[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.