Elizabeth S.
Mullen, President/CEO, Women’s Information Network Against
Breast Cancer Written Testimony - FDA Advisory Committee
Devices and Radiological Health (CDRH) Panel March 1, 2000
to Discuss the Availability of Saline-Filled Breast Implants
I very much appreciate the opportunity to submit my written
testimony to you for consideration. I had hoped to be here
today in person but was unable to make the trip from
California due to circumstances beyond my control. My
remarks will adhere to the 10-minute oral testimony limit.
I am the Founder, President and CEO of the national
nonprofit organization, Women’s Information Network Against
Breast Cancer (WIN ABC). As such, I am representing WIN ABC
for the purposes of this testimony and would like to
communicate from the perspective not only of an advocate,
but, also, as a breast cancer survivor who has had a
mastectomy and immediate breast reconstruction (lattisimus
dorsi) with a saline-filled breast implant, and finally as a
woman who deeply cares about the issue being addressed today
and throughout this week - the availability of saline-filled
breast implants and a woman’s right to choose.
I am in no way being reimbursed for my involvement in
addressing this panel. I do not have any financial ties,
including grants or other compensation with implant
manufacturers or health professional societies. My
organization has received grants from a few pharmaceutical
companies (Amgen and GlaxoWelcome). I am not a witness or
party to a pending lawsuit related to breast implants and I
do not derive a portion of my income from surgical
procedures using breast implants or from treating patients
with complaints they believe are related to breast implants.
My Perspective as a Breast Cancer Survivor and as a Woman
I was diagnosed with breast cancer nearly 7-1/2 years ago at
the age of 33. Judging from the size of my tumor, my
physicians estimated that the malignancy had been there for
7-10 years. Breast cancer had not been on my physicians’
radar screens, nor had it been on mine. I quite simply, did
not fit the profile of a woman with breast cancer. Or so it
seemed. Wrong assumptions had been made regarding my health
status, and, as a result, when I was finally diagnosed with
breast cancer, my treatment options were limited. Due to the
size and location of the tumor in my breast and the size of
my breast in relation to the size of the tumor, had I opted
for breast-conserving surgery, I would have, in essence,
ended up with a partial mastectomy. Due to these factors,
there was consensus that a mastectomy was my best surgical
option. I was, to say the least, fraught with sadness and
fear over the prospect of losing my breast, facing
chemotherapy and the prospect of dying within 2 to 3 years.
I was overwhelmed, confused and numb. Being misdiagnosed for
several years robbed me of some very important choices.
I was fortunate that my surgical oncologist called in a
plastic and reconstructive surgeon for my initial surgical
consult. My first glimpse of hope in the painful days
following my diagnosis was learning that breast
reconstruction was an option for me. The prospect from
waking up after surgery without a breast was devastating to
me. When my plastic surgeon explained that I could have an
immediate breast reconstruction, my outlook began to improve
and I began to regain my strength of spirit. Because of many
factors, I was not a good candidate for a TRAM flap
reconstruction, so reconstruction with an implant was my
best option - my only option as it turned out. I remember
making love with my husband for the last time before my
mastectomy and reconstruction. It was so bittersweet - what
would it be like after my surgery? There were so many
unknowns. I share this with you because the personal and
intimate perspectives of women all too often get bypassed in
forums such as this. Just as the science is critical as you
consider the efficacy of saline-filled breast implants, so,
too, is the conscience - body, mind and spirit of
individuals who choose to have surgery with implants - be it
for a cosmetic augmentation or a breast reconstruction. How
do you quantify hope? Self-esteem? Body image? Sexuality?
How do hope, self-esteem and a positive self-image impact a
33 year-old woman fighting for her life after breast cancer
surgery? Or a teenage young lady with a chest defect
following reconstruction to correct the anomaly? Or a
50-year old woman that has never been comfortable with her
AA-size breasts who, following breast augmentation,
experiences a new sense of womanhood? I urge you to keep
this human and humane outlook in mind.
I am blessed to be married to the one and only true love of
my life - my high school sweetheart. I have known Ken since
I was 16 years old. We always knew that we would get
married, and for years we had the name of our first child
all picked out - Samantha Ann Mullen - SAM for short. Sam, a
daughter we will never know. Because of my chemotherapy
protocol, Ken and I will never be able to have children
together. Although we had never been warned about it,
chemotherapy threw me into permanent menopause - I never had
a choice in the matter. Choice. One word that means so much.
When a woman faces the diagnosis of breast cancer, she
experiences a range of feelings that often include loss of
control and grief over the possible loss of a breast. But,
the good news is, women have choices including important
choices in breast reconstruction. Limiting these choices by
limiting or eliminating the availability of saline-filled
breast implants would be a tragic and devastating blow to
women. What’s at stake here today and throughout this week
is a woman’s right to choose. And here’s where my
perspective shifts from that of an individual patient and a
woman who has experienced first-hand the positive impact of
breast reconstruction with an implant to that of a women’s
health advocate, working to ensure equal access to quality
health care for individuals.
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My Perspective as an Advocate and CEO of WIN against
Breast Cancer
"Knowledge is the antidote to fear." -- Ralph Waldo Emerson
I founded the WIN Against Breast Cancer organization
following my own experiences with breast cancer. The WIN
organization was established to provide patients with the
information and resources that they need to make confident
and informed health care decisions. We place particular
focus on helping women and men understand their treatment
options and empowering individuals with the even knowledge
about their choices in health care. Choice and knowledge.
Informed decision-making are at the core of the WIN
organization’s mission and goals. WIN ABC strives to provide
individuals from all cultural and socioeconomic backgrounds
with responsible, unbiased information about breast health,
breast cancer and personal health responsibility. WIN was
also founded to be a catalyst for change and partnership and
to serve as a conduit by which individuals and organizations
can be linked to one another in areas of common interest and
purpose.
I will leave the science to the scientists and clinicians.
But I would like to highlight a few key points regarding the
great implant debate. The device: breast implants have been
studied for 20 years and have been under intense scrutiny
for a large portion of that time. The science: is sound and
ongoing. Product improvement: I have been able to see first
hand, and experience first hand, the improvements that have
been made in product development with respect to
saline-filled breast implants over the years.
I started off this portion of my remarks with the quote
about knowledge. Another important development with respect
to the devices under consideration by this panel -
saline-filled breast implants, is the improvement in
provider and consumer education. The bottom line: we fear
what we do not know and understand. As an advocate who has
worked with hundreds of women over the years and dozens of
providers, I can report first-hand that what I refer to as "mythconceptions"
are often times tragic barriers to women seeking life-saving
breast cancer screening and treatment services. I cannot
count the number of times women have called our organization
following a sound bite on the news about the "dangers of
implants" or the "deadly side effects of Tamoxifen" or the
"long-term ineffectiveness of lumpectomies", for example.
Hype destroys hope. Misinformation leads to disintegration
of health. Overstated? Unfortunately not. Women often fear
the prospect of losing their breast to cancer more than
chemotherapy or the disease itself. This fear is a barrier
to a woman examining herself or seeking screening and
treatment services. Often times, and tragically, women will
ignore a palpable lump for years and present in clinic with
open sores on their breast with late stage disease because
of the fear of losing a breast. Many women do not know that
breast reconstruction, immediate or delayed, is an option
for them. When women fully understand their options - the
benefits and risks and are given access to peer support,
second opinions, and culturally sensitive, linguistically
appropriate educational materials, they are more likely to
make intelligent, confident treatment decisions and more
likely will comply with treatment. And when physicians are
made aware of these issues and barriers, they can more
effectively communicate with their patients and improve
outcomes. I will never forget the day when I was making
rounds with a surgical oncologist. I was with him as he
delivered a breast cancer diagnosis to a Latina patient. The
patient clearly needed a mastectomy, but, because of a
variety of reasons, refused surgery. On her second visit to
the clinic to again discuss options, her surgeon called me
in again and told the patient that I had had a mastectomy
and reconstruction. We showed her my reconstruction and
explained the procedure. The unknown of the surgical
outcomes was now a known - she could envision the end result
of a breast reconstruction and knowledgeably and willingly
agreed to the surgery. Her choice was made real and
tangible. She chose treatment over fear and flight from
treatment. The choice - her right to choose - saved her
life. She was the rule, not the exception.
In closing, I am
going back to the beginning of my remarks. I was given my
breast cancer diagnosis over the telephone. The entire
conversation lasted no more than 3 minutes. Three minutes
frozen in time that forever changed my life. It is a time
frame that makes me very uneasy. Not because of a bad
memory, but because every 3 minutes, another woman is
diagnosed with breast cancer. Every day, women are seeking
breast cancer treatment options that include reconstruction
with saline-filled breast implants - often their best and
often their only reconstructive option. An option that can
result in a new lease on life at a time when life seems so
fragile and precarious. A choice that means hope, healing
and vitality to the all too many women confronted with a
diagnosis of breast cancer every day in this country and
around the world.
I will close with a favorite scripture of mine:
"Where there is no vision, people perish." -- Proverbs
It is my sincere hope that your vision, insight and wisdom
will result in preserving the availability of saline-filled
breast implants and the opportunity and right for women to
choose whether or not to use these devices. Device - funny,
as I look in the mirror, it is hard for me to consider that
my feminine silhouette is attributed to a device…this
device, this implant has become a part of me. And, I dare
say, has outlived my original prognosis of 2-3 years by
several years for which I am grateful on many levels. Other
women deserve that chance.
Thank you.
Elizabeth "Betsy" Mullen
Founder, President/CEO
WIN Against Breast Cancer
www.winabc.org
Office: (626) 332-2255
E-Mail: betsy@winabc.org
