Letter to FDA on Silicon gel-filled breast implants


July 20, 2006
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket No. 2006P-0151—“Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants (SGFBI’s) for an indefinite time due to the 2006 peer-reviewed published research finding significant levels of ionized platinum are released after implantation from second and third generation SGFBI’s”
To Whom It May Concern:
Consumers Union, the independent, non-profit publisher of Consumer Reports, would like to endorse the letter of June 28, 2006 from the National Research Center for Women and Families (NRCWF) in support of the above petition, staying approval of SGFBI’s pending further research on the problem of ionized platinum leakage.
We have not conducted any independent research on this issue, but we believe the scientific issues raised by others should be addressed before the FDA proceeds. In this decade, public confidence has been severely shaken by a number of FDA approvals and then subsequent withdrawals or the need to post Black Box Warnings. Until the scientific issues cited by the NRCWF are addressed, the FDA should not proceed with the approval of SGFBI’s, especially given their look history of unexpected adverse events and the recent controversies surrounding efforts to approve a new generation of implants.
Thank you for your consideration of this request.
Sincerely,
William Vaughan
Senior Policy Analyst
Washington Office