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FDA COMMISSIONER ISSUES STATEMENT ON SALINE BREAST IMPLANTS

 WASHINGTON, Jan. 5 /PRNewswire/ -- David Kessler, M.D., commissioner of the Food and Drug Administration, issued the following statement on saline breast implants:
 Today I am announcing the start of a process to require manufacturers of saline breast implants to submit evidence that they are safe and effective. We are proposing to call for all relevant data for the agency to review. After reviewing public comments, the agency will publish a final rule requiring manufacturers to submit data within 90 days. In addition, in the next few days, we will propose to call for safety and effectiveness data on testicular and penile implants, devices that were also on the market before 1976, when FDA was given regulatory authority over them.
 -0- 1/5/93
 /NOTE: TV broadcasters, please use open caption for the hearing impaired./
 /CONTACT: Betsy Adams of the Food and Drug Administration, 301-443-3285/


CO: Food and Drug Administration ST: District of Columbia IN: MTC SU:

DC -- DC008 -- 1698 01/05/93 11:35 EST
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Publication:PR Newswire
Date:Jan 5, 1993
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