‘‘(A) issue appropriate, voluntary guidance 
for clinical care, removal, and replacement for 
the implant, including appropriate coverage by 
government health care systems; and 
‘‘(B) require such guidance to be clearly 
expressed in the labeling and all marketing ma-
terials for such implant. 
‘‘(2) PREVIOUSLY APPROVED APPLICATIONS.— 
In the case of each application for a breast implant 
approved under section 515 before the date of the 
enactment of this section, the Secretary shall— 
‘‘(A) not later than 90 days after such 
date of enactment, issue guidance for the im-
plant in accordance with paragraph (1)(A); 
‘‘(B) require such guidance to be clearly 
expressed in the labeling and all marketing ma-
terials for the implant; and 
‘‘(C) require dissemination of such guid-
ance to patients who received the implant be-
fore the inclusion of such guidance into the la-
beling for the implant. 
‘‘(c) REPORTS TO CONGRESS.— 
‘‘(1) REQUIREMENT.—On an annual basis, the 
Secretary shall submit to the Congress a report that 
summarizes the progress of postmarket studies and 
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findings with respect to the safety and effectiveness 
of each breast implant approved under section 515, 
including the findings on safety for the life of the 
implant under subsection (a). 
‘‘(2) FIRST REPORT.—The Secretary shall sub-
mit the first report under this subsection for a 
breast implant not later than— 
‘‘(A) 120 days after approving an applica-
tion for the implant under section 515; or 
‘‘(B) if an application for the implant was 
approved under section 515 before the date of 
the enactment of this section, 120 days after 
such date of enactment. 
‘‘(d) BREAST IMPLANT ADVISORY PANELS.— 
‘‘(1) REVIEW OF 10-YEAR LONGITUDINAL STUD-
IES.—The Breast Implant Advisory Panel of the 
General and Plastic Surgery Advisory Committee of 
the Food and Drug Administration shall meet— 
‘‘(A) in 2007 to review the results and 
quality of the research under the 10-year longi-
tudinal studies required by the Food and Drug 
Administration for saline breast implants ap-
proved under section 515; and 
‘‘(B) in each of 2008 and 2009 to review 
the progress of the 10-year longitudinal studies 
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required by the Food and Drug Administration 
for silicone gel breast implants approved under 
section 515. 
‘‘(2) MEMBERSHIP.—With respect to member-
ship on any advisory committee of the Food and 
Drug Administration (including any subcommittee 
or panel thereof) that considers issues concerning 
breast implants, the following applies: 
‘‘(A) The Secretary may not grant any ex-
emptions for conflicts related to personal finan-
cial interests. 
‘‘(B) Before adding a member to the com-
mittee, the Secretary shall post a notice on the 
Internet site of such Administration that the in-
dividual involved will become a member of the 
committee. The notice shall include a summary 
of the professional and educational background 
of the individual. 
‘‘(C) The individual may not serve at any 
meeting of the committee until 30 days after 
the notice is posted on such site. 
‘‘(e) STUDY ON THE IONIZATION OF PLATINUM.— 
‘‘(1) IN GENERAL.—Not later than 365 days 
after the date of the enactment of this section, the 
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Secretary shall complete a study and submit a re-
port to the Congress on— 
‘‘(A) the ionization and levels of platinum 
in silicone breast implants, analyzing the plat-
inum found in silicone gel breast implants in 
vivo as well as levels and ionization found in 
women’s tissues, breast milk, and other bodily 
fluids; and 
‘‘(B) the potential short-term and long- 
term risks of the presence of platinum or plat-
inum salts. 
‘‘(2) PANEL OF INDEPENDENT SCIENTISTS.— 
The Secretary shall establish a panel of independent 
scientists, including scientists from the Centers for 
Disease Control and Prevention and the National In-
stitutes of Health, for the purpose of designing and 
conducting the study under this subsection. No sci-
entist with financial ties to a breast implant com-
pany, silicone company, or plastic surgeon shall 
serve on such panel or participate in the design or 
conduct of such studies. 
‘‘(f) DEFINITION.—For purposes of this section, the 
term ‘breast implant’ means a device intended to be im-
planted to augment or reconstruct the female breast that, 
except as provided in subsection (d)(1)(A), contains a filler 
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material comprised of a substance or substances other 
than sterile isotonic saline.’’. 
SEC. 5. SCIENTIFIC WORKSHOP ON USE OF EMERGENCY 
CONTRACEPTION BY WOMEN UNDER AGE 18. 
The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall con-
vene a scientific workshop within six months after the date 
of the enactment of this Act to review and evaluate current 
scientific data on the use of emergency contraception by 
females of childbearing potential under the age of 18. The 
scientific workshop shall— 
(1) address the scientific questions identified in 
the recent limited approval of Plan B emergency 
contraception; and 
(2) include among the participants in the work-
shop— 
(A) scientific and clinical representatives 
from the American Academy of Pediatrics, the 
American College of Obstetricians and Gyne-
cologists, the Society of Adolescent Medicine, 
the American Medical Association, the National 
Institutes of Health, and the Agency for 
Healthcare Research and Quality; 
(B) scientific and clinical researchers who 
have carried out research on use of contracep-
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tives, including emergency contraceptives, by 
women under the age of 18; and 
(C) the appropriate review divisions of the 
Food and Drug Administration and the profes-
sional scientific and clinical staff within such 
divisions. 
Æ 
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