian advocacy organization in the 
United States, NCAI is dedicated to advocating on behalf of our member 
tribal governments on a broad range of issues affecting the health, 
welfare, and self-determination of Indian Nations. I greatly appreciate 
the opportunity to make comments on H.R. 1383, the Native American 
Breast and Cervical Cancer Treatment Technical Amendment Act of 2001, 
and ask that this statement be included in the hearing record.
    I would like to begin by thanking Mr. Udall of New Mexico and the 
cosponsors of H.R. 1383 for taking the initiative to correct language 
in the Breast and Cervical Cancer Treatment and Prevention Act so that 
Indian women will not be denied treatment for breast and cervical 
cancer.
    NCAI member tribal governments strongly endorsed the inclusion of 
Indian women in the Breast and Cervical Cancer Treatment Program 
through a resolution passed earlier this year at its midyear session. 
This bill makes an extremely important yet simple technical change to 
the ``Breast and Cervical Cancer Treatment and Prevention Act'' (P.L. 
106-354) that will improve the coverage of breast and cervical cancer 
treatment for American Indian and Alaska Native women.
    The Breast and Cervical Cancer Treatment and Prevention Act gives 
states the option to extend coverage to certain women who have breast 
or cervical cancer who have been screened by programs operated under 
Title XV of the Public Health Service Act (the National Breast and 
Cervical Cancer Early Detection program) and who have no ``creditable 
coverage.''
    The Health Insurance Portability and Accountability Act of 1996 
(HIPPA) established the term ``creditable coverage.'' Under HIPPA, the 
term ``creditable coverage'' is defined to include a reference to the 
medical care program of the Indian Health Service (IHS). In short, the 
reference to ``creditable coverage'' in the Breast and Cervical Cancer 
Treatment and Prevention Act effectively excludes Indian women from 
receiving Medicaid breast and cervical cancer treatment as provided for 
under the Act.
    The Indian health reference to IHS/tribal care was originally 
included in HIPPA so that members of Indian Tribes eligible for IHS 
would not be treated as having a break in coverage (and thus subject to 
pre-existing exclusions and waiting periods when seeking health 
insurance) simply because they had received care through Indian health 
programs, rather than through a conventional health insurance program. 
Thus, in the HIPPA context, the inclusion of the IHS/tribal provision 
was intended to benefit American Indians and Alaska Natives.
    Unfortunately, use of the HIPPA definition of ``credible coverage'' 
in the recent ``Breast and Cervical Cancer Treatment and Prevention 
Act'' has the exact opposite effect, and rather than benefiting 
American Indian women, it works to penalize them from receiving 
coverage under the Breast and Cervical Cancer Treatment and Prevention 
Act.
    In fact, the many Indian women who rely on IHS/tribal programs for 
basic health care are excluded from the new law's eligibility for 
Medicaid. Not only does the definition deny coverage to Indian women, 
but the provision runs counter to the general Medicaid rule treating 
IHS facilities as full Medicaid providers. Without this important 
correction, the many Indian women impacted by breast and cervical 
cancer will be left without the resources needed to reverse this trend 
because of their exclusion from the new Medicaid coverage option.
    H. R. 1383, would remedy these problems by clarifying that, for 
purposes of the ``Breast and Cervical Cancer Prevention and Treatment 
Act,'' the term ``creditable coverage'' shall not include IHS-funded 
care so that American Indian and Alaska Native women can be covered by 
Medicaid for breast and cervical cancer treatment.
    Improving the health of Indian women in Indian Country is an 
important component of NCAI's health agenda. I am confident to say that 
NCAI supports H.R. 1383 as an important technical amendment to ensure 
that American Indian and Alaska Native women receive life-saving breast 
and cervical cancer treatment. We look forward to working with this 
committee to improve the health and the well-being of Indian people. 
Thank you once again for the opportunity to provide this statement in 
support of H.R. 1383, the Native American Breast and Cervical Cancer 
Treatment Technical Amendment Act of 2001.

    Mr. Bilirakis. Well, thank you, Ms. Johnson. And it clearly 
was an oversight; certainly was not intended. You are correct 
there.
    Well, there is so much. Mr. Morgan, you mention in your 
written testimony that 21 States presently collect data on 
benign brain tumors.
    Mr. Morgan. Yes.
    Mr. Bilirakis. So I guess my questions are: What is done 
with this data, and has the collection of the data led to 
improvements in public health? Because you emphasize the 
collection of the data and it should be listed on the registry, 
and I tend to agree with you. I am just wondering what the 
positive effect of that would be. Explain.
    Mr. Morgan. Yes. The 21 States that do collect, three of 
those States only began in--or the legislation was only passed 
in the last year, which includes California. The registry data, 
in general, is used to determine incidence of morbidity, 
treatment outcomes and so on. And within the States, I presume 
that that is being done. Within the United States, there is no 
national data base, except from a small non-profit that I am a 
member of the board of, the Central Brain Tumor Registry of the 
United States. And the reason that we know, for example, that 
the mortality 5-year survival rates for women with meningiomas 
is lower than breast cancer is because that data allows that to 
come together from the States, and that is based on, I think, 
12 States. Does that answer your question?
    Mr. Bilirakis. I guess I am looking for a little more than 
that. The collection of the data, in other words, how does it 
directly help in terms of improvements in public health? What 
is it? Is there a determination of environmental factors that 
might lead to----
    Mr. Morgan. Exactly. In order--I mean the overall concept 
of collecting the data not only allows you to understand what 
kinds of treatments have what kinds of effects and so on, but 
in the end the true desire is to determine the etiology, the 
cause. And without the data, there is no way to look. There is 
nothing to go looking for.
    Mr. Bilirakis. All right. Great. That is what I figured, 
but I just wanted to hear it from you.
    Dr. Howell, I understand that less than 5 percent of 
Federal funds for cancer research are spent on blood cancers, 
and yet, as I understand it, blood cancers account for about 11 
percent--might be more--of all cancer deaths in the United 
States. So give me your opinion. Have you looked into the NIH 
research, and do you feel that they are neglecting blood cancer 
research?
    Mr. Howell. Well, the NIH estimate of 5 percent of the 
outlay for cancer research going toward blood cancers is that, 
an estimate. I can't dispute or agree with that estimate. I can 
say this: That there has been good work done by the National 
Cancer Institutes and other institutes, and we are on the edge 
of a time now when research investment will save lives. 
Gleevec, a non-toxic, genetic therapy, developed just recently, 
has borne that out. And the point I would make is that research 
by the NIH, that kind of investment, and by private funders, 
such as WE, will result in lives saved now, and the promise is 
greater than it has ever been.
    Mr. Bilirakis. So you are satisfied that generally--nobody 
is really ever satisfied, because we never think enough money 
goes into research--but as far as the NIH funding for research 
is concerned, that it is basically doing the job?
    Mr. Howell. The NIH is launching good programs. We would 
like to see greater investment at the NIH and among private 
funders as well, because that extra investment is what is 
needed to leverage this increased scientific understanding that 
might help.
    Mr. Bilirakis. This committee, has hearings as you can 
imagine on a number of different sicknesses and illnesses, many 
of which many of us have never even heard of. And, of course, 
we have had Muhammad Ali and just so many others here pleading 
for more money for Parkinson's research, for instance.
    What we try to do here in the Congress is--and, really, I 
think we have been pretty cooperative. We just feel we are an 
ivory tower, and we don't really know how much money should go 
into research for Parkinson's against the owners of that 
illness. Therefore, we leave it up to NIH to make that 
determination, although every once in a while we will write a 
letter and ask them for a greater emphasis, regarding a 
particular illness.
    I just wanted you to know that that is basically a policy 
that we establish here, because, who are we to tell them? We 
like to think, too, as you have indicated, that when they are 
right on the verge of a breakthrough, then they can focus more 
dollars there, and how can we tell them where those dollars 
should go?
    Mr. Howell. Well, I should say, Mr. Chairman, that the 
National Cancer Institute convened a Progress Review Group on 
blood-related cancers and worked with that group and agreed 
that this was an areas where focus and emphasis would have a 
strong return on investment, based on the therapies and the 
discoveries that have come to light recently. So I don't think 
we are in dispute with the National Cancer Institute or the 
National Institutes of Health that more investment here is 
timely.
    Mr. Bilirakis. Yes, sir. Thank you. Ms. Hoffman, Ms. 
Saraceni, your stories are just--well, they trouble us; there 
is no question about that, particularly Ms. Hoffman. But I do 
know that my colleagues are going to concentrate on those 
particular areas. And I would now yield to Mr. Green.
    Mr. Green. Thank you, Mr. Chairman, and I do have some 
questions on the other issues, but this is the first time we 
have been able to do this, and I thank you again for having 
hearing. I would like to first ask Ms. Noonan-Saraceni, you 
mention in your testimony that there is little research being 
done on the effects of implants on women who use them for 
reconstruction following a mastectomy, but we know that more 
than 70 percent the mastectomy patients experience some 
complications. Can you comment on the situation and your 
concerns about the lack of research, as a breast cancer 
survivor?
    Ms. Noonan-Saraceni. As a breast cancer survivor, I 
mentioned earlier that I am more ill now than I was prior to. I 
just basically have statistics that there has not been any 
breast cancer patients in the NIH studies, so from there the 
statistics are basically what has been sent in from women that 
we have done--the manufacturers.
    Mr. Green. If Ms. Hoffman or Dr. Zuckerman would comment on 
it.
    Ms. Zuckerman. Yes. Let me just mention the complication 
rate of over 70 percent is based on the manufacturers' own 
studies. The only studies that have been conducted were 
conducted in order to get approval for saline breast implants. 
And so when the studies were submitted to the FDA a couple of 
years ago, they provided data on just a few hundred, I think it 
was about 300, breast cancer survivors who had used implants, 
and their complication rates for Magan and Mentor, the two 
manufacturers, were over 70 percent. But those are the only 
studies, and they did not look at illnesses. So when we say 
there is no research on mastectomy patients, we mean that there 
is research on complications, what are called local 
complications, such as infection, but not on systemic diseases, 
such as cancer, autoimmune disease or other diseases.
    Mr. Green. Okay. Dr. Zuckerman, one of the things the 
legislation calls for is improved informed consent for patients 
so they know exactly what the risks are for implants before 
they get them. Can you tell our committee, for the record, a 
little bit about the current information provided to implant 
patients and why it is not sufficient?
    Ms. Zuckerman. Sure. Basically, the doctors really have 
total freedom to provide the information that they see fit. One 
of the interesting developments of recent years is that plastic 
surgeons are frequently requiring patients to sign forms that 
basically give away their legal rights but don't necessarily 
give them much in the way of informed consent rights. And so 
when the FDA approved saline breast implants in the year 2000, 
the Advisory Committee specified that it was absolutely 
essential that patients be given informed consent, better 
information about risks. The FDA did not require the surgeons 
to do that, and so it really is up to the surgeons.
    Most of the information that is available is available 
from, basically two different sources: One is the manufacturers 
themselves. They do have package inserts, just the same kind of 
inserts that you might see when you buy cold medication, for 
example, written in the same teeny tiny type that people can't 
read. In addition to that, in the case of implants, the package 
insert is given to the surgeon. The surgeon is the person who 
buys the implant, not the patient, and so there is not a 
requirement to give that information directly to the patient. 
So that is one potential source of information that patients 
may see but don't necessarily get to see. And the other is 
information from the FDA itself. They do have a patient 
brochure which is quite good but is not totally up to date, 
does not include information from these new studies showing 
increased risks of cancers, for example, and increased risks of 
autoimmune diseases.
    So the short answer is currently there is no requirement, 
and that means that some doctors do a great job of providing 
information about risks, and other doctors provide very poor 
information or no information practically at all.
    Mr. Green. Okay. In your testimony, you point out that 
Congress has already told NIH once that they need to perform a 
study on breast implants, including a study on the breast 
cancer survivors. And there is some reluctance, I guess, from 
the NIH's own behalf to perform the study. Can you comment on 
why you think there is that resistance to getting this 
information the first time around and what we can do in the 
future to really find out this need?
    Ms. Zuckerman. Sure. It was really shocking to me, as a 
congressional staffer at the time, that Congress would ask that 
something be done and it would just be ignored like that. And, 
basically, the person who was the head of NIH was Bernadine 
Healy who was the first woman head of the NIH. She just refused 
to include mastectomy patients in the study. I think it was 
because including cancer patients makes the study more 
complicated and makes it more expensive. You have to deal with 
things like some of the patients get chemotherapy and some get 
radiation and some don't, things like that. It does make a 
study more expensive.
    My training is in epidemiology, so I really understand 
research design, but on the other hand, this is a very 
important group of women. So even though the study might have 
cost more, might have been more complicated, I don't think 
anybody in this room thinks that breast cancer patients don't 
deserve to have studies to find out whether implants are safe 
for them. So I think that if--I hope that if the Congress this 
time, well, first of all, puts it in a bill as opposed to, I 
think in a letter to Bernadine Healy, I think that having it in 
legislation will make a big difference, hopefully.
    Mr. Green. Thank you. Thank you, Mr. Chairman.
    Mr. Bilirakis. I am contemplating maybe a brief second 
round, I might add at this point. These good people have waited 
a long, long time for us to get back here to get started. The 
least we could do is give them an opportunity to communicate to 
us. Mr. Blunt to inquire.
    Mr. Blunt. Thank you, Mr. Chairman. Thank you again for 
holding this hearing. Let me ask, first of all, Dr. Zuckerman, 
what do you think that the average person when they get the 
safe and effective determination from FDA would assume that 
means?
    Ms. Zuckerman. Well, if they are like everybody I know, 
they assume that it means that a product is really truly safe. 
I think one of the shocking things to me is that when you have 
a product that is really cosmetic--implants are a cosmetic 
product; they don't save lives. They may improve the quality of 
life for some women, particularly women after a mastectomy, but 
they are not life saving. And so you would think the standard 
would be higher. But in this particular case, saline breast 
implants were approved despite a very high complication rate. 
Silicone gel breast implants have never been approved at all.
    So I think that patients do assume that if they are sold 
even in this country, they must be safe and especially if they 
are approved, they must really be safe. And in this case, I was 
at the Advisory Committee meeting when experts were looking at 
the data, and they were saying things like, ``Well, I guess 
they are safe if you define safe as not killing people,'' which 
I don't think is a good standard for a cosmetic device.
    Mr. Blunt. I might ask you, Ms. Hoffman, the same question. 
When you were told these were safe and they are FDA approved as 
safe and effective, what did you assume that meant?
    Ms. Hoffman. I was told not only that they were safe but 
they would last a lifetime, so I assumed that they would not 
cause me to have to have additional surgery. I did not know 
that they would cause me to not be able to work or to become 
uninsurable. I was put on disability, I lost my businesses, I 
lost my health insurance, and now I have trouble getting health 
insurance. Even women who have removed their breast implants 
have trouble getting health insurance. It is as thought the 
health insurance companies know something that the rest of us 
don't, because we are excluded. I would say those----
    Mr. Blunt. Would you say it is fair--did you rely on what 
the doctor told you at that point or did you really rely on the 
FDA? At the point you were making this decision, did you even 
think to ask, ``What does the FDA say?''
    Ms. Hoffman. Really, at that time, I didn't know very much 
about the FDA. I relied solely upon my searching.
    Mr. Blunt. Ms. Noonan-Saraceni, what did you rely on when 
you decided to have this done, in terms of advice?
    Ms. Noonan-Saraceni. Well, as you know, I was 25 years old 
when I had the cancer, so I was 30 when I went to have the 
reconstructive surgery done. At the time, I went to three 
different plastic surgeons. At no time, from any of the plastic 
surgeons, was I ever told there was any complications or any 
health risks. In fact, I was told, ``Well, you could probably 
get hit by a mack truck and the implant will survive.'' But, 
again, I didn't know to even look to the FDA or even to see if 
there was a record on the FDA at that point, because I mean at 
that point in my life, I thought doctors were God and they 
didn't make mistakes.
    Mr. Blunt. I guess, going back to your testimony, you 
probably felt like you were hit by a Mack truck----
    Ms. Noonan-Saraceni. Yes, I did. Thank you.
    Mr. Blunt. [continuing] during part of that. Ms. Hoffman, 
how did the FDA respond to your complaints that your surgeon 
and the manufacturer were ignoring the complaints you were 
making to them? What did the FDA do when you contacted them?
    Ms. Hoffman. They were dismissive. They did not follow up. 
My plastic surgeon remains a clinical investigator in the 
clinical trials today.
    Mr. Blunt. He remains what? Your plastic surgeon he or she 
remains what?
    Ms. Hoffman. A clinical investigator. He continues to 
enroll patients in this study in spite of the fact that he did 
not report my complications to be included in the study.
    Mr. Blunt. So you assumed you were going to be part of a 
study, because he was doing that, and you were not included in 
that study?
    Ms. Hoffman. By law, I had to be part of a study to receive 
silicone breast implants after the moratorium in 1992. And as 
part of the protocol of the study, any complications that I 
experienced were mandated to be reported by the plastic surgeon 
who was the clinical investigator. Those were to be reported to 
the sponsor, to the manufacturer and included in the study 
data. And that did not happen in my case.
    Mr. Blunt. Dr. Zuckerman, you watched this approval 
process. How do you think FDA could have improved what they did 
in the follow-up? I know that is maybe too broad a question, 
but give us some thought as to what you--where you think FDA 
made their most significant mistakes in those two processes?
    Ms. Zuckerman. Sure. I would be delighted to answer that 
question, but how much time do you have?
    Mr. Blunt. Well, not much probably is the answer to that.
    Ms. Zuckerman. Right. Well, a couple of things. One was 
that the Advisory Committee made a lot of suggestions about 
what they thought needed to be done, and they actually asked--
their hope was that the FDA would have to--I'm sorry, that the 
manufacturer would have to provide more data and better data 
before implant approval or non-approval would be decided. But 
the FDA instructed the Advisory Committee that all they could 
advise was yes or not. And then they said, in a way that I 
thought was quite biased, ``And you know, if you say you don't 
want to approve these, they are going to have to be removed 
from the market immediately.'' So it seemed to me quite a 
biased arrangement where the instructions were clearly headed 
toward one direction, which was approval.
    The other thing was the Advisory Committee said things 
like, ``Girls under the age of 18 should not be able to have 
breast implants, because they are too young and they have never 
been tested on anybody that young,'' and they made other kinds 
of restrictions, and the FDA officials never instructed the 
Advisory Committee that these were instructions that they could 
not follow, that they didn't have--FDA didn't have the 
authority to make the kinds of caveats that the Advisory 
Committee was making.
    But perhaps the biggest issue of all was the fact that the 
FDA made its--that both the Advisory Committee and the FDA 
afterwards made decisions based on just 3 years of data. When 
you have an implanted device that is going to be in somebody's 
body for a lot longer than 3 years, I think it is very 
dangerous to make an approval based on only 3 years, especially 
when there are all these problems in just the first 3 years.
    Mr. Blunt. I guess you could see the follow-up there. You 
know, you can't, obviously, assuming it is a safe--that it 
truly is safe and effective, you wouldn't want to go an entire 
lifetime before you approved it to anybody else, but I think I 
see your point.
    Mr. Chairman, I have got one other meeting that I have got 
to go to. If I could ask one more question, not to interfere 
with the second question.
    Mr. Bilirakis. Without objection, please proceed.
    Mr. Blunt. You mentioned, I think in your testimony, that 
the number of young women, women under 18, has risen 
dramatically who are having these implants done. Do you have 
some idea how hard is that to get done if you are under 18? Do 
you have to have parental consent in every State? What do you 
find out? I assume, in most cases, for young girls, this is 
augmentation, but I don't know. Could you talk to us a little 
bit about that?
    Ms. Zuckerman. Yes, absolutely. Any surgery for anybody 
under the age of 18 has to have the approval of a parent, 
whether it is breast implants or anything else. Because there 
is no real teeth in this whole issue of informed consent, we 
are particularly concerned that 17, 16-year old girls really 
don't have the information that they need to make these 
decisions, and the parents aren't necessarily given that 
information either. So the number of teens getting breast 
implants for augmentation--I am only talking about 
augmentation--has more than doubled in the last 3 years, and 
there is a lot of advertisements for breast implants in 
magazines that teenage girls read.
    So there is a lot of pressure, of course, and I have a 14-
year old daughter. Anybody who has a teenager knows there is a 
lot of pressure to look a certain way. It is a very vulnerable 
time, and I think it is very dangerous to be having ads and 
other pressures on these girls without having the kind of 
information about risks that they need. I am not even sure you 
could convince a 16-year-old girl anyway, but at least that 
their parents could use.
    Mr. Blunt. Thank you, Mr. Chairman.
    Mr. Bilirakis. I thank the gentleman. Ms. Johnson, how many 
Native American and native Alaskan women, in terms of 
percentage, I suppose, receive health care under the Indian 
Health Service?
    Ms. Johnson. I am not sure of that number. I certainly 
could get that to you. I know as far as number of women who 
would be affected by this technical amendment, there is about 
90 to 100 Native American women who are in this category of 
breast or cervical cancer on an annual basis.
    Mr. Bilirakis. Ninety to 100 on an annual basis.
    Ms. Johnson. Yes.
    Mr. Bilirakis. Well, let me ask you then, this is more of a 
general, generic question, I guess. How accessible to these 
women is Indian Health Service as against other health--whether 
it be Medicaid or whatever?
    Ms. Johnson. Okay. Actually, Native Americans rely on 
Indian Health Service as their primary service provider, 
period.
    Mr. Bilirakis. They rely on it.
    Ms. Johnson. Excuse me?
    Mr. Bilirakis. Yes. They rely on it.
    Ms. Johnson. They rely on upon it as the primary service 
provider, whether the tribe itself is a self-governance tribe 
and actually compacts with Indian Health Service to provide 
their services or they are a direct service tribe where the 
Indian Health Service provides the service directly. And the 
reason why this has become such an issue for us is because when 
you are compact tribe and you provide your own Indian Health 
Service--you take on your own responsibility for Indian Health 
Service, the pot of money at Indian Health is non-existent or 
very, very small for any kind of major health issues that come 
to you, that affect you. And the tribe has to--once that 
allocation is gone for that year, the allocation is gone, and 
there is no more money. It doesn't matter what the 
circumstances are without getting special approval from Indian 
Health Service.
    Mr. Bilirakis. Well, then why do we have then separate 
Indian Health Services? We are talking about good people who 
are Americans. I mean why is not the health services that are 
available to the American people, in terms of Medicaid, 
Medicare, whatever the case may be, why is that not just 
available to them? Why is it we have separate Indian Health 
Services?
    Ms. Johnson. Well, there is a number of things. Part of it 
is--some of it is in the treaty rights with the government-to-
government relationship to provide----
    Mr. Bilirakis. I know, but that goes way back to the----
    Ms. Johnson. Right.
    Mr. Bilirakis. Yes.
    Ms. Johnson. And because of a lot of the areas of our 
communities, the remoteness of our villages and the reservation 
boundaries, to get adequate coverage like the general public 
gets provided would probably if the private was trying to 
provide it, it would be non-existence totally. So the Federal 
Government provides this service to us, and I have to say as a 
person who has received Indian health care all my life until I 
came to DC, in fact that was a real interesting experience.
    Mr. Bilirakis. Yes. Apparently, it has treated you pretty 
well.
    Ms. Johnson. Yes. They treated us pretty well. And my tribe 
is actually a compact tribe, where we actually provide, through 
a contract with Indian Health Service, our own care. And it 
wasn't until recently that when we were fully Medicaid-
eligible, when we actually could apply for--when we had tribal 
members who were insurance-eligible, many of our jobs and 
occupations don't have health care coverage unless you are with 
the Federal Government on a reservation. So the provision of 
insurance and insurance coverage is limited, and therefore 
Indian Health Service picks up the gap in those provisions.
    Mr. Bilirakis. I guess I can see where there would be a gap 
there; obviously, there is. We know that there is a lot of 
uninsured out there, and so that would be beneficial. Is the 
quality--maybe the benefits, are the benefits basically 
comparable in terms of what is available? I shouldn't say 
quality. I would like to think the quality is----
    Ms. Johnson. There is tremendous shortage in health care. 
Even in Indian Health Service, the care providers--you know, 
the lines are always long, you have long, long waits for 
surgery or other issues related to that. Tribes are very 
challenged by having to make decisions about what is a 
priority. Prevention versus treatment is a major issue, because 
when you have to prioritize your limited health resources, it 
goes more to treatment. We do very little in the ways of 
prevention. As you know, diabetes and other things are majorly 
affecting and sweeping through our communities in substantial 
numbers that we don't have--we have to travel long, long 
distances for any kind of treatment. Blood transfusions are 
non-existent, mammograms----
    Mr. Bilirakis. Well, my time is up, you have separate 
Indian health care, and I have always wondered--I understand 
that back in the days before Medicaid and Medicare, which are 
all relatively recent, that Indian health care would have been 
certainly the thing back then, but I just wonder today if that 
is a good idea, and look at the gap that we are talking about 
here as a result of this legislation.
    Well, all right. It is a subject, though, that I have 
always wondered about, and I am certainly not sitting here 
saying I am against Indian health care, but I just wonder if 
that really the best for the Native Americans today, 
considering today's circumstances? If you have anything on 
that, please write me a memo or something.
    All right. Does the gentleman have anything?
    Mr. Green. No, no other questions.
    Mr. Bilirakis. We generally have written questions that we 
would like to submit to the panelists after the hearing and 
request responses in writing from you, and we would appreciate 
your, of course, being amenable to furnish those answers to me. 
And I would like to hear from Ms. Johnson regarding my 
question, in general.
    Mr. Green. I was just going to see if we could leave the 
record open for a number of days, whatever the requisite that 
we have.
    Mr. Bilirakis. Yes, that is customary the record is open. 
And you have been very helpful. I know I have learned an awful 
lot. Thank you very much. The hearing is adjourned.
    [Whereupon, at 5:18 p.m., the subcommittee was adjourned.]
    [Additional material submitted for the record follows:]
    Joint Prepared Statement of Hon. Tom Udall, a Representative in 
     Congress from the State of New Mexico; Hon. J.D. Hayworth, a 
  Representative in Congress from the State of Arizona; and Hon. J.C. 
     Watts, a Representative in Congress from the State of Oklahoma
    Mr. Chairman: Thank you for including H.R. 1383 in your hearing 
today on raising health awareness. These are very important issues and 
we thank you for the opportunity to offer this joint statement on our 
legislation.
    On Tuesday April 3, 2001, the three of us joined by Representatives 
Dave Camp, Dale Kildee, Patrick Kennedy, Rosa DeLauro, and Sherrod 
Brown introduced the ``Native American Breast and Cervical Cancer 
Treatment Technical Amendment Act of 2001.'' This legislation makes a 
simple but extremely important technical change to the ``Breast and 
Cervical Cancer Treatment and Prevention Act'' (P.L. 106-354) to 
improve the coverage of breast and cervical cancer treatment for 
American Indian and Alaska Native women.
    The Breast and Cervical Cancer Treatment Act which Congress passed 
last year gives states the option to extend coverage to certain women 
who have been screened by programs operated under Title XV of the 
Public Health Service Act (the National Breast and Cervical Cancer 
Early Detection program) and who have no ``creditable coverage.'' The 
term ``creditable coverage'' was established by the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA). Under the HIPAA 
definition, creditable coverage includes a reference to the medical 
care program of the Indian Health Service (IHS). In short, the 
reference to ``creditable coverage'' in the law effectively excludes 
Indian women from receiving Medicaid breast and cervical cancer 
treatment as provided for under this Act.
    The Indian health reference to IHS/tribal care was originally 
included in HIPAA so that members of Indian Tribes eligible for IHS 
would not be treated as having a break in coverage (and thus subject to 
pre-existing exclusions and waiting periods when seeking health 
insurance) simply because they had received care through Indian health 
programs, rather than through a conventional health insurance program. 
Thus, in the HIPAA context, the inclusion of the IHS/tribal provision 
was intended to benefit American Indians and Alaska Natives, not 
penalize them.
    However, use of the HIPAA definition in the recent ``Breast and 
Cervical Cancer Treatment and Prevention Act'' has the exact opposite 
effect. In fact, the many Indian women who rely on IHS/tribal programs 
for basic health care are excluded from the new law's eligibility for 
Medicaid. Not only does the definition deny coverage to Indian women, 
but the provision also runs counter to the general Medicaid rule 
treating IHS facilities as full Medicaid providers.
    This legislation would resolve these problems by clarifying that, 
for purposes of the ``Breast and Cervical Cancer Prevention and 
Treatment Act,'' the term ``creditable coverage'' shall not include 
IHS-funded care so that American Indian and Alaska Native women can be 
covered by Medicaid for breast and cervical cancer treatment. Since a 
number of states are currently moving forward to provide Medicaid 
coverage under the state option, the need for this legislation is 
immediate to ensure that American Indian and Alaska Native women are 
not denied from receiving life-saving breast and cervical cancer 
treatment.
    In addition to enjoying support of 112 of our colleagues, H.R. 1383 
is also supported by the American Cancer Society and the American 
College of Obstetricians and Gynecologists. We would like to ask that 
their letters of support be included in the record.
    Mr. Chairman, this legislation is a simple yet critical change that 
will help many American Indian and Native Alaskan women enjoy longer, 
healthier lives in spite of cancer. There is absolutely no reason why 
these women should be denied treatment for breast and cervical cancers. 
However, this is precisely what happens because of the definition of 
creditable coverage, combined with the fact that not all American 
Indian and Native Alaskan women have access to breast and cervical 
cancer treatment at I.H.S. health facilities. H.R. 1383 will ensure 
that American Indian and Native Alaskan will receive the treatment they 
need and deserve.
    Again, thank you for allowing us the opportunity to offer our 
statement for the record today. We hope the committee will see the 
merits of this legislation that is critically important to many 
American Indian and Native Alaskan women.
                                 ______
                                 
Prepared Statement of Christopher Conway, President, Mentor Corporation

    Dear Mr. Chairman, thank you for this opportunity to submit 
testimony on behalf of Mentor Corporation to the Committee on the 
safety and efficacy of breast implants. As a leading global medical 
device company, we address a wide variety of health-related needs, 
including incontinence, prostate cancer, impotence, and aesthetic and 
reconstructive surgery. Mentor Corporation manufactures breast implants 
for purposes of breast reconstruction and breast augmentation.
    We share the Committee's concern that the best studies, information 
and facts be available to the public. We believe like the Committee 
that women have the right to know the risks and benefits of any medical 
procedure and device they might choose. Nevertheless, we have serious 
concerns about HR 1961 and do not believe that as currently drafted 
this legislation will achieve the Committee's goals.
    The bill does not accurately reflect the history or status of 
breast implants in the United States. The findings are based largely on 
anecdote and poorly constructed and discredited studies and ignore the 
conclusions of the National Academy of Science's own Institute of 
Medicine study and other findings by several multidisciplinary panels 
of internationally-recognized scientists and physicians. Among the many 
findings, the IOM panel found that breast implants are safe and do not 
pose serious health risk for women. The studies also show that women 
can safely breast feed their babies, receive adequate breast care, 
including mammography and experience no greater risk for breast or 
other cancers than women without implants.
    HR 1961 also ignores the federal regulations and requirements for 
breast implants. Premarket approval for saline implants requires 
rigorous research and study that does not stop with the approval of the 
product. We are required to conduct and submit reports on a 10-year-
post-approval study to assess the long-term clinical performance of 
this device. Continued approval of our product is also contingent on 
our compliance with the FDA statutes and regulations for medical 
devices including regular inspections and reports.
    Finally, the legislation does not recognize the plethora of 
unbiased information currently available to breast implant patients, 
including our company's patient information booklet, which contains a 
discussion of the risks of breast implants and the materials widely 
available on the FDA's new breast implant web site.
    We believe this testimony will provide the Committee with a more 
balanced perspective on the safety of breast implants by reviewing the 
status of past and ongoing research, the FDA's regulatory approval and 
oversight process for breast implants, and the unbiased information 
currently available to women considering implants.
    the history of saline and silicone breast implants 1
---------------------------------------------------------------------------
    \1\ See ``Chronology of FDA Breast Implant Activities,'' attached.
---------------------------------------------------------------------------
    There have been continued advances in the manufacture and 
regulation of breast implants over the last decade, including a greater 
scrutiny by the government and its scientific agencies, as well as by 
several multidisciplinary panels of internationally-recognized 
scientists and physicians. There are two general types of breast 
implants approved for marketing, saline-filled and silicone gel-filled, 
both of which our company offers to women meeting certain criteria. 
Saline-filled implants have an external silicone shell and are filled 
with sterile saline (salt water) by the doctor at the time of surgery. 
Silicone gel-filled implants have an external silicone shell but are 
pre-filled with silicone gel.
Saline Filled Implants
    Saline implants have been available to women for more than 25 
years. The FDA published a proposal in 1993 and a final rule in 1999, 
calling for safety and effectiveness data for saline-filled implants. 
Saline implants are available for breast reconstruction surgery and to 
women 18 years and older for breast augmentation.
    The FDA granted premarket approval (PMA) for saline implants in May 
2000 to Mentor, following their extensive review of the very large body 
of safety and efficacy data. Among our detailed submissions to the 
FDA--which involved more than 400 binders (approximately 750,000 
pages)--were numerous preclinical studies, including chemical, 
toxicological, mechanical and manufacturing data. The submission also 
included results from clinical studies documenting the types and rates 
of local complications, as well as benefits, experienced by patients. 
These data are provided in both physician and patient labeling. The FDA 
also provides this information (including 3-year cumulative risk rates) 
on its public web sites.
Silicone Gel-Filled Implants
    Silicone gel-filled implants are available for limited use. In 
1992, the FDA approved our company's adjunct study for silicone gel-
filled implants for reconstruction and revision only. In 2000, the FDA 
approved our ``core gel'' study (or IDE study) for breast augmentation, 
reconstruction, and revision for a specified number of patients at a 
limited number of sites. Mentor first began manufacturing breast 
implants in 1984.

                studies on the safety of breast implants
uc
    Over the past decade, there has been very extensive further 
documentation of the safety and efficacy of breast implants that comes 
from a range of sources, including:

 Over 17 in-depth epidemiology studies (including many 
        conducted by the leading medical and scientific institutions in 
        this country) that have addressed long-term safety concerns 
        such as potential immune effects or cancer
 Numerous clinical studies conducted by Mentor, including the 
        saline prospective study, the adjunct study and most recently 
        Mentor's core gel study
 Extensive preclinical studies conducted by Mentor using state-
        of-the-art methods
 Clinical studies conducted by outside organizations
 A wealth of studies in peer-reviewed published literature
 Findings of scientific expert panels, including the Institute 
        of Medicine, the National Science Panel and the International 
        Review Group
Institute of Medicine Study on Silicone Implants 2
---------------------------------------------------------------------------
    \2\ See the Institute of Medicine ``Information for Women about the 
Safety of Silicone Breast Implants,'' attached.
---------------------------------------------------------------------------
    Because of issues regarding the safety of silicone implants, 
Congress asked the Department of Health and Human Services in 1997 to 
sponsor a study on silicone breast implants. HHS appointed the 
Institute of Medicine, part of the National Academy of Sciences, to 
conduct an independent and unbiased review of all past and ongoing 
scientific research regarding the safety of silicone breast implants.
    IOM established a thirteen-member committee of distinguished 
medical, scientific and academic experts to conduct this study of both 
augmentation and reconstruction patients. The committee set out to 
evaluate past and ongoing studies of the relationship, if any, between 
implants and systemic disease; evaluate the complications during or 
after implant surgery; assess the biologic and immunologic effects of 
silicone and other chemical components of breast implants; assess the 
impact of breast implants, if any, on the offspring of women with 
implants and on breastfeeding; and assess the accuracy of mammograms. 
The committee studied and reviewed thousands of published scientific 
reports, citing almost 1,200 references in the text of the report, 80% 
of which are from peer-reviewed literature. It also studied selected 
industry research reports on silicone breast implants and heard 
presentations from the public, including representatives of consumer 
groups, researchers, and women with silicone breast implants.
    The committee's work resulted in a 440-page report (published in 
book form in 2000) with the following findings:

 There is no evidence that silicone implants are responsible 
        for any major diseases of the whole body.
 There is no plausible evidence of a novel autoimmune disease 
        caused by implants.
 There was no increase in either primary or recurrent breast 
        cancer in women with breast implants. Some studies even suggest 
        lower rates of breast cancer in implanted women.
 The major issues with implants are local, but not life-
        threatening, complications. These include, implant removal, 
        ruptures, deflations, capsulare contracture, disfigurement, 
        infection and pain. (Note: Mentor's recently completed Saline-
        Prospective Study already has, and its Core Gel Study currently 
        underway will, provide detailed incidence rate data for these 
        local complications.)
 There is no danger in breast-feeding.
 No studies of women with breast implants show increases in 
        cancer deaths because of mammographic diagnostic delay.
 Implants are not lifetime devices; risks accumulate over time, 
        and many women should expect to have more than one implant.
National Science Panel and International Review Group Studies on 
        Silicone Implants
    The National Science Panel, commissioned by the coordinating judge 
(Judge Pointer) for the federal breast implant litigation, and The 
International Review Group, commissioned by the British Minister of 
Health both in 1998, also reviewed, analyzed and critiqued the 
scientific literature pertaining to the possible link between silicone 
breast implants and connective tissue disease. The unanimous findings 
of both reports showed that breast implants constructed from or filled 
with silicone do not constitute any significant risk for connective 
tissue disease.
Adjunct and Core Gel Studies on Silicone Implants
    Silicone gel-filled breast implants are currently available to 
women through an adjunct study and a ``core gel'' study, both of which 
are FDA-approved for our and at least one other company. These studies 
ensure that close attention is being given to the safety and efficacy 
of silicone gel-filled implants.
    The adjunct study, FDA-approved in 1992, was developed to make 
silicone-gel filled breast implants available for reconstruction and 
revision patients to collect short-term complication data. Eligible 
women include those who have had breast cancer surgery, a severe injury 
to the breast, a birth defect that affects the breast, or a medical 
condition causing a severe breast abnormality and those who needed to 
have an existing implant replaced for medical reasons. Each woman in 
the adjunct study is required to have informed consent. Also 
Institutional Review Boards, composed of scientists, health 
professionals and community members who do not have a bias as to the 
outcome, oversee this study.
    The core gel study is an IDE (investigational device exemption) 
study, which means it has been reviewed and approved by the FDA to 
ensure the data is meaningful and that patients are not exposed to 
unreasonable risks. This study was FDA-approved in 2000 for breast 
augmentation, reconstruction and revision for a specified number of 
patients at a limited number of sites. Generally, the IDE study data is 
used as the basis for a future PMA application to market the device for 
the clinical indications studied. Each woman who participates in an IDE 
study must give informed consent. Also an Institutional Review Board 
(IRB), composed of scientists, health professionals and community 
members who do not have a bias as to the outcome, oversee the study.
Saline Prospective Study
    Our company's Saline Prospective Study, submitted to the FDA in 
2000 as part of the PMA approval process, was a 36-month prospective 
study (with IRB oversight) that assessed all complications with breast 
implants as well as quality of life measures. It included both 
augmentation and reconstruction patients. Among the findings were:

 Risks were consistent with those reported in the medical 
        literature for similar devices and indications.
 Augmentation patients have low risk.
 While reconstruction patients are at higher risk, they have 
        greater potential emotional and physical benefits.
 Patients needing surgery on an existing implant experience 
        similar or somewhat higher complication rates than surgery for 
        primary implants.
 Despite some possible complications, patients report high 
        levels of satisfaction and improved quality of life.

    federal regulations and requirements for saline breast implants

    The FDA has outlined rigorous conditions of approval for saline-
filled breast implants that we must comply with in order to ensure 
continued approval of the PMA. One such condition is a 10-year post-
approval study to assess the long-term clinical performance of the 
device. All patients enrolled in the Saline Prospective Study are asked 
to enroll in this post-approval study. Safety data must be collected 
annually out to 10 years. In addition, our company along with the other 
company with PMA approval must conduct a focus-group study to obtain 
immediate feedback on the patient brochure, ``Making an Informed 
Decision,'' for both augmentation and reconstruction patients. We must 
also conduct a retrieval study, which must collect visual examination, 
physical and histological data on removed implants to determine reason 
for failure. Mechanical testing (i.e., fatigue rupture and shelf-life) 
is also required to collect additional information.
    Continued approval of our PMA is also contingent upon:

 Submission of annual post-approval reports
 Adverse reaction and device defect reporting
 Various other reporting requirements under the FDA Medical 
        Device Reporting Regulation
    In addition, the FDA conducts regular inspections at our company 
and manufacturing facilities to make sure that we are in compliance 
with applicable FDA statutes and regulations. The FDA provides reports 
of these inspections to us once the inspection is closed. In addition, 
the FDA routinely performs investigations of companies to examine 
allegations by individuals of possible wrongdoing. HR 1961 includes 
references to such an investigation. The FDA should be allowed to 
adequately perform an investigation without outside interference.
            making informed decisions about breast implants
    Our company believes that women have the right to complete and 
accurate information about the potential health risks and advantages of 
breast implants in order to make informed decisions. In the past five 
years, there has been a dramatic increase in the information available 
for women considering implants from a variety of sources, including:

 Patient information brochures created by our company that lay 
        out among other information risks, contraindications, questions 
        to ask a surgeon about reconstruction and augmentation and the 
        FDA MedWatch contact to report problems.3
---------------------------------------------------------------------------
    \3\ See Mentor's ``Saline-Filled Breast Implant Surgery: Making an 
Informed Decision,'' attached.
---------------------------------------------------------------------------
 FDA's Breast Implant Information Page (http://www.fda.gov/
        cdrh/breastimplants) provides a breast implant customer 
        handbook and other information that allows the customer to 
        differentiate between breast implant labels and access 
        information about possible complications, recent studies on 
        breast implants.
 FDA's MedWatch (http://www.fda.gov/medwatch/index.html) or (1-
        888-463-INFOFDA) is available if a patient feels she has 
        experienced a serious problem(s) related to her breast 
        implants, she should have her health care professional report 
        the problem(s) to the FDA.
 Online copies of the IOM, NSP and IRG reports are available to 
        the public and can be obtained on the following web sites:
     IOM: http://www.nap.edu/catalog/9618.html
     NSP: http://www.fjc.gov/BREIMLIT/SCIENCE/report.htm
     IRG: http://www.silicone-review.gov.uk/
 Junk Science web site (http://www.junkscience.com/) provides 
        an extensive list of links to informative, recent newspaper 
        articles concerning the current medical status and social 
        opinion of breast implants. Many of the stories highlight the 
        fact vs. fiction/ myths vs. reality aspects of breast implants.
    In conclusion, I thank the Committee for the opportunity to submit 
testimony in order to ensure that a balanced record exists on the 
safety of breast implants. In order to create a fair record of the 
history of breast implants, I ask the Chairman to include the following 
documents for the record:

 Chronology of FDA Breast Implant Activities
 Institute of Medicine ``Information for Women About the Safety 
        of Silicone Breast Implants''
 Mentor's ``Saline-Filled Breast Implant Surgery: Making an 
        Informed Decision''
    Thank you.
