FDA HAS OPTIONS ON IMPLANT AVAILABILITY

                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: SUNDAY, January 5, 1992                   TAG: 9201050068
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-7   EDITION: METRO  
SOURCE: Associated Press
DATELINE:                                 LENGTH: Short
FDA HAS OPTIONS ON IMPLANT AVAILABILITY
It is up to the Food and Drug Administration to decide the future of silicone-filled breast implants.
In November, a federal advisory panel found that scientific data submitted by four manufacturers was insufficient to prove the safety of the devices.
FDA Commissioner David Kessler has a number of options open to him, among them:

Disapproval, and removing implants from the market. The manufacturers would have the option of collecting further safety data through clinical trials. Such trials might be limited in size and duration, and could be restricted to certain kinds of patients; for example, they might involve only reconstruction patients.

Continued availability under public health need, while the manufacturers gather more safety data. Implant makers would probably be held to a strict time frame for data collection. This was the recommendation made by the advisory panel.
The advisory committee's recommendations are not binding, but the agency usually follows its advice.
The FDA has chosen this option in the case of heart valves and devices used to tie a woman's tubes. The valves have since been approved, but the tubal devices have yet to be.

Approval, allowing unlimited use of the implants.

by Archana Subramaniam by CNB