IV
104TH CONGRESS
2D SESSION
H. RES. 527
Relating to breast implants, the Food and Drug Administration, and public
health.
IN THE HOUSE OF REPRESENTATIVES
SEPTEMBER 19, 1996
Mr. MCINTOSH submitted the following resolution; which was referred to the
Committee on Commerce
RESOLUTION
Relating to breast implants, the Food and Drug
Administration, and public health.
Whereas breast implant safety is a public health issue of fun-
damental importance, particularly for those women who
are diagnosed with breast cancer and who face urgent de-
cisions about reconstruction and women who already have
implants;
Whereas conflicting information has been provided to the
public about the safety of silicone gel breast implants;
Whereas the Food and Drug Administration imposed restric-
tions on the availability and use of breast implants, based
primarily on concerns of a possible relationship between
silicone gel breast implants and connective tissue disease;
•HRES 527 IH
Whereas breast cancer patients seeking reconstruction may
only gain access to silicone gel breast implants through
participation in a clinical trial under an approved proto-
col;
Whereas only a small fraction of the postmastectomy patients
in the United States who seek reconstruction have access
to silicone gel breast implants through clinical trials;
Whereas research has been undertaken by many prestigious
medical centers and universities on the issue of silicone
gel breast implants and connective tissue disease;
Whereas controlled scientific studies conducted by these pres-
tigious universities to date show no clinically relevant risk
of connective tissue disease for women with silicone
breast implants nor any connection between the devices
and systemic connective tissue diseases or classic auto-
immune symptoms;
Whereas the Food and Drug Administration has not issued
a definitive statement on the relationship between silicone
gel breast implants and connective tissue disease;
Whereas the Food and Drug Administration has not provided
substantial information on breast care for women with
implants;
Whereas the National Cancer Institute has not provided sub-
stantial information on breast care for women with im-
plants, waiting for the Food and Drug Administration’s
lead in this matter; and
Whereas the controversy over silicone breast implants has a
broader impact on the public health by adversely affect-
ing the supply of raw materials used in other products,
such as pacemakers, heart valves, hip and knee joints,
and artificial blood vessels: Now, therefore, be it
•HRES 527 IH
Resolved, That it is the sense of the House of Rep-
resentatives that the Food and Drug Administration
should take immediate steps to—
(1) ensure that women with breast cancer and
other women seeking breast reconstruction have en-
hanced access to silicone gel breast implants; and
(2) eliminate requirements that these women
participate in clinical studies in order to obtain the
silicone implants.
In addition, the Food and Drug Administration should
take immediate steps to resolve the fears and concerns of
women with breast cancer and women who have breast im-
plants by issuing a definitive statement on the relationship
or lack thereof between silicone gel breast implants and
connective tissue disease, classic auto-immune symptoms,
and other serious diseases.
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