IV
104TH CONGRESS
2D SESSION
H. RES. 449
Relating to breast implants, the Food and Drug Administration, and breast
care.
IN THE HOUSE OF REPRESENTATIVES
JUNE 6, 1996
Mrs. VUCANOVICH (for herself, Mr. CALVERT, Mrs. CLAYTON, Mr. HOBSON,
Mr. HUTCHINSON, Mrs. JOHNSON of Connecticut, Mr. LIPINSKI, Mr.
MYERS of Indiana, Mr. PETRI, and Mr. WAMP) submitted the following
resolution; which was referred to the Committee on Commerce
RESOLUTION
Relating to breast implants, the Food and Drug
Administration, and breast care.
Whereas breast implant safety is a public health issue of fun-
damental importance, particularly for those women who
already have implants and women who are diagnosed
with breast cancer facing urgent decisions about recon-
struction;
Whereas manufacturers of silicone breast implants are en-
couraged to pursue the premarket approval application
process with the Food and Drug Administration;
Whereas conflicting information has been provided to the
public about the safety of silicone gel breast implants;
HRES 449 IH
Whereas the Food and Drug Administration imposed restric-
tions on the availability and use of breast implants, based
on concerns of a possible relationship between silicone gel
breast implants and connective tissue disease;
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 post-mastectomy pa-
tients 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 greater incidence of
connective tissue disease in women with implants than
those without;
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 gel breast implants has
a broader impact on the public health by adversely affect-
HRES 449 IH
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
Resolved, That it is the sense of the House of Rep-
resentatives that the Food and Drug Administration
should take immediate steps to resolve the fears and con-
cerns of women with breast cancer by issuing a definitive
statement on the relationship (or lack thereof) between sil-
icone gel breast implants and connective tissue disease,
classic auto-immune symptoms, and other serious dis-
eases. In addition, the Food and Drug Administration and
the National Cancer Institute should develop recommenda-
tions for breast care practices for women with breast im-
plants.
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