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Silicone breast implant access by reconstruction patients to be improved -- FDA petition response.

This article was originally published in The Gray Sheet

Executive Summary

SILICONE BREAST IMPLANT ACCESS TO BE IMPROVED FOR RECONSTRUCTION PATIENTS, FDA says in an Oct. 15 response to a citizen's petition. In the response, signed by FDA Lead Deputy Commissioner Michael Friedman, the agency says that although it still does not have enough data to lift current restrictions on silicone breast implant availability, it will take specific steps to ensure that breast reconstruction patients have access to the products. The petition, submitted in September 1996 by the Y-ME National Breast Cancer Organization, sought broader availability of the implants.

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