From: Marga Massey [Marga.Massey@hsc.utah.edu]
Sent: Saturday, April 10, 2004 2:39 PM
To: fdadockets@oc.fda.gov
Subject: Re: Comments on Draft Guidance for Industry and FDA Staff on
Saline, Silicone Gel, and Alternative Breast Implants

Dear Sir or Madam:

I am writing to express my support for the FDA General and Plastic
Surgery Devices panel's vote in October 2003 to approve the PMA for
silicone gel-filled breast implants with conditions (Docket #
2004D-002). 

Silicone breast implants have a long history of clinical data to
support safety and efficacy.  A number of studies done outside of the
United States positively address issues raised during the FDA panel
hearing.  

As a plastic surgeon, I want to be able to offer my patients a choice
of implants, including silicone gel implants.  The vast majority of
breast implants used outside the U.S. are silicone gel-filled
implants.

 
With proper informed consent and patient education, the gel filled
implant can be safely and satisfactorily used in the US. 

While additional testing and data gathering on the device may be
appropriate, it can be appropriately accomplished following FDA
approval.  

Thank you for your consideration.

Sincerely,



Marga F. Massey, M.D.
Assistant Professor
Director of Clinical and Basic Science Research
Division of Plastic Surgery
Department of Surgery
University of Utah SOM
Room 3B-205

Office: 801-585-2318
Pager: 801-339-1005