General and
Plastic Surgery Devices Panel
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville MD 20857-0001
Re: Submission of Comments 11-13 April 2005 FDA Hearing on
Silicone Breast Implant Devices
To The Members of the Panel:
The undersigned eighteen organizations and individuals
support the availability of silicone breast implants as an
option for all persons choosing breast reconstruction. We
offer no opinion or comment on the availability and use of
silicone breast implants for cosmetic or other purposes.
Consistent with the missions of our organizations, we
endorse no product from any manufacturer. Our comments are
limited to the availability of silicone breast implants for
the 20% of patients with breast cancer, breast disease, or
other medical needs only.
Breast reconstruction with silicone breast implants
following a mastectomy is a profoundly personal decision. We
support the right of each patient to select and receive
individualized treatment options. Further, we encourage all
patients to make health care decisions in consultation with
expert clinicians, after receiving and understanding
in-depth information about the benefits, risks, unknowns and
uncertainties of all state-of-the art options for care.
Current options for post-mastectomy reconstruction are
limited. Not all are suitable or possible for every patient.
External prostheses can be impractical, and saline-filled
breast implants often may not achieve acceptable symmetry,
appearance or comfort.
Since patients differ by health status, and by emotional,
physical and personal needs, they require a wide variety of
post-mastectomy reconstruction options. Breast cancer and
prophylactic mastectomy patients who choose implants do so
with a different risk/benefit analysis than do those who
choose implants for other reasons. After losing a breast to
cancer, most women with an implant consider it as necessary
-- or even crucial -- for their healing, recovery and
quality of life. Various studies document the mental health
and quality of life benefits of reconstruction. Self image
and body image are important to many who seek
reconstruction, regardless of age. Despite the purported
availability of silicone implants through clinical trials,
it has been very difficult for patients to participate in
the studies, as many physicians are unaware of the trials,
or are unable to offer them.
Recent peer-reviewed studies -- including NCI’s
meta-analysis and long-term Scandinavian studies --
reaffirmed reviews published by the Institute of Medicine,
the U.S. Federal Court’s National Science Panel, the
European Parliament’s Scientific and Technology Options
Assessment, and the British Ministry of Health. According to
scientific evidence, no link exists between
silicone-gel-filled breast implants and connective tissue
diseases, or other autoimmune or rheumatic conditions. These
illnesses occur with the same frequency in women with and
women without breast implants. There is NO survival
disadvantage for women with breast implants.
Breast cancer patients considering silicone gel-filled (or
any type of) breast implant must receive detailed accurate
information about the device's risks, benefits and
complications, including incidence of capsular contracture
and rupture. No breast cancer treatment or medical procedure
is without risk. Neither are other medical devices, which do
not last forever. These treatments and devices are not
completely predictable or completely understood. Silicone
breast implants for reconstruction should not be held to a
different standard.
We advocate ongoing data collection and reporting based on
long term follow up of all patients who receive silicone
implants for reconstruction. Follow-up mechanisms, including
privacy-protected recipient registries and physician
tracking, will facilitate medical professional education,
training and disclosure; data compilation and analysis;
regulatory oversight; and prompt communication of
significant findings to patients and providers.
In conclusion, the undersigned ¬eighteen organizations and
individuals respectfully recommend that the panel make
silicone breast implants available for mastectomy patients
who seek reconstruction subsequent to a breast cancer
diagnosis, prophylactic mastectomy, or other medical needs.
American College of Surgeons
www.facs.org
Bosom Buddies
www.bosombuddies.org
Breast Cancer Resource Committee
www.bcresource.org
Cancer Research and Prevention Foundation
www.preventcancer.org
Connie R. Curran, EdD, RN, FAAN
Elizabeth A. Hart, President/CEO
HART INTERNATIONAL
9051 Oakpath Lane
Dallas, TX 75243
PH: 214.349.139 Fax: 214.349.1193
ehart@hart-international.com
FORCE: Facing our Risk of Cancer Empowered
http://www.facingourrisk.org
Living Beyond Breast Cancer
www.lbbc.org
National Coalition for Cancer Survivorship (NCCS)
www.canceradvocacy.org/
National Patient Advocate Foundation
www.patientadvocate.org
Research Advocacy Network
www.researchadvocacy.org
Rise Sister Rise
www.bcresource.org/rise.htm
Society for Women’s Health Research
www.womenshealthresearch.org
Susan G. Komen Breast Cancer Foundation
www.komen.org
Virginia Breast Cancer Foundation
www.vbcf.org
Vital Options International
www.vitaloptions.org
Women’s Information Network Against Breast Cancer
www.winabc.org
Contact: Betsy Mullen, Founder, President/CEO
E-mail: winabc@aol.com;
betsy@winabc.org
Y-ME National Breast Cancer Organization
www.y-me.org
