This article summarizes the regulatory actions of the Food & Drug Administration as related to gel-filled silicone breast implants. It also relates the actions to the influences of outside forces such as press coverage, congressional investigations, and consumer activism.
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References
1.
Karen Koskoff—statement made during presentation to the Food & Drug Administration, related to proposed actions on silicone breast implants, November 12, 1991, Gaithersburg, MD.
2.
Public Law 94–295, 90 Stat539(1976) codified at 21 U.S.C. Section 360(c)-(k).
3.
Statement by Walter Gundaker, Acting Director, Center of Devices and Radiological Health, before the Subcommittee on Human Resources and Intergovernmental Relations Committee on Government Operations—U.S. House of Representatives, Decembver 18, 1990.
4.
BrandKGJohnsonKHBuoenLC. Foreign body tumorignesis. CRC Critical Review in Toxicology 1976, Volume 4, p. 353.
5.
Letter from Sidney Wolfe, M.D., to FDA Commissioner Frank Young, November 9, 1988.
6.
FDA Drug Bulletin, Vol. 19#1, February 1989.
7.
Plastic Surgery News, January 1990, p. 7.
8.
RyleeRobertT, Vice President, Dow Corning, in letter to doctors, December 6, 1990.
9.
Washington Post, November 28, 1990.
10.
Diana Zuckerman—Staff member in letter to Congressman Ted Weiss, September 12, 1991.
11.
FDA notice, Silicone Gel-Filled Breast Prostheses; Silicone Inflatable Breast Prostheses: Patient Risk Information. Docket No. 91N-0372, September 20, 1991.
12.
The Recorder, October 9, 1991.
13.
Time, February 10, 1992, p. 46.
14.
Abilene Reporter News, May 15, 1992.
15.
Houston Chronicle, December 24, 1992, p. 1.
16.
Houston Chronicle, January 6, 1993.
17.
Federal Register, Part X, Department of Health and Human Services, Food and Drug Administration; 21 CFR Part 878, General and Plastic Surgery Devices; Effective Date of Requirement for Premarket Approval of Silicone Inflatable Breast Prosthesis; Proposed Rule.
18.
FDA Talk, Paper T93–15, March 22, 1993.
19.
ReesTDWood-Smith. Cosmetic Facial Surgery, W. B. Saunders Co., Philadelphia, 1973, pp. 232–243.
20.
Personal communication to author from Frank Young, M.D., PhD. Commissioner of Food and Drugs—March 13, 1989.
21.
Personal communication with RichardWebster MDVarnerJan.
22.
Presentation of Gordon Johnson, MD at Controversies in Breast and Facial Augmentation, August 7, 1992 (to be published in the American Journal of Cosmetic Surgery).
