FDAnews
www.fdanews.com/articles/134439-breast-implant-panel-requested-fda-oversight-questioned

Breast Implant Panel Requested, FDA Oversight Questioned

February 18, 2011
Rep. Rosa DeLauro (D-Conn.) is “strongly urging” CDRH to hold an advisory committee meeting to release all available information on 10-year postmarket study results for saline breast implants and address issues with FDA oversight of the trials. CDRH should provide all results for the postmarket Core studies — large, long-term studies of Allergan’s and Mentor’s gel implants, she said. The request, sent in a letter to CDRH Director Jeffrey Shuren Feb. 7, comes after a recent FDA review showed a possible association between saline and silicone gel-filled breast implants and a rare kind of cancer, anaplastic large cell lymphoma.
Devices & Diagnostics Letter