§289g–3. Breast implant research

(a) In general

The Director of NIH may conduct or support research to examine the long-term health implications of silicone breast implants, both gel and saline filled. Such research studies may include the following:

(1) Developing and examining techniques to measure concentrations of silicone in body fluids and tissues.

(2) Surveillance of recipients of silicone breast implants, including long-term outcomes and local complications.

(b) Definition

For purposes of this section, the term "breast implant" means a breast prosthesis that is implanted to augment or reconstruct the female breast.

(July 1, 1944, ch. 373, title IV, §498C, as added Pub. L. 107–250, title II, §215(b), Oct. 26, 2002, 116 Stat. 1615 .)

Breast Implants; Study by Comptroller General

Pub. L. 107–250, title II, §214, Oct. 26, 2002, 116 Stat. 1615 , provided that:

"(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 accurate 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."