I
105TH CONGRESS
1ST SESSION
H. R. 366
To require the surgical removal of silicone gel and saline filled breast im-
plants, to provide for research on silicone and other chemicals used
in the manufacture of breast implants, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JANUARY 7, 1997
Mr. TRAFICANT (for himself, Mr. HASTINGS of Florida, Mr. THOMPSON, Mr.
RANGEL, Mr. Menendez, Ms. JACKSON-LEE, Ms. MOLINARI, Mr.
HINCHEY, Mr. LIPINSKI, Mr. HYDE, Ms. NORTON, Mr. DELLUMS, and
Ms. DELAURO) introduced the following bill; which was referred to the
Committee on Commerce
A BILL
To require the surgical removal of silicone gel and saline
filled breast implants, to provide for research on silicone
and other chemicals used in the manufacture of breast
implants, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Breast Implant Ac-
countability Act’’.
HR 366 IH
SEC. 2. SURGICAL REMOVAL OF BREAST IMPLANT.
(a) IN GENERAL.—Each manufacturer of a breast
implant shall notify each individual who has had a silicone
gel or saline filled breast implant implanted before Janu-
ary 1, 1994, that the manufacturer—
(1) will provide funds for medical, surgical, hos-
pital expenses related to the surgical removal of such
breast implant at the request of the individual who
has had such an implant implanted, and
(2) will allow the notice recipient to select the
physician and hospital or surgery center for the re-
moval.
A breast implant which is removed is the property of the
individual from whom it was removed and it shall be given
to such individual in an appropriate condition.
(b) NOTICE.—The notice required by subsection (a)
shall be published in national publications and newspapers
of general circulation. The notice shall set forth necessary
information for notice recipients to locate and obtain ap-
propriate medical care and treatment.
(c) EXPENSES.—The medical, surgical, and hospital
expenses related to the surgical removal of a breast im-
plant which a manufacturer will provide shall include pre-
and post-operative care and treatment, including subse-
quent surgery to remove residual silicone, scar capsules,
and granulomas, mammograms, and medication.
HR 366 IH
SEC. 3. RESEARCH.
(a) IN GENERAL.—The Secretary of Health and
Human Services shall conduct, or contract to have con-
ducted, research on the physiological, neurological, and
immunological effects of silicone toxicity and toxicity of
other chemicals found in, or used in the process of manu-
facturing, breast implants.
(b) SUBJECTS.—The research under subsection (a)
shall include as subjects individuals who are included in
the class action designated, in silicone gel breast implant
product liability litigation designated MDL 926, Northern
District of Alabama, if they volunteer for such research.
SEC. 4. CONSENT.
No physician may implant a breast implant which in-
cludes silicone unless the patient to receive such implant
has executed a consent form, prescribed by the Secretary
of Health and Human Services by regulation, which states
that the patient has been informed of all the health risks
associated with breast implants and exposure to silicone
oil, silica, and other chemicals used in the manufacture
of breast implants.
SEC. 5. PHYSICIAN SERVICES.
No physician may refuse the treatment of a patient
because the patient has received a breast implant.
HR 366 IH
SEC. 6. ORGAN AND BLOOD DONATIONS.
(a) ORGAN DONATIONS.—The Secretary of Health
and Human Services may not make a grant under section
371 of the Public Health Service Act (42 U.S.C. 271) to
an organ procurement organization if such organization
has allowed an individual who has a breast implant in
their body to donate an organ of the individual’s body.
(b) BLOOD DONATION.—The Secretary of Health
and Human Services may not license any entity engaged
in the collection of blood under section 351 of the Public
Health Service Act (42 U.S.C. 262) if such entity receives
blood from an individual who has a breast implant in their
body.
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