Page:United States Statutes at Large Volume 116 Part 2.djvu/833

 PUBLIC LAW 107-250—OCT. 26, 2002 116 STAT. 1615 (1) The type of information necessary to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in pediatric populations. (2) Protections for pediatric subjects in clinical investigations of the safety or effectiveness of such devices. SEC. 214. BREAST IMPLANTS; STUDY BY COMPTROLLER GENERAL. 42 USC 289g-3 (a) IN GENERAL.— The Comptroller General of the United States shall conduct a study to determine the following with respect to breast implants: (1) The content of information typically provided by health professionals to women who consult with such professionals on the issue of whether to undergo breast implant surgery. (2) Whether such information is provided by physicians or other health professionals, and whether the information is provided verbally or in writing, and at what point in the process of determining whether to undergo surgery is such information provided. (3) Whether the information presented, as a whole, provides a complete and acciu-ate discussion of the risks and benefits of breast implants, and the extent to which women who receive such information understand the risks and benefits. (4) The number of adverse events that have been reported, and whether such events have been adequately investigated. (5) With respect to women who participate as subjects in research being carried out regarding the safety and effectiveness of breast implants: (A) The content of information provided to the women during the process of obtaining the informed consent of the women to be subjects, and the extent to which such information is updated. (B) Whether such process provides written explanations of the criteria for being subjects in the research. (C) The point at which, in the planning or conduct of the research, the women are provided information regarding the provision of informed consent to be subjects. (b) REPORT. —The Comptroller General shall submit to the Congress a report describing the findings of the study. (c) DEFINITION.— For purposes of this section, the term "breast implant" means a breast prosthesis that is implanted to augment or reconstruct the female breast. SEC. 215. BREAST IMPLANTS; RESEARCH THROUGH NATIONAL INSTITUTES OF HEALTH. (a) REPORT ON STATUS OF CURRENT RESEARCH. —Not later than Deadline. 180 days after the date of the enactment of this Act, the Director Reports. of the National Institutes of Health shall submit to the Congress a report describing the status of research on breast implants (as defined in section 213(c)) being conducted or supported by such Institutes. (b) RESEARCH ON LONG-TERM IMPLICATIONS.— Part H of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is amended by adding at the end of the following section: "SEC. 498C. BREAST IMPLANT RESEARCH. 42 USC 289g-3. "(a) IN GENERAL. — The Director of NIH may conduct or support research to examine the long-term health implications of silicone 99-194O-03 -27:QL3Part2

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