2006P-0151
  

  
 Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC3
  



  

  
Submitter : 
  

  
Dr. Patricia  Tetreault
  

  
Date & Time: 
  

  
06/29/2006 02:06:48
  



  

  
Organization : 
  

  
University of Nebraska
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I encourage you to decide in favor of protecting women and children's health. Given the research that indicates there are toxins found in women's bodies, including breast milk, it is vital to act conservatively to protect health. Please stay the approval letter for silicone-filled breast implants 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 SGFBIs.